Ferric carboxymaltose

Medication reference

Limited reviewed summaryThis monograph will be updated in the future.

Selected DailyMed label FDA safety resources (2)

Review note before using historical content

Historical snapshot omits the new boxed warning

The older local summary does not include the August 2026 label / September 2026 FDA boxed-warning communication about severe prolonged hypophosphatemia. Existing reviewed claims IVR-FERRIC-CARBOXYMALTOSE-004 and -005 address this change.

Safety sources and review scope

Review-note ID: H62-INJECTAFER-WARNING. The historical source remains preserved; this note does not qualify its complete monograph.

Review note before using historical content

Historical amount wording can confuse a dose with a course

The catalog wording Common course dose 750 mg or up to 1,000 mg depending on weight and indication does not fully specify the regimen or total course. Preparation math does not choose a dose or a course.

Safety sources and review scope

Review-note ID: H62-INJECTAFER-COURSE. The historical source remains preserved; this note does not qualify its complete monograph.

Historical source. Current clinical review is incomplete. This monograph will be updated in the future.

Ferric Carboxymaltose-Injectafer® (opens in a new tab)Original source URL: https://globalrph.com/dilution/ferric-carboxymaltose-inj-injectafer/ | Retrieved 2026-11-04

Source dates, location and integrity

This historical article is separate from the reviewed claim cards. Product formulations and source dates may differ.

Original source URL: https://globalrph.com/dilution/ferric-carboxymaltose-inj-injectafer/ (opens in a new tab)
Source date: Not established in the retrieved source
Retrieved: 2026-11-04T19:46:53.748774+00:00
Source location: div.post-content
Packaged content SHA-256: dc9ebb5f2cde1f01f9e2559d93eb3e50639d90f5aacacf8609524ae45ea6696f
Original response SHA-256: 11d6ebc71e578aae2484c8352f1eed6bcae047439a4c6fa17871fc5ef136e526
Source body SHA-256: 1c70040c7d05338425947e39baf4e4feed8d63471545eff88ce9fcab987b0a64

INJECTAFER® (ferric carboxymaltose injection)

[ Usual Diluents ]	[ Standard Dilution ]	[ Storage and Stability ]
DESCRIPTION	CLINICAL PHARMACOLOGY	INDICATIONS AND USAGE
CONTRAINDICATIONS	PRECAUTIONS	ADVERSE REACTIONS
DOSAGE AND ADMINISTRATION	HOW SUPPLIED	WARNINGS
PRESCRIBING HIGHLIGHTS: Please see package insert for additional information and possible updates to ensure safe and effective use of this medication. The authors make no claims of the accuracy of the information contained herein; and these suggested doses are not a substitute for clinical judgment. Neither GlobalRPh Inc. nor any other party involved in the preparation of this program shall be liable for any special, consequential, or exemplary damages resulting in whole or part from any user's use of or reliance upon this material. Please read the disclaimer carefully BEFORE accessing or using this site. BY ACCESSING OR USING THIS SITE, YOU AGREE TO BE BOUND BY THE TERMS AND CONDITIONS SET FORTH IN THE DISCLAIMER.

Iron supplements - other

Usual Diluents Return to article top

Standard Dilutions [Amount of drug] [Infusion volume] [Infusion rate] Return to article top

[Patients weighing 50 kg (110 lb) or more ] May administer undiluted slow intravenous push at ~ 100mg/min. [750mg] [15 ml] [~7.5 minutes]

Give Injectafer in two doses separated by at least 7 days. Give each dose as 750 mg for a total cumulative dose not to exceed 1500 mg of iron per course.

-OR- Administer via infusion, dilute up to 750 mg of iron in no more than 250 mL of sterile 0.9% sodium chloride injection, USP, such that the concentration of the infusion is in the range of 2 mg to 4 mg of iron per mL. [750mg] [250 ml] [15-20 minutes] Each mL of Injectafer contains 50 mg of elemental iron.

[Patients weighing LESS than 50 kg (110 lb) ] May administer undiluted slow intravenous push at ~ 100mg/min. [15mg/kg ] [dose (ml)= (15mg/kg) / 50 ] [~7.5 minutes]

Give Injectafer in two doses separated by at least 7 days. Give each dose as 15 mg/kg body weight for a total cumulative dose not to exceed 1500 mg of iron per course.

Stability: When added to an infusion bag containing 0.9% sodium chloride injection, USP, at concentrations ranging from 2 mg to 4 mg of iron per mL, Injectafer solution is physically and chemically stable for 72 hours when stored at room temperature. To maintain stability, do not dilute to concentrations less than 2 mg iron/mL.Inspect parenteral drug products visually for the absence of particulate matter and discoloration prior to administration. The product contains no preservatives. Each vial of Injectafer is intended for single-use only. Any unused drug remaining after injection must be discarded.

Avoid extravasation of Injectafer since brown discoloration of the extravasation site may be long lasting. Monitor for extravasation. If extravasation occurs, discontinue the Injectafer administration at that site.

WARNINGS Return to article top

See warnings and precautions below.

DESCRIPTION Return to article top

Description: Ferric carboxymaltose, an iron replacement product, is an iron carbohydrate complex with the chemical name of polynuclear iron (III) hydroxide 4(R)-(poly-(1?4)-O-a-D-glucopyranosyl)-oxy-2(R),3(S),5(R),6-tetrahydroxy-hexanoate. It has a relative molecular weight of approximately 150,000 Da corresponding to the following empirical formula: [FeOx(OH)y(H2O)z]n [{(C6H10O5)m (C6H12O7)}l]k, where n ˜ 103, m ˜ 8, l ˜ 11, and k ˜ 4 (l represents the mean branching degree of the ligand). Injectafer (ferric carboxymaltose injection) is a dark brown, sterile, aqueous, isotonic colloidal solution for intravenous injection. Each mL contains 50 mg iron as ferric carboxymaltose in water for injection. Injectafer is available in 15 mL single-use vials. Sodium hydroxide and/or hydrochloric acid may have been added to adjust the pH to 5.0-7.0. Vial closure is not made with natural rubber latex.

CLINICAL PHARMACOLOGY: Return to article top

Mechanism of Action: Ferric carboxymaltose is a colloidal iron (III) hydroxide in complex with carboxymaltose, a carbohydrate polymer that releases iron.

INDICATIONS AND USAGE Return to article top

INDICATIONS AND USAGE: Injectafer is indicated for the treatment of iron deficiency anemia in adult patients: >who have intolerance to oral iron or have had unsatisfactory response to oral iron; >who have non-dialysis dependent chronic kidney disease. USE IN SPECIFIC POPULATIONS -------------- Pregnancy Pregnancy Category C Risk Summary Adequate and well controlled studies in pregnant women have not been conducted. However, animal reproduction studies have been conducted with ferric carboxymaltose. In these studies, administration of ferric carboxymaltose to rabbits during the period of organogenesis caused fetal malformations and increased implantation loss at maternally toxic doses of approximately 12% to 23% of the human weekly dose of 750 mg (based on body surface area). The incidence of major malformations in human pregnancies has not been established for Injectafer. However, all pregnancies, regardless of exposure to any drug, has a background rate of 2 to 4% for major malformations, and 15 to 20% for pregnancy loss. Injectafer should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Animal Data Administration of ferric carboxymaltose to rats as a one-hour intravenous infusion up to 30 mg/kg/day iron on gestation days 6 to 17 did not result in adverse embryofetal findings. This daily dose in rats is approximately 40% of the human weekly dose of 750 mg based on body surface area. In rabbits, ferric carboxymaltose was administered as a one-hour infusion on gestation days 6 to 19 at iron doses of 4.5, 9, 13.5, and 18 mg/kg/day. Malformations were seen starting at the daily dose of 9 mg/kg (23% of the human weekly dose of 750 mg). Spontaneous abortions occurred starting at the daily iron dose of 4.5 mg/kg (12% of the human weekly dose based on body surface area). Pre-implantation loss was at the highest dose. Adverse embryofetal effects were observed in the presence of maternal toxicity. A pre- and post-natal development study was conducted in rats at intravenous doses up to 18 mg/kg/day of iron (approximately 23% of the weekly human dose of 750 mg on a body surface area basis). There were no adverse effects on survival of offspring, their behavior, sexual maturation or reproductive parameters. Nursing Mothers A study to determine iron concentrations in breast milk after administration of Injectafer (n=11) or oral ferrous sulfate (n=14) was conducted in 25 lactating women with postpartum iron deficiency anemia. Mean breast milk iron levels were higher in lactating women receiving Injectafer than in lactating women receiving oral ferrous sulfate. Pediatric Use Safety and effectiveness have not been established in pediatric patients. Geriatric Use Of the 1775 subjects in clinical studies of Injectafer, 50% were 65 years and over, while 25% were 75 years and over. No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.

CONTRAINDICATIONS Return to article top

Contraindications: Hypersensitivity to Injectafer or any of its inactive components.

PRECAUTIONS Return to article top

WARNINGS AND PRECAUTIONS:

Hypersensitivity Reactions Serious hypersensitivity reactions, including anaphylactic-type reactions, some of which have been life-threatening and fatal, have been reported in patients receiving Injectafer. Patients may present with shock, clinically significant hypotension, loss of consciousness, and/or collapse. Monitor patients for signs and symptoms of hypersensitivity during and after Injectafer administration for at least 30 minutes and until clinically stable following completion of the infusion. Only administer Injectafer when personnel and therapies are immediately available for the treatment of serious hypersensitivity reactions. [see Adverse Reactions ]. In clinical trials, serious anaphylactic/anaphylactoid reactions were reported in 0.1% (2/1775) of subjects receiving Injectafer. Other serious or severe adverse reactions potentially associated with hypersensitivity which included, but not limited to, pruritus, rash, urticaria, wheezing, or hypotension were reported in 1.5% (26/1775) of these subjects.
Hypertension In clinical studies, hypertension was reported in 3.8% (67/1,775) of subjects in clinical trials 1 and 2. Transient elevations in systolic blood pressure, sometimes occurring with facial flushing, dizziness, or nausea were observed in 6% (106/1,775) of subjects in these two clinical trials. These elevations generally occurred immediately after dosing and resolved within 30 minutes. Monitor patients for signs and symptoms of hypertension following each Injectafer administration [see Dosage and Administration].
Laboratory Test Alterations In the 24 hours following administration of Injectafer, laboratory assays may overestimate serum iron and transferrin bound iron by also measuring the iron in Injectafer.

ADVERSE REACTIONS Return to article top

ADVERSE REACTIONS:

The most common adverse reactions (≥ 2%) are nausea, hypertension, flushing, hypophosphatemia, and dizziness. To report SUSPECTED ADVERSE REACTIONS, contact American Regent at 1-800-734-9236 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

See PACKAGE INSERT for PATIENT COUNSELING INFORMATION and Medication Guide.

DOSAGE AND ADMINISTRATION Return to article top

DOSAGE AND ADMINISTRATION:

For patients weighing 50 kg (110 lb) or more: Give Injectafer in two doses separated by at least 7 days. Give each dose as 750 mg for a total cumulative dose not to exceed 1500 mg of iron per course.

For patients weighing less than 50 kg (110 lb): Give Injectafer in two doses separated by at least 7 days. Give each dose as 15 mg/kg body weight for a total cumulative dose not to exceed 1500 mg of iron per course.

