CONTRAINDICATIONS

WARNINGS AND PRECAUTIONS

Hypersensitivity Reactions: Reactions such as flushing and dyspnea have been observed within minutes following administration and may occur in patients with no history of exposure to Vizamyl. Before administering Vizamyl, ask patients about prior reactions to drugs, especially those containing polysorbate 80. Have resuscitation equipment and trained personnel available

Risk for Image Misinterpretation and Other Errors: Errors may occur while interpreting Vizamyl positron-emission tomography (PET) images. Image interpretation is performed independently of the patient’s clinical information. The use of clinical information in the interpretation of Vizamyl images has not been evaluated and may lead to errors. Extensive brain atrophy may limit the ability to distinguish grey and white matter on a Vizamyl scan. Motion artifacts may distort the image. Images should be interpreted only by readers who have completed a reader training program available from GE Healthcare
Radiation Risk: Like all radiopharmaceuticals, Vizamyl contributes to a patient’s long-term, cumulative radiation exposure and cancer risk. Ensure safe handling to protect patients and healthcare workers from unintentional radiation exposure

ADVERSE REACTIONS

The most commonly reported adverse reactions in clinical trials were flushing (2%), increased blood pressure (2%), headache (1%), nausea and dizziness (1%)

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

USE IN SPECIFIC POPULATIONS

Pregnancy: All radiopharmaceuticals, including Vizamyl, have potential to cause fetal harm. There are no available data on Vizamyl in pregnant woman to evaluate drug associated risk of major birth defects, miscarriage or adverse maternal or fetal outcome Advise women about the potential for adverse pregnancy outcomes based on the radiation dose and gestational timing of exposure
Lactation: There are no data on presence of flutemetamol or its metabolites in human milk. The benefits of breastfeeding should be considered along with the mother’s clinical need for Vizamyl and any potential adverse effects on the breastfed child. Because many drugs are excreted in human milk and there is a potential for radiation exposure to nursing infants, advise a lactating woman to interrupt breastfeeding and pump and discard breast milk for 24 hours after administration to minimize radiation exposure to a breastfeeding infant
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. The major risks of overdosage relate to increased radiation exposure and long-term risk for neoplasia. In case of overdose of radioactivity, hydration and frequent urination should be encouraged

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

To report SUSPECTED ADVERSE REACTIONS, contact GE Healthcare at 800-654-0118 or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

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