Prior to receiving their first INFeD® therapeutic dose, all patients should be given
a test dose of 0.5 mL (25 mg). The test dose should be administered at a gradual
rate over at least 30 seconds.
Individual doses of 2 mL or less may be given on a daily basis until the calculated
total amount required has been reached. Administer undiluted at a slow, gradual
rate not to exceed 50 mg (1 mL) per minute.
Prior to the first intramuscular INFeD therapeutic dose, administer an intramuscular
test dose of 0.5 mL. Although anaphylactic reactions usually are 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.
If no adverse reactions are observed, INFeD® can be
given according to the following schedule until the calculated total amount required
has been reached.
Maximum daily dose of INFeD
Infants <5 kg (11 lbs)
0.5 mL (25 mg)
Children <10 kg (22 lbs)
1.0 mL (50 mg)
2.0 mL (100 mg)
Instructions for Intramuscular Administration
- Inject only into the muscle mass of the upper outer quadrant of the buttock (never
into the arm or other exposed areas)
- Inject deeply with a 2-inch or 3-inch 19-gauge or 20-gauge needle
- If the patient is standing, he/she should be bearing his/her weight on the leg opposite
the injection site, or if in bed, he/she should be in the lateral position with
the injection site uppermost
- Z-track technique is recommended to avoid injection or leakage into subcutaneous
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INFeD is indicated in the treatment of patients with documented iron deficiency in whom oral administration is unsatisfactory or impossible.
Important Safety Information
Anaphylactic-type reactions, including fatalities, have followed the parenteral administration of iron dextran injection. A test dose should be administered prior to the first therapeutic dose, followed by the full therapeutic dose if no signs or symptoms of anaphylactic-type reactions are seen. Resuscitation equipment and personnel trained in the detection and treatment of anaphylactic-type reactions must be readily available during all INFeD administrations. Patients should be observed for signs or symptoms of anaphylactic-type reactions during all INFeD administrations. Fatal reactions have followed the test dose and 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. INFeD should be used with caution in individuals with histories of significant allergies and/or asthma, and is contraindicated in patients with hypersensitivity to the product and patients with all anemias not associated with iron deficiency. INFeD should be used with extreme care in patients with serious impairment of liver function, and should not be used during the acute phase of infectious kidney disease. Unwarranted therapy with parenteral iron will cause excess storage of iron with the consequent possibility of exogenous hemosiderosis, which is particularly apt to occur in patients with hemoglobinopathies and other refractory anemias.