Flutemetamol F-18 (1 brand name, 1 dosage form, 1 route)
Available dosage forms: INJECTABLE.
Routes of administration: INTRAVENOUS.
Brand Names
- VIZAMYL
Indications and Usage
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
Contraindications
VIZAMYL is contraindicated in patients with a history of hypersensitivity reaction to VIZAMYL or polysorbate 80 [see Warnings and Precautions (5.1)].
Adverse Reactions
The following clinically significant adverse reaction is described elsewhere in the labeling: Hypersensitivity Reactions [see Warnings and Precautions (5.1)]
Mechanism of Action
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 3H-flutemetamol binding in postmortem human brain sections was demonstrated using autoradiography, silver-stained protein, and immunohistochemistry (monoclonal antibody to amyloid beta) correlation studies.
Overdosage
The major risks of overdose relate predominantly to increased radiation exposure, with long-term risks for neoplasia. In the event of administration of a radiation overdose with VIZAMYL, hydration and frequent urination should be encouraged to minimize radiation exposure to the subject. It is unknown whether or not flutemetamol is dialyzable.