"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) "...
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 )|
|Increased blood pressure||10 (1%)|
Read the Vizamyl (flutemetamol f 18 injection) Side Effects Center for a complete guide to possible side effects
Pharmacodynamic 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.
With in a clinical study of patients with a range of cognitive impairment, some patients were receiving the following medications: donepezil, galantamine, memantine, rivastigmine. Mean cortical Standardized Uptake Value (SUV) ratios did not differ between the patients taking or not taking these concomitant medications.
Last reviewed on RxList: 12/3/2013
This monograph has been modified to include the generic and brand name in many instances.
Additional Vizamyl Information
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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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