DaTscan™

PRODUCT INDICATION AND USE

DATSCAN is indicated as an adjunct to other diagnostic evaluations for striatal dopamine transporter visualization using single photon emission computed tomography (SPECT) brain imaging in adult patients with:

Important Safety Information About DaTscan™ (ioflupane I 123 injection)

CONTRAINDICATIONS

• • DaTscan is contraindicated in patients with known serious hypersensitivity to ioflupane I 123

WARNINGS AND PRECAUTIONS

• • Hypersensitivity Reactions: Hypersensitivity reactions, including dyspnea, edema, rash, erythema, and pruritus, have been reported following DaTscan administration.
• • Thyroid Accumulation: DaTscan may contain up to 6% of free iodide (iodine-123). Thyroid uptake of iodine-123 may result in an increased long-term risk for thyroid neoplasia. To decrease thyroid accumulation of iodine-123, block the thyroid gland before administration of DaTscan.

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 DaTscan image. The impact of dopamine agonists and antagonists on DaTscan imaging results has not been established.

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 DaTscan in a pregnant woman. All radiopharmaceuticals have potential to cause fetal harm. There are no available data on DaTscan use in pregnant women to evaluate for a drug- associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. Advise pregnant woman of the potential risks of fetal exposure to radiation with the administration of DaTscan.
• • Lactation: Iodine 123 (I 123), the radionuclide in DaTscan, 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 DaTscan administration to minimize radiation exposure to a breastfeeding infant.
• • Pediatric Use: The safety and efficacy of DaTscan 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 observed in the parkinsonian syndrome studies.
• • Renal Impairment: DaTscan is excreted by the kidney and patients with severe renal impairment may have increased radiation exposure and altered DaTscan images.

OVERDOSAGE

• • The risks of overdose relate predominantly to increased radiation exposure, with the long-term risks for neoplasia. In case of overdosage of radioactivity, frequent urination and defecation should be encouraged to minimize radiation exposure to the patient.

PROCEDURE — Radiation Safety

• • DaTscan emits radiation and must be handled with safety measures to minimize radiation exposure to clinical personnel and patients.

Prior to DaTscan administration, please read the full Prescribing Information for additional Important Safety Information.

To report SUSPECTED ADVERSE REACTIONS, contact GE HealthCare at 800 654 0118 (option 2, then option 1) or the FDA at 800 FDA 1088 or www.fda.gov/medwatch.