Concomitant use may increase the risk for anaphylactic-type reactions to iron dextran product.
Source: NLP:iron dextran
Iron Dextran Interactions
Brand names: Infed
Route: Intramuscular, Intravenous
FDA Black Box Warning
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. If no signs or symptoms of anaphylactic-type reactions follow the test dose, administer the full therapeutic INFeD dose. During all INFeD administrations, observe for signs or symptoms of anaphylactic-type reactions. Fatal reactions have been reported following the test dose of iron dextran injection. Fatal reactions have also occurred in situations where the test dose was tolerated. Use INFeD 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 INFeD. WARNING: RISK FOR ANAPHYLACTIC-TYPE REACTIONS See full prescribing information for complete boxed warning. Anaphylactic-type reactions, including fatalities, have been reported following the parenteral administration of iron dextran injection. ( 5.1 ) 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. If no signs or symptoms of anaphylactic-type reactions follow the test dose, administer the full therapeutic INFeD dose. During all INFeD administrations, observe for signs or symptoms of anaphylactic-type reactions. Fatal reactions have been reported following the test dose of iron dextran injection. Fatal reactions have also occurred in situations where the test dose was tolerated. Use INFeD only in patients in whom clinical and laborato
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 )
Pregnancy & Breastfeeding
8.1 Pregnancy Risk Summary Parenteral iron administration may be associated with hypersensitivity reactions [see Warnings and Precautions ( 5.1 )] , which may have serious consequences, such as fetal bradycardia (see Clinical Considerations). Advise pregnant persons of the potential risk to the fetus. Available data from postmarketing reports with iron dextran use in pregnancy are insufficient to assess the risk of major birth defects or miscarriage. There are risks to the pregnant person and fetus associated with untreated iron deficiency anemia in pregnancy ( see Clinical Considerations). 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 the maximum human dose. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defects, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. Clinical Considerations Disease-Associated Maternal and/or Embryo/Fetal Risk Untreated iron deficiency anemia (IDA) in pregnancy is associated with adverse maternal outcomes such as post-partum anemia. Adverse pregnancy outcomes associated with IDA include increased risk for preterm delivery and low birth weight. Fetal /Neonatal Adverse Reactions Severe adverse reactions including circulatory failure (severe hypotension, shock including in the context of anaphylactic reaction) may occur in pregnant persons with intravenous iron administration (such as INFeD) which may have serious consequences on the fetus such as fetal bradycardia, especially during the second and third trimester. Data Animal Data 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 ha
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