INFeD

(IRON DEXTRAN INJECTION, USP)

WARNING: THE PARENTERAL USE OF COMPLEXES OF IRON AND CARBOHYDRATES HAS RESULTED IN ANAPHYLACTIC-TYPE REACTIONS. DEATHS ASSOCIATED WITH SUCH ADMINISTRATION HAVE BEEN REPORTED. THEREFORE, INFeD SHOULD BE USED ONLY IN THOSE PATIENTS IN WHOM THE INDICATIONS HAVE BEEN CLEARLY ESTABLISHED AND LABORATORY INVESTIGATIONS CONFIRM AN IRON DEFICIENT STATE NOT AMENABLE TO ORAL IRON THERAPY. BECAUSE FATAL ANAPHYLACTIC REACTIONS HAVE BEEN REPORTED AFTER ADMINISTRATION OF IRON DEXTRAN INJECTION, THE DRUG SHOULD BE GIVEN ONLY WHEN RESUSCITATION TECHNIQUES AND TREATMENT OF ANAPHYLACTIC AND ANAPHYLACTOID SHOCK ARE READILY AVAILABLE.

TEST DOSE REQUIRED: PRIOR TO RECEIVING THEIR FIRST INFeD THERAPEUTIC DOSE, ALL PATIENTS SHOULD BE GIVEN AN INTRAVENOUS OR INTRAMUSCULAR TEST DOSE OF 0.5 mL. (See PRECAUTIONS: General.) IF ADMINISTERED INTRAVENOUSLY, THE TEST DOSE SHOULD BE GIVEN AT A GRADUAL RATE OVER AT LEAST 30 SECONDS.

Although anaphylactic reactions known to occur following INFeD administration are usually evident within a few minutes, or sooner, it is recommended that a period of an hour or longer elapse before the remainder of the initial therapeutic dose is given.

Anaphylaxis and other hypersensitivity reactions have been reported after uneventful test doses as well as therapeutic doses of iron dextran injection. Therefore, administration of subsequent test doses during therapy should be considered.

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