DaTscan — Important Safety Information for Consumers
What is DaTscanTM(Ioflupane I 123 Injection)
DaTscan is a radioactive drug that is injected into your bloodstream so that images can be taken with a
single-photon emission computed tomography (SPECT) camera. DaTscan may be used, in addition to
other diagnostic evaluations, to identify suspected Parkinsonian syndromes (PS) or suspected dementia
with Lewy bodies (DLB) in adults.
DaTscan is available only by prescription and may be ordered by your doctor.
Important Safety Information About DaTscan
You should not be given DaTscan if:
• You are sensitive to any of the ingredients of DaTscan. Talk with your doctor; he or she can help you
understand what the drug ingredients are
What is the most important information you should know about DaTscan?
• Allergic and injection-site reactions could occur following a DaTscan injection. If you have any symptoms of an allergic nature, including low blood pressure; trouble breathing; throat tightness; swelling of your face, lips, or tongue; or rash and itching, inform your doctor or go to your nearest emergency room right away
• To help decrease the amount of thyroid exposure to radiation: Your doctor will give you a medication at least one hour before you receive DaTscan. The purpose of this medication is to minimize the amount of radioactive iodine going into your thyroid gland
• Pregnancy: Clinical studies have not been conducted with DaTscan on pregnant women. Any radioactive drug, including DaTscan, may cause harm to the fetus. If you are pregnant or think you may be pregnant, talk to your doctor about whether receiving DaTscan is appropriate
• If you are a nursing mother, talk to your doctor about interrupting nursing after receiving DaTscan or not to receive DaTscan at all. If you receive DaTscan, pumping, and discarding breast milk for at least six days after receiving DaTscan can reduce the risks of radiation exposure to your nursing infant
• If you have kidney and/or liver problems: The effects of kidney and or liver damage from the use of DaTscan are not certain. DaTscan is removed by the kidney, and patients with severe kidney problems may have increased radiation exposure. Tell your doctor if you have reduced kidney or liver function
• Children: DaTscan is not approved for use in children
The most common side effects of DaTscan:
• The most commonly reported side effects include injection-site pain, headache, nausea and upset stomach, dry mouth, skin rash, hives, or dizziness
What you should know about taking DaTscan with other medications:
• Be sure to tell your doctor what drugs, including any over-the-counter medications, you are taking so that he or she can decide whether you should stop taking any of them for a period of time before using DaTscan
Questions about the procedure:
• Always talk with your doctor if you have any questions about the SPECT imaging procedure or the use of DaTscan
Your doctor should advise you to:
• Drink plenty of water prior to and after receiving DaTscan, and go to the bathroom frequently for the first 48 hours after receiving DaTscan
The safety information included here is not comprehensive. If you have any questions, please be sure to discuss them with your doctor.
For more information about DaTscan, call GE Healthcare Customer Service at 800 292 8514.
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.
Please see the full Prescribing Information for DaTscan at www.Datscan.com.