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Vizamyl

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Vizamyl

WARNINGS

Included as part of the PRECAUTIONS section.

PRECAUTIONS

Hypersensitivity Reactions

Hypersensitivity reactions such as flushing and dyspnea have been observed within minutes following Vizamyl administration. These reactions may occur in patients with no history of prior exposure to Vizamyl.

Before administering Vizamyl, as k patients about prior reactions to drugs, especially those containing polysorbate 80.

Have resuscitation equipment and trained personnel immediately available at the time of Vizamyl administration [see CONTRAINDICATIONS].

Risk For Image Misinterpretation And Other Errors

Errors may occur while using Vizamyl PET images to estimate brain neuritic plaque density [see Clinical Studies].

Image interpretation is performed in dependently 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 [see DOSAGE AND ADMINISTRATION]. Motion artifacts may distort the image [see DOSAGE AND ADMINISTRATION].

Vizamyl scan results are indicative of the brain neuritic amyloid plaque content only at the time of image acquisition and a negative scan result does not preclude the development of brain amyloid in the future.

Radiation Risk

Vizamyl, similar to other radio pharmaceuticals , contributes to a patient's overall long-term cumulative radiation exposure. Long-term cumulative radiation exposure is associated with an increased risk of cancer. Ensure safe handling to protect patients and health care workers from unintentional radiation exposure [see DOSAGE AND ADMINISTRATION].

Nonclinical Toxicology

Carcinogenesis, Mutagenesis, Impairment of Fertility

Animal studies have not been performed to evaluate the carcinogenicity potential of flutemetamol. Flutemetamol was positive for mutagenicity in two in vitro assays: the bacterial reverse mutation assay (Ames test) and the mouse lymphoma assay.

Flutemetamol was negative for genotoxicity after in vivo exposure in rats to flutemetamol at the highest cumulative dose level tested, as measured in bone marrow micronucleus assays (157 and 27 micro gram/kg/day for 2 and 14 days respectively) and an unscheduled DNA synthesis assay in rat hepatocytes (39 micro gram/kg/day).

Use In Specific Populations

Pregnancy

Pregnancy Category C

It is not known whether Vizamyl can cause fetal harm when administered to a pregnant woman or if it can affect reproduction capacity. Animal reproduction studies have not been conducted with Vizamyl. All radio pharmaceuticals, including Vizamyl, have the potential to cause fetal harm. The likelihood of fetal harm depends on the stage of fetal development, and the magnitud of the radiopharmaceutical dose. Vizamyl should be given to a pregnant woman only if clearly needed. Assess pregnancy status before administering Vizamyl to a female of reproductive potential.

Nursing Mothers

It is not known whether flutemetamol is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for radiation expo sure to nursing infants from Vizamyl, avoid use of the drug in a breastfeeding mother or have the mother temporarily interrupt breastfeeding for 24 hours (greater than 10 half-lives of radioactive decay for the F 18 isotope) after exposure to Vizamyl. If breastfeeding is interrupted, the patient should pump and discard her breast milk and use alternate infant nutrition sources (e.g., stored breast milk or infant formula) for 24 hours after administration of the drug.

Pediatric Use

Vizamyl is not indicated for use in pediatric patients.

Geriatric Use

Of the 761 subjects in clinical studies of Vizamyl, 447 (59%) were 65 y ears or over, while 246 (32%) were 75 years or over. No overall differences in safety were observed between these subjects and younger subjects.

Last reviewed on RxList: 12/3/2013
This monograph has been modified to include the generic and brand name in many instances.

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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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