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Medication Reference

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Version 6.4Release date 2026-11-04For healthcare professionals
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Medication reference

Imetelstat (Rytelo)

Monograph awaiting updateThis monograph will be updated in the future.

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

RYTELO - imetelstat (opens in a new tab)Original source URL: https://globalrph.com/dilution/rytelo-imetelstat/ | 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/rytelo-imetelstat/ (opens in a new tab)
Source date
Not established in the retrieved source
Retrieved
2026-11-04T19:50:40.604861+00:00
Source location
div.post-content
Packaged content SHA-256
dbdb56270dd2ea6fe0ee037fe990a76754db06fd4039d34dc2fea04369e8057e
Original response SHA-256
e6beeef1e54e057e778fdf51378150ab7a1d49ccb1384ab857920681eaefaf11
Source body SHA-256
c523b91f310d88d18fd8f5de030a0794b85f2724cd427b6af01fc541c11e27a8

RYTELOTM (imetelstat) for injection

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.

Drug UPDATES: [Drug information (pdf)]
PACKAGE INSERT -Dosing: Click (+) next to Dosage and Administration section (drug info link)

Usual Diluents Return to article top

NS

Standard Dilutions [Amt of drug] [Infusion vol] [Infusion rate] Return to article top

[Calculated dose - total volume =500mL] [2 hours]
Dosing information below.

Preparation and Administration

RYTELO is provided as a lyophilized powder in a single-dose vial for intravenous infusion only and must be reconstituted and diluted prior to administration.

Use aseptic technique to prepare RYTELO.

RYTELO does not contain a preservative.

Reconstitution:

  • Calculate the dose of RYTELO needed based on the patient's body weight (kg).
  • Determine the number of RYTELO vials needed to achieve the required dose (total mg) per Table 4. More than one vial may be needed to achieve a full dose.
  • Remove the RYTELO vials from the refrigerator and allow the vials to sit for 10 minutes to 15 minutes (not to exceed 30 minutes) to adjust to room temperature 20°C to 25°C (68°F to 77°F) before use.
  • Reconstitute each vial of RYTELO with the volume of 0.9% Sodium Chloride Injection provided in Table 4 directly onto the lyophilized powder to obtain a concentration of 31.4 mg/mL of imetelstat.
Table 4: Reconstitution Volumes
Strength* Volume of 0.9% Sodium Chloride Injection for Reconstitution per Vial Final Concentration of Reconstituted Solution per Vial Deliverable Volume per Vial
47 mg 1.8 mL 31.4 mg/mL† 1.5 mL
188 mg 6.3 mL 31.4 mg/mL† 6 mL
*Recommended to use the appropriate combination of vial strengths to most closely match the intended dose based on the patient's weight.
†Each vial contains an overfill to account for loss of liquid during preparation and extraction of the reconstituted solution, resulting in the final concentration.
  • Swirl each vial gently to avoid foaming until the powder is fully reconstituted (not to exceed 15 minutes). Do not shake.
  • Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. The reconstituted solution in each vial should appear as a clear to slightly hazy solution, essentially free of visible contaminants, particles and/or particulates. Do not use if discoloration or particulate matter is present.
  • Use the reconstituted solution immediately to prepare the RYTELO diluted solution in the infusion bag.

Dilution:

  • Calculate the required volume of the reconstituted RYTELO solution needed to obtain the appropriate dose according to the patient's body weight.
  • Withdraw a volume equal to the required reconstituted RYTELO solution from a 500 mL infusion bag of 0.9% Sodium Chloride Injection and discard it.
  • Add the required volume of reconstituted RYTELO solution into the infusion bag so that the total final volume of RYTELO solution in the bag is approximately 500 mL. Discard any unused portion of the reconstituted solution remaining in each vial.
  • Gently invert the infusion bag at least 5 times to ensure that the reconstituted RYTELO is well-mixed. Do not shake the infusion bag prior to administration.

Diluted RYTELO Solution Storage:

  • If not used immediately, ensure that diluted solution for infusion is used within the total timeframes specified below, according to storage temperature:
    • When stored at room temperature 20°C to 25°C (68°F to 77°F):
      The total time from the reconstitution of RYTELO to completion of the intravenous infusion should not exceed 18 hours from the time of reconstitution.
    • When stored refrigerated 2°C to 8°C (36°F to 46°F):
      The total time from the reconstitution of RYTELO to completion of the intravenous infusion should not exceed 48 hours from the time of reconstitution.

Administration:

  • Administer the diluted RYTELO solution by intravenous infusion only over a period of 2 hours.
Description:
RYTELO for injection contains imetelstat, an oligonucleotide telomerase inhibitor for intravenous use. Imetelstat sodium is a white to off-white or slightly yellow, amorphous, solid powder. It is highly soluble in aqueous solutions, including in 0.9% Sodium Chloride Injection, at both refrigerated and room temperatures. Imetelstat sodium is hygroscopic.

The chemical name for the imetelstat sodium drug substance is DNA, d(3'-amino-3'-deoxy-P-thio) (T-A-G-G-G-T-T-A-G-A-C-A-A), 5'-[O-[2-hydroxy-3-(hexadecanoylamino)propyl] phosphorothioate], sodium salt (1:13). The molecular formula is C148H198N68O53P13S13Na13 (as sodium salt), which equates to a formula weight of 4896 g/mol. The molecular formula for the free acid form is C148H211N68O53P13S13 which equates to a formula weight of 4610 g/mol.

RYTELO (imetelstat) for injection is a sterile, preservative-free, white to off-white or slightly yellow lyophilized powder for intravenous infusion after reconstitution and dilution. Each single-dose vial provides either 47 mg of imetelstat (equivalent to 50 mg imetelstat sodium) or 188 mg of imetelstat (equivalent to 200 mg imetelstat sodium). The following inactive ingredients may be added during manufacturing: sodium carbonate anhydrous (for the 47 mg preparation) / sodium carbonate monohydrate (for the 188 mg preparation) or hydrochloric acid (to adjust to pH of 7.0 to 8.5).