The dosage of Injectafer is expressed in mg of elemental iron. Each mL of Injectafer contains 50 mg of elemental iron. Injectafer treatment may be repeated if iron deficiency anemia reoccurs.

Administer Injectafer intravenously, either as an undiluted slow intravenous push or by infusion. When administering as a slow intravenous push, give at the rate of approximately 100 mg (2 mL) per minute. When administered via infusion, dilute up to 750 mg of iron in no more than 250 mL of sterile 0.9% sodium chloride injection, USP, such that the concentration of the infusion is not less than 2 mg of iron per mL and administer over at least 15 minutes.

When added to an infusion bag containing 0.9% sodium chloride injection, USP, at concentrations ranging from 2 mg to 4 mg of iron per mL, Injectafer solution is physically and chemically stable for 72 hours when stored at room temperature. To maintain stability, do not dilute to concentrations less than 2 mg iron/mL.

Inspect parenteral drug products visually for the absence of particulate matter and discoloration prior to administration. The product contains no preservatives. Each vial of Injectafer is intended for single-use only. Any unused drug remaining after injection must be discarded.

HOW SUPPLIED Return to article top

DOSAGE FORMS AND STRENGTHS: 750 mg iron/15 mL single-use vial. NDC 0517-0650-01 750 mg iron/15 mL Single-Use Vial Individually boxed NDC 0517-0650-02 750 mg iron/15 mL Single-Use Vial Packages of 2

Storage and Stability Return to article top

Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F). [See the USP controlled room temperature]. Do not freeze. Admixture stability: When added to an infusion bag containing 0.9% sodium chloride injection, USP, at concentrations ranging from 2 mg to 4 mg of iron per mL, Injectafer solution is physically and chemically stable for 72 hours when stored at room temperature. To maintain stability, do not dilute to concentrations less than 2 mg iron/mL

Open this historical article on its own

Reviewed statements and exact sources

These statements have a limited product-specific scope. Full dosing, compatibility, renal, dialysis and monitoring review remains pending.

Dilution

For a prescribed adult infusion of 750 mg or 1000 mg, 250 mL of sterile 0.9% Sodium Chloride Injection is a supported diluent volume.

Claim ID: IVR-FERRIC-CARBOXYMALTOSE-001

Applies to: Injectafer U.S. ferric carboxymaltose 50 mg iron/mL single-dose vials. Local preparation claim limited to prescribed adult 750 mg or 1000 mg infusions; no cumulative-dose selection, lower-dose schedule or IV-push instruction.

Source 1, source 2, and exact locations

Review basis: Separately edited professional reference

Source 1
Injectafer, American Regent Inc (opens in a new tab)
Exact location: 2.4 Preparation and Administration; UUID ee8dc4fc-1a47-422e-99c0-59a5fd228ac7
Publisher: DailyMed / current submitted U.S. prescribing information
Source family: U.S. product prescribing information
Retrieved: 2026-11-04T18:47:16.185362+00:00
Source 2
Iron as Ferric Carboxymaltose (Ferinject) Intravenous for Adults (opens in a new tab)
Exact location: Infusion fluids; Methods of intravenous administration > Intermittent intravenous infusion, dilution table 500 to 1000 mg row
Publisher: Galway University Hospitals / Medinfo Galway
Source family: Independent institutional administration guide (Ireland)
Retrieved: 2026-11-04T18:54:48.674621+00:00
Ferinject rather than U.S. Injectafer. Both are ferric carboxymaltose 50 mg iron/mL. Guide independently edited but partly label-derived. Only explicitly concordant infusion and hypersensitivity statements transferred. Different injection rates, lower-dose infusion times and cumulative-dose schedules were excluded.

This is preparation of an already prescribed dose, not a dose recommendation. U.S. label permits no more than 250 mL; 250 mL is the common supported point.

Concentration

Keep the infusion concentration at or above 2 mg iron/mL.

Claim ID: IVR-FERRIC-CARBOXYMALTOSE-002

Source 1, source 2, and exact locations

Review basis: Separately edited professional reference

Source 1
Injectafer, American Regent Inc (opens in a new tab)
Exact location: 2.4 Preparation and Administration; UUID ee8dc4fc-1a47-422e-99c0-59a5fd228ac7
Publisher: DailyMed / current submitted U.S. prescribing information
Source family: U.S. product prescribing information
Retrieved: 2026-11-04T18:47:16.185362+00:00
Source 2
Iron as Ferric Carboxymaltose (Ferinject) Intravenous for Adults (opens in a new tab)
Exact location: Methods of intravenous administration > Intermittent intravenous infusion, minimum permitted concentration
Publisher: Galway University Hospitals / Medinfo Galway
Source family: Independent institutional administration guide (Ireland)
Retrieved: 2026-11-04T18:54:48.674621+00:00
Ferinject rather than U.S. Injectafer. Both are ferric carboxymaltose 50 mg iron/mL. Guide independently edited but partly label-derived. Only explicitly concordant infusion and hypersensitivity statements transferred. Different injection rates, lower-dose infusion times and cumulative-dose schedules were excluded.

Infusion

Infuse the reviewed 750 mg or 1000 mg adult preparation over at least 15 minutes.

Claim ID: IVR-FERRIC-CARBOXYMALTOSE-003

Source 1, source 2, and exact locations

Review basis: Separately edited professional reference

Source 1
Injectafer, American Regent Inc (opens in a new tab)
Exact location: 2.4 Preparation and Administration; UUID ee8dc4fc-1a47-422e-99c0-59a5fd228ac7
Publisher: DailyMed / current submitted U.S. prescribing information
Source family: U.S. product prescribing information
Retrieved: 2026-11-04T18:47:16.185362+00:00
Source 2
Iron as Ferric Carboxymaltose (Ferinject) Intravenous for Adults (opens in a new tab)
Exact location: Methods of intravenous administration > Intermittent intravenous infusion, dilution table 500 to 1000 mg row
Publisher: Galway University Hospitals / Medinfo Galway
Source family: Independent institutional administration guide (Ireland)
Retrieved: 2026-11-04T18:54:48.674621+00:00
Ferinject rather than U.S. Injectafer. Both are ferric carboxymaltose 50 mg iron/mL. Guide independently edited but partly label-derived. Only explicitly concordant infusion and hypersensitivity statements transferred. Different injection rates, lower-dose infusion times and cumulative-dose schedules were excluded.

Boxed Warning

Injectafer can cause severe, prolonged hypophosphatemia, with serious outcomes including hospitalization, osteomalacia and fractures.

Claim ID: IVR-FERRIC-CARBOXYMALTOSE-004

Source 1, source 2, and exact locations

Review basis: FDA postmarketing safety assessment

Source 1
Injectafer, American Regent Inc (opens in a new tab)
Exact location: Boxed Warning: Symptomatic Hypophosphatemia; UUID 3752161e-cce5-482b-9fb5-5e41f88bd163; 5.1 Symptomatic Hypophosphatemia
Publisher: DailyMed / current submitted U.S. prescribing information
Source family: U.S. product prescribing information
Retrieved: 2026-11-04T18:47:16.185362+00:00
Source 2
FDA adds boxed warning to Injectafer for symptomatic hypophosphatemia (opens in a new tab)
Exact location: What Is FDA Doing?; What Did FDA Find?
Publisher: U.S. FDA Drug Safety Communication
Source family: FDA postmarketing safety assessment
Retrieved: 2026-11-04T18:54:47.961615+00:00
FDA communication describes separate postmarketing assessment using FAERS/AEMS, literature and Sentinel. Same regulatory decision as updated label, but additional safety assessment beyond a label mirror.

Monitoring

Check serum phosphate before a repeat course in patients at risk, and before any repeat course within 3 months; correct pre-existing hypophosphatemia.

Claim ID: IVR-FERRIC-CARBOXYMALTOSE-005

Source 1, source 2, and exact locations

Review basis: FDA postmarketing safety assessment

Source 1
Injectafer, American Regent Inc (opens in a new tab)
Exact location: Boxed Warning; 2.1 Laboratory Testing; 5.1 Symptomatic Hypophosphatemia, UUID 88fa8329-1f43-4fa0-ba3b-0659154d8057
Publisher: DailyMed / current submitted U.S. prescribing information
Source family: U.S. product prescribing information
Retrieved: 2026-11-04T18:47:16.185362+00:00
Source 2
FDA adds boxed warning to Injectafer for symptomatic hypophosphatemia (opens in a new tab)
Exact location: What Should Health Care Providers Do?, first two bullets
Publisher: U.S. FDA Drug Safety Communication
Source family: FDA postmarketing safety assessment
Retrieved: 2026-11-04T18:54:47.961615+00:00
FDA communication describes separate postmarketing assessment using FAERS/AEMS, literature and Sentinel. Same regulatory decision as updated label, but additional safety assessment beyond a label mirror.

Monitoring

Observe for hypersensitivity during treatment and for at least 30 minutes after administration.

Claim ID: IVR-FERRIC-CARBOXYMALTOSE-006

Source 1, source 2, and exact locations

Review basis: Separately edited professional reference

Source 1
Injectafer, American Regent Inc (opens in a new tab)
Exact location: 5.2 Hypersensitivity Reactions
Publisher: DailyMed / current submitted U.S. prescribing information
Source family: U.S. product prescribing information
Retrieved: 2026-11-04T18:47:16.185362+00:00
Source 2
Iron as Ferric Carboxymaltose (Ferinject) Intravenous for Adults (opens in a new tab)
Exact location: Important information, monitoring bullet; Further information, intravenous iron monitoring paragraph
Publisher: Galway University Hospitals / Medinfo Galway
Source family: Independent institutional administration guide (Ireland)
Retrieved: 2026-11-04T18:54:48.674621+00:00
Ferinject rather than U.S. Injectafer. Both are ferric carboxymaltose 50 mg iron/mL. Guide independently edited but partly label-derived. Only explicitly concordant infusion and hypersensitivity statements transferred. Different injection rates, lower-dose infusion times and cumulative-dose schedules were excluded.

Mechanism

Ferric carboxymaltose is an iron(III) hydroxide complex with a carbohydrate polymer that releases iron.

Claim ID: IVR-FERRIC-CARBOXYMALTOSE-007

Mechanism provenance: Independently corroborated

Source 1, source 2, and exact locations

Review basis: Separately authored drug specific review

Source 1
Injectafer, American Regent Inc (opens in a new tab)
Exact location: 12.1 Mechanism of Action; UUID 528d89e9-b665-4bc1-aeee-564e7a4bb201
Publisher: DailyMed / current submitted U.S. prescribing information
Source family: U.S. product prescribing information
Retrieved: 2026-11-04T18:47:16.185362+00:00
Source 2
Ferric carboxymaltose: a review of its use in iron-deficiency anaemia. (opens in a new tab)
Exact location: Abstract: first sentence (ferric hydroxide core and carbohydrate shell) and the paragraph beginning with the macromolecular complex description; PubMed XML PubmedArticle[MedlineCitation/PMID="19405553"]/MedlineCitation/Article/Abstract/AbstractText
Publisher: Peer reviewed scientific literature indexed by NCBI PubMed
Source family: Lyseng-Williamson KA et al. 2009 drug specific scientific review
Retrieved: 2026-11-04T18:57:55.140225+00:00
Separately authored drug-specific review, distinct from an FDA/DailyMed label mirror. The abstract discusses Ferinject ferric carboxymaltose chemistry; it supports this molecular mechanism but not U.S. Injectafer package identity. Historical review, not an independent new experimental study. Its administration-time and safety summaries were not used.

