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Parenteral and Oral Iron Products

Disclaimer - Please see package insert for additional information and possible updates. 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.   Read the disclaimer

Parenteral Formulations (monographs)

Ferumoxytol - Feraheme® INJECTAFER® (ferric carboxymaltose injection)
Iron sucrose -Venofer® Low-molecular-weight dextran - Infed®
Sodium Ferric gluconate complex - Ferrlecit® TRIFERIC ® (ferric pyrophosphate citrate) solution

Background


Normal Serum Iron Levels

Males (adult) 75 - 175 mcg/dL
Females (adult) 65 - 165 mcg/dL
Children 50 - 120 mcg/dL


 

Oral Iron Supplements

Iron Supplement Tablet Size Elemental Iron Usual Dose for Iron
deficiency anemia
1
Ferrous fumarate 325 mg 106 mg 1 tab bid
Ferrous gluconate 325 mg 36 mg 2 tabs tid
Ferrous sulfate 325 mg 65 mg 1 tab tid
Polysaccharide iron Niferex® caps:
Niferex® -150 forte:
Niferex® Elixir:
60 mg
150 mg
100 mg/5 ml
1 cap qd (Forte)
1. Usual total daily dose (IDA): 150-200 mg Fe (elemental iron) per day [Range: 60 to100 mg elemental iron every 12 hours or up to 60 mg elemental iron every 6 hours]


General dosage information for oral iron formulations:

Iron Deficiency Anemia:
Treatment: 60 mg of elemental Fe (iron) orally every 6 to 12 hours (e.g. 2 to 4 times per day)

Prophylaxis: 60 mg of elemental Fe (iron) orally every day.

Recommended Daily Intake
Men: 8 mg elemental Fe (iron) orally once daily
Women: 18 mg elemental Fe (iron) orally once daily
Pregnant women: 27 mg elemental Fe (iron) orally once daily
Lactating women: 9 mg elemental Fe (iron) orally once daily


Administration
May cause gastrointestinal discomfort, nausea, constipation or diarrhea.  For maximum absorption take on empty stomach, but may take with or after meals to minimize GI irritation.   Addition info here.



Parenteral Iron Formulations

Parenteral Iron formulation Elemental Iron/mL Dose for CKD pts on hemodialysis Dose for patients not on dialysis
Low-MW dextran - Infed® 50 mg 100 mg IV 3 times/week
(every dialysis) x 10 doses (1 gram)
500-1000 mg slow IV infusion
(250 - 1000 ml NS)

See IV dilution section. Also see iron dextran calculator.
Ferric carboxymaltose inj -INJECTAFER®   ---- See below
Ferumoxytol - Feraheme® 30 mg 510 mg x 2 doses (3 to 8 days apart) - see monograph below. 510 mg x 2 doses (3 to 8 days apart) - see monograph below.
Iron sucrose -Venofer® 20 mg 100 mg IV 3 times/week
(every dialysis) x 10 doses
200 mg IV x 5 doses during a 14 day period.

Alternatively:
(a) 500mg slow IV infusion on day 1 and day 14.

OR

(b) 300 mg, 300 mg, then 400mg - each dose 14 days apart,
Sodium Ferric gluconate complex - Ferrlecit® 12.5 mg 125 mg IV 3 times/week
(every dialysis session) x 8 doses (1 gram).
See monograph below
250 mg IV over 1 hour (4.2 mg/min)1
1. References:
a.  Folkert VW, et al. Chronic use of sodium ferric gluconate complex in hemodialysis patients: Safety of higher-dose (> or = 250 mg) administration. Am J Kidney Dis 2003;41:651–657.

b. Jain AK, Bastani B. Safety profile of a high dose ferric gluconate in patients with severe chronic renal insufficiency. J Nephrol 2002;15:681-3.

c.Javier AM. Weekly administration of high-dose sodium ferric gluconate is safe and effective in peritoneal dialysis patients. Nephrol Nurs J 2002;29:183-6.

d. Seligman PA, Dahl NV, Strobos J, Kimko HC, Schleicher RB, Jones M, Ducharme MP. Single-dose pharmacokinetics of sodium ferric gluconate complex in iron-deficient subjects.Pharmacotherapy. 2004 May;24(5):574-83.



Low-molecular-weight dextran - Infed®: top of page

Parenteral iron treatment should be administered only when iron deficiency is not correctable with oral treatment.
PRECAUTIONS (See package insert for additional precautions / warnings)

General
Unwarranted therapy with parenteral iron will cause excess storage of iron with the consequent possibility of exogenous hemosiderosis. Such iron overload is particularly apt to occur in patients with hemoglobinopathies and other refractory anemias that might be erroneously diagnosed as iron deficiency anemias.