CLINICAL PHARMACOLOGY: Return to article top

Mechanism of Action:

Imetelstat is an oligonucleotide human telomerase inhibitor that binds to the template region of the RNA component of human telomerase (hTR), inhibits telomerase enzymatic activity and prevents telomere binding.

Increased telomerase activity and human telomerase reverse transcriptase (hTERT) RNA expression have been reported in MDS and malignant stem and progenitor cells. Nonclinical studies showed imetelstat treatment led to reduction of telomere length, reduction of malignant stem and progenitor cell proliferation, and induction of apoptotic cell death.

INDICATIONS AND USAGE Return to article top

INDICATIONS AND USAGE:

RYTELO is indicated for the treatment of adult patients with low- to intermediate-1 risk myelodysplastic syndromes (MDS) with transfusion-dependent anemia requiring 4 or more red blood cell units over 8 weeks who have not responded to or have lost response to or are ineligible for erythropoiesis-stimulating agents (ESA).

CONTRAINDICATIONS Return to article top

Contraindications:

None.

WARNINGS AND PRECAUTIONS:
  • Thrombocytopenia: Grade 3 and Grade 4 thrombocytopenia occurred; obtain complete blood cell counts prior to initiation of RYTELO, weekly for the first two cycles, and prior to each cycle thereafter to monitor. Delay or dose reduce as recommended. (2.3, 5.1)
  • Neutropenia: Grade 3 and Grade 4 neutropenia occurred; obtain complete blood cell counts prior to initiation of RYTELO, weekly for the first two cycles, and prior to each cycle thereafter to monitor. Delay or dose reduce as recommended. (2.3, 5.2)
  • Infusion-Related Reactions: Premedicate before infusion. Interrupt, decrease the rate of infusion, or permanently discontinue RYTELO based on severity. (2.2, 2.3, 5.3)
  • Embryo-Fetal Toxicity: Can cause embryo-fetal harm. Advise females of reproductive potential of potential risk to a fetus and to use effective contraception. (5.4, 8.1, 8.3)

ADVERSE REACTIONS Return to article top

ADVERSE REACTIONS:
Most common adverse reactions (incidence ≥10% with a difference between arms of >5% compared to placebo), including laboratory abnormalities are decreased platelets, decreased white blood cells, decreased neutrophils, increased AST, increased alkaline phosphatase, increased ALT, fatigue, prolonged partial thromboplastin time, arthralgia/myalgia, COVID-19 infections, and headache. (6.1)

To report SUSPECTED ADVERSE REACTIONS, contact Geron Corporation at 1-855-437-6664 (1-855-GERONMI) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

See PACKAGE INSERT for PATIENT COUNSELING INFORMATION and Medication Guide. Drug information (pdf)

DOSAGE AND ADMINISTRATION Return to article top

DOSAGE AND ADMINISTRATION:
2.1. Recommended Dosage

The recommended dosage of RYTELO is 7.1 mg/kg administered as an intravenous infusion over 2 hours every 4 weeks. Discontinue RYTELO if a patient does not experience a decrease in red blood cell (RBC) transfusion burden after 24 weeks of treatment (administration of 6 doses) or if unacceptable toxicity occurs at any time [see Dosage and Administration (2.3)].

2.2. Recommended Premedications

Administer the following pre-treatment medications at least 30 minutes prior to dosing to prevent or reduce potential infusion-related reactions:

  • diphenhydramine (or equivalent) 25 mg to 50 mg, intravenously or orally
  • hydrocortisone (or equivalent) 100 mg to 200 mg, intravenously or orally

Monitor patients for adverse reactions for at least one hour after the infusion has been completed [see Warnings and Precautions (5.3) and Adverse Reactions (6.1)].

2.3. Dosage Modifications for Adverse Reactions

Recommended dose reductions for Grade 3 and Grade 4 adverse reactions are found in Table 1.

The management of Grade 3 and Grade 4 adverse reactions may require temporary dose delay, dose reduction, or treatment discontinuation and are presented in Table 2 and Table 3. RYTELO treatment should be permanently discontinued if the patient cannot tolerate the lowest dose level of 4.4 mg/kg.

Table 1: Recommended Dose Reduction for RYTELO for Grade 3 and Grade 4 Adverse Reactions
Dose Reduction Dose Every 4 Weeks
First dose reduction 5.6 mg/kg
Second dose reduction 4.4 mg/kg

Dosage Modifications for Hematologic (Grade 3 and Grade 4) Adverse Reactions

Monitor complete blood cell counts prior to administration of RYTELO, weekly for the first two cycles, prior to each cycle thereafter, and as clinically indicated. Delay the next cycle if absolute neutrophil count is less than 1 × 109/L or platelets are less than 50 × 109/L. Modify dose as described in Table 2 - Refer to insert: Table 2: Dosage Modifications for Patients with Hematologic Adverse Reactions (Grade 3 and Grade 4) Drug information (pdf).

Dosage Modifications for Non-hematologic Adverse Reactions

Dosage modifications for infusion-related reactions and other adverse drug reactions, including elevated liver function tests (LFTs), are described in Table 3. Monitor liver function tests prior to administration of RYTELO, weekly for the first cycle, prior to each cycle thereafter, and as clinically indicated.

Table 3: Dosage Modifications for Patients with Non-hematologic Adverse Reactions- see Drug information (pdf).

2.4. Preparation and Administration

RYTELO is provided as a lyophilized powder in a single-dose vial for intravenous infusion only and must be reconstituted and diluted prior to administration.