Separately authored drug-specific review, distinct from an FDA/DailyMed label mirror. The abstract discusses Ferinject ferric carboxymaltose chemistry; it supports this molecular mechanism but not U.S. Injectafer package identity. Historical review, not an independent new experimental study. Its administration-time and safety summaries were not used.
The current product-specific U.S. label and a separate scientific document support this bounded mechanism statement.

FDA safety resources for this medication (2)

FDA Injectafer safety communication (September1,2026) (opens in a new tab)
FDA AEMS Q1 2026: hypophosphatemia signal history (June 4 status; later FDA boxed-warning action applies) (opens in a new tab)
Dated FDA status and source scope
Potential-signal tables are safety-review resources. Inclusion alone does not establish causality or a treatment change.
FDA table status date: 2026-06-04
Status in that table: FDA is evaluating the need for regulatory action.
Exact table location: January - March 2026 safety table, data row 13 (header excluded): Product Name / Product Class = Injectafer (ferric carboxymaltose injection); Signal = Hypophosphatemia; Additional Information (as of 2026-06-04)
Scope: Matches the expressly listed product/ingredient for safety-resource navigation only. It does not reconcile a stocked manufacturer, package NDC, lot or full monograph and does not establish causality.

Read the linked communication and current prescribing information before use. Resource dates and affected product scopes differ; a listed resource is not a full monograph or a lot-specific clearance.

Product identifiers and clinical review status

This monograph will be updated in the future. The individually cited reviewed claims below have completed a limited review; restored historical material remains separately labelled and unverified.

Primary label metadata - product reconciliation incomplete

Exact selected U.S. product traced to current SPL; full identity reconciliation incomplete.

View product identifiers and primary-label provenance

Selected product scope: Injectafer U.S. ferric carboxymaltose 50 mg iron/mL single-dose vials. Local preparation claim limited to prescribed adult 750 mg or 1000 mg infusions; no cumulative-dose selection, lower-dose schedule or IV-push instruction.
Field ID: IVR-FERRIC-CARBOXYMALTOSE-META-PRODUCT-SCOPE
Primary source (opens in a new tab) | Product data elements and the claim-specific formulation described in the cited preparation sections
Complete product reconciliation: pending.
Labeler: American Regent, Inc.
Field ID: IVR-FERRIC-CARBOXYMALTOSE-META-LABELER
Primary source (opens in a new tab) | SPL author/assignedEntity/representedOrganization/name
Complete product reconciliation: pending.
Application number(s): NDA203565
Field ID: IVR-FERRIC-CARBOXYMALTOSE-META-APPLICATION-NUMBERS
Primary source (opens in a new tab) | SPL subjectOf/approval/id/@extension
Complete product reconciliation: pending.
NDC(s): 0517-0602-01; 0517-0650-01; 0517-0620-01
Field ID: IVR-FERRIC-CARBOXYMALTOSE-META-NDCS
Primary source (opens in a new tab) | SPL manufacturedProduct/asContent/containerPackagedProduct/code/@code and How Supplied
Complete product reconciliation: pending.
DailyMed Set ID: 517b4a19-45b3-4286-9f6a-ced4e10447de
Field ID: IVR-FERRIC-CARBOXYMALTOSE-META-SETID
Primary source (opens in a new tab) | SPL document/setId/@root
Complete product reconciliation: pending.
SPL version: 30
Field ID: IVR-FERRIC-CARBOXYMALTOSE-META-SPL-VERSION
Primary source (opens in a new tab) | SPL document/versionNumber/@value
Complete product reconciliation: pending.
Label printed revision date: August 2026; SPL effective August 19, 2026
Field ID: IVR-FERRIC-CARBOXYMALTOSE-META-LABEL-REVISION-DATE
Primary source (opens in a new tab) | Printed revision statement in the selected label; distinct from SPL effectiveTime
Complete product reconciliation: pending.
SPL effective date: 2026-08-19
Field ID: IVR-FERRIC-CARBOXYMALTOSE-META-REVISION-DATE
Primary source (opens in a new tab) | SPL document/effectiveTime/@value
Complete product reconciliation: pending.
Retrieved: 2026-11-04T18:47:16.185362+00:00
Field ID: IVR-FERRIC-CARBOXYMALTOSE-META-RETRIEVED-AT
Primary source (opens in a new tab) | Timestamp recorded when source bytes were retrieved
Complete product reconciliation: pending.
Downloaded XML SHA-256: 6a7dd1d7996aba40a3ece4cdfc904a2112706ba57df15418896696818f63ea3a
Field ID: IVR-FERRIC-CARBOXYMALTOSE-META-XML-SHA256
Primary source (opens in a new tab) | SHA-256 computed over the exact downloaded XML bytes
Complete product reconciliation: pending.

What remains to be completed

A complete indication-specific adult, pediatric and neonatal dosing review
Complete product reconciliation across formulation, container, manufacturer/labeler, application and NDC
Renal-function method, population and dose-adjustment reconciliation
Modality-specific intermittent dialysis and CRRT parameters and dosing
Comprehensive incompatibility, stability, sterility-based BUD and monitoring review

Supplemental historical fields

Restored-data provenance and review notes

Source release: 2026-08-31. Current clinical review is incomplete. Original uses of current, verified, or normalized describe the historical source. They do not inherit the status of separately reviewed statements. Product formulations and source dates can differ.

Current review annotations for historical renal, dialysis, mechanism, and product fields

Separate renal reference: Open Renal Dosing Master

Renal

Status

not_locally_normalized

Original classification

current_label_review_required

Entries

General note

Preserve the source-specific renal-function basis. An indexed CrCl table is not interchangeable with unindexed CrCl or eGFR. Generic advice to check a method does not identify the equation for a dose row.

Dialysis

Status

no_local_structured_regimen

Entries

General note

Named modality alone does not establish applicability. CRRT subtype, effluent rate, residual renal function, timing and interruptions require review. Historical absence is not evidence that no guidance exists.

Mechanisms

Source kind
first_look
Local pointer
/mechanism
Original level
drug_specific
Provenance classification
historical_drug_specific_uncorroborated
Label derived verified
false
Independently corroborated
false
Exact label section
Not recorded
Original source note
Not recorded
Review status
historical_unverified
Note
Drug-specific wording in the old file is not proof of independent corroboration or an exact label locator. Consult separately published current mechanism claims where present.
Source kind
label_snapshot
Local pointer
/mechanism_summary
Original level
drug_specific
Provenance classification
historical_drug_specific_uncorroborated
Label derived verified
false
Independently corroborated
false
Exact label section
Not recorded
Original source note
Concise GlobalRPh summary reviewed against the selected DailyMed label clinical-pharmacology or microbiology content.
Review status
historical_unverified
Note
Drug-specific wording in the old file is not proof of independent corroboration or an exact label locator. Consult separately published current mechanism claims where present.

Future update

Status: pending_review
Message: This monograph will be updated in the future as current exact-product and claim-level review is completed.
Source unavailable: false
Reason: The historical content is restored; comprehensive contemporary verification remains incomplete.

Historical first look: uses, mechanism, dosing context, and administration

Recovered v5.1 source content; historical, awaiting current review.

Id: ferric-carboxymaltose
Source ID
H51-799DF38F1A9E4C633836A996
Generic name: Ferric carboxymaltose
Source ID
H51-318BC85CAF6959295E7B0E5C
Class: Iron and hematinic
Source ID
H51-51EBFA90CF13DC539C6E409E
Subclass: IV iron
Source ID
H51-AF8596C1ECDB872376D43DCA
Primary uses: Iron deficiency anemia in selected patients
Source ID
H51-629F9DE008D159E51E8E5995
Iron deficiency in selected heart failure populations per label
Source ID
H51-CF79D219367ED83E59C110A3
Mechanism: Delivers iron for reticuloendothelial processing, transferrin transport, storage, and hemoglobin synthesis.
Source ID
H51-24868AE4B6133FBF055E2A50
Mechanism level: drug_specific
Source ID
H51-960F15A4D5B280265D9362C7
Basic dosing orientation: Adult infusion | Existing preparation record; use current package insert for indication-specific selection | Common course dose 750 mg or up to 1,000 mg depending on weight and indication | Not normalized in the preparation record | See current package insert and professional guidance | IV infusion; Adult | Dose per label and body weight | Dose per label and body weight | Patient- and indication-specific | See current package insert | IV push
Source ID
H51-F280B30E6BCF63BC499D5863
Administration orientation: Infuse over at least 15 minutes; Slow undiluted IV at label-specified rate; 50 mg/mL stock; Slow undiluted IV at label-specified rate
Source ID
H51-E8C66F9B18FD696A55F41E4A
Renal and population orientation: Separate renal reference: Open Renal Dosing Master (opens in a new tab)Renal dosing status has not been locally normalized; use the current package insert before ordering or administration.
Source ID
H51-136F3AED40C3558F1F111914
Key safety orientation: Serious hypersensitivity and symptomatic hypophosphatemia.
Source ID
H51-B5D5691254595E48BEC3E65E
Extravasation can cause long-lasting skin discoloration.
Source ID
H51-A4A56778B781724B29F40571
Coverage path: structured_local_snapshot
Source ID
H51-644C369E16E2AAFB38247EC3
Coverage path label: Structured GlobalRPh route snapshot
Source ID
H51-39F16CE508D5BAF578F64909
Official label url: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=517b4a19-45b3-4286-9f6a-ced4e10447de (opens in a new tab)
Source ID
H51-36A4F192E40902E7901018EF
Legacy title: Ferric carboxymaltose (Injectafer)
Source ID
H51-C8285AA5AC4139412C69BDEA
Review note: First-look orientation only. Verify indication, patient population, weight basis, organ function, exact IV product, dose, concentration, compatibility, rate, and current labeling before use.
Source ID
H51-56F6A0B6B45D36E8C1147137
Search text: Ferric carboxymaltose Iron and hematinic IV iron Iron deficiency anemia in selected patients Iron deficiency in selected heart failure populations per label Delivers iron for reticuloendothelial processing, transferrin transport, storage, and hemoglobin synthesis. Adult infusion | Existing preparation record; use current package insert for indication-specific selection | Common course dose 750 mg or up to 1,000 mg depending on weight and indication | Not normalized in the preparation record | See current package insert and professional guidance | IV infusion; Adult | Dose per label and body weight | Dose per label and body weight | Patient- and indication-specific | See current package insert | IV push Infuse over at least 15 minutes; Slow undiluted IV at label-specified rate; 50 mg/mL stock; Slow undiluted IV at label-specified rate Renal dosing status has not been locally normalized; use the current package insert before ordering or administration. Serious hypersensitivity and symptomatic hypophosphatemia. Extravasation can cause long-lasting skin discoloration. Structured GlobalRPh route snapshot INJECTAFER INJECTAFER (ferric carboxymaltose) injection DailyMed label snapshot dosage administration dosage forms strengths mechanism
Source ID
H51-FF83DFFCE2A5751A85112593
Official search url: https://dailymed.nlm.nih.gov/dailymed/search.cfm?labeltype=all&query=Ferric+carboxymaltose (opens in a new tab)
Source ID
H51-C6FA4A1FC9A2E3B99A2F566E
Official access mode: direct_label
Source ID
H51-8CCC719CB2C3166516A806DC
Official access url: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=517b4a19-45b3-4286-9f6a-ced4e10447de (opens in a new tab)
Source ID
H51-62D18FF98D31A6BD708A4F4B
Official search query: Ferric carboxymaltose
Source ID
H51-429621CAB9DC45927E6A6CE5
Official access reason: Very-high-confidence exact IV product label selected during the v5.1 build-time review. Open the current full DailyMed monograph and verify the stocked product before use.
Source ID
H51-3795A250926FE1321727E2D0
Label snapshot available: true
Source ID
H51-EF5953488D1902FC2A8ED306
Label snapshot setid: 517b4a19-45b3-4286-9f6a-ced4e10447de
Source ID
H51-AB7A675B4AA6A70E4760D22D

No separate structured rows were bundled for continuous infusion, dialysis, CRRT. Historical article content and source links may cover these topics.