INFeD should be used with caution in individuals with histories of significant allergies and/or asthma.

Anaphylaxis and other hypersensitivity reactions have been reported after uneventful test doses as well as therapeutic doses of iron dextran injection. Therefore, administration of subsequent test doses during therapy should be considered. (See DOSAGE AND ADMINISTRATION: Administration.)

Epinephrine should be immediately available in the event of acute hypersensitivity reactions. (Usual adult dose: 0.5 mL of a 1:1000 solution, by subcutaneous or intramuscular injection.)

Note: Patients using beta-blocking agents may not respond adequately to epinephrine. Isoproterenol or similar beta-agonist agents may be required in these patients.

Patients with rheumatoid arthritis may have an acute exacerbation of joint pain and swelling following the administration of INFeD.

Reports in the literature from countries outside the United States (in particular, New Zealand) have suggested that the use of intramuscular iron dextran in neonates has been associated with an increased incidence of gram-negative sepsis, primarily due to E. Coli.

A test dose of 25 mg infused over 5 minutes should be given. Infusion should then be stopped for 1 hour. If there is no reaction after 1 hour continue. Fatal anaphylactic reactions are possible.
May also be given IM or slow IVP (1 ml/min x 2 min = 100 mg). Epinephrine should be immediately available.

Parenterally administered iron does not give a faster response compared to oral administration, therefore, the rate of recovery from anemia should be the same. Reticulocyte count will increase in 3-4 days and peak in 7-10 days.

DOSAGE AND ADMINISTRATION
Oral iron should be discontinued prior to administration of INFeD.

Dosage
I. Iron Deficiency Anemia: Periodic hematologic determination (hemoglobin and hematocrit) is a simple and accurate technique for monitoring hematological response, and should be used as a guide in therapy. It should be recognized that iron storage may lag behind the appearance of normal blood morphology. Serum iron, total iron binding capacity (TIBC) and percent saturation of transferrin are other important tests for detecting and monitoring the iron deficient state.

After administration of iron dextran complex, evidence of a therapeutic response can be seen in a few days as an increase in the reticulocyte count.

Although serum ferritin is usually a good guide to body iron stores, the correlation of body iron stores and serum ferritin may not be valid in patients on chronic renal dialysis who are also receiving iron dextran complex.

Although there are significant variations in body build and weight distribution among males and females, the accompanying table and formula represent a convenient means for estimating the total iron required. This total iron requirement reflects the amount of iron needed to restore hemoglobin concentration to normal or near normal levels plus an additional allowance to provide adequate replenishment of iron stores in most individuals with moderately or severely reduced levels of hemoglobin. It should be remembered that iron deficiency anemia will not appear until essentially all iron stores have been depleted. Therapy, thus, should aim at not only replenishment of hemoglobin iron but iron stores as well.

Factors contributing to the formula are shown below.
mg blood iron mL blood g hemoglobin mg iron
————— = ————— x ————— x —————
lb body weight lb body weight mL blood g hemoglobin

a. Blood volume . . . . . . . . . . . . . . . .65 mL/kg of body weight

b. Normal hemoglobin (males and females)
over 15 kg (33 lbs) . . . . . . . . . . . .14.8 g/dl
15 kg (33 lbs) or less . . . . . . . . . .12.0 g/dl

c. Iron content of hemoglobin . . . . . . . . . . . . . .0.34%
d. Hemoglobin deficit
e. Weight

Based on the above factors, individuals with normal hemoglobin levels will have approximately 33 mg of blood iron per kilogram of body weight (15 mg/lb).

Note: The table and accompanying formula are applicable for dosage determinations only in patients with iron deficiency anemia; they are not to be used for dosage determinations in patients requiring iron replacement for blood loss.

