Iodinated I-131 Albumin

MEGATOPE is indicated in adults for use in determinations of total blood and plasma volumes.

None Known.

Aseptic meningitis and pyrogenic reactions have been reported following cisternography with MEGATOPE. The safety and effectiveness of MEGATOPE for cisternography have not been established. MEGATOPE is not approved for this use.

General In the use of any radioactive material, care should be taken to minimize radiation exposure to the patient and healthcare providers consistent with proper patient management. Radiopharmaceuticals should be used by or under control of healthcare providers who are qualified by specific training and experience in the safe use and handling of radionuclides and whose experience and training have been approved by the appropriate government agency authorized to license the use of radionuclides. Carcinogenesis, Mutagenesis, Impairment of Fertility No long-term animal studies have been performed to evaluate carcinogenic potential or whether iodinated I 131 albumin affects fertility in males or females. Pregnancy Iodine-131 crosses the placenta and can permanently impair fetal thyroid function. MEGATOPE should be administered to a pregnant woman only if clearly needed. Administration of an appropriate thyroid blocking agent is recommended before use of MEGATOPE in a pregnant woman to protect the woman and fetus from accumulation of iodine-131 (see DOSAGE AND ADMINISTRATION). There are no data on iodinated I 131 albumin use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage or other adverse maternal or fetal outcomes. Animal reproduction studies have not been conducted. All radiopharmaceuticals have the potential to cause fetal harm depending on the fetal stage of development and the magnitude of the radiation 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 defect, 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. Nursing Mothers Iodine-131 is present in human milk. There are no data on the effect of iodinated I 131 albumin on the breastfed infant or milk production. Because of the potential for serious adverse reactions in the breastfed infant, including transient hypothyroidism, advise women not to breastfeed during treatment with MEGATOPE and for 80 days after the final dose. Pediatric Use Safety and effectiveness of MEGATOPE in pediatric patients have not been established. Geriatric Use Clinical studies of MEGATOPE did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients.

The following adverse reactions have been identified with the use of radioiodinated albumin products. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Immune System Disorders: Hypersensitivity