Historical dilution and intermittent infusion preparation

Recovered v5.1 source content; historical, awaiting current review.

Population	Amount	Reconstitution	Diluent	Final volume	Concentration	Rate	Stability	Notes
Source ID `H51-B1333AE825FF9D52F97C6FD8` Adult infusion Source ID `H51-9239E12FAE7E860033816505`	Common course dose 750 mg or up to 1,000 mg depending on weight and indication Source ID `H51-1DFA4FB3ACCA6962484B51DB`	Withdraw prescribed volume from vial. Source ID `H51-E47596F85480B8ABC1537CBC`	NS only Source ID `H51-AFFA597EC161C35F045CB5BE`	Up to 250 mL Source ID `H51-4A4CA3D44E43BDEEB161D848`	At least 2 mg/mL Source ID `H51-43A51122EACD15E616C979EE`	Infuse over at least 15 minutes Source ID `H51-23A92B289F51EA7A74E93FF8`	Use the shorter of current product labeling, validated stability data, and the applicable USP <797> sterility-based BUD ceiling. Source ID `H51-A07A7D92436A35C84A3F5CE4`	Course schedule and maximum single dose depend on body weight and current label. Source ID `H51-B0360439CF37D9599E810FE1`

Historical DailyMed label snapshot

Recovered v5.1 source content; historical, awaiting current review.

Id: ferric-carboxymaltose
Source ID
H51-7157B910680F7535BAE02621
Catalog name: Ferric carboxymaltose
Source ID
H51-1059E058B48C97E2CFDFF6ED
Selection status: accepted_high_confidence
Source ID
H51-CEFA671B6F4E7B7EAD5BAD56
Confidence: very_high
Source ID
H51-EB30D708945BED21C4D463B6
Match path: search_to_exact_label
Source ID
H51-3BF840FFCC10D3B8367B4802
Brand name: INJECTAFER
Source ID
H51-85A1E23B7648F6111F4287B6
Label title: INJECTAFER (ferric carboxymaltose) injection
Source ID
H51-EC443EA5D9AEBA2182726EAB
Setid: 517b4a19-45b3-4286-9f6a-ced4e10447de
Source ID
H51-2B205C5979DA599DFA2E019F
Route: Slow intravenous push or intravenous infusion, product-label dependent
Source ID
H51-76BF600DD35840E3766C1D50
Dosage form: Iron-carbohydrate injection solution
Source ID
H51-4715570BD339D35AEEA5B72E
Dosage administration summary: For adults and qualifying pediatric patients weighing 50 kg or more, one labeled option is 750 mg given twice at least 7 days apart; another labeled option permits a single calculated dose up to the product limit.
Source ID
H51-0AF43ED69FD2679432B17F67
Administer by slow intravenous push or after dilution for infusion only as described in the current label, and observe for hypersensitivity.
Source ID
H51-B6B555B99E7AD2EC5523A50D
Dose selection depends on body weight, treatment course, indication, and prior exposure; monitor phosphate in patients at risk of hypophosphatemia.
Source ID
H51-863851B78B48581731878AF9
Dosage forms strengths: 50 mg elemental iron per mL
Source ID
H51-2C3AA278AC588597F2B39F0F
100 mg/2 mL vial
Source ID
H51-E6EC84B43784F7387082CDD5
500 mg/10 mL vial
Source ID
H51-C99513465B42E52DD7286A7B
750 mg/15 mL vial
Source ID
H51-E48AE24BD99F115CBA1B6969
1,000 mg/20 mL vial
Source ID
H51-D7AF5CC39ED9D67403FB6E35
Mechanism summary: Ferric carboxymaltose is an iron-carbohydrate complex that releases bioavailable iron for transport and incorporation into hemoglobin and iron stores.
Source ID
H51-FEFCEAF2F1657611D185FA8B
Scope note: Selected INJECTAFER label. Do not interchange milligram doses or administration limits with another intravenous iron product.
Source ID
H51-C160960EA8D159FE15C3E77C
Official label url: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=517b4a19-45b3-4286-9f6a-ced4e10447de (opens in a new tab)
Source ID
H51-B6A03A6D04D97A48E7DEE666
Reviewed on: 2026-08-31
Source ID
H51-1FD892961A8342E291005F81
Mechanism source: Concise GlobalRPh summary reviewed against the selected DailyMed label clinical-pharmacology or microbiology content.
Source ID
H51-E779851A01E0660B0399C506
Source sections: Dosage and Administration
Source ID
H51-ECE9A3BF16BAE0393FDBD056
Dosage Forms and Strengths
Source ID
H51-92D8792C51CF35818CE18999
Clinical Pharmacology or Microbiology as applicable
Source ID
H51-32B12BBD5DE6F55796333946
Retrieval method: Manual build-time review of the current DailyMed full prescribing information for the selected Set ID; no live server retrieval is required during page use.
Source ID
H51-E06B17E6B89049B89BB56240
Label status: current
Source ID
H51-DA86850465F8E1D5DD8C95CE
Disclaimer: Verify the exact formulation, strength, manufacturer, NDC, route, current label revision, patient-specific order, institutional policy, and monitoring before use.
Source ID
H51-F257D68A8AE4DF1A20791973

Historical IV-push guidance

Recovered v5.1 source content; historical, awaiting current review.

Population	Dose scope	Concentration	Rate	Status
Source ID `H51-A7C13CF5B9737AE31ABEEEB3` Adult Source ID `H51-E16184F5BEBBD468B7810CF4`	Dose per label and body weight Source ID `H51-DD5E856E8BFA004830D9AAED`	50 mg/mL stock Source ID `H51-68C9548852EFAFA7968AEA22`	Slow undiluted IV at label-specified rate Source ID `H51-362B7D311DA1BCFA37B294B4`	Product-label method; monitor for hypersensitivity Source ID `H51-43FBF6F8E4D01FCB59314984`

Historical indication and population dosing

Recovered tables and source-separated snapshots; full clinical revalidation remains pending.

Existing dose and route snapshots

Route	Population	Indication	Dose	Interval	Duration	Administration	Source level	Notes
Source ID `H51-E1203DF4BF09FEC39D35B8E7` IV infusion Source ID `H51-43E88F040D792261FA5EED58`	Adult infusion Source ID `H51-2152BB76C6FEEAC449DEF6EB`	Existing preparation record; use current package insert for indication-specific selection Source ID `H51-5A9ADFEBF84BB26FB738CBD6`	Common course dose 750 mg or up to 1,000 mg depending on weight and indication Source ID `H51-3DB11DE2258ADC4AB6C6C5D0`	Not normalized in the preparation record Source ID `H51-C09A57C893D09DE5CD9B3692`	See current package insert and professional guidance Source ID `H51-875CF44F35973185C6FBAC12`	Infuse over at least 15 minutes Source ID `H51-23DDAA791330408F8AFA7E10`	Existing GlobalRPh structured preparation snapshot Source ID `H51-6D3D02779CA7CD85F95A7FA3`	Course schedule and maximum single dose depend on body weight and current label. Source ID `H51-1C27F1C6D030C03074CD36AE`
Source ID `H51-B9AD9861741F9514F7F5B6C7` IV push Source ID `H51-18ED48EABD3679725008938E`	Adult Source ID `H51-FF887764EF45A182E8C2791B`	Dose per label and body weight Source ID `H51-8D14C13F1A2999B877F3AC7C`	Dose per label and body weight Source ID `H51-36BDDF5B18DB5CFAA4B6263B`	Patient- and indication-specific Source ID `H51-3353AF31F0A27729DF8BE23F`	See current package insert Source ID `H51-C016160C26E030D0F6AE5DDB`	Slow undiluted IV at label-specified rate Source ID `H51-7F9E153AA574361584411F13`	Existing GlobalRPh IV push snapshot Source ID `H51-30C1D48F22EA2CBDA084EE9E`	Product-label method; monitor for hypersensitivity Source ID `H51-2182635877FF13004DF03DAA`

Historical renal-function guidance

Recovered v5.1 source content; historical, awaiting current review.

Separate renal reference: Open Renal Dosing Master

Classification: current_label_review_required
Source ID
H51-12CFDAB46E4F7CE7D867DBD8
Summary: Renal dosing status has not been locally normalized; use the current package insert before ordering or administration.
Source ID
H51-625253FFF5F01C0B02CC4B8B
Method note: Use the renal function estimate and body-size convention specified by the selected label or institutional protocol. Do not interchange Cockcroft-Gault CrCl, indexed eGFR, and de-indexed eGFR without confirming the dosing source.
Source ID
H51-55EB34D6033525330F84BD92

Historical Common IV uses

Recovered v5.1 source content; historical, awaiting current review.

Iron deficiency anemia in selected patients
Source ID
H51-A897C9B0F7F099ECC1E78599
Iron deficiency in selected heart failure populations per label
Source ID
H51-C117AE7652470EC6DBABBB5D

Historical Warnings and safeguards

Recovered v5.1 source content; historical, awaiting current review.

Serious hypersensitivity and symptomatic hypophosphatemia.
Source ID
H51-C9B6A554F994EF33381413B1
Extravasation can cause long-lasting skin discoloration.
Source ID
H51-FDA625F0A7F22E1CF1F690D4

Historical Monitoring

Recovered v5.1 source content; historical, awaiting current review.

Observe during and at least 30 minutes after administration
Source ID
H51-E2BADED2EB0ABB133C82337E
Hemoglobin and iron indices
Source ID
H51-9AD69526CC5FF729CD486F17
Serum phosphate in repeat/high-risk courses
Source ID
H51-A9EDA1772056C3AA8B8A0E5F

Other recovered source fields and original editorial metadata

Original status words such as current, verified, or normalized describe the historical source release. They do not change the clinical review status of this release.

Catalog source fields

Id

ferric-carboxymaltose

Source ID

H51-A6994F39F1E9E83EE5F26CD4

Generic name

Ferric carboxymaltose

Source ID

H51-01AA6DE186003AF163A329EC

Brand names

Injectafer
Source ID
H51-AF4DDCB142721169C2705EBA

Class

Iron and hematinic

Source ID

H51-08287479D14CE03EDDAE88B7

Subclass

IV iron

Source ID

H51-9FFC285763F41AF7F9FFE622

Summary

High-dose IV iron administered by slow injection or infusion; dosing depends on weight, hemoglobin deficit, and product indication.