TOTAL INFeD® REQUIREMENT FOR HEMOGLOBIN RESTORATION AND IRON STORES REPLACEMENT*
PATIENT Milliliter Requirement of INFeD Based On Observed
LEAN BODY Hemoglobin of
WEIGHT
3 4 5 6 7 8 9 10
kg lb (g/dl) (g/dl) (g/dl) (g/dl) (g/dl) (g/dl) (g/dl) (g/dl)
*Table values were calculated based on a normal adult hemoglobin of 14.8 g/dl for weights greater than 15 kg (33 lbs) and a hemoglobin of 12.0 g/dl for weights less than or equal to 15 kg (33 lbs).
5 11 3 3 3 3 2 2 2 2
10 22 7 6 6 5 5 4 4 3
15 33 10 9 9 8 7 7 6 5
20 44 16 15 14 13 12 11 10 9
25 55 20 18 17 16 15 14 13 12
30 66 23 22 21 19 18 17 15 14
35 77 27 26 24 23 21 20 18 17
40 88 31 29 28 26 24 22 21 19
45 99 35 33 31 29 27 25 23 21
50 110 39 37 35 32 30 28 26 24
55 121 43 41 38 36 33 31 28 26
60 132 47 44 42 39 36 34 31 28
65 143 51 48 45 42 39 36 34 31
70 154 55 52 49 45 42 39 36 33
75 165 59 55 52 49 45 42 39 35
80 176 63 59 55 52 48 45 41 38
85 187 66 63 59 55 51 48 44 40
90 198 70 66 62 58 54 50 46 42
95 209 74 70 66 62 57 53 49 45
100 220 78 74 69 65 60 56 52 47
105 231 82 77 73 68 63 59 54 50
110 242 86 81 76 71 67 62 57 52
115 253 90 85 80 75 70 64 59 54
120 264 94 88 83 78 73 67 62 57

*Table values were calculated based on a normal adult hemoglobin of 14.8 g/dl for weights greater than 15 kg (33 lbs) and a hemoglobin of 12.0 g/dl for weights less than or equal to 15 kg (33 lbs).


The total amount of INFeD in mL required to treat the anemia and replenish iron stores may be approximated as follows:

Adults and Children over 15 kg (33 lbs): See Dosage Table.
Alternatively the total dose may be calculated:

Dose (mL) = 0.0442 (Desired Hb - Observed Hb) x LBW + (0.26 x LBW)

Based on: Desired Hb = the target Hb in g/dl.

Observed Hb = the patient’s current hemoglobin in g/dl.

LBW = Lean body weight in kg. A patient’s lean body weight (or actual body weight if less than lean body weight) should be utilized when determining dosage.

For males: LBW = 50 kg + 2.3 kg for each inch of patient’s height over 5 feet

For females: LBW = 45.5 kg + 2.3 kg for each inch of patient’s height over 5 feet


Children 5 - 15 kg (11 - 33 lbs): See Dosage Table.

INFeD should not normally be given in the first four months of life. (See package insert for PRECAUTIONS: Pediatric Use)

Alternatively the total dose may be calculated:
Dose (mL) = 0.0442 (Desired Hb - Observed Hb) x W + (0.26 x W)

Based on: Desired Hb = the target Hb in g/dl. (Normal Hb for Children 15 kg or less is 12 g/dl)

W = Weight in kg.


II. Iron Replacement for Blood Loss: Some individuals sustain blood losses on an intermittent or repetitive basis. Such blood losses may occur periodically in patients with hemorrhagic diatheses (familial telangiectasia; hemophilia; gastrointestinal bleeding) and on a repetitive basis from procedures such as renal hemodialysis.

Iron therapy in these patients should be directed toward replacement of the equivalent amount of iron represented in the blood loss. The table and formula described under I.Iron Deficiency Anemia are not applicable for simple iron replacement values.

Quantitative estimates of the individual’s periodic blood loss and hematocrit during the bleeding episode provide a convenient method for the calculation of the required iron dose.

The formula shown below is based on the approximation that 1 mL of normocytic, normochromic red cells contains 1 mg of elemental iron:

Replacement iron (in mg) = Blood loss (in mL) x hematocrit

Example: Blood loss of 500 mL with 20% hematocrit

Replacement Iron = 500 x 0.20 = 100 mg

Administration
The total amount of INFeD required for the treatment of iron deficiency anemia or iron replacement for blood loss is determined from the table or appropriate formula (See Dosage).

I. Intravenous Injection - PRIOR TO RECEIVING THEIR FIRST INFeD THERAPEUTIC DOSE, ALL PATIENTS SHOULD BE GIVEN AN INTRAVENOUS TEST DOSE OF 0.5 mL. (See PRECAUTIONS: General.) THE TEST DOSE SHOULD BE ADMINISTERED AT A GRADUAL RATE OVER AT LEAST 30 SECONDS. Although anaphylactic reactions known to occur following INFeD administration are usually evident within a few minutes, or sooner, it is recommended that a period of an hour or longer elapse before the remainder of the initial therapeutic dose is given.

