Iron dextran

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.

The circulating iron released from iron dextran, which is subject to physiological control, replenishes hemoglobin and depleted iron stores.

See Full Prescribing Information for weight-based dosing and administration information. Weight in Kg Weight in Kg INFeD dose volume 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. 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.

INFeD is contraindicated in patients who have demonstrated a previous hypersensitivity to iron dextran. Known hypersensitivity to INFeD

Boxed warning (risk for anaphylactic-type reactions): Anaphylactic-type reactions, including fatalities, have been reported following the parenteral administration of iron dextran injection. Have resuscitation equipment and personnel trained in the detection and treatment of anaphylactic-type reactions readily available during INFeD administration. Administer a test INFeD dose prior to the first therapeutic dose. Delayed Reactions: May occur with large intravenous doses. Increased Risk of Toxicity in Patients with Underlying Conditions: Monitor for toxicity in these patients. Iron Overload: Excessive therapy can lead to iatrogenic hemosiderosis. Do not administer to patients with iron overload. Periodically monitor hematologic and iron parameters.

The following clinically significant adverse reactions are described elsewhere in the labeling: Hypersensitivity Reactions Delayed Reactions Increased Risk of Toxicity in Patients with Underlying Conditions Iron Overload Fetal bradycardia 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. Gastrointestinal disorders: Abdominal pain, nausea, vomiting, diarrhea.

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.

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).