Source ID

H51-6FC16D0A48CDF3158016F196

Populations

Adult
Source ID
H51-9C17924A993EC828D72AEC33
Pediatric per current label
Source ID
H51-84FA31ADB00CBC18A6AE78A1

Evidence tier

Core reference - verify current label

Source ID

H51-60FA7E9881C1A36337897BFB

High alert

false

Source ID

H51-E1559980F7BC225DD1F0927A

Hazardous

false

Source ID

H51-AC4B2689C5FB60E1D8284799

Status

Active

Source ID

H51-F2952288FE7D9AEEAADD19A9

Reviewed

2026-08-29

Source ID

H51-1ED02B27FA16DB651B1E9B82

Version added

1.2

Source ID

H51-00F26FBAD36479C6C09C0CFA

Sources

Label	Url	Kind
Source ID `H51-57EBF63CDAC45788E9223710` DailyMed label search Source ID `H51-76E1FAEC72ABAFA275561BFA`	https://dailymed.nlm.nih.gov/dailymed/search.cfm?query=Ferric+carboxymaltose (opens in a new tab) Source ID `H51-776484AB3AFA381AC0DB6F34`	Primary Source ID `H51-2FBFF00A78156870BBF0AF3E`
Source ID `H51-BFDC158DCBCDA2F29BEEFDA0` GlobalRPh legacy IV dilution monograph Source ID `H51-4D607ECB0BB2B7BDDEF11CF1`	legacy:auto Source ID `H51-33A920848E81BBE7E9454C1F`	Legacy Source ID `H51-228FB000C367A3DB0BE283A3`

Legacy title

Ferric carboxymaltose (Injectafer)

Source ID

H51-12A6B482E1D07449A183A7E1

Clinical release verification

Audit version: 3.4
Source ID
H51-C1B8109B7CE75D33B92D3AB9
Audited on: 2026-08-30
Source ID
H51-34A1E275B80682FEE1078DA6
Level: amber
Source ID
H51-A8C7EF196B1D29C45DF8BDE5
Release gate: trusted_professional_source_present_exact_label_unconfirmed
Source ID
H51-FDF1EF029C313B05CADA3710
Exact current label candidate: false
Source ID
H51-3D0E533F07AC62554325F197
Numeric support ratio: 0
Source ID
H51-A081904C1D6B70FF1E834134
Reference url count: 1
Source ID
H51-90680EF036916EA95A17786D
Broken reference count: 0
Source ID
H51-24AFF8F0E282C1F4941A6502
Point of use confirmation required: true
Source ID
H51-99DAC8CD12A65F44A6E4F4C1
Note: Do not treat this record as a fully current product-specific monograph until the exact IV formulation and current sources are confirmed.
Source ID
H51-105711904E3A51EBB0D24DE7
Dailymed search url: https://dailymed.nlm.nih.gov/dailymed/search.cfm?query=Ferric%20carboxymaltose (opens in a new tab)
Source ID
H51-1C956F4A7C732DE49E53C06A

Version updated

5.1

Source ID

H51-AC70B2913C9A19E649B94605

Dosing source fields

Id

ferric-carboxymaltose

Source ID

H51-5D818859DC79C04CD9F8ACF9

Generic name

Ferric carboxymaltose

Source ID

H51-776FDC8027613CCA6EA8D6AC

Coverage status

direct_official_label_access_plus_local_snapshot

Source ID

H51-A4AB0775E28F2D0E47939E45

Package insert

Query name: Ferric carboxymaltose
Source ID
H51-D9BA12C2892F9B561874EF81
Product and route must match: true
Source ID
H51-0A740408B920002089493DAD
Live current label enabled: false
Source ID
H51-D2CB732A295AB8C540E2D634
Source priority: Reviewed local summary when available, then a verified DailyMed label or product search when available, followed by professional references and institutional policy.
Source ID
H51-6ADEAA720F888A20F2427752
Direct official label access enabled: true
Source ID
H51-A36CA0BF2C6334A7F25A3AED
Outbound server request required: false
Source ID
H51-4EF742DD3F0D8789A7BC604E
Local summary status: not_bundled
Source ID
H51-5095452034C39A56A909B862

Clinical review

Locally normalized: false
Source ID
H51-3590793AC7D7E9552A2F6EC6
Reviewed: 2026-08-29
Source ID
H51-B251D298AF785FB288C95ACC
Status: Direct official package-insert access enabled; indication-specific local normalization pending.
Source ID
H51-608C56A5D8FA4030D1435297

Clinical release verification

Audit version: 3.4
Source ID
H51-B20337015D1531C102831B72
Audited on: 2026-08-30
Source ID
H51-CE25F393A162BB17C2E985F8
Level: amber
Source ID
H51-99A371893C0D610BB0AF28C8
Release gate: trusted_professional_source_present_exact_label_unconfirmed
Source ID
H51-CD571E86EB9BCB1F58CF1E4E
Exact current label candidate: false
Source ID
H51-275B1BBC6D54464F35A286C5
Numeric support ratio: 0
Source ID
H51-48F624FC64BC9EC28D5F7A79
Reference url count: 1
Source ID
H51-0A50D04BE44C41ADB556220A
Broken reference count: 0
Source ID
H51-21B4294074B307530F9FB199
Point of use confirmation required: true
Source ID
H51-6E2B0FEFFCC94EF9A6785F04
Note: Do not treat this record as a fully current product-specific monograph until the exact IV formulation and current sources are confirmed.
Source ID
H51-B8F5169973793AC98399F4DB
Dailymed search url: https://dailymed.nlm.nih.gov/dailymed/search.cfm?query=Ferric%20carboxymaltose (opens in a new tab)
Source ID
H51-D8E01E1E6BE477A2F76E7C81

Historical preparation assessment

Recovered v5.1 source content; historical, awaiting current review.

ferric-carboxymaltose

Source ID

H51-D99E363C7C4CB0972EF16327

Name

Ferric carboxymaltose

Source ID

H51-FC0B2101C7781B9EED3CD3C2

Brands

Injectafer

Source ID

H51-10319B3369E8B37E69CE1240

Therapeutic class

Iron and hematinic

Source ID

H51-77DBEC49AD19A6415A5C3FEB

Review version

3.1

Source ID

H51-98545D6778A3F6A6DB2BB086

Review date

2026-08-30

Source ID

H51-DA4AB10C09D6ECB725DC7008

Release status

structured_record_current_label_not_confirmed

Source ID

H51-8180DF9B2C06D43673704F8D

Market status

Status: no_current_us_iv_spl_confirmed
Source ID
H51-3F6B463E9727605D4942F4BF
Basis: No high-confidence current IV SPL was automatically selected; legacy information is segregated
Source ID
H51-F06DC2FD483E18AA254E5B56

Ten point assessment

Exact formulation

Not established in the currently normalized record. Use the current-label panel before clinical use.

Source ID

H51-65EBF5D8B7CA898219DCD322

Reconstitution concentration

Withdraw prescribed volume from vial.

Source ID

H51-5D02E91A1FD35A525CC5D1D1

Maximum or recommended final concentration

Not established in the currently normalized record. Use the current-label panel before clinical use.

Source ID

H51-D024BB7F483943EE1096FEF5

Appropriate standardized containers

Up to 250 mL

Source ID

H51-7DAB227A548424A0387A1E85

Adult dosing range

Common course dose 750 mg or up to 1,000 mg depending on weight and indication Dose per label and body weight Dose per label and body weight

Source ID

H51-6B5DF4E67240AA6D6E4F0283

Pediatric dosing range

Not established in the currently normalized record. Use the current-label panel before clinical use.

Source ID

H51-BAD0729B6098BE4FF37DA270

Neonatal dosing range

Not established in the currently normalized record. Use the current-label panel before clinical use.

Source ID

H51-D739A2CB6D5603342E857929

Infusion time

Infuse over at least 15 minutes Slow undiluted IV at label-specified rate

Source ID

H51-5E06DFE442DD9B16762968FD

Fluid restriction alternatives

Not established in the currently normalized record. Use the current-label panel before clinical use.

Source ID

H51-562EEEB1A0B65FC448AA2817

Current manufacturer labeling

Match confidence: unresolved
Source ID
H51-A76D59EC7BBF83567DA13F09
Url: https://dailymed.nlm.nih.gov/dailymed/search.cfm?query=Ferric+carboxymaltose (opens in a new tab)
Source ID
H51-1EE18B08FD9EF9493D49BD2D

Field provenance

Exact formulation

Primary: not_found
Source ID
H51-63EDBF3DD39CDD6480F69220

Reconstitution concentration

Primary: existing_structured_record
Source ID
H51-22BCD99070D2D2C504225BD9

Maximum or recommended final concentration

Primary: not_found
Source ID
H51-7FA9073D3B8CAD2730F5409D

Appropriate standardized containers

Primary: existing_structured_record
Source ID
H51-1EC8D2724E759DD10973AAFF

Adult dosing range

Primary: existing_structured_record
Source ID
H51-C715A439567F5D8C14B91A45

Pediatric dosing range

Primary: not_found
Source ID
H51-9EF1E992631C7E385FE63155

Neonatal dosing range

Primary: not_found
Source ID
H51-12134CA38198587ECB2660DA

Infusion time

Primary: existing_structured_record
Source ID
H51-FFE23C0E4A603474173F6B1B

Fluid restriction alternatives

Primary: not_found
Source ID
H51-59ADCF122429728AB5459BCD

Current manufacturer labeling

Primary: DailyMed search gateway
Source ID
H51-47A4872F6378F7B5C8FAE070

Population applicability

Adult

Applicability: supported_or_source_present
Source ID
H51-CF243B2E0ECD8F88DCFFDC85
Guide generation allowed: true
Source ID
H51-5D33F2F6E8006E151C0A7E04

Pediatric

Applicability: supported_or_source_present
Source ID
H51-1ADF24EC9C3766140C46DE4B
Guide generation allowed: false
Source ID
H51-6ED6898F124FA04E4C38CFBC

Neonatal

Applicability: not_established
Source ID
H51-990659CAF0301F0B30ACB5A6
Guide generation allowed: false
Source ID
H51-319CE21EE2BAADC558561B6F

Route presence

Structured dilution: true
Source ID
H51-3BAD10FCE0734C8992A2509C
Iv push: true
Source ID
H51-F8E2AF70572BADCB596756DE
Continuous infusion: false
Source ID
H51-A0A87B29D7344CDD054C958E
Pediatric source: true
Source ID
H51-C31DC38721F9A9F576201D3A
Neonatal source: false
Source ID
H51-CAAA8817F98FD68367321611

Legacy reference

Status: not_available
Source ID
H51-8E79673C400DCAAC9D922CFC

Label resolution

Status: build_environment_network_unavailable
Source ID
H51-28B10F4CDF62089598059411

Source files

catalog.json
Source ID
H51-F336AF50C7B1021B4B283D91
dosing.json
Source ID
H51-B639B02325012D94E5961B64
legacy-map.json
Source ID
H51-74D3DC3F16AFF1D55C404F2B
new-in-v1.2.json
Source ID
H51-2483B6EB3EA435A2DA69F805

Clinical release note

Preparation instructions are released only at the evidence level shown. Legacy content remains visibly separate. Exact product, NDC, route, current labeling, and institutional policy must be confirmed.

Source ID

H51-093D1969D340085F8AAC4E80

Historical statement IDs and source locations

These IDs identify recovered source units. They are not evidence-qualified clinical claims.