Individual doses of 2 mL or less may be given on a daily basis until the calculated total amount required has been reached. INFeD is given undiluted at a slow gradual rate not to exceed 50 mg (1 mL) per minute.

2.Intramuscular Injection - PRIOR TO RECEIVING THEIR FIRST INFeD THERAPEUTIC DOSE, ALL PATIENTS SHOULD BE GIVEN AN INTRAMUSCULAR TEST DOSE OF 0.5 mL. (See PRECAUTIONS: General.) The test dose should be administered in the same recommended test site and by the same technique as described in the last paragraph of this section. Although anaphylactic reactions known to occur following INFeD administration are usually evident within a few minutes or sooner, it is recommended that at least an hour or longer elapse before the remainder of the initial therapeutic dose is given.

If no adverse reactions are observed, INFeD can be given according to the following schedule until the calculated total amount required has been reached. Each day’s dose should ordinarily not exceed 0.5 mL (25 mg of iron) for infants under 5 kg (11 lbs); 1.0 mL (50 mg of iron) for children under 10 kg (22 lbs); and 2.0 mL (100 mg of iron) for other patients.

INFeD should be injected only into the muscle mass of the upper outer quadrant of the buttock - never into the arm or other exposed areas - and should be injected deeply, with a 2-inch or 3-inch 19 or 20 gauge needle. If the patient is standing, he/she should be bearing his/her weight on the leg opposite the injection site, or if in bed, he/she should be in the lateral position with injection site uppermost. To avoid injection or leakage into the subcutaneous tissue, a Z-track technique (displacement of the skin laterally prior to injection) is recommended.

NOTE: Do not mix INFeD with other medications or add to parenteral nutrition solutions for intravenous infusion.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever the solution and container permit.


HOW SUPPLIED
INFeD® (Iron Dextran Injection USP) containing 50 mg of elemental iron per mL, is available in 2 mL single dose amber vials (for intramuscular or intravenous use) in cartons of 10 (NDC 52544-931-02).

Store at 20°-25°C (68°-77°F) [See USP Controlled Room Temperature].

Rx Only


REFERENCES
Hatton RC, Portales IT, Finlay A, Ross EA. Removal of Iron Dextran by Hemodialysis: An In Vitro Study. Am J Kid Dis. 1995; 26(2):327-330.

Manuel MA, Stewart WK, St. Clair Neill GD, Hutchinson F. Loss of Iron-Dextran through Cuprophane Membrane of a Disposable Coil Dialyser. Nephron. 1972;9:94-98.

Literature revised: March 2006

Product No.: 1001-02

Watson Pharma, Inc.
A subsidiary of Watson Pharmaceuticals, Inc.
Morristown, NJ 07962 USA


Source: [package insert]



High-molecular-weight dextran- Dexferrum®: top of page

Currently reviewing monograph- will add upon request

Ferumoxytol - Feraheme®: top of page

Feraheme® (ferumoxytol) Injection
For Intravenous (IV) use
Initial U.S. Approval: 2009

DESCRIPTION
Feraheme, an iron replacement product, is a non-stoichiometric magnetite (superparamagnetic iron oxide) coated with polyglucose sorbitol carboxymethylether. The overall colloidal particle size is 17-31 nm in diameter. The chemical formula of Feraheme is Fe5874O8752-C11719H18682O9933Na414 with an apparent molecular weight of 750 kDa.

Feraheme injection is an aqueous colloidal product that is formulated with mannitol. It is a black to reddish brown liquid, and is provided in single use vials containing 510 mg of elemental iron. Each mL of the sterile colloidal solution of Feraheme injection contains 30 mg of elemental iron and 44 mg of mannitol, and has low bleomycin-detectable iron. The formulation is isotonic with an osmolality of 270-330 mOsm/kg. The product contains no preservatives, and has a pH of 6 to 8.


CLINICAL PHARMACOLOGY
Mechanism of Action
Feraheme consists of a superparamagnetic iron oxide that is coated with a carbohydrate shell, which helps to isolate the bioactive iron from plasma components until the iron-carbohydrate complex enters the reticuloendothelial system macrophages of the liver, spleen and bone marrow. The iron is released from the iron-carbohydrate complex within vesicles in the macrophages. Iron then either enters the intracellular storage iron pool (e.g., ferritin) or is transferred to plasma transferrin for transport to erythroid precursor cells for incorporation into hemoglobin.

INDICATIONS AND USAGE:
Feraheme is an iron replacement product indicated for the treatment of iron deficiency anemia in adult patients with chronic kidney disease (CKD).