Use aseptic technique to prepare RYTELO.

RYTELO does not contain a preservative.

Reconstitution:

  • Calculate the dose of RYTELO needed based on the patient's body weight (kg).
  • Determine the number of RYTELO vials needed to achieve the required dose (total mg) per Table 4. More than one vial may be needed to achieve a full dose.
  • Remove the RYTELO vials from the refrigerator and allow the vials to sit for 10 minutes to 15 minutes (not to exceed 30 minutes) to adjust to room temperature 20°C to 25°C (68°F to 77°F) before use.
  • Reconstitute each vial of RYTELO with the volume of 0.9% Sodium Chloride Injection provided in Table 4 directly onto the lyophilized powder to obtain a concentration of 31.4 mg/mL of imetelstat.
Table 4: Reconstitution Volumes
Strength* Volume of 0.9% Sodium Chloride Injection for Reconstitution per Vial Final Concentration of Reconstituted Solution per Vial Deliverable Volume per Vial
47 mg 1.8 mL 31.4 mg/mL† 1.5 mL
188 mg 6.3 mL 31.4 mg/mL† 6 mL
*Recommended to use the appropriate combination of vial strengths to most closely match the intended dose based on the patient's weight.
†Each vial contains an overfill to account for loss of liquid during preparation and extraction of the reconstituted solution, resulting in the final concentration.
  • Swirl each vial gently to avoid foaming until the powder is fully reconstituted (not to exceed 15 minutes). Do not shake.
  • Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. The reconstituted solution in each vial should appear as a clear to slightly hazy solution, essentially free of visible contaminants, particles and/or particulates. Do not use if discoloration or particulate matter is present.
  • Use the reconstituted solution immediately to prepare the RYTELO diluted solution in the infusion bag.

Dilution:

  • Calculate the required volume of the reconstituted RYTELO solution needed to obtain the appropriate dose according to the patient's body weight.
  • Withdraw a volume equal to the required reconstituted RYTELO solution from a 500 mL infusion bag of 0.9% Sodium Chloride Injection and discard it.
  • Add the required volume of reconstituted RYTELO solution into the infusion bag so that the total final volume of RYTELO solution in the bag is approximately 500 mL. Discard any unused portion of the reconstituted solution remaining in each vial.
  • Gently invert the infusion bag at least 5 times to ensure that the reconstituted RYTELO is well-mixed. Do not shake the infusion bag prior to administration.

Diluted RYTELO Solution Storage:

  • If not used immediately, ensure that diluted solution for infusion is used within the total timeframes specified below, according to storage temperature:
    • When stored at room temperature 20°C to 25°C (68°F to 77°F):
      The total time from the reconstitution of RYTELO to completion of the intravenous infusion should not exceed 18 hours from the time of reconstitution.
    • When stored refrigerated 2°C to 8°C (36°F to 46°F):
      The total time from the reconstitution of RYTELO to completion of the intravenous infusion should not exceed 48 hours from the time of reconstitution.

Administration:

  • Administer the diluted RYTELO solution by intravenous infusion only over a period of 2 hours.
DOSAGE FORMS AND STRENGTHS:
  • For injection: 47 mg powder in a single-dose vial for reconstitution.
  • For injection: 188 mg powder in a single-dose vial for reconstitution.

Storage and Stability Return to article top

Store vials refrigerated at 2°C to 8°C (36°F to 46°F) in original carton.

Do not freeze.

Diluted RYTELO Solution Storage:

  • If not used immediately, ensure that diluted solution for infusion is used within the total timeframes specified below, according to storage temperature:
    • When stored at room temperature 20°C to 25°C (68°F to 77°F):
      The total time from the reconstitution of RYTELO to completion of the intravenous infusion should not exceed 18 hours from the time of reconstitution.
    • When stored refrigerated 2°C to 8°C (36°F to 46°F):
      The total time from the reconstitution of RYTELO to completion of the intravenous infusion should not exceed 48 hours from the time of reconstitution.

Open this historical article on its own

Product identifiers and clinical review status

This monograph will be updated in the future. Historical material is available where present in the original sources; full current exact-product and claim-level review remains pending.

Exact formulation, concentration, container, manufacturer, regulatory identifiers, and a reproducible label snapshot have not all been reconciled.

What remains to be completed
  • Retrievable exact-product SPL XML with version, revision, retrieval date and reproducible hash
  • Clinically reviewed, individually identified statements with two exact source mappings
  • Exact formulation, strength, container, manufacturer/labeler, application and NDC reconciliation
  • Renal-function methods and dialysis/CRRT modality review where applicable
  • Mechanism provenance, clinical source disagreements and full medication-specific safety reconciliation

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 fieldsSeparate renal reference: Open Renal Dosing Master (opens in a new tab)
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
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        Exact label section
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        Original source note
        Not recorded
        Review status
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        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
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      Message
      This monograph will be updated in the future as current exact-product and claim-level review is completed.
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      Reason
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      Historical first look: uses, mechanism, dosing context, and administration

