VIZAMYL*
Manufacturer DetailsGENERIC*
USA AND CANADA
Compositions:
Flutemetamol F-18 Injection,
Flutemetamol F-18 Injection,
| Strength | Rate | Packing Style |
|---|---|---|
| mg | 0.00 | vial injection |
List of Related Indications:
- Positron emission tomography (PET) for imaging brain in Alzheimers Disease (AD)
List Of Drugs:
- Flutemetamol F 18 -Viamyl- @-(Oct 2013)- Diagnostic Agents
Indication Type Description:
Drug Interaction
Indication
Adverse Reaction
Contra-Indications
Dosages/ Overdosage Etc
Patient Information
Pharmacology/ Pharmacokinetics
Pregnancy and lactation
Drug Interaction:
Pharmacodynamic drug-drug interaction studies have not been performed
in patients to establish the extent, if any, to which concomitant medications
may alter Vizamyl image results.
Within a clinical study of patients with a range of cognitive impairment,
some patients were receiving the following medications: donepezil,
galantamine, memantine, rivastigmine.
Mean cortical Standardized Uptake Value (SUV) ratios did not differ between
the patients taking or not taking these concomitant medications
Indication:
VIZAMYL (flutemetamol F 18 injection) for intravenous use
Initial U.S. Approval: 2013
Drug Name- Vizamyl
Active Ingredient - Flutemetamol F 18 Injection
A radioactive diagnostic drug for use with positron emission tomography( PET)
imaging of the brain in adults evaluated for Alzheimers Disease (AD)
and dementia
Indication-
Diagnostic aid for Alzheimers Disease( AD) and dementia
Approved by FDA on 25-10--2013 (Ref- FDA approved List- 2013)
Adverse Reaction:
Most commonly reported adverse reactions were flushing (2%),
headache (1%), increased blood pressure (2%), nausea (1%),
and dizziness (1%).
Contra-Indications:
CONTRAINDICATIONS
Known hypersensitivity to Vizamyl or any excipient, including polysorbate 80
WARNINGS AND PRECAUTIONS
Hypersensitivity reactions: Ask patients about prior reactions to Vizamyl.
Observe for hypersensitivity signs and symptoms following Vizamyl
administration. Have resuscitation equipment and trained personnel
available at time of Vizamyl administration
Image interpretation errors (especially false positives) have been observed
Radiation risk: Vizamyl, similar to all radiopharmaceuticals, contributes
to a patients long-term cumulative radiation exposure.
Ensure safe handling to protect patients and health care workers from
unintentional radiation exposure
Dosages/ Overdosage Etc:
Indication-
Diagnostic aid for Alzheimers Disease( AD) and dementia
INDICATIONS AND USAGE
Vizamyl is a radioactive diagnostic agent indicated for Positron Emission
Tomography (PET) imaging of the brain to estimate â amyloid neuritic
plaque density in adult patients with cognitive impairment who are
being evaluated for Alzheimer’s disease (AD) or other causes of
cognitive decline.
A negative Vizamyl scan indicates sparse to no neuritic plaques, and is
inconsistent with a neuropathological diagnosis of AD at the time of image
acquisition; a negative scan result reduces the likelihood that a patients
cognitive impairment is due to AD. A positive
Vizamyl scan indicates moderate to frequent amyloid neuritic plaques;
neuropathological examination has shown this amount of neuritic plaque
is present in patients with AD, but may also be present in patients with
other types of neurologic conditions, as well as older people with
normal cognition. Vizamyl is an adjunct to other diagnostic evaluations
Limitations of Use:
A positive Vizamyl scan does not establish a diagnosis of AD or other
cognitive disorder
Safety and effectiveness of Vizamyl have not been established for:
Predicting development of dementia or other neurological condition
Monitoring responses to therapies
DOSAGE AND ADMINISTRATION
Use appropriate radiation safety handling measures
Administer 185 megabecquerels (MBq) [5 millicuries (mCi)] within
40 seconds as a single intravenous bolus in a total volume of 10 mL or less
Follow injection with an intravenous flush of 5 to 15 mL of 0.9% sterile sodium
chloride injection
Obtain 20-minute PET images starting approximately 90 minutes after
intravenous injection
Image interpretation: Refer to full prescribing information
The radiation dose absorbed from a 185-MBq (5-mCi) dose of Vizamyl is
5.92 mSv in an adult
DOSAGE FORMS AND STRENGTHS
Injection: 150 MBq/mL (4.05 mCi/mL) at reference date and time in
10 or 30 mL multi-dose vials
Patient Information:
PATIENT COUNSELING INFORMATION
Instruct patients to inform their healthcare provider if they:
are pregnant or breast feeding, or have had prior reactions to Vizamyl or any
component, including polysorbate 80, or have reduced renal or hepatic function
Instruct patients to increase their level of hydration before and after receiving
Vizamyl (Flutemetamol F 18 Injection) and to void frequently for the first 24
hours following Vizamyl administration.
Pharmacology/ Pharmacokinetics:
CLINICAL PHARMACOLOGY
1. Mechanism of Action
Flutemetamol F 18 binds to â-amyloid 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 â-amyloid, the dissociation constant (K d) for flutemetamol was 6.7 nM.
Selectivity of [3H]flutemetamol binding in post-mortem human brain sections was
demonstrated using autoradiography, silver-stained protein, and immunohistochemistry
(monoclonal antibody to â-amyloid) correlation studies
2. Pharmacokinetics
Following intravenous injection of 185 MBq (5 mCi) of Vizamyl in humans,
flutemetamol F 18 plasma concentrations declined by approximately 75%
in the first 20 minutes post-injection, and by approximately 90% in the first
180 minutes.
The F 18 in circulation during the 30-120 minutes imaging window in plasma
was principally associated with flutemetamol metabolites.
Excretion was approximately 37% renal (28-45%; n=6) and 52% hepatobiliary
(40-65%; n=6).
Pregnancy and lactation:
USE IN SPECIFIC POPULATIONS
1. Pregnancy
Pregnancy Category C: It is not known whether Vizamyl can cause fetal harm when
administered to a pregnant woman or if it can affect reproduction capacity.
Animal reproduction studies have not been conducted with Vizamyl.
All radiopharmaceuticals, including Vizamyl, have the potential to cause fetal harm.
The likelihood of fetal harm depends on the stage of fetal development, and the
magnitude of the radiopharmaceutical dose.
Vizamyl should be given to a pregnant woman only if clearly needed.
Assess pregnancy status before administering Vizamyl to a female of reproductive
potential.
2. Nursing Mothers
It is not known whether flutemetamol is excreted in human milk. Because many drugs
are excreted in human milk and because of the potential for radiation exposure
to nursing infants from Vizamyl, avoid use of the drug in a breastfeeding mother
or have the mother temporarily interrupt breastfeeding for 24 hours
(greater than 10 half-lives of radioactive decay for the F 18 isotope) after
exposure to Vizamyl.
If breastfeeding is interrupted, the patient should pump and discard her breast milk
and use alternate infant nutrition sources (e.g., stored breast milk or infant formula)
for 24 hours after administration of the drug.
3. Pediatric Use
Vizamyl is not indicated for use in pediatric patients.
4.Geriatric Use
Of the 761 subjects in clinical studies of Vizamyl, 447 (59%) were 65 years or over,
while 246 (32%) were 75 years or over. No overall differences in safety were
observed between these subjects and younger subjects.