Historical ID	Original source location	Status
`H51-A6994F39F1E9E83EE5F26CD4`	catalog.json `/records/103/id`	Historical; current review incomplete
`H51-01AA6DE186003AF163A329EC`	catalog.json `/records/103/generic_name`	Historical; current review incomplete
`H51-AF4DDCB142721169C2705EBA`	catalog.json `/records/103/brand_names/0`	Historical; current review incomplete
`H51-08287479D14CE03EDDAE88B7`	catalog.json `/records/103/class`	Historical; current review incomplete
`H51-9FFC285763F41AF7F9FFE622`	catalog.json `/records/103/subclass`	Historical; current review incomplete
`H51-6FC16D0A48CDF3158016F196`	catalog.json `/records/103/summary`	Historical; current review incomplete
`H51-A897C9B0F7F099ECC1E78599`	catalog.json `/records/103/common_uses/0`	Historical; current review incomplete
`H51-C117AE7652470EC6DBABBB5D`	catalog.json `/records/103/common_uses/1`	Historical; current review incomplete
`H51-B1333AE825FF9D52F97C6FD8`	catalog.json `/records/103/preparations/0`	Historical; current review incomplete
`H51-9239E12FAE7E860033816505`	catalog.json `/records/103/preparations/0/population`	Historical; current review incomplete
`H51-1DFA4FB3ACCA6962484B51DB`	catalog.json `/records/103/preparations/0/amount`	Historical; current review incomplete
`H51-E47596F85480B8ABC1537CBC`	catalog.json `/records/103/preparations/0/reconstitution`	Historical; current review incomplete
`H51-AFFA597EC161C35F045CB5BE`	catalog.json `/records/103/preparations/0/diluent`	Historical; current review incomplete
`H51-4A4CA3D44E43BDEEB161D848`	catalog.json `/records/103/preparations/0/final_volume`	Historical; current review incomplete
`H51-43A51122EACD15E616C979EE`	catalog.json `/records/103/preparations/0/concentration`	Historical; current review incomplete
`H51-23A92B289F51EA7A74E93FF8`	catalog.json `/records/103/preparations/0/rate`	Historical; current review incomplete
`H51-A07A7D92436A35C84A3F5CE4`	catalog.json `/records/103/preparations/0/stability`	Historical; current review incomplete
`H51-B0360439CF37D9599E810FE1`	catalog.json `/records/103/preparations/0/notes`	Historical; current review incomplete
`H51-A7C13CF5B9737AE31ABEEEB3`	catalog.json `/records/103/iv_push/0`	Historical; current review incomplete
`H51-E16184F5BEBBD468B7810CF4`	catalog.json `/records/103/iv_push/0/population`	Historical; current review incomplete
`H51-DD5E856E8BFA004830D9AAED`	catalog.json `/records/103/iv_push/0/dose_scope`	Historical; current review incomplete
`H51-68C9548852EFAFA7968AEA22`	catalog.json `/records/103/iv_push/0/concentration`	Historical; current review incomplete
`H51-362B7D311DA1BCFA37B294B4`	catalog.json `/records/103/iv_push/0/rate`	Historical; current review incomplete
`H51-43FBF6F8E4D01FCB59314984`	catalog.json `/records/103/iv_push/0/status`	Historical; current review incomplete
`H51-D18DA44E2E11F4BAC0A487F6`	catalog.json `/records/103/iv_push/0/notes`	Historical; current review incomplete
`H51-C9B6A554F994EF33381413B1`	catalog.json `/records/103/warnings/0`	Historical; current review incomplete
`H51-FDA625F0A7F22E1CF1F690D4`	catalog.json `/records/103/warnings/1`	Historical; current review incomplete
`H51-E2BADED2EB0ABB133C82337E`	catalog.json `/records/103/monitoring/0`	Historical; current review incomplete
`H51-9AD69526CC5FF729CD486F17`	catalog.json `/records/103/monitoring/1`	Historical; current review incomplete
`H51-A9EDA1772056C3AA8B8A0E5F`	catalog.json `/records/103/monitoring/2`	Historical; current review incomplete
`H51-9C17924A993EC828D72AEC33`	catalog.json `/records/103/populations/0`	Historical; current review incomplete
`H51-84FA31ADB00CBC18A6AE78A1`	catalog.json `/records/103/populations/1`	Historical; current review incomplete
`H51-60FA7E9881C1A36337897BFB`	catalog.json `/records/103/evidence_tier`	Historical; current review incomplete
`H51-E1559980F7BC225DD1F0927A`	catalog.json `/records/103/high_alert`	Historical; current review incomplete
`H51-AC4B2689C5FB60E1D8284799`	catalog.json `/records/103/hazardous`	Historical; current review incomplete
`H51-F2952288FE7D9AEEAADD19A9`	catalog.json `/records/103/status`	Historical; current review incomplete
`H51-1ED02B27FA16DB651B1E9B82`	catalog.json `/records/103/reviewed`	Historical; current review incomplete
`H51-00F26FBAD36479C6C09C0CFA`	catalog.json `/records/103/version_added`	Historical; current review incomplete
`H51-57EBF63CDAC45788E9223710`	catalog.json `/records/103/sources/0`	Historical; current review incomplete
`H51-76E1FAEC72ABAFA275561BFA`	catalog.json `/records/103/sources/0/label`	Historical; current review incomplete
`H51-776484AB3AFA381AC0DB6F34`	catalog.json `/records/103/sources/0/url`	Historical; current review incomplete
`H51-2FBFF00A78156870BBF0AF3E`	catalog.json `/records/103/sources/0/kind`	Historical; current review incomplete
`H51-BFDC158DCBCDA2F29BEEFDA0`	catalog.json `/records/103/sources/1`	Historical; current review incomplete
`H51-4D607ECB0BB2B7BDDEF11CF1`	catalog.json `/records/103/sources/1/label`	Historical; current review incomplete
`H51-33A920848E81BBE7E9454C1F`	catalog.json `/records/103/sources/1/url`	Historical; current review incomplete
`H51-228FB000C367A3DB0BE283A3`	catalog.json `/records/103/sources/1/kind`	Historical; current review incomplete
`H51-12A6B482E1D07449A183A7E1`	catalog.json `/records/103/legacy_title`	Historical; current review incomplete
`H51-C1B8109B7CE75D33B92D3AB9`	catalog.json `/records/103/clinical_release_verification/audit_version`	Historical; current review incomplete
`H51-34A1E275B80682FEE1078DA6`	catalog.json `/records/103/clinical_release_verification/audited_on`	Historical; current review incomplete
`H51-A8C7EF196B1D29C45DF8BDE5`	catalog.json `/records/103/clinical_release_verification/level`	Historical; current review incomplete
`H51-FDF1EF029C313B05CADA3710`	catalog.json `/records/103/clinical_release_verification/release_gate`	Historical; current review incomplete
`H51-3D0E533F07AC62554325F197`	catalog.json `/records/103/clinical_release_verification/exact_current_label_candidate`	Historical; current review incomplete
`H51-7EE4DF3D1D3C048059E40214`	catalog.json `/records/103/clinical_release_verification/selected_setid`	Historical; current review incomplete
`H51-F79E921C506F154AFCEB7511`	catalog.json `/records/103/clinical_release_verification/selected_label_title`	Historical; current review incomplete
`H51-A081904C1D6B70FF1E834134`	catalog.json `/records/103/clinical_release_verification/numeric_support_ratio`	Historical; current review incomplete
`H51-90680EF036916EA95A17786D`	catalog.json `/records/103/clinical_release_verification/reference_url_count`	Historical; current review incomplete
`H51-24AFF8F0E282C1F4941A6502`	catalog.json `/records/103/clinical_release_verification/broken_reference_count`	Historical; current review incomplete
`H51-99DAC8CD12A65F44A6E4F4C1`	catalog.json `/records/103/clinical_release_verification/point_of_use_confirmation_required`	Historical; current review incomplete
`H51-105711904E3A51EBB0D24DE7`	catalog.json `/records/103/clinical_release_verification/note`	Historical; current review incomplete
`H51-1C956F4A7C732DE49E53C06A`	catalog.json `/records/103/clinical_release_verification/dailymed_search_url`	Historical; current review incomplete
`H51-AC70B2913C9A19E649B94605`	catalog.json `/records/103/version_updated`	Historical; current review incomplete
`H51-7157B910680F7535BAE02621`	dailymed-label-snapshots-v5.1.json `/records/24/id`	Historical; current review incomplete
`H51-1059E058B48C97E2CFDFF6ED`	dailymed-label-snapshots-v5.1.json `/records/24/catalog_name`	Historical; current review incomplete
`H51-CEFA671B6F4E7B7EAD5BAD56`	dailymed-label-snapshots-v5.1.json `/records/24/selection_status`	Historical; current review incomplete
`H51-EB30D708945BED21C4D463B6`	dailymed-label-snapshots-v5.1.json `/records/24/confidence`	Historical; current review incomplete
`H51-3BF840FFCC10D3B8367B4802`	dailymed-label-snapshots-v5.1.json `/records/24/match_path`	Historical; current review incomplete
`H51-85A1E23B7648F6111F4287B6`	dailymed-label-snapshots-v5.1.json `/records/24/brand_name`	Historical; current review incomplete
`H51-EC443EA5D9AEBA2182726EAB`	dailymed-label-snapshots-v5.1.json `/records/24/label_title`	Historical; current review incomplete
`H51-2B205C5979DA599DFA2E019F`	dailymed-label-snapshots-v5.1.json `/records/24/setid`	Historical; current review incomplete
`H51-76BF600DD35840E3766C1D50`	dailymed-label-snapshots-v5.1.json `/records/24/route`	Historical; current review incomplete
`H51-4715570BD339D35AEEA5B72E`	dailymed-label-snapshots-v5.1.json `/records/24/dosage_form`	Historical; current review incomplete
`H51-0AF43ED69FD2679432B17F67`	dailymed-label-snapshots-v5.1.json `/records/24/dosage_administration_summary/0`	Historical; current review incomplete
`H51-B6B555B99E7AD2EC5523A50D`	dailymed-label-snapshots-v5.1.json `/records/24/dosage_administration_summary/1`	Historical; current review incomplete
`H51-863851B78B48581731878AF9`	dailymed-label-snapshots-v5.1.json `/records/24/dosage_administration_summary/2`	Historical; current review incomplete
`H51-2C3AA278AC588597F2B39F0F`	dailymed-label-snapshots-v5.1.json `/records/24/dosage_forms_strengths/0`	Historical; current review incomplete
`H51-E6EC84B43784F7387082CDD5`	dailymed-label-snapshots-v5.1.json `/records/24/dosage_forms_strengths/1`	Historical; current review incomplete
`H51-C99513465B42E52DD7286A7B`	dailymed-label-snapshots-v5.1.json `/records/24/dosage_forms_strengths/2`	Historical; current review incomplete
`H51-E48AE24BD99F115CBA1B6969`	dailymed-label-snapshots-v5.1.json `/records/24/dosage_forms_strengths/3`	Historical; current review incomplete
`H51-D7AF5CC39ED9D67403FB6E35`	dailymed-label-snapshots-v5.1.json `/records/24/dosage_forms_strengths/4`	Historical; current review incomplete
`H51-FEFCEAF2F1657611D185FA8B`	dailymed-label-snapshots-v5.1.json `/records/24/mechanism_summary`	Historical; current review incomplete
`H51-C160960EA8D159FE15C3E77C`	dailymed-label-snapshots-v5.1.json `/records/24/scope_note`	Historical; current review incomplete
`H51-78B6FDA3E6404024F68BCD8B`	dailymed-label-snapshots-v5.1.json `/records/24/labeler`	Historical; current review incomplete
`H51-B6A03A6D04D97A48E7DEE666`	dailymed-label-snapshots-v5.1.json `/records/24/official_label_url`	Historical; current review incomplete
`H51-1FD892961A8342E291005F81`	dailymed-label-snapshots-v5.1.json `/records/24/reviewed_on`	Historical; current review incomplete
`H51-E779851A01E0660B0399C506`	dailymed-label-snapshots-v5.1.json `/records/24/mechanism_source`	Historical; current review incomplete
`H51-ECE9A3BF16BAE0393FDBD056`	dailymed-label-snapshots-v5.1.json `/records/24/source_sections/0`	Historical; current review incomplete
`H51-92D8792C51CF35818CE18999`	dailymed-label-snapshots-v5.1.json `/records/24/source_sections/1`	Historical; current review incomplete
`H51-32B12BBD5DE6F55796333946`	dailymed-label-snapshots-v5.1.json `/records/24/source_sections/2`	Historical; current review incomplete
`H51-E06B17E6B89049B89BB56240`	dailymed-label-snapshots-v5.1.json `/records/24/retrieval_method`	Historical; current review incomplete
`H51-DA86850465F8E1D5DD8C95CE`	dailymed-label-snapshots-v5.1.json `/records/24/label_status`	Historical; current review incomplete
`H51-F257D68A8AE4DF1A20791973`	dailymed-label-snapshots-v5.1.json `/records/24/disclaimer`	Historical; current review incomplete
`H51-5D818859DC79C04CD9F8ACF9`	dosing.json `/records/103/id`	Historical; current review incomplete
`H51-776FDC8027613CCA6EA8D6AC`	dosing.json `/records/103/generic_name`	Historical; current review incomplete
`H51-A4AB0775E28F2D0E47939E45`	dosing.json `/records/103/coverage_status`	Historical; current review incomplete
`H51-D9BA12C2892F9B561874EF81`	dosing.json `/records/103/package_insert/query_name`	Historical; current review incomplete
`H51-0497D06A376CA8A71A49590E`	dosing.json `/records/103/package_insert/preferred_setid`	Historical; current review incomplete
`H51-0A740408B920002089493DAD`	dosing.json `/records/103/package_insert/product_and_route_must_match`	Historical; current review incomplete
`H51-D2CB732A295AB8C540E2D634`	dosing.json `/records/103/package_insert/live_current_label_enabled`	Historical; current review incomplete
`H51-6ADEAA720F888A20F2427752`	dosing.json `/records/103/package_insert/source_priority`	Historical; current review incomplete
`H51-A36CA0BF2C6334A7F25A3AED`	dosing.json `/records/103/package_insert/direct_official_label_access_enabled`	Historical; current review incomplete
`H51-4EF742DD3F0D8789A7BC604E`	dosing.json `/records/103/package_insert/outbound_server_request_required`	Historical; current review incomplete
`H51-5095452034C39A56A909B862`	dosing.json `/records/103/package_insert/local_summary_status`	Historical; current review incomplete
`H51-12CFDAB46E4F7CE7D867DBD8`	dosing.json `/records/103/renal/classification`	Historical; current review incomplete
`H51-625253FFF5F01C0B02CC4B8B`	dosing.json `/records/103/renal/summary`	Historical; current review incomplete
`H51-55EB34D6033525330F84BD92`	dosing.json `/records/103/renal/method_note`	Historical; current review incomplete
`H51-E1203DF4BF09FEC39D35B8E7`	dosing.json `/records/103/existing_route_snapshots/0`	Historical; current review incomplete
`H51-43E88F040D792261FA5EED58`	dosing.json `/records/103/existing_route_snapshots/0/route`	Historical; current review incomplete
`H51-2152BB76C6FEEAC449DEF6EB`	dosing.json `/records/103/existing_route_snapshots/0/population`	Historical; current review incomplete
`H51-5A9ADFEBF84BB26FB738CBD6`	dosing.json `/records/103/existing_route_snapshots/0/indication`	Historical; current review incomplete
`H51-3DB11DE2258ADC4AB6C6C5D0`	dosing.json `/records/103/existing_route_snapshots/0/dose`	Historical; current review incomplete
`H51-C09A57C893D09DE5CD9B3692`	dosing.json `/records/103/existing_route_snapshots/0/interval`	Historical; current review incomplete
`H51-875CF44F35973185C6FBAC12`	dosing.json `/records/103/existing_route_snapshots/0/duration`	Historical; current review incomplete
`H51-23DDAA791330408F8AFA7E10`	dosing.json `/records/103/existing_route_snapshots/0/administration`	Historical; current review incomplete
`H51-6D3D02779CA7CD85F95A7FA3`	dosing.json `/records/103/existing_route_snapshots/0/source_level`	Historical; current review incomplete
`H51-1C27F1C6D030C03074CD36AE`	dosing.json `/records/103/existing_route_snapshots/0/notes`	Historical; current review incomplete