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

      Id
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      Generic name
      Imetelstat (Rytelo)
      Source IDH51-82EC1A8F9F1DF2C816F44A61
      Class
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      Source IDH51-70588BEEABDBB0AC16F3DEBB
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      Source IDH51-5A47FC86C7437AC670BD1841
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      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.
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      Legacy title
      Imetelstat (Rytelo)
      Source IDH51-258B3A19080E5360D7DE3EBF
      Review note
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      Source IDH51-A270D3DD9024C73503A948DB
      Search text
      Imetelstat (Rytelo) Biologics and immunotherapy Legacy GlobalRPh directory entry The current labeled immune, hematologic, neurologic, metabolic, or inflammatory indication for this targeted biologic. An oligonucleotide that binds the telomerase RNA template and inhibits telomerase activity. The existing GlobalRPh dose and preparation quick reference loads automatically below. Treat it as historical continuity, then confirm the exact current DailyMed label, population, indication, renal function, and institutional policy. Route, dilution, concentration, and administration details load automatically from the existing GlobalRPh quick reference below; current exact-product verification remains required. Renal dosing status has not been locally normalized; use the current package insert before ordering or administration. Legacy content must be reconciled against current labeling and institutional policy before clinical use. Automatic legacy GlobalRPh quick reference
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      Official access mode
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      No source-backed DailyMed action has been verified for this umbrella or legacy record; identify the exact product before searching.
      Source IDH51-C5BDB1753C062705E89BBD64

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

      Historical renal-function guidance

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

      Separate renal reference: Open Renal Dosing Master (opens in a new tab)
      Classification
      current_label_review_required
      Source IDH51-04A4D8FF749D8C9F39D52F7C
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      Source IDH51-782F114CA1EB4EBEB67846F5
      Method note
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      Source IDH51-9B0DFB16E04DC2D6E35274BE

      Historical Warnings and safeguards

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

      1. Legacy content must be reconciled against current labeling and institutional policy before clinical use.
        Source IDH51-C002D8C7AC52837D9D60B1C4

      Historical Stability notes

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

      1. Legacy product stability information is not automatically equivalent to a USP <797> BUD.
        Source IDH51-E958CDBD12B2441CF46C05D5
      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
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      Imetelstat (Rytelo)
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      Generic name
      Imetelstat (Rytelo)
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      Dosing source fields

      Id
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      Source IDH51-C101686A1A2F79A8280D8F2C
      Audited on
      2026-08-30
      Source IDH51-26D458756DFF4BCE1F4782E0
      Level
      red
      Source IDH51-F26E9FEDE55318D6DB27A169
      Release gate
      unverified_or_unclassified_sources_do_not_release_as_current
      Source IDH51-AD03EB0A0AB8D9D0058AB6B8
      Exact current label candidate
      false
      Source IDH51-8B0D57D2462EA2EA4699B1E2
      Reference url count
      0
      Source IDH51-DEE0051C334A7FA4227E2343
      Broken reference count
      0
      Source IDH51-EAFF8B13CF3BF40C7C8E4F22
      Point of use confirmation required
      true
      Source IDH51-1495A4A9337563EE738B0DE5
      Note
      Do not treat this record as a fully current product-specific monograph until the exact IV formulation and current sources are confirmed.
      Source IDH51-84E8FE45D36C9AD1B2A7840B
      Historical preparation assessment

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

      Id
      imetelstat-rytelo
      Source IDH51-A2B2CAFF3C7168007843CCA3
      Name
      Imetelstat (Rytelo)
      Source IDH51-F17425C40F2DD0BE0992F286
      Therapeutic class
      Biologics and immunotherapy
      Source IDH51-04B2B88329994CD80204FC42
      Review version
      3.1
      Source IDH51-20D359BB8B2CBD90BBC087D8
      Review date
      2026-08-30
      Source IDH51-7C04DBAC7DAD2E323B061D63
      Release status
      no_released_dilution_current_label_review_required
      Source IDH51-1F45A4971B647DE30C265040
      Market status
      Status
      no_current_us_iv_spl_confirmed
      Source IDH51-93D828894AA2C561FE711678
      Basis
      No high-confidence current IV SPL was automatically selected; legacy information is segregated
      Source IDH51-7A48A29F133969F4CEC88158
      Ten point assessment
      Exact formulation
      Not established in the currently normalized record. Use the current-label panel before clinical use.
      Source IDH51-ED87C8892F4E0C0C08CBB7C5
      Reconstitution concentration
      Not established in the currently normalized record. Use the current-label panel before clinical use.
      Source IDH51-8A915034E79D5915F9DBBCCD
      Maximum or recommended final concentration
      Not established in the currently normalized record. Use the current-label panel before clinical use.
      Source IDH51-6E232F81DF93B5AD1358393B
      Appropriate standardized containers
      Not established in the currently normalized record. Use the current-label panel before clinical use.
      Source IDH51-81B0F63C65AEE069CA982172
      Adult dosing range
      Not established in the currently normalized record. Use the current-label panel before clinical use.
      Source IDH51-E68076EC6F0CFAE205061E16
      Pediatric dosing range
      Not established in the currently normalized record. Use the current-label panel before clinical use.
      Source IDH51-9566423C2DD587EA284932C5
      Neonatal dosing range
      Not established in the currently normalized record. Use the current-label panel before clinical use.
      Source IDH51-FEC0EFAB9F3CCB8273216566
      Infusion time
      Not established in the currently normalized record. Use the current-label panel before clinical use.
      Source IDH51-85A578F1FABE621692203700
      Fluid restriction alternatives
      Not established in the currently normalized record. Use the current-label panel before clinical use.
      Source IDH51-78093A87AB279FDCCC5A5134
      Current manufacturer labeling
      Match confidence
      unresolved
      Source IDH51-0FD1872789C3739B4E59DD3C
      Field provenance
      Exact formulation
      Primary
      not_found
      Source IDH51-84D75DD8FDEA14A2B4965A5D
      Reconstitution concentration
      Primary
      not_found
      Source IDH51-BD5040FE8DCC9B84066561BF
      Maximum or recommended final concentration
      Primary
      not_found
      Source IDH51-4F000F4C36B95DC1512A2E25
      Appropriate standardized containers
      Primary
      not_found
      Source IDH51-47B515297827976EB60232EA
      Adult dosing range
      Primary
      not_found
      Source IDH51-874FEC8096962CA0E80C6F72
      Pediatric dosing range
      Primary
      not_found
      Source IDH51-2294AB999C0F994CB9909F1C
      Neonatal dosing range
      Primary
      not_found
      Source IDH51-AFAF0AB271BDE36EC93C0EC7
      Infusion time
      Primary
      not_found
      Source IDH51-6C644BC2D625621DCF2A3764
      Fluid restriction alternatives
      Primary
      not_found
      Source IDH51-559ED8C4E8F7E3C3750F3332
      Current manufacturer labeling
      Primary
      DailyMed search gateway
      Source IDH51-88D2C7D02B27C6380FFF9706
      Population applicability
      Adult
      Applicability
      not_established
      Source IDH51-C9CF0C49D978057C291BAE6F
      Guide generation allowed
      false
      Source IDH51-AF1BB0B3DE282C76FE724914
      Pediatric
      Applicability
      not_established
      Source IDH51-4928649292F6678AD46B8A00
      Guide generation allowed
      false
      Source IDH51-2944B1B3D82F61C1DDB1C6D0
      Neonatal
      Applicability
      not_established
      Source IDH51-21A494DD05CC4DA0FF71DF86
      Guide generation allowed
      false
      Source IDH51-8A3123274B90B6BC166F40D4
      Route presence
      Structured dilution
      false
      Source IDH51-A1FFB783196922B1E5A73B3E
      Iv push
      false
      Source IDH51-3FFEC2C9D95A01602AFE0AF8
      Continuous infusion
      false
      Source IDH51-03FED7682A4A54479BD1F5EB
      Pediatric source
      false
      Source IDH51-E0D8D919FC4A4C76CC00ED52
      Neonatal source
      false
      Source IDH51-49B4378288C81FD82A4132B5
      Legacy reference
      Status
      not_available
      Source IDH51-10366B0F82C225C7BB3B73EA
      Label resolution
      Status
      build_environment_network_unavailable
      Source IDH51-50C1C26CF3E55BAA447E0DA7
      Source files
      1. catalog.json
        Source IDH51-30A308A34FDD2496B24E940E
      2. dosing.json
        Source IDH51-558AD495116EE4B49E566486
      3. legacy-map.json
        Source IDH51-661989382797954043136707
      4. review-queue.json
        Source IDH51-DAB833C8842051C7A7FC1053
      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 IDH51-5D67094AEDBABB190EB71F19
      Historical statement IDs and source locations

