Iron Dextran

FDA Drug Information • Also known as: Infed, Iron Dextran

Brand Names: Infed, Iron Dextran
Dosage Form: POWDER
Product Type: BULK INGREDIENT

Description

11 DESCRIPTION INFeD (iron dextran injection USP) is an iron replacement product provided as a dark brown, slightly viscous sterile liquid complex of ferric hydroxide and dextran for intravenous or intramuscular use. Each mL contains the equivalent of 50 mg of elemental iron (as an iron dextran complex), approximately 0.9% sodium chloride, in water for injection. Sodium hydroxide and/or hydrochloric acid may have been used to adjust pH. The pH of the solution is between 4.5 to 7.0.

What Is Iron Dextran Used For?

1 INDICATIONS AND USAGE INFeD is indicated for treatment of adult and pediatric patients of age 4 months and older with documented iron deficiency who have intolerance to oral iron or have had an unsatisfactory response to oral iron. INFeD, an iron replacement product, is indicated for treatment of adult and pediatric patients of age 4 months and older with documented iron deficiency who have intolerance to oral iron or an unsatisfactory response to oral iron. (1)

Dosage and Administration

2 DOSAGE AND ADMINISTRATION 2.1 Important Pre-Treatment Information Discontinue administration of any iron-containing products prior to administration of INFeD. Assess baseline hematologic (hemoglobin and hematocrit) and iron storage parameters (serum iron, total iron binding capacity, and percent saturation of transferrin) to monitor response to therapy. Administer a test dose of INFeD prior to administration of therapeutic dose [see Dosage and Administration (2.4)]. 2.2 Recommended Dosage for Iron Deficiency Anemia Calculate the INFeD dose based upon Table 1 and formulas below. Continue INFeD until hemoglobin is within the normal range and iron stores are replete. Administer daily doses of no more than 2 mL of INFeD until the total required dose is administered. Monitor response to therapy by evaluating hematologic parameters (hemoglobin and hematocrit) and iron storage parameters (serum iron, total iron binding capacity, and percent saturation of transferrin). Iron storage parameters may improve prior to hematologic parameters. Serum ferritin may not be an accurate measure of body iron stores in patients on chronic dialysis. Table 1: Total INFeD Requirement for Hemoglobin Restoration and Iron Stores Replacement in Patients with Iron Deficiency Anemia* Alternatively, the total dose may be calculated using the formulas below: Adults and Children over 15 kg (33 lbs) Dose (mL) = 0.0442 (Desired Hb - Observed Hb) x LBW + (0.26 x LBW) Based on:

Desired Hb = the target hemoglobin in g/dL [Normal hemoglobin (males and females) for body weight over 15 kg (33 lbs) is 14.8 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

To calculate a patient's weight in kg when lbs are known: Weight in Kg Children 5 to 15 kg (11 to 33 lbs) Otherwise, the total dose may be calculated using the formula below: Dose (mL) = 0.0442 (Desired Hb - Observed Hb) x W + (0.26 x W) Based on:

Desired Hb = the target hemoglobin in g/dL [Normal hemoglobin for children with body weight of 15 kg (33 lbs) or less is 12 g/dL.]

W = body weight in kg

To calculate a patient's weight in kg when lbs are known: Weight in Kg 2.3 Recommended Dosage of Iron Replacement for Blood Loss Calculate the INFeD dose based upon the formula below which is based upon the approximate amount of blood loss and pretreatment hematocrit. The formula is based on the approximation that 1 mL of normocytic, normochromic red cells contains 1 mg of elemental iron. INFeD Dose (in mL) = [Blood loss (in mL) x hematocrit] ÷ 50 mg/mL Example: Blood loss of 500 mL with 20% hematocrit Replacement Iron = 500 x 0.20 = 100 mg INFeD dose volume = INFeD dose volume 2.4 Administration The...

