iron dextran complex (Rx)

Brand and Other Names:INFeD, Dexferrum
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

injectable solution

  • 50mg (Fe)/mL

Iron-deficiency Anemia

25-100 mg IV or deep IM qDay PRN

Not to exceed 100 mg (2 mL)/day

Iron deficiency: Dose = 0.0442(Desired Hgb - Observed Hgb) x Lean BW(kg) + (0.26 × Lean BW)

Blood loss: total iron dose in mg = blood loss (mL) x HCT

Dosage Forms & Strengths

injectable solution

  • 50mg (Fe)/mL

Iron-deficiency Anemia

>15 kg: 0.0442(Desired Hgb - Observed Hgb) x Lean BW(kg) + (0.26 × Lean BW)

5-15 kg

  • Not to be given in first 4 months of life
  • Dose = 0.0442(Desired Hgb - Observed Hgb) x BW(kg) + (0.26 × BW)
  • Desired hemoglobin usually 12 g/dL
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Interactions

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            Adverse Effects

            1-10%

            Abdominal pain

            Diarrhea

            Nausea

            Vomiting

            Arthralgia

            Arthritis

            Soreness

            Inflammation

            Pruritus

            Rash

            Urticaria

            Brown discoloration of skin

            Frequency Not Defined

            Seizure

            Chest pain

            Hypotensive shock

            Dyspnea

            Respiratory arrest

            Leukocytosis

            Anaphylaxis

            Hematuria

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            Warnings

            Black Box Warnings

            Anaphylactic type reactions, sometimes fatal, have occurred with parenteral use of this product.

            Have resuscitation equipment and personnel trained in detection and treatment of anaphylactic-type reactions readily available during administration.

            Administer a test dose prior to first therapeutic dose; if no signs or symptoms of anaphylactic-type reactions follow the test dose, administer the full therapeutic dose

            During all administrations, observe for signs or symptoms of anaphylactic-type reactions; fatal reactions reported following test dose of iron dextran injection; fatal reactions have also occurred in situations where test dose was tolerated

            Use drug only in patients in whom clinical and laboratory investigations have established an iron-deficient state not amenable to oral iron therapy

            Patients with a history of drug allergy or multiple drug allergies may be at increased risk of anaphylactic-type reactions to drug

            Contraindications

            History of hypersensitivity to product or excipients

            Cautions

            Iron overload

            • Excessive therapy with parenteral iron can lead to excess storage of iron with the possibility of iatrogenic hemosiderosis
            • All adult and pediatric patients receiving drug require periodic monitoring of hematologic and iron parameters (hemoglobin, hematocrit, serum ferritin and transferrin saturation); do not administer drug to patients with evidence of iron overload

            Risk of toxicity in patients with underlying conditions

            • Monitor for iron toxicity when drug is used in patients with serious impairment of liver function
            • May increase pathogenicity of certain microorganisms; product should not be used during acute phase of infectious kidney disease
            • Adverse reactions experienced following administration of drug may exacerbate cardiovascular complications in patients with pre-existing cardiovascular disease
            • Patients with rheumatoid arthritis may have an acute exacerbation of joint pain and swelling following the administration of iron dextran
            • Patients with history of significant allergies and/or asthma may have increased risk of hypersensitivity reactions

            Delayed reactions

            • Large intravenous doses, such as used with total dose infusions (TDI), associated with increased incidence of adverse reactions
            • Adverse reactions are frequently delayed (1 to 2 days) reactions typified by one or more of the following symptoms: arthralgia, backache, chills, dizziness, moderate to high fever, headache, malaise, myalgia, nausea, and vomiting
            • The onset is usually 24 to 48 hours after administration and symptoms generally subside within 3 to 4 days; etiology of reactions is not known; do not exceed a total daily dose of 2 mL undiluted iron dextran

            Hypersensitivity reactions

            • Serious hypersensitivity reactions, including anaphylactic-type reactions, some of which have been life-threatening and fatal, reported following parenteral administration of iron dextran products
            • Such reactions have been generally characterized by sudden onset of respiratory difficulty and/or cardiovascular collapse; fatal reactions reported following the test dose of iron dextran and have also occurred in situations where test dose was tolerated
            • Administer only in a setting where resuscitation equipment and medications are available; administer test dose prior to first therapeutic dose; observe patients for at least one hour after test dose before administering remainder of initial therapeutic dose
            • During all product administrations, observe patients for signs or symptoms of anaphylactic-type reactions
            • Use drug only in patients in whom clinical and laboratory investigations have established an iron deficient state not amenable to oral iron therapy
            • Factors that affect risk for anaphylactic-type reactions to iron dextran products are not fully known but limited clinical data suggest risk may be increased among patients with history of drug allergy or multiple drug allergies; additionally, concomitant use of angiotensin-converting enzyme inhibitor drugs may increase 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 products; if hypersensitivity reactions occur during administration, stop infusion immediately and manage reaction medically
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            Pregnancy & Lactation

            Pregnancy

            There are no adequate and well-controlled studies in pregnant women; should be used during pregnancy only if potential benefit justifies potential risk to fetus

            Severe adverse reactions including circulatory failure (severe hypotension, shock including in the context of anaphylactic reaction) may occur in pregnant women with parenteral iron products, which may cause fetal bradycardia, especially during second and third trimester

            Animal data

            • Iron dextran has been shown to be teratogenic and embryocidal in mice, rats, rabbits, dogs, and monkeys when given in doses of about 3 times maximum human dose; 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

            Lactation

            Exercise caution when product is administered to a nursing woman; traces of unmetabolized iron dextran are excreted in human milk

            Pregnancy Categories

            A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

            B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

            C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

            D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

            X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

            NA: Information not available.

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            Pharmacology

            Mechanism of Action

            Replacement of iron stores found in hemoglobin, myoglobin, and enzymes; works to transport oxygen via hemoglobin

            Pharmacokinetics

            Half-Life: 6 hr

            Onset: 7-9 days (serum ferritin peak)

            Peak Plasma Time: 10 days

            Absorption: Within 72 hr (IM)

            Excretion: Minimal through urine and feces

            Dialyzable: No

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            Administration

            IV Preparation

            Standard diluent: Dose/250-1000 mL 0.9% NaCl

            Minimum volume: 250 mL 0.9% NaCl

            IV Administration

            IV may be administered bolus at <50 mg/min or diluted in 250-1000 mL 0.9% NaCl

            Infuse over 1-6 hr; infuse initial 25 mL slowly

            Observe for allergic reactions; have epinephrine nearby

            IM Administration

            IM: Use z-track technique for IM administration (deep into upper outer quadrant of buttock)

            Observe for allergic reactions; have epinephrine nearby

            Storage

            Store at room temp

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            Formulary

            FormularyPatient Discounts

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            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
            2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
            3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
            4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
            PA Prior Authorization
            Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
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            Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.