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

      Historical IDOriginal source locationStatus
      H51-9369A902FF271498AFCDB101catalog.json
      /records/130/id      		Historical; current review incomplete
      H51-658D743339FBB4707353BD68catalog.json
      /records/130/legacy_title      		Historical; current review incomplete
      H51-87589838BCDBE281BFCFB82Dcatalog.json
      /records/130/generic_name      		Historical; current review incomplete
      H51-D065154E18E003E1D611E447catalog.json
      /records/130/class      		Historical; current review incomplete
      H51-D245E2F6C2F0000123646570catalog.json
      /records/130/subclass      		Historical; current review incomplete
      H51-F6EE8C47138F32CD562431A1catalog.json
      /records/130/summary      		Historical; current review incomplete
      H51-C002D8C7AC52837D9D60B1C4catalog.json
      /records/130/warnings/0      		Historical; current review incomplete
      H51-E958CDBD12B2441CF46C05D5catalog.json
      /records/130/stability_notes/0      		Historical; current review incomplete
      H51-77CB2FC04E20B680B38A3F6Ecatalog.json
      /records/130/populations/0      		Historical; current review incomplete
      H51-F37E08F07A26F4C9A907D36Fcatalog.json
      /records/130/evidence_tier      		Historical; current review incomplete
      H51-DDED16FD7F0AB113250721B2catalog.json
      /records/130/high_alert      		Historical; current review incomplete
      H51-80B80FC2682E2013C50DEF68catalog.json
      /records/130/hazardous      		Historical; current review incomplete
      H51-C2DC7B204E1EE06AFC534B71catalog.json
      /records/130/status      		Historical; current review incomplete
      H51-41DE5D402AA286A1CCC9AB6Bcatalog.json
      /records/130/reviewed      		Historical; current review incomplete
      H51-807EED7F176948B5259B4A63catalog.json
      /records/130/version_added      		Historical; current review incomplete
      H51-03883CE77D4C611630A20E61catalog.json
      /records/130/sources/0      		Historical; current review incomplete
      H51-CAF9C7485E0995E0166EAE9Ccatalog.json
      /records/130/sources/0/label      		Historical; current review incomplete
      H51-BA5BBCAE0C61C6F7B4B8BE81catalog.json
      /records/130/sources/0/url      		Historical; current review incomplete
      H51-7D0BE73D88DD98C52ACDCE05catalog.json
      /records/130/sources/0/kind      		Historical; current review incomplete
      H51-D5EED60CA50C24895D0C6331catalog.json
      /records/130/clinical_release_verification/audit_version      		Historical; current review incomplete
      H51-1EA64735E26609D1164EFEB9catalog.json
      /records/130/clinical_release_verification/audited_on      		Historical; current review incomplete
      H51-455D83208E13DB57AC5C1CDDcatalog.json
      /records/130/clinical_release_verification/level      		Historical; current review incomplete
      H51-3DB0142DF9DB09F41A35071Ccatalog.json
      /records/130/clinical_release_verification/release_gate      		Historical; current review incomplete
      H51-C3254B6453AEDCD984D3C067catalog.json
      /records/130/clinical_release_verification/exact_current_label_candidate      		Historical; current review incomplete
      H51-1BB5582A826BF464B13772F9catalog.json
      /records/130/clinical_release_verification/selected_setid      		Historical; current review incomplete
      H51-AE471F1699096674D8D5977Ecatalog.json
      /records/130/clinical_release_verification/selected_label_title      		Historical; current review incomplete
      H51-32FF39A704511F742A182898catalog.json
      /records/130/clinical_release_verification/numeric_support_ratio      		Historical; current review incomplete
      H51-552977811BE3C986F9099658catalog.json
      /records/130/clinical_release_verification/reference_url_count      		Historical; current review incomplete
      H51-F6C9F2E81CE9EFADFD50B0B2catalog.json
      /records/130/clinical_release_verification/broken_reference_count      		Historical; current review incomplete
      H51-70B04806FCC8A8058A1D6996catalog.json
      /records/130/clinical_release_verification/point_of_use_confirmation_required      		Historical; current review incomplete
      H51-103547124B667ABFD72E4B4Bcatalog.json
      /records/130/clinical_release_verification/note      		Historical; current review incomplete
      H51-E49C09038B2D1B055A1E1991catalog.json
      /records/130/clinical_release_verification/dailymed_search_url      		Historical; current review incomplete
      H51-2BFD19FB5A0F795F840BCF4Ddosing.json
      /records/130/id      		Historical; current review incomplete
      H51-761C8F4479052388D19E34C5dosing.json
      /records/130/generic_name      		Historical; current review incomplete
      H51-AAA95D1DFA0E4255686CF050dosing.json
      /records/130/coverage_status      		Historical; current review incomplete
      H51-6DB6C008C218C42B78D079D8dosing.json
      /records/130/package_insert/query_name      		Historical; current review incomplete
      H51-A6BDEDC14BDED961C34C9BA3dosing.json
      /records/130/package_insert/preferred_setid      		Historical; current review incomplete
