General: Because body iron excretion is limited and excess tissue iron can be hazardous, caution should be exercised to withhold iron administration in the presence of evidence of tissue iron overload. Patients receiving Maxifer require periodic monitoring of hematologic and hemanitic parameters (hemoglobin, hematocrit, serum ferritin and transferrin saturation). Iron therapy should be withheld in patients with evidence of iron overload. Transferrin saturation values increase rapidly after IV administration of iron sucrose; thus serum iron values may be reliably obtained 48 hrs after IV dosing. (See Dosage & Administration and Overdosage.)
Hypersensitivity Reactions: Serious hypersensitivity reactions have been rarely reported in patients receiving Maxifer. No life-threatening hypersensitivity reactions were observed in studies A, B, C and 2 post-marketing safety studies. Several cases of mild or moderate reports worldwide were observed between 1992 and 2002 based on estimated use in >2 million patients. (See Adverse Reactions.)
Hypotension: Hypotension has been reported frequently in hemodialysis patients receiving iron IV. Hypotension following administration of Maxifer may be related to rate of administration and total dose administered. Caution should be taken to administer Maxifer according to recommended guidelines. (See Dosage & Administration.)
Carcinogenicity, Mutagenicity & Impairment of Fertility: No long-term studies in animals have been performed to evaluate the carcinogenic potential of Maxifer. It was not genotoxic in the Ames test, the mouse lymphoma cell (L5178YfTK+/-) forward mutation test, the human lymphocyte chromosome aberration test or the mouse micronucleus test. Maxifer at IV doses up to iron 15 mg/kg/day (about 1.2 times the recommended maximum human dose on a body surface area basis) was found to have no effect on fertility and reproductive performance of male and female rats.
Use in pregnancy: Pregnancy Category B: Teratology studies have been performed in rats at IV doses up to iron 13 mg/kg/day (about 0.5 times the recommended maximum human dose on a body surface area basis) and rabbits at IV doses up to iron 13 mg/kg/day (about 1 times the recommended maximum human dose on a body surface area basis) and have revealed no evidence of impaired fertility or harm to the fetus due to Maxifer. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, Maxifer should be used during pregnancy only if clearly needed.
Use in lactation: Maxifer is excreted in milk of rats. It is not known whether Maxifer is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Maxifer is administered to a nursing woman.
Use in children: Safety and effectiveness of Maxifer in pediatric patients have not been established. In a country where Maxifer is available for use in children, at a single site, 5 premature infants (<1,250 g weight) developed necrotizing enterocolitis and 2 of the 5 expired during or following a period when they received Maxifer, several other medications and erythropoietin. Necrotizing enterocolitis may be a complication of prematurity in very low-birth weight infants. No causal relationship to Maxifer or any other drugs could be established.
Use in the elderly: Studies A, B and C did not include sufficient numbers of subjects ≥65 years to determine whether they respond differently from younger subjects. Of the 1,051 patients in 2 post-marketing safety studies of Maxifer, 40% were ≥65 years. No overall differences in safety were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.