Infed

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.

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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)

5.1Hypersensitivity Reactions

Serious hypersensitivity reactions, including anaphylactic-type reactions, some of which have been life-threatening and fatal, have been reported following the parenteral administration of iron dextran products, including INFeD. Such reactions have been generally characterized by sudden onset of respiratory difficulty and/or cardiovascular collapse. Fatal reactions have been reported following the test dose of iron dextran and have also occurred in situations where the test dose was tolerated.

Administer only in a setting where resuscitation equipment and medications are available. Administer a test dose of INFeD prior to the first therapeutic dose [see Dosage and Administration (2.4)]. Observe patients for at least one hour after the test dose before administering the remainder of the initial therapeutic dose. During all INFeD administrations, observe patients for signs or symptoms of anaphylactic-type reactions.

Use INFeD only in patients in whom clinical and laboratory investigations have established an iron deficient state not amenable to oral iron therapy. 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. If hypersensitivity reactions occur during administration, stop INFeD immediately and manage reaction medically.