Oral and parenteral Iron Products
Ferumoxytol - feraheme®
Feraheme® (ferumoxytol) Injection For Intravenous (IV) use Initial U.S. Approval: 2009 DESCRIPTION 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 INDICATIONS AND USAGE: DOSAGE AND ADMINISTRATION: 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: History of allergic reaction to any intravenous iron product. WARNINGS AND PRECAUTIONS ADVERSE REACTIONS DOSAGE FORMS AND STRENGTHS: Source: AMAG Pharmaceuticals Inc. |
Iron sucrose -venofer®
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 Pharmacodynamics INDICATIONS AND USAGE: DOSAGE AND ADMINISTRATION:
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) Adult Patients with Non-Dialysis Dependent-Chronic Kidney Disease (NDD-CKD) Adult Patients with Peritoneal Dialysis Dependent-Chronic Kidney Disease (PDD-CKD) Pediatric Patients (2 years of age and older) with HDD-CKD for iron maintenance treatment 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: WARNINGS AND PRECAUTIONS ---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 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: 10 mL single-use vial / 200 mg elemental iron (20 mg/mL) Monitoring Parameters: Pharmacy Specifications: 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: AMERICAN REGENT, INC. Venofer is manufactured under license from Vifor (International) Inc., Switzerland. Revised: 9/2012 |
Injectafer® (ferric carboxymaltose injection)
Mechanism of Action: Ferric carboxymaltose is a colloidal iron (III) hydroxide in complex with carboxymaltose, a carbohydrate polymer that releases iron. INDICATIONS AND USAGE: USE IN SPECIFIC POPULATIONS -------------- 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 Pediatric Use Geriatric Use WARNINGS AND PRECAUTIONS: DOSAGE AND ADMINISTRATION 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 ]
-OR- Each mL of Injectafer contains 50 mg of elemental iron. [Patients weighing LESS than 50 kg (110 lb) ]
-OR- 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 |
Sodium ferric gluconate complex - ferrlecit®
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:
Detailed info: 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 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 CONTRAINDICATIONS: WARNINGS AND PRECAUTIONS
ADVERSE REACTIONS DOSAGE FORMS AND STRENGTHS:: Source: |
Triferic ® (ferric pyrophosphate citrate) solution
Drug UPDATES: TRIFERIC ® (ferric pyrophosphate citrate) solution [Drug information / PDF] 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: Limitation of Use HOW SUPPLIED:
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Low-molecular-weight dextran - Infed®
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 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.
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]
Background
Normal Serum Iron Levels |
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Males (adult) | 75 - 175 mcg/dL |
Females (adult) | 65 - 165 mcg/dL |
Children | 50 - 120 mcg/dL |
Oral Iron Supplements |
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Iron Supplement | Tablet Size | Elemental Iron | Usual Dose for Iron deficiency anemia1 |
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: Prophylaxis: 60 mg of elemental Fe (iron) orally every day. Recommended Daily Intake Administration |
Parenteral Iron Formulations |
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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® | ---- | ||
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) |
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: 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). |
250 mg IV over 1 hour (4.2 mg/min) |
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. |
Reference(s)
National Institutes of Health, U.S. National Library of Medicine, DailyMed Database.
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