      H51-95027ECCE9E357EF38D3ED0Fdosing.json
      /records/130/package_insert/product_and_route_must_match      		Historical; current review incomplete
      H51-5A0DCE83E897EDA34ED139BFdosing.json
      /records/130/package_insert/live_current_label_enabled      		Historical; current review incomplete
      H51-5C8CD8C054831FF9D72D6580dosing.json
      /records/130/package_insert/source_priority      		Historical; current review incomplete
      H51-7CDC3DB35BA193A73C4CCDCEdosing.json
      /records/130/package_insert/direct_official_label_access_enabled      		Historical; current review incomplete
      H51-55E3D9D3331BDED13AA3D8A2dosing.json
      /records/130/package_insert/outbound_server_request_required      		Historical; current review incomplete
      H51-E4FA1DA06DAABE1EAAF94C56dosing.json
      /records/130/package_insert/local_summary_status      		Historical; current review incomplete
      H51-04A4D8FF749D8C9F39D52F7Cdosing.json
      /records/130/renal/classification      		Historical; current review incomplete
      H51-782F114CA1EB4EBEB67846F5dosing.json
      /records/130/renal/summary      		Historical; current review incomplete
      H51-9B0DFB16E04DC2D6E35274BEdosing.json
      /records/130/renal/method_note      		Historical; current review incomplete
      H51-7392DABF6867A5E93E41EEDCdosing.json
      /records/130/clinical_review/locally_normalized      		Historical; current review incomplete
      H51-62169376CA8C124C4DF32A66dosing.json
      /records/130/clinical_review/reviewed      		Historical; current review incomplete
      H51-D97C799CA8E178F89084C63Fdosing.json
      /records/130/clinical_review/status      		Historical; current review incomplete
      H51-C101686A1A2F79A8280D8F2Cdosing.json
      /records/130/clinical_release_verification/audit_version      		Historical; current review incomplete
      H51-26D458756DFF4BCE1F4782E0dosing.json
      /records/130/clinical_release_verification/audited_on      		Historical; current review incomplete
      H51-F26E9FEDE55318D6DB27A169dosing.json
      /records/130/clinical_release_verification/level      		Historical; current review incomplete
      H51-AD03EB0A0AB8D9D0058AB6B8dosing.json
      /records/130/clinical_release_verification/release_gate      		Historical; current review incomplete
      H51-8B0D57D2462EA2EA4699B1E2dosing.json
      /records/130/clinical_release_verification/exact_current_label_candidate      		Historical; current review incomplete
      H51-50540DF5F8FA9C6B744903E8dosing.json
      /records/130/clinical_release_verification/selected_setid      		Historical; current review incomplete
      H51-974B4455581A096B1E8682CBdosing.json
      /records/130/clinical_release_verification/selected_label_title      		Historical; current review incomplete
      H51-463898C8B8FDFCFA32714CF8dosing.json
      /records/130/clinical_release_verification/numeric_support_ratio      		Historical; current review incomplete
      H51-DEE0051C334A7FA4227E2343dosing.json
      /records/130/clinical_release_verification/reference_url_count      		Historical; current review incomplete
      H51-EAFF8B13CF3BF40C7C8E4F22dosing.json
      /records/130/clinical_release_verification/broken_reference_count      		Historical; current review incomplete
      H51-1495A4A9337563EE738B0DE5dosing.json
      /records/130/clinical_release_verification/point_of_use_confirmation_required      		Historical; current review incomplete
      H51-84E8FE45D36C9AD1B2A7840Bdosing.json
      /records/130/clinical_release_verification/note      		Historical; current review incomplete
      H51-C9CA9E5AFB04F62C8A86ACCEdosing.json
      /records/130/clinical_release_verification/dailymed_search_url      		Historical; current review incomplete
      H51-D971BCC7945EC65F944CC11Bfirst-look-v5.1.json
      /records/130/id      		Historical; current review incomplete
      H51-82EC1A8F9F1DF2C816F44A61first-look-v5.1.json
      /records/130/generic_name      		Historical; current review incomplete
      H51-70588BEEABDBB0AC16F3DEBBfirst-look-v5.1.json
      /records/130/class      		Historical; current review incomplete
      H51-03F6E8AFE8DADFB0AACB30CAfirst-look-v5.1.json
      /records/130/subclass      		Historical; current review incomplete
      H51-A78AA3A6CD6CFF56DA1DD4ADfirst-look-v5.1.json
      /records/130/primary_uses/0      		Historical; current review incomplete
      H51-F77A28C716890C7C0F74A6A3first-look-v5.1.json
      /records/130/mechanism      		Historical; current review incomplete
      H51-48B0FA598289062F276A4562first-look-v5.1.json
      /records/130/mechanism_level      		Historical; current review incomplete
      H51-F454B0C317711E9193D664EFfirst-look-v5.1.json
      /records/130/basic_dosing_orientation      		Historical; current review incomplete
      H51-5A47FC86C7437AC670BD1841first-look-v5.1.json
      /records/130/administration_orientation      		Historical; current review incomplete
      H51-58C170DF2A8C02FC953C3205first-look-v5.1.json
      /records/130/renal_and_population_orientation      		Historical; current review incomplete
