Version May 2024
Brain imaging: IV: 5 mCi (185 MBq); maximum: 20 mcg mass dose.
There are no dosage adjustments provided in the manufacturer's labeling.
There are no dosage adjustments provided in the manufacturer's labeling.
Refer to adult dosing.
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.
1% to 10%:
Cardiovascular: Flushing (2%), increased blood pressure (2%)
Central nervous system: Dizziness (1%), headache (1%)
Gastrointestinal: Nausea (1%)
<1%: Hypersensitivity reaction (including flushing, dyspnea, chest pressure)
Known hypersensitivity to flutemetamol F18 or any component of the formulation, including polysorbate 80
Concerns related to adverse effects:
• Hypersensitivity: Hypersensitivity reactions, including flushing and dyspnea, have been reported within minutes following administration. Reactions may occur in patients with no prior exposure to flutemetamol F18. Appropriate equipment and emergency medications should be available during use.
• Malignancy: Patients are exposed to some radiation during treatment; large cumulative amounts of radiation exposure may increase the risk of cancer.
Dosage form specific issues:
• Polysorbate 80: Some dosage forms may contain polysorbate 80 (also known as Tweens). Hypersensitivity reactions, usually a delayed reaction, have been reported following exposure to pharmaceutical products containing polysorbate 80 in certain individuals (Isaksson, 2002; Lucente 2000; Shelley, 1995). Thrombocytopenia, ascites, pulmonary deterioration, and renal and hepatic failure have been reported in premature neonates after receiving parenteral products containing polysorbate 80 (Alade, 1986; CDC, 1984). See manufacturer’s labeling.
Special handling:
• Radiopharmaceutical: Use appropriate precautions for handling, disposal, and minimizing exposure to patients and healthcare personnel. Use only under supervision of individuals with experience/training in the handling of radioactive materials approved by the applicable regulatory authority.
Other warnings/precautions:
• Experienced staff: Images should only be interpreted by specially trained personnel.
• Limitations: A positive scan does not establish a diagnosis of Alzheimer disease or other cognitive disorders. Safety and effectiveness have not been established for predicting the development of a neurological condition (eg, dementia) or monitoring responses to therapy. Image interpretation provides an estimate of the brain beta-amyloid plaque density; it does not determine clinical diagnosis.
• Risk for misinterpretation and other errors: Errors in estimating brain neuritic plaque density may occur when using flutemetamol F18 PET images. In addition, the use of clinical information in the interpretation of images has not been evaluated and may lead to errors; image interpretation is performed independently of the patient's clinical information. Other factors contributing to the potential for misinterpretation include: extensive brain atrophy (limits the ability to distinguish gray and white matter on scan) and motion artifacts (may distort image). A negative scan result does not preclude the development of brain amyloid in the future.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Solution, Intravenous [preservative free]:
Vizamyl: 4.05 mCi/mL (1 ea) [contains alcohol, usp, polysorbate 80]
No
Solution (Vizamyl Intravenous)
4.05 mci/mL (per each): $3,960.00
Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.
IV: Administer as a single intravenous bolus injection within 40 seconds. Administer in a total volume of 10 mL or less. Following the injection, flush with 5 to 15 mL of NS. Instruct patients to increase their hydration before and after administration (to minimize radiation to the bladder); encourage voiding before and after imaging and frequently during the 24 hours following administration.
Radiopharmaceutical; waterproof gloves should be worn and effective shielding, including lead-glass syringe shields, should be used during handling and administration.
Brain imaging: 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 disease (AD) and other causes of cognitive decline. Flutemetamol F18 is an adjunct to other diagnostic evaluations. Note: A positive scan does not establish a diagnosis of AD or other cognitive disorder.
Flutemetamol F18 may be confused with Florbetapir F 18
Radiopharmaceutical: Use appropriate precaution for handling, disposal, and minimizing exposure to patients and healthcare personnel. Use under supervision of experienced personnel. Should be stored in original lead container or adequate radiation shield.
None known.
There are no known significant interactions.
Pregnancy status should be evaluated prior to use in women of reproductive potential (Parker 2010).
All radiopharmaceuticals have the potential to cause fetal harm. Elective diagnostic procedures should be delayed until after delivery (Parker 2010).
It is not known if flutemetamol F18 is present in breast milk.
According to the manufacturer, the decision to breastfeed following imaging should consider the risk of infant exposure, the benefits of breastfeeding to the infant, and the benefits of treatment to the mother. The manufacturer recommends patients pump and discard breast milk for 24 hours after administration to minimize potential infant exposure via breast milk. Elective diagnostic procedures should be delayed until breastfeeding has stopped (Parker 2010).
Flutemetamol F18 binds to β-amyloid plaques in the brain; the F-18 isotope produces a positron signal that is detected by a PET scanner.
Distribution: Diffuses across blood brain barrier; continual signal increases are observed in the brain from time of administration to 30 minutes postadministration in subjects with positive scans; stable values are observed thereafter up to at least 120 minutes postinjection
Excretion: Renal: ~37%; Hepatobiliary: ~52%
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