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IMPORTANT SAFETY INFORMATION for DaTscan (Ioflupane I 123 injection)
- DaTscan 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 DaTscan administration
Thyroid Accumulation: The DaTscan 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 DaTscan; failure to do so may increase the long-term risk for thyroid neoplasia
- 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
- 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
Renal and Hepatic Impairment: The effect of renal or hepatic impairment on DaTscan imaging has not been established. The kidney excretes DaTscan; patients with severe renal impairment may have increased radiation exposure and altered DaTscan images
- 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
- 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.
The information on this website is intended for use only by customers and healthcare professionals in the United States. GE, the GE Monogram, and DaTscan are trademarks of General Electric Company.
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