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Dexferrum Prices from CanadianPharmacyKing

Dexferrum 50 mg/ml

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$367.00

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$ 367.00

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1 container (1): Dexferrum 50 mg/ml: $367.00

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Dexferrum Information

Company Name: American Regent, Inc.

Dexferrum (Iron)

Dexferrum (Iron) Warning: Risk For Anaphylactic-type Reactions

Anaphylactic-type reactions, including fatalities, have followed the parenteral administration of iron dextran injection.

Dexferrum (Iron) Description

Dexferrum (Iron) (IRON DEXTRAN INJECTION) is a dark brown, slightly viscous sterile liquid complex of ferric oxyhydroxide for intravenous use. Each mL contains: 50 mg elemental iron as an iron dextran complex. Sodium chloride may have been added for tonicity. Water for injection q.s. pH (range 4.5-7.0) adjusted with hydrochloric acid and, if necessary, sodium hydroxide. Sterile, nonpyrogenic.

Therapeutic Class: Hematinic

Dexferrum (Iron) Indications And Usage

Dexferrum (Iron) is indicated for treatment of patients with documented iron deficiency in whom oral administration is unsatisfactory or impossible.

Dexferrum (Iron) Contraindications

Hypersensitivity to the product. All anemias not associated with iron deficiency.

Dexferrum (Iron) Warnings

Risk for Anaphylactic-type Reactions:
The factors that affect the risk for anaphylactic-type reactions to iron dextran products are not fully known but limited clinical data suggest the risk may be increased among patients with a history of drug allergy or multiple drug allergies. Additionally, concomitant use of angiotensin-converting enzyme inhibitor drugs may increase the risk for reactions to an iron dextran product. The extent of risk for anaphylactic-type reactions following exposure to any specific iron dextran product is unknown and may vary among the products. Iron dextran products differ in chemical characteristics and may differ in clinical effects. Iron dextran products are not clinically interchangeable.

Delayed Reactions:
The maximum daily dose should not exceed 2 mL undiluted iron dextran.

Risks in Patients with Underlying Conditions:
Adverse reactions experienced following administration of Dexferrum (Iron) may exacerbate cardiovascular complications in patients with pre-existing cardiovascular disease.

Carcinogenesis:
The long latent period between the injection of a potential carcinogen and the appearance of a tumor makes it impossible to measure accurately the risk in man. There have, however, been several reports in the literature describing tumors at the injection site in humans who had previously received intramuscular injections of iron-carbohydrate complexes.

Dexferrum (Iron) Precautions

General:
Dexferrum (Iron) 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, administer a test dose prior to the first administration of Dexferrum (Iron) . (See and

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.) 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 Dexferrum (Iron) .

Information For Patients:

Drug/Laboratory Test Interactions:
The drug may cause falsely elevated values of serum bilirubin and falsely decreased values of serum calcium.

Serum iron determinations (especially by colorimetric assays) may not be meaningful for 3 weeks following the administration of iron dextran.

Serum ferritin peaks approximately 7 to 9 days after an intravenous dose of Dexferrum (Iron) and slowly returns to baseline after about 3 weeks.

Examination of the bone marrow for iron stores may not be meaningful for prolonged periods following iron dextran therapy because residual iron dextran may remain in the reticuloendothelial cells.

Bone scans with 99m Tc-labeled bone seeking agents, in the presence of high serum ferritin levels or following iron dextran infusions, have been reported to show reduction of bony uptake, marked renal activity, and excessive blood pool and soft tissue accumulation.

Carcinogenesis, Mutagenesis, Impairment Of Fertility:
No consistent adverse fetal effects were observed in mice, rats, rabbits, dogs and monkeys at doses of 50 mg iron/kg or less. Fetal and maternal toxicity has been reported in monkeys at a total intravenous dose of 90 mg iron/kg over a 14 day period. Similar effects were observed in mice and rats on administration of a single dose of 125 mg iron/kg. Fetal abnormalities in rats and dogs were observed at doses of 250 mg iron/kg and higher. The animals used in these tests were not iron deficient. There are no adequate and well-controlled studies in pregnant women. Dexferrum (Iron) should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Placental Transfer:

Nursing Mothers:

Pediatric Use:

Dexferrum (Iron) Overdosage

Overdosage with iron dextran is unlikely to be associated with any acute manifestations. Dosages of iron dextran in excess of the requirements for restoration of hemoglobin and replenishment of iron stores may lead to hemosiderosis. Periodic monitoring of serum ferritin levels may be helpful in recognizing a deleterious progressive accumulation of iron resulting from impaired uptake of iron from the reticuloendothelial system in concurrent medical conditions such as chronic renal failure, Hodgkins disease, and rheumatoid arthritis. The LD of iron dextran is not less than 500 mg/kg in the mouse.

Dexferrum (Iron) Dosage And Administration

Oral iron should be discontinued prior to administration of Dexferrum (Iron) .

Dexferrum (Iron) How Supplied

Dexferrum (Iron) (Iron Dextran Injection) containing 50 mg of elemental iron per mL.

Store at 20° - 25°C (68° - 77°F); excursions permitted to 15° - 30°C (59° - 86°F) (See USP Controlled Room Temperature).

Dexferrum (Iron) References:

IN0234Rev. 8/08 U.S. Patent 5,624,668MG #7721

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