`H51-B9AD9861741F9514F7F5B6C7`	dosing.json `/records/103/existing_route_snapshots/1`	Historical; current review incomplete
`H51-18ED48EABD3679725008938E`	dosing.json `/records/103/existing_route_snapshots/1/route`	Historical; current review incomplete
`H51-FF887764EF45A182E8C2791B`	dosing.json `/records/103/existing_route_snapshots/1/population`	Historical; current review incomplete
`H51-8D14C13F1A2999B877F3AC7C`	dosing.json `/records/103/existing_route_snapshots/1/indication`	Historical; current review incomplete
`H51-36BDDF5B18DB5CFAA4B6263B`	dosing.json `/records/103/existing_route_snapshots/1/dose`	Historical; current review incomplete
`H51-3353AF31F0A27729DF8BE23F`	dosing.json `/records/103/existing_route_snapshots/1/interval`	Historical; current review incomplete
`H51-C016160C26E030D0F6AE5DDB`	dosing.json `/records/103/existing_route_snapshots/1/duration`	Historical; current review incomplete
`H51-7F9E153AA574361584411F13`	dosing.json `/records/103/existing_route_snapshots/1/administration`	Historical; current review incomplete
`H51-30C1D48F22EA2CBDA084EE9E`	dosing.json `/records/103/existing_route_snapshots/1/source_level`	Historical; current review incomplete
`H51-2182635877FF13004DF03DAA`	dosing.json `/records/103/existing_route_snapshots/1/notes`	Historical; current review incomplete
`H51-3590793AC7D7E9552A2F6EC6`	dosing.json `/records/103/clinical_review/locally_normalized`	Historical; current review incomplete
`H51-B251D298AF785FB288C95ACC`	dosing.json `/records/103/clinical_review/reviewed`	Historical; current review incomplete
`H51-608C56A5D8FA4030D1435297`	dosing.json `/records/103/clinical_review/status`	Historical; current review incomplete
`H51-B20337015D1531C102831B72`	dosing.json `/records/103/clinical_release_verification/audit_version`	Historical; current review incomplete
`H51-CE25F393A162BB17C2E985F8`	dosing.json `/records/103/clinical_release_verification/audited_on`	Historical; current review incomplete
`H51-99A371893C0D610BB0AF28C8`	dosing.json `/records/103/clinical_release_verification/level`	Historical; current review incomplete
`H51-CD571E86EB9BCB1F58CF1E4E`	dosing.json `/records/103/clinical_release_verification/release_gate`	Historical; current review incomplete
`H51-275B1BBC6D54464F35A286C5`	dosing.json `/records/103/clinical_release_verification/exact_current_label_candidate`	Historical; current review incomplete
`H51-A6283060D4E3EB08C99B2695`	dosing.json `/records/103/clinical_release_verification/selected_setid`	Historical; current review incomplete
`H51-F6DA5B5F3FF9FB7886387C31`	dosing.json `/records/103/clinical_release_verification/selected_label_title`	Historical; current review incomplete
`H51-48F624FC64BC9EC28D5F7A79`	dosing.json `/records/103/clinical_release_verification/numeric_support_ratio`	Historical; current review incomplete
`H51-0A50D04BE44C41ADB556220A`	dosing.json `/records/103/clinical_release_verification/reference_url_count`	Historical; current review incomplete
`H51-21B4294074B307530F9FB199`	dosing.json `/records/103/clinical_release_verification/broken_reference_count`	Historical; current review incomplete
`H51-6E2B0FEFFCC94EF9A6785F04`	dosing.json `/records/103/clinical_release_verification/point_of_use_confirmation_required`	Historical; current review incomplete
`H51-B8F5169973793AC98399F4DB`	dosing.json `/records/103/clinical_release_verification/note`	Historical; current review incomplete
`H51-D8E01E1E6BE477A2F76E7C81`	dosing.json `/records/103/clinical_release_verification/dailymed_search_url`	Historical; current review incomplete
`H51-799DF38F1A9E4C633836A996`	first-look-v5.1.json `/records/103/id`	Historical; current review incomplete
`H51-318BC85CAF6959295E7B0E5C`	first-look-v5.1.json `/records/103/generic_name`	Historical; current review incomplete
`H51-51EBFA90CF13DC539C6E409E`	first-look-v5.1.json `/records/103/class`	Historical; current review incomplete
`H51-AF8596C1ECDB872376D43DCA`	first-look-v5.1.json `/records/103/subclass`	Historical; current review incomplete
`H51-629F9DE008D159E51E8E5995`	first-look-v5.1.json `/records/103/primary_uses/0`	Historical; current review incomplete
`H51-CF79D219367ED83E59C110A3`	first-look-v5.1.json `/records/103/primary_uses/1`	Historical; current review incomplete
`H51-24868AE4B6133FBF055E2A50`	first-look-v5.1.json `/records/103/mechanism`	Historical; current review incomplete
`H51-960F15A4D5B280265D9362C7`	first-look-v5.1.json `/records/103/mechanism_level`	Historical; current review incomplete
`H51-F280B30E6BCF63BC499D5863`	first-look-v5.1.json `/records/103/basic_dosing_orientation`	Historical; current review incomplete
`H51-E8C66F9B18FD696A55F41E4A`	first-look-v5.1.json `/records/103/administration_orientation`	Historical; current review incomplete
`H51-136F3AED40C3558F1F111914`	first-look-v5.1.json `/records/103/renal_and_population_orientation`	Historical; current review incomplete
`H51-B5D5691254595E48BEC3E65E`	first-look-v5.1.json `/records/103/key_safety_orientation/0`	Historical; current review incomplete
`H51-A4A56778B781724B29F40571`	first-look-v5.1.json `/records/103/key_safety_orientation/1`	Historical; current review incomplete
`H51-644C369E16E2AAFB38247EC3`	first-look-v5.1.json `/records/103/coverage_path`	Historical; current review incomplete
`H51-39F16CE508D5BAF578F64909`	first-look-v5.1.json `/records/103/coverage_path_label`	Historical; current review incomplete
`H51-36A4F192E40902E7901018EF`	first-look-v5.1.json `/records/103/official_label_url`	Historical; current review incomplete
`H51-C8285AA5AC4139412C69BDEA`	first-look-v5.1.json `/records/103/legacy_title`	Historical; current review incomplete
`H51-56F6A0B6B45D36E8C1147137`	first-look-v5.1.json `/records/103/review_note`	Historical; current review incomplete
`H51-FF83DFFCE2A5751A85112593`	first-look-v5.1.json `/records/103/search_text`	Historical; current review incomplete
`H51-C6FA4A1FC9A2E3B99A2F566E`	first-look-v5.1.json `/records/103/official_search_url`	Historical; current review incomplete
`H51-8CCC719CB2C3166516A806DC`	first-look-v5.1.json `/records/103/official_access_mode`	Historical; current review incomplete
`H51-62D18FF98D31A6BD708A4F4B`	first-look-v5.1.json `/records/103/official_access_url`	Historical; current review incomplete
`H51-429621CAB9DC45927E6A6CE5`	first-look-v5.1.json `/records/103/official_search_query`	Historical; current review incomplete
`H51-3795A250926FE1321727E2D0`	first-look-v5.1.json `/records/103/official_access_reason`	Historical; current review incomplete
`H51-EF5953488D1902FC2A8ED306`	first-look-v5.1.json `/records/103/label_snapshot_available`	Historical; current review incomplete
`H51-AB7A675B4AA6A70E4760D22D`	first-look-v5.1.json `/records/103/label_snapshot_setid`	Historical; current review incomplete
`H51-D99E363C7C4CB0972EF16327`	preparation-assessments-v3.8.json `/103/id`	Historical; current review incomplete
`H51-FC0B2101C7781B9EED3CD3C2`	preparation-assessments-v3.8.json `/103/name`	Historical; current review incomplete
`H51-10319B3369E8B37E69CE1240`	preparation-assessments-v3.8.json `/103/brands`	Historical; current review incomplete
`H51-77DBEC49AD19A6415A5C3FEB`	preparation-assessments-v3.8.json `/103/therapeutic_class`	Historical; current review incomplete
`H51-98545D6778A3F6A6DB2BB086`	preparation-assessments-v3.8.json `/103/review_version`	Historical; current review incomplete
`H51-DA4AB10C09D6ECB725DC7008`	preparation-assessments-v3.8.json `/103/review_date`	Historical; current review incomplete
`H51-8180DF9B2C06D43673704F8D`	preparation-assessments-v3.8.json `/103/release_status`	Historical; current review incomplete
`H51-3F6B463E9727605D4942F4BF`	preparation-assessments-v3.8.json `/103/market_status/status`	Historical; current review incomplete
`H51-F06DC2FD483E18AA254E5B56`	preparation-assessments-v3.8.json `/103/market_status/basis`	Historical; current review incomplete
`H51-65EBF5D8B7CA898219DCD322`	preparation-assessments-v3.8.json `/103/ten_point_assessment/exact_formulation`	Historical; current review incomplete
`H51-5D02E91A1FD35A525CC5D1D1`	preparation-assessments-v3.8.json `/103/ten_point_assessment/reconstitution_concentration`	Historical; current review incomplete
`H51-D024BB7F483943EE1096FEF5`	preparation-assessments-v3.8.json `/103/ten_point_assessment/maximum_or_recommended_final_concentration`	Historical; current review incomplete
`H51-7DAB227A548424A0387A1E85`	preparation-assessments-v3.8.json `/103/ten_point_assessment/appropriate_standardized_containers`	Historical; current review incomplete
`H51-6B5DF4E67240AA6D6E4F0283`	preparation-assessments-v3.8.json `/103/ten_point_assessment/adult_dosing_range`	Historical; current review incomplete
`H51-BAD0729B6098BE4FF37DA270`	preparation-assessments-v3.8.json `/103/ten_point_assessment/pediatric_dosing_range`	Historical; current review incomplete
`H51-D739A2CB6D5603342E857929`	preparation-assessments-v3.8.json `/103/ten_point_assessment/neonatal_dosing_range`	Historical; current review incomplete
`H51-5E06DFE442DD9B16762968FD`	preparation-assessments-v3.8.json `/103/ten_point_assessment/infusion_time`	Historical; current review incomplete
`H51-562EEEB1A0B65FC448AA2817`	preparation-assessments-v3.8.json `/103/ten_point_assessment/fluid_restriction_alternatives`	Historical; current review incomplete
`H51-F219293D7D282F9A4C04D511`	preparation-assessments-v3.8.json `/103/ten_point_assessment/current_manufacturer_labeling/setid`	Historical; current review incomplete
`H51-B1B15F8A502226A71A8CB52A`	preparation-assessments-v3.8.json `/103/ten_point_assessment/current_manufacturer_labeling/title`	Historical; current review incomplete
`H51-E4AFA5AE4875C69BA224978A`	preparation-assessments-v3.8.json `/103/ten_point_assessment/current_manufacturer_labeling/published_date`	Historical; current review incomplete
`H51-D26E3AD1D603D2C2BB6A9BDE`	preparation-assessments-v3.8.json `/103/ten_point_assessment/current_manufacturer_labeling/manufacturer`	Historical; current review incomplete
`H51-A76D59EC7BBF83567DA13F09`	preparation-assessments-v3.8.json `/103/ten_point_assessment/current_manufacturer_labeling/match_confidence`	Historical; current review incomplete
`H51-1EE18B08FD9EF9493D49BD2D`	preparation-assessments-v3.8.json `/103/ten_point_assessment/current_manufacturer_labeling/url`	Historical; current review incomplete
`H51-63EDBF3DD39CDD6480F69220`	preparation-assessments-v3.8.json `/103/field_provenance/exact_formulation/primary`	Historical; current review incomplete
`H51-22BCD99070D2D2C504225BD9`	preparation-assessments-v3.8.json `/103/field_provenance/reconstitution_concentration/primary`	Historical; current review incomplete
`H51-7FA9073D3B8CAD2730F5409D`	preparation-assessments-v3.8.json `/103/field_provenance/maximum_or_recommended_final_concentration/primary`	Historical; current review incomplete
`H51-1EC8D2724E759DD10973AAFF`	preparation-assessments-v3.8.json `/103/field_provenance/appropriate_standardized_containers/primary`	Historical; current review incomplete
`H51-C715A439567F5D8C14B91A45`	preparation-assessments-v3.8.json `/103/field_provenance/adult_dosing_range/primary`	Historical; current review incomplete
`H51-9EF1E992631C7E385FE63155`	preparation-assessments-v3.8.json `/103/field_provenance/pediatric_dosing_range/primary`	Historical; current review incomplete
`H51-12134CA38198587ECB2660DA`	preparation-assessments-v3.8.json `/103/field_provenance/neonatal_dosing_range/primary`	Historical; current review incomplete
`H51-FFE23C0E4A603474173F6B1B`	preparation-assessments-v3.8.json `/103/field_provenance/infusion_time/primary`	Historical; current review incomplete
`H51-59ADCF122429728AB5459BCD`	preparation-assessments-v3.8.json `/103/field_provenance/fluid_restriction_alternatives/primary`	Historical; current review incomplete
`H51-47A4872F6378F7B5C8FAE070`	preparation-assessments-v3.8.json `/103/field_provenance/current_manufacturer_labeling/primary`	Historical; current review incomplete
`H51-CF243B2E0ECD8F88DCFFDC85`	preparation-assessments-v3.8.json `/103/population_applicability/adult/applicability`	Historical; current review incomplete
`H51-5D33F2F6E8006E151C0A7E04`	preparation-assessments-v3.8.json `/103/population_applicability/adult/guide_generation_allowed`	Historical; current review incomplete
`H51-1ADF24EC9C3766140C46DE4B`	preparation-assessments-v3.8.json `/103/population_applicability/pediatric/applicability`	Historical; current review incomplete
`H51-6ED6898F124FA04E4C38CFBC`	preparation-assessments-v3.8.json `/103/population_applicability/pediatric/guide_generation_allowed`	Historical; current review incomplete
`H51-990659CAF0301F0B30ACB5A6`	preparation-assessments-v3.8.json `/103/population_applicability/neonatal/applicability`	Historical; current review incomplete
`H51-319CE21EE2BAADC558561B6F`	preparation-assessments-v3.8.json `/103/population_applicability/neonatal/guide_generation_allowed`	Historical; current review incomplete
`H51-3BAD10FCE0734C8992A2509C`	preparation-assessments-v3.8.json `/103/route_presence/structured_dilution`	Historical; current review incomplete
`H51-F8E2AF70572BADCB596756DE`	preparation-assessments-v3.8.json `/103/route_presence/iv_push`	Historical; current review incomplete
`H51-A0A87B29D7344CDD054C958E`	preparation-assessments-v3.8.json `/103/route_presence/continuous_infusion`	Historical; current review incomplete
`H51-C31DC38721F9A9F576201D3A`	preparation-assessments-v3.8.json `/103/route_presence/pediatric_source`	Historical; current review incomplete
`H51-CAAA8817F98FD68367321611`	preparation-assessments-v3.8.json `/103/route_presence/neonatal_source`	Historical; current review incomplete
`H51-8E79673C400DCAAC9D922CFC`	preparation-assessments-v3.8.json `/103/legacy_reference/status`	Historical; current review incomplete
`H51-28B10F4CDF62089598059411`	preparation-assessments-v3.8.json `/103/label_resolution/status`	Historical; current review incomplete
`H51-F336AF50C7B1021B4B283D91`	preparation-assessments-v3.8.json `/103/source_files/0`	Historical; current review incomplete
`H51-B639B02325012D94E5961B64`	preparation-assessments-v3.8.json `/103/source_files/1`	Historical; current review incomplete
`H51-74D3DC3F16AFF1D55C404F2B`	preparation-assessments-v3.8.json `/103/source_files/2`	Historical; current review incomplete
`H51-2483B6EB3EA435A2DA69F805`	preparation-assessments-v3.8.json `/103/source_files/3`	Historical; current review incomplete
`H51-093D1969D340085F8AAC4E80`	preparation-assessments-v3.8.json `/103/clinical_release_note`	Historical; current review incomplete

