ADVERSE REACTIONS: The most commonly reported adverse reactions in NDA clinical trials were flushing (2%) and increased blood pressure, headache, nausea, and dizziness (at 1% each). DRUG INTERACTIONS: Drug-drug interaction studies have not been performed in patients to establish the extent, if any, to which concomitant medications may alter Vizamyl image results.

SPECIFIC POPULATIONS -- Pregnancy: It is not known whether Vizamyl can cause fetal harm when administered to a pregnant woman or if it can affect reproductive capacity. Radiopharmaceuticals, including Vizamyl, have the potential to cause fetal harm, the likelihood of which depends on the stage of fetal development and the magnitude of the radiopharmaceutical dose. Vizamyl should be given to a pregnant woman only if clearly needed. Nursing Mothers: It is not known whether flutemetamol is excreted in human milk. Because many drugs are excreted in human milk and there is a potential for radiation exposure to nursing infants, avoid use of Vizamyl in a breastfeeding mother or have the mother temporarily interrupt breastfeeding for 24 hours after exposure. Pediatric Use: Vizamyl is not indicated for use in pediatric patients. Geriatric Use: No overall differences in safety were observed between older and younger subjects. OVERDOSAGE: The clinical consequence of overdosing with Vizamyl has not been reported. It is unknown whether or not flutemetamol is dialyzable. In case of overdose of radioactivity, hydration and frequent urination should be encouraged.


Prior to Vizamyl administration, please read the Full Prescribing Information.

CONTACT:

Andrew Ausanka-Crues
PR Manager, RadNet
(805) 451-0931
acrues@RadNet.com

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