DOSAGE AND ADMINISTRATION:
The recommended dose of Feraheme is an initial 510 mg dose followed by a second 510 mg dose 3 to 8 days later. Administer Feraheme as an intravenous infusion in 50-200 mL 0.9% Sodium Chloride Injection, USP or 5% Dextrose Injection, USP over at least 15 minutes. Administer while the patient is in a reclined or semi-reclined position.

Feraheme, when added to intravenous infusion bags containing either 0.9% Sodium Chloride Injection, USP (normal saline), or 5% Dextrose Injection, USP, at concentrations of 2-8 mg elemental iron per mL, should be used immediately but may be stored at controlled room temperature (25°C +/- 2°C) for up to 4 hours.

The dosage is expressed in terms of mg of elemental iron, with each mL of Feraheme containing 30 mg of elemental iron. Evaluate the hematologic response (hemoglobin, ferritin, iron and transferrin saturation) at least one month following the second Feraheme infusion. The recommended Feraheme dose may be readministered to patients with persistent or recurrent iron deficiency anemia.

For patients receiving hemodialysis, administer Feraheme once the blood pressure is stable and the patient has completed at least one hour of hemodialysis. Monitor for signs and symptoms of hypotension following each Feraheme infusion.

Allow at least 30 minutes between administration of Feraheme and administration of other medications that could potentially cause serious hypersensitivity reactions and/or hypotension, such as chemotherapeutic agents or monoclonal antibodies.

Inspect parenteral drug products visually for the absence of particulate matter and discoloration prior to administration.

CONTRAINDICATIONS:
Known hypersensitivity to Feraheme or any of its components.

History of allergic reaction to any intravenous iron product.


WARNINGS AND PRECAUTIONS
--Hypersensitivity Reactions: Observe for signs and symptoms of hypersensitivity during and after Feraheme administration for at least 30 minutes and until clinically stable following completion of each administration.
--Hypotension: Feraheme may cause hypotension. Monitor for signs and symptoms of hypotension following each administration of Feraheme.
--Iron Overload: Regularly monitor hematologic responses during Feraheme therapy. Do not administer Feraheme to patients with iron overload.
-- Magnetic Resonance Imaging: Feraheme can alter magnetic resonance imaging (MRI) studies.

ADVERSE REACTIONS
The most common adverse reactions (greater than or equal 2%) following the administration of Feraheme are diarrhea, nausea, dizziness, hypotension, constipation, and peripheral edema.


DOSAGE FORMS AND STRENGTHS:
Feraheme (30 mg/mL) is available for intravenous injection in single use vials. Each vial contains 510 mg of elemental iron in 17 mL.

Source:
Package Insert data: 
FERAHEME
ferumoxytol injection
Manufactured and Distributed by:

AMAG Pharmaceuticals Inc.
Lexington, MA 02421
Revised: 03/2015

Iron sucrose -Venofer®: top of page

Description:
Venofer® (iron sucrose injection, USP) is a brown, sterile, aqueous, complex of polynuclear iron (III)-hydroxide in sucrose for intravenous use. Venofer® is supplied in 5 mL and 10 mL single dose vials. Each 5 mL vial contains 100 mg elemental iron (20 mg/mL) and each 10 mL vial contains 200 mg elemental iron (20 mg/mL). Contains no preservatives. Store in original carton at 25°C (77°F). Excursions permitted to 15°-30°C (59°-86°F). Do not freeze.

Mechanism of Action
Venofer is an aqueous complex of poly-nuclear iron (III)-hydroxide in sucrose. Following intravenous administration, Venofer is dissociated into iron and sucrose and the iron is transported as a complex with transferrin to target cells including erythroid precursor cells. The iron in the precursor cells is incorporated into hemoglobin as the cells mature into red blood cells.

Pharmacodynamics
Following intravenous administration, Venofer is dissociated into iron and sucrose. In 22 patients undergoing hemodialysis and receiving erythropoietin (recombinant human erythropoietin) therapy treated with iron sucrose containing 100 mg of iron, three times weekly for three weeks, significant increases in serum iron and serum ferritin and significant decreases in total iron binding capacity occurred four weeks from the initiation of iron sucrose treatment.

INDICATIONS AND USAGE:
Venofer is an iron replacement product indicated for the treatment of iron deficiency anemia in patients with chronic kidney disease (CKD).

