Vizamyl

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 ( 1 )

VIZAMYL is contraindicated in patients with a history of hypersensitivity reaction to VIZAMYL or polysorbate 80 [see Warnings and Precautions (5.1) ] . Known hypersensitivity to VIZAMYL or polysorbate 80 ( 4 )

Anaphylaxis and Other Serious Hypersensitivity Reactions: Always have emergency resuscitation equipment and trained personnel available at the time of VIZAMYL administration. ( 5.1 ) Risk of Image Misinterpretation and Other Errors: Image interpretation errors have been observed. ( 5.2 ) 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. ( 2.1 , 2.2 , 5.3 )

5.1Anaphylaxis and Other Serious Hypersensitivity Reactions

Serious hypersensitivity reactions including anaphylaxis, presenting with flushing, dyspnea, and hypotension, have been observed within minutes following VIZAMYL administration. These reactions may occur in patients with no history of exposure to VIZAMYL [see Adverse Reactions (6.1 , 6.2) ] . Obtain a history of allergy or hypersensitivity reactions. Always have resuscitation equipment and trained personnel immediately available at the time of VIZAMYL administration.