VIZAMYL
Clinical safety rating: caution
Comprehensive clinical and safety monograph for VIZAMYL (VIZAMYL).
Vizamyl is a radiopharmaceutical that binds to beta-amyloid plaques in the brain, enabling visualization via PET imaging.
| Metabolism | Flutemetamol F 18 is not metabolized; eliminated by renal and hepatobiliary routes. |
| Excretion | Primarily renal excretion as unchanged drug (90-95%) with the remainder excreted via feces (5-10%). |
| Half-life | Terminal elimination half-life is approximately 45-50 minutes in patients with normal renal function, allowing for rapid clearance and early imaging within 4 hours post-injection. |
| Protein binding | 95-98% bound to plasma proteins, primarily albumin. |
| Volume of Distribution | Volume of distribution is approximately 0.8-1.2 L/kg, indicating distribution beyond plasma into total body water and tissues. |
| Bioavailability | Intravenous: 100% bioavailability. |
| Onset of Action | Intravenous: Within minutes following injection, as the drug rapidly crosses the blood-brain barrier to bind to amyloid plaques. |
| Duration of Action | Duration of imaging window is approximately 15-20 minutes, with optimal scanning performed 30-60 minutes post-injection due to rapid clearance from normal brain tissue. |
For diagnostic imaging: 370 MBq (10 mCi) administered as a slow intravenous bolus (approximately 1 mL/sec).
| Dosage form | INJECTABLE |
| Renal impairment | No dose adjustment required for renal impairment; however, renal excretion is minimal (approximately 5% of injected dose). |
| Liver impairment | No specific dose adjustment guidelines for hepatic impairment. Use caution in severe hepatic disease due to potential for altered pharmacokinetics. |
| Pediatric use | Safety and efficacy in pediatric patients have not been established; not recommended for use in children. |
| Geriatric use | No specific dose adjustment required; clinical studies included patients aged 65 and older with no overall differences in safety or efficacy observed. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for VIZAMYL (VIZAMYL).
| Breastfeeding | It is not known whether flutemetamol F-18 is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for radiation exposure to nursing infants, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother. The M/P ratio is not known. |
| Teratogenic Risk | VIZAMYL (flutemetamol F-18) is a radiopharmaceutical diagnostic agent. There are no adequate and well-controlled studies in pregnant women. Animal reproduction studies have not been conducted. It is not known whether VIZAMYL can cause fetal harm when administered to a pregnant woman. The radiation exposure from the diagnostic dose is considered low, but the potential for fetal risk from radiation exists, especially during organogenesis in the first trimester. Use only if clearly needed and potential benefit justifies risk. |
■ FDA Black Box Warning
No boxed warning.
| Serious Effects |
["Hypersensitivity to flutemetamol F 18 or any component of the product."]
| Precautions | ["Risk of image misinterpretation; false positive or negative scans possible.","Not for predicting disease progression or monitoring treatment response.","Radiation exposure; risk cumulative."] |
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| Fetal Monitoring | No specific maternal or fetal monitoring is required beyond standard radiation safety precautions. Administered activity should be minimized, and ensure proper hydration to facilitate voiding and reduce radiation exposure. |
| Fertility Effects | No studies on fertility have been conducted. It is unknown whether VIZAMYL affects fertility in males or females. |