Ioflupane I 123 Injection

CONTRAINDICATIONS

• Ioflupane I 123 Injection is contraindicated in patients with known hypersensitivity to the active substance, any of the excipients, or iodine

WARNINGS AND PRECAUTIONS

• Hypersensitivity Reactions: Hypersensitivity reactions, generally consisting of skin erythema and pruritus, have been reported following Ioflupane I 123 Injection administration
• Thyroid Accumulation: The Ioflupane I 123 Injection may contain up to 6% of free iodide (iodine 123 or I-123). To decrease thyroid accumulation of I-123, block the thyroid gland at least one hour before administration of Ioflupane I 123 Injection; failure to do so may increase the long-term risk for thyroid neoplasia

ADVERSE REACTIONS

• In clinical trials, headache, nausea, vertigo, dry mouth, or dizziness of mild to moderate severity were reported. In postmarketing experience, hypersensitivity reactions and injection-site pain have been reported

DRUG INTERACTIONS

• Drugs that bind to the dopamine transporter with high affinity may interfere with the Ioflupane I 123 Injection image. The impact of dopamine agonists and antagonists on Ioflupane I 123 Injection imaging results has not been established
• These potentially interfering drugs consist of: amoxapine, amphetamine, benztropine, bupropion, buspirone, cocaine, mazindol, methamphetamine, methylphenidate, norephedrine, phentermine, phenylpropanolamine, selegiline, and sertraline. Selective serotonin reuptake inhibitors (paroxetine and citalopram) may increase or decrease ioflupane binding to the dopamine transporter. Whether discontinuation of these drugs prior to Ioflupane I 123 Injection administration may minimize the interference with an Ioflupane I 123 Injection image is unknown

USE IN SPECIFIC POPULATIONS

• Pregnancy: Radioactive iodine products cross the placenta and can permanently impair fetal thyroid function. Administration of a thyroid blocking agent is recommended before the use of Ioflupane I 123 Injection in a pregnant woman. All radiopharmaceuticals have potential to cause fetal harm. There are no available data on Ioflupane I 123 Injection use in pregnant woman to evaluate for a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. Advise pregnant women of the potential risks of fetal exposure to radiation with the administration of Ioflupane I 123 Injection
• Lactation: Iodine 123 (I 123), the radionuclide in Ioflupane I 123 Injection, is present in human milk. There is no information on the effects on breastfed infants or on milk. Advise a lactating woman to interrupt breastfeeding and pump and discard breast milk for at least 6 days after Ioflupane I 123 Injection administration to minimize radiation exposure to a breastfeeding infant
• Pediatric Use: The safety and efficacy of Ioflupane I 123 Injection have not been established in pediatric patients
• Geriatric Use: There were no differences in responses between elderly patients and younger patients that would require a dose adjustment
• Renal and Hepatic Impairment: The effect of renal or hepatic impairment on Ioflupane I 123 Injection imaging has not been established. The kidney excretes Ioflupane I 123 Injection; patients with severe renal impairment may have increased radiation exposure and altered Ioflupane I 123 Injection image

OVERDOSAGE

• It is unknown whether or not ioflupane is dialyzable. The major risks of overdosage relate to increased radiation exposure and long-term risk for neoplasia. In case of radioactivity overdosage, frequent urination and defecation should be encouraged to minimize radiation exposure to the patient

PROCEDURE — Radiation Safety

• Ioflupane I 123 Injection emits radiation and must be handled with safety measures to minimize radiation exposure to clinical personnel and patients

Prior to Ioflupane I 123 Injection administration, please read the full Prescribing Information for additional Important Risk Information.