DOSAGE AND ADMINISTRATION:
See detailed information below this summary table
Population Dose
Adult patients Hemodialysis Dependent-Chronic Kidney Disease (HDD-CKD) 100 mg slow intravenous injection or infusion
Non-Dialysis Dependent-Chronic Kidney Disease (NDD-CKD) 200 mg slow intravenous injection or infusion
Peritoneal Dialysis Dependent-Chronic Kidney Disease (PDD-CKD) 300 mg or 400 mg intravenous infusion
Pediatric patients HDD-CKD, PDD-CKD or NDD-CKD 0.5 mg/kg slow intravenous injection or infusion

Venofer must only be administered intravenously either by slow injection or by infusion. The dosage of Venofer is expressed in mg of elemental iron. Each mL contains 20 mg of elemental iron.

Adult Patients with Hemodialysis Dependent-Chronic Kidney Disease (HDD-CKD)
Administer Venofer 100 mg undiluted as a slow intravenous injection over 2 to 5 minutes, or as an infusion of 100 mg diluted in a maximum of 100 mL of 0.9% NaCl over a period of at least 15 minutes, per consecutive hemodialysis session. Venofer should be administered early during the dialysis session. The usual total treatment course of Venofer is 1000 mg. Venofer treatment may be repeated if iron deficiency reoccurs.

Adult Patients with Non-Dialysis Dependent-Chronic Kidney Disease (NDD-CKD)
Administer Venofer 200 mg undiluted as a slow intravenous injection over 2 to 5 minutes or as an infusion of 200 mg in a maximum of 100 mL of 0.9% NaCl over a period of 15 minutes. Administer on 5 different occasions over a 14 day period. There is limited experience with administration of an infusion of 500 mg of Venofer, diluted in a maximum of 250 mL of 0.9% NaCl, over a period of 3.5 to 4 hours on day 1 and day 14. Venofer treatment may be repeated if iron deficiency reoccurs.

Adult Patients with Peritoneal Dialysis Dependent-Chronic Kidney Disease (PDD-CKD)
Administer Venofer in 3 divided doses, given by slow intravenous infusion, within a 28 day period: 2 infusions each of 300 mg over 1.5 hours 14 days apart followed by one 400 mg infusion over 2.5 hours 14 days later. Dilute Venofer in a maximum of 250 mL of 0.9% NaCl. Venofer treatment may be repeated if iron deficiency reoccurs.

Pediatric Patients (2 years of age and older) with HDD-CKD for iron maintenance treatment
The dosing for iron replacement treatment in pediatric patients with HDD-CKD has not been established.

For iron maintenance treatment: Administer Venofer at a dose of 0.5 mg/kg, not to exceed 100 mg per dose, every two weeks for 12 weeks given undiluted by slow intravenous injection over 5 minutes or diluted in 25 mL of 0.9% NaCl and administered over 5 to 60 minutes. Venofer treatment may be repeated if necessary.

Pediatric Patients (2 years of age and older) with NDD-CKD or PDD-CKD who are on erythropoietin therapy for iron maintenance treatment

The dosing for iron replacement treatment in pediatric patients with NDD-CKD or PDD-CKD has not been established.

For iron maintenance treatment: Administer Venofer at a dose of 0.5 mg/kg, not to exceed 100 mg per dose, every four weeks for 12 weeks given undiluted by slow intravenous injection over 5 minutes or diluted in 25 mL of 0.9% NaCl and administered over 5 to 60 minutes. Venofer treatment may be repeated if necessary.



CONTRAINDICATIONS:
Known hypersensitivity to Venofer

WARNINGS AND PRECAUTIONS
--Hypersensitivity Reactions: Observe for signs and symptoms of hypersensitivity during and after Venofer administration for at least 30 minutes and until clinically stable following completion of each administration. Only administer Venofer when personnel and therapies are immediately available for the treatment of serious hypersensitivity reactions.

---Hypotension: Venofer may cause hypotension. Monitor for signs and symptoms of hypotension during and following each administration of Venofer.

--Iron Overload: Regularly monitor hematologic responses during Venofer therapy. Do not administer Venofer to patients with iron overload.

ADVERSE REACTIONS
The most common adverse reactions (greater than or equal2%) following the administration of Venofer are diarrhea, nausea, vomiting, headache, dizziness, hypotension, pruritus, pain in extremity, arthralgia, back pain, muscle cramp, injection site reactions, chest pain, and peripheral edema.

To report SUSPECTED ADVERSE REACTIONS, contact American Regent, Inc. at 1-800-734-9236 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

DOSAGE FORMS AND STRENGTHS:
Venofer is supplied sterile in 10 mL, 5 mL, and 2.5 mL single-use vials. Each 10 mL vial contains 200 mg elemental iron, each 5 mL vial contains 100 mg elemental iron, and each 2.5 mL vial contains 50 mg elemental iron (20 mg/mL).