Side Effects (Adverse Reactions)

6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: Hypersensitivity Reactions [see Warnings and Precautions (5.1)] Delayed Reactions [see Warnings and Precautions (5.2)] Increased Risk of Toxicity in Patients with Underlying Conditions [see Warnings and Precautions (5.3)] Iron Overload [see Warnings and Precautions (5.4)] Fetal bradycardia [see Use in Specific Populations (8.1)] The following adverse reactions associated with the use of INFeD were identified in clinical studies or postmarketing reports. Because some of these reactions were reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Blood and lymphatic system disorders: Leukocytosis, lymphadenopathy. Cardiac disorders: Cardiac arrest, tachycardia, bradycardia, arrhythmias. Gastrointestinal disorders: Abdominal pain, nausea, vomiting, diarrhea. General disorders and administration site conditions: chest pain, chest tightness, weakness, malaise, febrile episodes, chills, shivering, sterile abscess, atrophy/fibrosis (intramuscular injection site), brown skin and/or underlying tissue discoloration (staining), soreness or pain at or near intramuscular injection sites, swelling, inflammation. Musculoskeletal and connective tissue disorders: Arthralgia, arthritis (may represent reactivation in patients with quiescent rheumatoid arthritis – [see Warnings and Precautions (5.3)], myalgia, backache. Nervous system disorders: Convulsions, seizures, syncope, headache, unresponsiveness, paresthesia, dizziness, numbness, unconsciousness, altered taste. Psychiatric disorders: Disorientation Respiratory, thoracic and mediastinal disorders: Respiratory arrest, dyspnea, bronchospasm, wheezing. Renal and urinary disorders: Hematuria. Skin and subcutaneous disorders: Urticaria, pruritus, purpura, rash, sweating. Vascular disorders: Cyanosis, shock, hypertension, hypotension, flushing (flushing and hypotension may occur from too rapid injections by the intravenous route), local phlebitis at or near intravenous injection site. Most common adverse reactions are nausea, vomiting, chest pain, backache, hypersensitivity, dyspnea, hypotension, pruritus, flushing, dizziness. (6) To report SUSPECTED ADVERSE REACTIONS, contact Allergan at 1-800-678-1605 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Drug Interactions

7 DRUG INTERACTIONS 7.1 Drug/Laboratory Test Interactions Drug interactions involving INFeD have not been studied. Concomitant use of angiotensin-converting enzyme inhibitor drugs may increase the risk for anaphylactic-type reactions to an iron dextran product. Large doses of iron dextran (5 mL or more) have been reported to give a brown color to serum from a blood sample drawn 4 hours after administration. INFeD 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 INFeD. 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 involving 99m Tc-diphosphonate have been reported to show a dense, crescentic area of activity in the buttocks, following the contour of the iliac crest, 1 to 6 days after intramuscular injections of INFeD. Bone scans with 99m Tc-labeled bone seeking agents, in the presence of high serum ferritin levels or following INFeD infusions, have been reported to show reduction of bony uptake, marked renal activity, and excessive blood pool and soft tissue accumulation.

Contraindications

4 CONTRAINDICATIONS INFeD is contraindicated in patients who have demonstrated a previous hypersensitivity to iron dextran [see Warnings and Precautions (5.1)]. Known hypersensitivity to INFeD (4)

Overdosage

10 OVERDOSAGE Excessive dosages of INFeD may lead to accumulation of iron in storage sites potentially leading to hemosiderosis. Do not administer INFeD to patients with iron overload [see Warnings and Precautions (5.4)]. INFeD is not removed by hemodialysis [see Clinical Pharmacology (12.3)].

How Supplied

16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 How Supplied INFeD (iron dextran injection USP) containing 50 mg of elemental iron per mL, is available as a dark brown, slightly viscous, sterile solution in 2 mL single-dose amber vials in cartons of 10 (NDC 0023-6082-10). Product repackaged by: Henry Schein, Inc., Bastian, VA 24314 From Original Manufacturer/Distributor's NDC and Unit of Sale To Henry Schein Repackaged Product NDC and Unit of Sale Total Strength/Total Volume (Concentration) per unit NDC 0023-6082-10 2 mL single dose amber vial in cartons of 10 NDC 0404-9879-02 1 2mL single dose vial in a bag (Vial bears NDC 0023-6082-10) 50 mg of elemental iron per mL 16.2 Stability and Storage Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F). [See USP Controlled Room Temperature].

About This Information

This drug information is sourced from FDA-approved labeling via the openFDA database. It is intended for educational and reference purposes only. This is not medical advice. Always consult your healthcare provider before making decisions about medication. Drug information may be updated by the FDA; check with your pharmacist for the most current information.

What are side effects?

Side effects are unwanted reactions that can occur when taking a medication. They range from mild (headache, nausea) to severe (allergic reactions, organ damage). Not everyone experiences side effects, and severity varies. Report any concerning side effects to your doctor.

What are drug interactions?

Drug interactions occur when a medication is affected by another drug, food, or supplement. Interactions can make medications less effective or cause dangerous side effects. Always tell your doctor about all medications and supplements you take.