      H51-D002906D2CD294BC969A171Afirst-look-v5.1.json
      /records/130/key_safety_orientation/0      		Historical; current review incomplete
      H51-1A9B945A59E929166B5F4ACEfirst-look-v5.1.json
      /records/130/coverage_path      		Historical; current review incomplete
      H51-A8FEC0BBF106B2E8FFE230BDfirst-look-v5.1.json
      /records/130/coverage_path_label      		Historical; current review incomplete
      H51-3A8F7762E42D5F3E5474C98Afirst-look-v5.1.json
      /records/130/official_label_url      		Historical; current review incomplete
      H51-258B3A19080E5360D7DE3EBFfirst-look-v5.1.json
      /records/130/legacy_title      		Historical; current review incomplete
      H51-A270D3DD9024C73503A948DBfirst-look-v5.1.json
      /records/130/review_note      		Historical; current review incomplete
      H51-A09A49B1940FF148C4D65AFBfirst-look-v5.1.json
      /records/130/search_text      		Historical; current review incomplete
      H51-BB3BADDA91056980D24B4F88first-look-v5.1.json
      /records/130/official_search_url      		Historical; current review incomplete
      H51-E3891B63F834089FDFC12A4Efirst-look-v5.1.json
      /records/130/official_access_mode      		Historical; current review incomplete
      H51-34BDA0D3D0CBA2E267727144first-look-v5.1.json
      /records/130/official_access_url      		Historical; current review incomplete
      H51-6C0637FF26BFCD4A19B7D064first-look-v5.1.json
      /records/130/official_search_query      		Historical; current review incomplete
      H51-C5BDB1753C062705E89BBD64first-look-v5.1.json
      /records/130/official_access_reason      		Historical; current review incomplete
      H51-A2B2CAFF3C7168007843CCA3preparation-assessments-v3.8.json
      /130/id      		Historical; current review incomplete
      H51-F17425C40F2DD0BE0992F286preparation-assessments-v3.8.json
      /130/name      		Historical; current review incomplete
      H51-148D786419921EA1CCF2F630preparation-assessments-v3.8.json
      /130/brands      		Historical; current review incomplete
      H51-04B2B88329994CD80204FC42preparation-assessments-v3.8.json
      /130/therapeutic_class      		Historical; current review incomplete
      H51-20D359BB8B2CBD90BBC087D8preparation-assessments-v3.8.json
      /130/review_version      		Historical; current review incomplete
      H51-7C04DBAC7DAD2E323B061D63preparation-assessments-v3.8.json
      /130/review_date      		Historical; current review incomplete
      H51-1F45A4971B647DE30C265040preparation-assessments-v3.8.json
      /130/release_status      		Historical; current review incomplete
      H51-93D828894AA2C561FE711678preparation-assessments-v3.8.json
      /130/market_status/status      		Historical; current review incomplete
      H51-7A48A29F133969F4CEC88158preparation-assessments-v3.8.json
      /130/market_status/basis      		Historical; current review incomplete
      H51-ED87C8892F4E0C0C08CBB7C5preparation-assessments-v3.8.json
      /130/ten_point_assessment/exact_formulation      		Historical; current review incomplete
      H51-8A915034E79D5915F9DBBCCDpreparation-assessments-v3.8.json
      /130/ten_point_assessment/reconstitution_concentration      		Historical; current review incomplete
      H51-6E232F81DF93B5AD1358393Bpreparation-assessments-v3.8.json
      /130/ten_point_assessment/maximum_or_recommended_final_concentration      		Historical; current review incomplete
      H51-81B0F63C65AEE069CA982172preparation-assessments-v3.8.json
      /130/ten_point_assessment/appropriate_standardized_containers      		Historical; current review incomplete
      H51-E68076EC6F0CFAE205061E16preparation-assessments-v3.8.json
      /130/ten_point_assessment/adult_dosing_range      		Historical; current review incomplete
      H51-9566423C2DD587EA284932C5preparation-assessments-v3.8.json
      /130/ten_point_assessment/pediatric_dosing_range      		Historical; current review incomplete
      H51-FEC0EFAB9F3CCB8273216566preparation-assessments-v3.8.json
      /130/ten_point_assessment/neonatal_dosing_range      		Historical; current review incomplete
      H51-85A578F1FABE621692203700preparation-assessments-v3.8.json
      /130/ten_point_assessment/infusion_time      		Historical; current review incomplete
      H51-78093A87AB279FDCCC5A5134preparation-assessments-v3.8.json
      /130/ten_point_assessment/fluid_restriction_alternatives      		Historical; current review incomplete
      H51-B9F9A6D5B57BDF8D85867559preparation-assessments-v3.8.json
      /130/ten_point_assessment/current_manufacturer_labeling/setid      		Historical; current review incomplete
      H51-0C582510EFE566D5ADA58C1Fpreparation-assessments-v3.8.json
      /130/ten_point_assessment/current_manufacturer_labeling/title      		Historical; current review incomplete
      H51-590353DC4CEA4BDB57E348BBpreparation-assessments-v3.8.json
      /130/ten_point_assessment/current_manufacturer_labeling/published_date      		Historical; current review incomplete
      H51-7B53E352F7A606D817878F7Fpreparation-assessments-v3.8.json