10 mL single-use vial / 200 mg elemental iron (20 mg/mL)
5 mL single-use vial / 100 mg elemental iron (20 mg/mL)
2.5 mL single-use vial / 50 mg elemental iron (20 mg/mL)

Monitoring Parameters:
Patients receiving regular parenteral iron therapy require monitoring of hematologic parameters and iron indices (Hb, Hct, TSAT, and ferritin)
Sufficient IV iron should be administered to maintain TSAT between 20% and 50%. Iron therapy should be withheld in patients with TSAT greater than or equal50%
Iron therapy should be withheld in patients with ferritin values greater than or equal800 ng/mL. Since transferrin saturation values increase rapidly after IV administration of iron sucrose, serum iron values may be reliably obtained 48 hours after IV iron sucrose dosing .

Pharmacy Specifications:
Stability and storage
Contains no preservatives. Store in original carton at 20°C to 25°C (68° F to 77° F); excursions permitted to 15° to 30°C (59° to 86°F). [See USP Controlled Room Temperature]. Do not freeze.

Syringe Stability: Venofer, when diluted with 0.9% NaCl at concentrations ranging from 2 mg to 10 mg of elemental iron per mL, or undiluted (20 mg elemental iron per mL) and stored in a plastic syringe, was found to be physically and chemically stable for 7 days at controlled room temperature (25°C ± 2°C) and under refrigeration (4°C ± 2°C).

IV Admixture Stability: Venofer, when added to IV infusion bags (PVC or non-PVC) containing 0.9% NaCl at concentrations ranging from 1 mg to 2 mg of elemental iron per mL, has been found to be physically and chemically stable for 7 days at controlled room temperature (25°C ± 2°C).

Do not dilute to concentrations below 1 mg/mL.

Do not mix Venofer with other medications or add to parenteral nutrition solutions for intravenous infusion.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to infusion.

Source:
Package Insert data: 

AMERICAN REGENT, INC.
SHIRLEY, NY 11967

Venofer is manufactured under license from Vifor (International) Inc., Switzerland.

Revised: 9/2012

INJECTAFER® (ferric carboxymaltose injection) top of page

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

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.

WARNINGS AND PRECAUTIONS:
  1. 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.
  2. 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].
  3. 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.
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.

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.

SUMMARY

[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. 
 -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.
[15 mg/kg]  [250 ml]  [15-20 minutes]


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

Sodium Ferric gluconate complex - Ferrlecit®: top of page

INDICATIONS AND USAGE:
Ferrlecit is an iron replacement product for treatment of iron deficiency anemia in adult patients and in pediatric patients age 6 years and older with chronic kidney disease receiving hemodialysis who are receiving supplemental epoetin therapy.

DOSAGE AND ADMINISTRATION:
Summary:
  • Adult Patients - The recommended adult dosage is 10mL (125 mg of elemental iron) diluted in 100 mL of 0.9% sodium chloride administered by intravenous infusion over 1 hour per dialysis session or undiluted as a slow intravenous injection (at a rate of up to 12.5 mg/min) per dialysis session.
  • Pediatric Patients - The recommended pediatric dosage is 0.12 mL/kg (1.5 mg/kg of elemental iron) diluted in 25 mL 0.9% sodium chloride and administered by intravenous infusion over 1 hour per dialysis session.
  • Do not mix Ferrlecit with other medications or add to parenteral nutrition solutions for intravenous infusion.
  • Administer in 0.9% saline

Detailed info
The dosage of Ferrlecit is expressed in terms of mg of elemental iron. Each 5 mL sterile, single-use ampule or vial contains 62.5 mg of elemental iron (12.5 mg/mL).

Do not mix Ferrlecit with other medications, or add to parenteral nutrition solutions for intravenous infusion. The compatibility of Ferrlecit with intravenous infusion vehicles other than 0.9% sodium chloride has not been evaluated. Parenteral drug products should be inspected visually for particulate matter and discoloration before administration, whenever the solution and container permit. If diluted, use immediately.

Ferrlecit treatment may be repeated if iron deficiency reoccurs.

