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. |
| Molecular Weight | 286.3 |
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 | No adequate human studies; animal studies show fetal abnormalities. Avoid use unless benefit outweighs risk. |
| 2nd trimester | No adequate human studies; potential fetal risk. Use only if clearly needed. |
| 3rd trimester | No adequate human studies; potential neonatal adverse effects. Use only if clearly needed. |
Clinical note
Comprehensive clinical and safety monograph for VIZAMYL (VIZAMYL).
| Placental transfer | Crosses placenta; detected in fetal tissues. |
| Breastfeeding | Excreted in human milk; potential for serious adverse reactions in nursing infants. Discontinue drug or nursing. |
| Lactation Rating |
■ FDA Black Box Warning
No boxed warning.
| Serious Effects |
Hypersensitivity to flutemetamol or any excipient
| Precautions | Risk of image misinterpretation; false positive or negative scans possible., Not for predicting disease progression or monitoring treatment response., Radiation exposure; risk cumulative. |
| Food/Dietary | No known food interactions. No dietary restrictions are necessary before or after administration. |
| Clinical Pearls | Vizamyl (flutemetamol F 18) is a radioactive diagnostic agent for PET imaging of beta-amyloid neuritic plaques in the brain. It is indicated for adults with cognitive impairment being evaluated for Alzheimer's disease and other causes of cognitive decline. A negative scan indicates sparse to no neuritic plaques, inconsistent with Alzheimer's disease. A positive scan indicates moderate to frequent plaques; however, it does not establish a diagnosis of Alzheimer's disease as plaques can be present in other conditions. Scan interpretation should be performed by readers trained in flutemetamol PET imaging. Radiation exposure from the radioactive tracer should be considered, especially in pregnant or breastfeeding patients. |
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| L5 |
| 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. |
| 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. |
| Patient Advice | This medication is a radioactive tracer used for a brain imaging test called a PET scan. · The scan helps doctors evaluate for the presence of amyloid plaques, which are associated with Alzheimer's disease. · A negative scan makes Alzheimer's disease unlikely, but a positive scan does not confirm Alzheimer's disease. · Inform your doctor if you are pregnant, planning to become pregnant, or breastfeeding. · Drink plenty of water before and after the scan to help flush the radioactive tracer from your body. · There are no specific food or drug interactions with this diagnostic agent. · The injection site may be sore; report any severe reactions to your healthcare provider. |