Open the original GlobalRPh site monograph (historical; not revalidated) (opens in a new tab)

All medications Return to medication heading Application top

IV Dilution &Medication Reference

Historical snapshot omits the new boxed warning

Historical amount wording can confuse a dose with a course

INJECTAFER® (ferric carboxymaltose injection)

Usual Diluents Return to article top

Standard Dilutions [Amount of drug] [Infusion volume] [Infusion rate] Return to article top

WARNINGS Return to article top

DESCRIPTION Return to article top

CLINICAL PHARMACOLOGY: Return to article top

INDICATIONS AND USAGE Return to article top

CONTRAINDICATIONS Return to article top

PRECAUTIONS Return to article top

ADVERSE REACTIONS Return to article top

DOSAGE AND ADMINISTRATION Return to article top

HOW SUPPLIED Return to article top

Storage and Stability Return to article top

Reviewed statements and exact sources

Supplemental historical fields

Historical dilution and intermittent infusion preparation

Historical DailyMed label snapshot

Historical IV-push guidance

Historical indication and population dosing

Existing dose and route snapshots

Historical renal-function guidance

Historical Common IV uses

Historical Warnings and safeguards

Historical Monitoring

Catalog source fields

Id

Generic name

Brand names

Class

Subclass

Summary

Populations

Evidence tier

High alert

Hazardous

Status

Reviewed

Version added

Sources

Legacy title

Clinical release verification

Version updated

Dosing source fields

Id

Generic name

Coverage status

Package insert

Clinical review

Clinical release verification

IV Dilution &
Medication Reference