Flutemetamol f-18

VIZAMYL is indicated for positron emission tomography (PET) of the brain to estimate amyloid beta neuritic plaque density in adults with cognitive impairment for: Evaluation of Alzheimer's disease (AD) and other causes of cognitive decline Selection of patients who are indicated for amyloid beta-directed therapy as described in the prescribing information of the therapeutic products VIZAMYL is a radioactive diagnostic drug indicated for positron emission tomography (PET) of the brain to estimate amyloid beta neuritic plaque density in adults with cognitive impairment for: Evaluation of Alzheimer's disease (AD) and other causes of cognitive decline Selection of patients who are indicated for amyloid beta-directed therapy as described in the prescribing information of the therapeutic products

Flutemetamol F 18 binds to amyloid beta plaques in the brain and the F 18 isotope produces a positron signal that is detected by a PET scanner. In in vitro binding studies using postmortem human brain homogenates containing fibrillar amyloid beta, the dissociation constant (Kd) for flutemetamol was 6.7 nM. Selectivity of 3 H-flutemetamol binding in postmortem human brain sections was demonstrated using autoradiography, silver-stained protein, and immunohistochemistry (monoclonal antibody to amyloid beta) correlation studies.

The recommended amount of radioactivity is 185 MBq (5 mCi) administered as a single intravenous bolus within 40 seconds in a total volume of up to 10 mL. Follow injection with an intravenous flush of 5 mL to 15 mL of 0.9% sodium chloride injection. Obtain 10-minute to 20-minute PET images starting approximately 60 minutes to 120 minutes after drug administration. See full prescribing information for image interpretation and radiation dosimetry.

VIZAMYL is contraindicated in patients with a history of hypersensitivity reaction to VIZAMYL or polysorbate 80. Known hypersensitivity to VIZAMYL or polysorbate 80

Anaphylaxis and Other Serious Hypersensitivity Reactions: Always have emergency resuscitation equipment and trained personnel available at the time of VIZAMYL administration. Risk of Image Misinterpretation and Other Errors: Image interpretation errors have been observed. Radiation Risk: VIZAMYL contributes to a patient's long-term cumulative radiation exposure. Ensure safe drug handling to protect patients and health care providers from unintentional radiation exposure. Advise patients to hydrate before and after administration and to void frequently after administration.

The following clinically significant adverse reaction is described elsewhere in the labeling: Hypersensitivity Reactions Most common adverse reactions (incidence ≥ 1%) were flushing, increased blood pressure, headache, nausea, and dizziness.

Store VIZAMYL in the original container within radiation shielding at 2°C to 30°C (36°F to 86°F).