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Vizamyl

"The U.S. Food and Drug Administration today approved Vizamyl (flutemetamol F 18 injection), a radioactive diagnostic drug for use with positron emission tomography (PET) imaging of the brain in adults being evaluated for Alzheimer's disease (AD) "...

Vizamyl

Vizamyl Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Vizamyl (flutemetamol F 18) Injection is a molecular imaging agent used for Positron Emission Tomography (PET) imaging of the brain to estimate beta-amyloid neuritic plaque density in adult patients with cognitive impairment who are being evaluated for Alzheimer's Disease (AD) and other causes of cognitive decline. Common side effects include flushing, increased blood pressure, headache, nausea, and dizziness.

The recommended dose for Vizamyl is 185 megabecquerels (MBq) [5 millicuries (mCi)] in a maximum dose volume of10 mL, administered as a single intravenous bolus with in 40 seconds. The maximum mass dose is 20 micro grams. Vizamyl may interact with other drugs. Tell your doctor all medications and supplements you use. During pregnancy, Vizamyl should be used only if prescribed. Vizamyl should not be used during breastfeeding for 24 hours after exposure to Vizamyl. Consult your doctor before breastfeeding.

Our Vizamyl (flutemetamol F 18) Injection Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Vizamyl FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

Clinical Trials Experience

Clinical trials are conducted under widely varying conditions and adverse reaction rates observed in the clinical trials of Vizamyl cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.

In clinical trials , 761 adults (367 men and 394 women, 91% Caucasian) with a mean age of62 years (range 18-93 years) received Vizamyl. Most subjects (530, 70%) received a do se of 185 M Bq (5 mCi).

One subject out of 761 administered Vizamyl experienced a serious hypersensitivity reaction with flushing, dyspnea and chest pressure within minutes following Vizamyl administration and recovered with treatment.

Most adverse reactions were mild to moderate in intensity and resolved spontaneously. The most commonly reported adverse reactions (occurring in at least 1% of subjects) in Vizamyl-treated subjects are shown in Table 2.

Table 2: Adverse Reactions Reported in Clinical Trials of Vizamyl (N = 761 subjects)

Adverse Reaction N (percent of patients )
Flushing 16 (2%)
Increased blood pressure 10 (1%)
Headache 10 (1%)
Nausea 8 (1%)
Dizziness 8 (1%)

Read the entire FDA prescribing information for Vizamyl (Flutemetamol F 18 Injection) »

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Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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