Adult Dosage and Administration
The recommended dosage of Ferrlecit for the repletion treatment of iron deficiency in hemodialysis patients is 10 mL of Ferrlecit (125 mg of elemental iron). Ferrlecit may be diluted in 100 mL of 0.9% sodium chloride administered by intravenous infusion over 1 hour per dialysis session. Ferrlecit may also be administered undiluted as a slow intravenous injection (at a rate of up to 12.5 mg/min) per dialysis session. For repletion treatment most patients may require a cumulative dose of 1000 mg of elemental iron administered over 8 dialysis sessions. Ferrlecit has been administered at sequential dialysis sessions by infusion or by slow intravenous injection during the dialysis session itself.

Data from Ferrlecit postmarketing spontaneous reports indicate that individual doses exceeding 125 mg may be associated with a higher incidence and/or severity of adverse events.

Pediatric Dosage and Administration
The recommended pediatric dosage of Ferrlecit for the repletion treatment of iron deficiency in hemodialysis patients is 0.12 mL/kg Ferrlecit (1.5 mg/kg of elemental iron) diluted in 25 mL 0.9% sodium chloride and administered by intravenous infusion over 1 hour per dialysis session. The maximum dosage should not exceed 125 mg per dose.


CONTRAINDICATIONS:
Known hypersensitivity to sodium ferric gluconate or any of its inactive components.

WARNINGS AND PRECAUTIONS
  • Hypersensitivity Reactions: Monitor patients for signs and symptoms of hypersensitivity during and after Ferrlecit administration for at least 30 minutes and until clinically stable following completion of the infusion. Only administer Ferrlecit when personnel and therapies are immediately available for the treatment of anaphylaxis and other hypersensitivity reactions.
  • Hypotension: Ferrlecit may cause hypotension. Monitor patients for signs and symptoms of hypotension during and following each Ferrlecit dose.
  • Iron Overload: Regularly monitor hematologic responses during Ferrlecit therapy. Do not administer Ferrlecit to patients with iron overload.
  • Benzyl Alcohol Toxicity: Premature and low-birthweight infants may be more likely to develop toxicity.
ADVERSE REACTIONS
The most commonly reported adverse reactions (greater than or equal10%) in adult patients were nausea, vomiting and/or diarrhea, injection site reaction, hypotension, cramps, hypertension, dizziness, dyspnea, chest pain, leg cramps and pain. In patients 6 to 15 years of age the most common adverse reactions (greater than or equal10%) were hypotension, headache, hypertension, tachycardia and vomiting.

DOSAGE FORMS AND STRENGTHS::
Ferrlecit is supplied in a single use ampule or vial containing 62.5 mg of elemental iron in 5 mL.

Source:
Package Insert data: 
sanofi-aventis U.S. LLC
Bridgewater, NJ 08807
©2011 sanofi-aventis U.S. LLC
Revised: 8/2011

TRIFERIC ® (ferric pyrophosphate citrate) solution  top of page


Drug UPDATES:  TRIFERIC ® (ferric pyrophosphate citrate) solution
[Drug information  /  PDF]   led
Dosing:  Click (+) next to Dosage and Administration section (drug info link)

Initial U.S. Approval:  2015

Mechanism of Action: Triferic contains iron in the form of ferric pyrophosphate citrate and is added to hemodialysate solution to be administered to patients by transfer across the dialyzer membrane. Iron delivered into the circulation binds to transferrin for transport to erythroid precursor cells to be incorporated into hemoglobin.

INDICATIONS AND USAGE:
TRIFERIC is indicated for the replacement of iron to maintain hemoglobin in adult patients with hemodialysis-dependent chronic kidney disease (HDD- CKD).

Limitation of Use
Triferic is not intended for use in patients receiving peritoneal dialysis. ( 1.1)
Triferic has not been studied in patients receiving home hemodialysis ( 1.1)


HOW SUPPLIED:
Ampule: 27.2 mg of iron (III) per 5 mL (5.44 mg of iron (III) per mL).
Multiple dose ampule 272 mg iron (III) per 50 mL .(5.44 mg Fe (III)/mL)


Reference(s)

National Institutes of Health, U.S. National Library of Medicine, DailyMed Database.
Provides access to the latest drug monographs submitted to the Food and Drug Administration (FDA). Please review the latest applicable package insert for additional information and possible updates.  A local search option of this data can be found here.

Disclaimer

Listed dosages are for - Adult patients ONLY. 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. GlobalRPH does not directly or indirectly practice medicine or provide medical services and therefore assumes no liability whatsoever of any kind for the information and data accessed through the Service or for any diagnosis or treatment made in reliance thereon.

David F. McAuley, Pharm.D., R.Ph.  GlobalRPh Inc.
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