      /130/ten_point_assessment/current_manufacturer_labeling/manufacturer      		Historical; current review incomplete
      H51-0FD1872789C3739B4E59DD3Cpreparation-assessments-v3.8.json
      /130/ten_point_assessment/current_manufacturer_labeling/match_confidence      		Historical; current review incomplete
      H51-781DA6B9CF6302214EA58C41preparation-assessments-v3.8.json
      /130/ten_point_assessment/current_manufacturer_labeling/url      		Historical; current review incomplete
      H51-84D75DD8FDEA14A2B4965A5Dpreparation-assessments-v3.8.json
      /130/field_provenance/exact_formulation/primary      		Historical; current review incomplete
      H51-BD5040FE8DCC9B84066561BFpreparation-assessments-v3.8.json
      /130/field_provenance/reconstitution_concentration/primary      		Historical; current review incomplete
      H51-4F000F4C36B95DC1512A2E25preparation-assessments-v3.8.json
      /130/field_provenance/maximum_or_recommended_final_concentration/primary      		Historical; current review incomplete
      H51-47B515297827976EB60232EApreparation-assessments-v3.8.json
      /130/field_provenance/appropriate_standardized_containers/primary      		Historical; current review incomplete
      H51-874FEC8096962CA0E80C6F72preparation-assessments-v3.8.json
      /130/field_provenance/adult_dosing_range/primary      		Historical; current review incomplete
      H51-2294AB999C0F994CB9909F1Cpreparation-assessments-v3.8.json
      /130/field_provenance/pediatric_dosing_range/primary      		Historical; current review incomplete
      H51-AFAF0AB271BDE36EC93C0EC7preparation-assessments-v3.8.json
      /130/field_provenance/neonatal_dosing_range/primary      		Historical; current review incomplete
      H51-6C644BC2D625621DCF2A3764preparation-assessments-v3.8.json
      /130/field_provenance/infusion_time/primary      		Historical; current review incomplete
      H51-559ED8C4E8F7E3C3750F3332preparation-assessments-v3.8.json
      /130/field_provenance/fluid_restriction_alternatives/primary      		Historical; current review incomplete
      H51-88D2C7D02B27C6380FFF9706preparation-assessments-v3.8.json
      /130/field_provenance/current_manufacturer_labeling/primary      		Historical; current review incomplete
      H51-C9CF0C49D978057C291BAE6Fpreparation-assessments-v3.8.json
      /130/population_applicability/adult/applicability      		Historical; current review incomplete
      H51-AF1BB0B3DE282C76FE724914preparation-assessments-v3.8.json
      /130/population_applicability/adult/guide_generation_allowed      		Historical; current review incomplete
      H51-4928649292F6678AD46B8A00preparation-assessments-v3.8.json
      /130/population_applicability/pediatric/applicability      		Historical; current review incomplete
      H51-2944B1B3D82F61C1DDB1C6D0preparation-assessments-v3.8.json
      /130/population_applicability/pediatric/guide_generation_allowed      		Historical; current review incomplete
      H51-21A494DD05CC4DA0FF71DF86preparation-assessments-v3.8.json
      /130/population_applicability/neonatal/applicability      		Historical; current review incomplete
      H51-8A3123274B90B6BC166F40D4preparation-assessments-v3.8.json
      /130/population_applicability/neonatal/guide_generation_allowed      		Historical; current review incomplete
      H51-A1FFB783196922B1E5A73B3Epreparation-assessments-v3.8.json
      /130/route_presence/structured_dilution      		Historical; current review incomplete
      H51-3FFEC2C9D95A01602AFE0AF8preparation-assessments-v3.8.json
      /130/route_presence/iv_push      		Historical; current review incomplete
      H51-03FED7682A4A54479BD1F5EBpreparation-assessments-v3.8.json
      /130/route_presence/continuous_infusion      		Historical; current review incomplete
      H51-E0D8D919FC4A4C76CC00ED52preparation-assessments-v3.8.json
      /130/route_presence/pediatric_source      		Historical; current review incomplete
      H51-49B4378288C81FD82A4132B5preparation-assessments-v3.8.json
      /130/route_presence/neonatal_source      		Historical; current review incomplete
      H51-10366B0F82C225C7BB3B73EApreparation-assessments-v3.8.json
      /130/legacy_reference/status      		Historical; current review incomplete
      H51-50C1C26CF3E55BAA447E0DA7preparation-assessments-v3.8.json
      /130/label_resolution/status      		Historical; current review incomplete
      H51-30A308A34FDD2496B24E940Epreparation-assessments-v3.8.json
      /130/source_files/0      		Historical; current review incomplete
      H51-558AD495116EE4B49E566486preparation-assessments-v3.8.json
      /130/source_files/1      		Historical; current review incomplete
      H51-661989382797954043136707preparation-assessments-v3.8.json
      /130/source_files/2      		Historical; current review incomplete
      H51-DAB833C8842051C7A7FC1053preparation-assessments-v3.8.json
      /130/source_files/3      		Historical; current review incomplete
      H51-5D67094AEDBABB190EB71F19preparation-assessments-v3.8.json
      /130/clinical_release_note      		Historical; current review incomplete

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