Drug Information

Drug Interaction:

Pharmacodynamic drug-drug interaction studies have not been performed in patients

to establish the effects

Within a clinical study of patients with a range of cognitive impairment, some

patients with probable AD were receiving the following medications: donepezil,

galantamine, memantine.

Mean cortical Standardized Uptake Value (SUV) ratios did not differ between the

patients taking or not taking these concomitant medications.

In in vitro tests, none of the drugs tested, including the acetylcholinesterase

inhibitors donepezil, galantamine, and tacrine, altered florbetapir F 18

binding to its target.

Indication:

Amyvid (Florbetapir F 18 Injection) for intravenous use

Initial U.S. Approval: 2012

Drug Name- Amyvid

Active Ingredient - Florbetapir 18

Used as radioactive diagnostic aid for Positron Emmission Tomography (PET)

imaging of the brain to estimate Beta-amyloid neuritic plaque in adults who are

being evaluated for Alzehimers disease(AD) and other causes for cognitive decline

Indication-

Used as radioactive diagnostic aid for Positron Emission Tomography (PET)

imaging of the brain to estimate Beta-amyloid neuritic plaque in adults who are

being evaluated for Alzehimers disease(AD) and other causes for cognitive decline

Approved by FDA on 6-4-2012 (Ref- FDA Approved List- 2012)

Adverse Reaction:

The most common reported adverse reaction was headache, occurring in

2% of patients, followed by musculoskeletal pain, blood pressure increased,

fatigue, nausea, and injection site reaction, all occurring in <1% of patients

Contra-Indications:

CONTRAINDICATIONS

None

WARNINGS AND PRECAUTIONS

Image interpretation errors (especially false negatives) have been observed (

Radiation risk: Amyvid, similar to all radiopharmaceuticals, contributes to a

patient’s long-term cumulative radiation exposure.

Ensure safe handling to protect patients and health care workers from

unintentional radiation exposure

Dosages/ Overdosage Etc:

Active Ingredient - Florbetapir 18

INDICATIONS AND USAGE

Amyvid is a radioactive diagnostic agent 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)

and other causes of cognitive decline.

A negative Amyvid 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 patient’s cognitive impairment is due to AD.

A positive Amyvid scan indicates moderate to frequent amyloid neuritic plaques;

neuropathological examination has shown this amount of amyloid 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.

Amyvid is an adjunct to other diagnostic evaluations

Limitations of Use

A positive Amyvid scan does not establish a diagnosis of AD or other cognitive disorder

Safety and effectiveness of Amyvid have not been established for:

Predicting development of dementia or other neurologic condition;

Monitoring responses to therapies

DOSAGE AND ADMINISTRATION

Use appropriate radiation safety handling measures

Administer 370 MBq (10 mCi) as a single intravenous bolus in a total volume

of 10 mL or less

Obtain 10-minute PET images starting approximately 30 to 50 minutes after

intravenous injection

Image interpretation: Refer to full prescribing information

The radiation absorbed dose from a 370 MBq (10 mCi) dose of Amyvid

is 7 mSv in an adult

DOSAGE FORMS AND STRENGTHS

10mL, 30 mL, or 50 mL multidose vial containing a clear, colorless injectable

solution at a strength of 500-1900 MBq/mL (13.5-51 mCi/mL) florbetapir

F 18 at End of Synthesis (EOS)

Patient Information:

PATIENT COUNSELING INFORMATION

Instruct patients to inform their physician or healthcare provider if they are pregnant

or breastfeeding.

Inform patients who are breastfeeding to use alternate infant nutrition sources

(e.g., stored breast milk or infant formula) for 24 hours (>10 half-lives of radioactive

decay for the F 18 isotope) after administration of the drug or avoid use of the drug.

Pharmacology/ Pharmacokinetics:

1. Mechanism of Action

Florbetapir F 18 binds to â-amyloid plaques 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 â-amyloid plaques, the dissociation

constant (K d) for florbetapir was 3.7 ± 0.3 nM.

2.Pharmacokinetics

Following the intravenous administration of 370 MBq (10 mCi) of florbetapir F 18

to healthy volunteers, the drug was distributed throughout the body with less

than 5% of the injected F 18 radioactivity present in the blood by 20 minutes

following administration, and less than 2% present by 45 minutes after administration.

The residual F 18 in circulation during the 30-90 minute imaging window was

principally in the form of polar F 18 metabolites.

Whole body scanning following the intravenous injection showed accumulation

of radioactivity in the liver within four minutes post-injection, followed by elimination

of the radioactivity predominantly through the biliary/gastrointestinal tract with much

lower radioactivity detected in the bladder. Essentially all radioactivity collected

in the urine was present as polar metabolites of florbetapir F 18.

Pregnancy and lactation:

USE IN SPECIFIC POPULATIONS

1. Pregnancy

Pregnancy Category C.

It is not known whether Amyvid can affect reproductive capacity

or cause fetal harm when administered to a pregnant woman.

Animal reproduction studies have not been conducted with Amyvid.

Amyvid should be administered to a pregnant woman only if clearly needed.

All radiopharmaceuticals, including Amyvid, have a potential to cause fetal harm.

Assess pregnancy status before administering Amyvid to a female of reproductive

potential.

2. Nursing Mothers

It is not known whether Amyvid is excreted in human milk.

Because many drugs are excreted into human milk and because of the potential

for radiation exposure to nursing infants from Amyvid, avoid use of the drug in

a breastfeeding mother or have the mother temporarily interrupt breastfeeding

for 24 hours (>10 half-lives of radioactive decay for the F 18 isotope)

after exposure to Amyvid.

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

Amyvid is not indicated for use in pediatric patients.

4. Geriatric Use

Of 496 patients in completed clinical studies of Am yvid, 307 patients were

.65 years old (203 patients were over 75 years of age).

No overall differences in safety or effectiveness were observed between these

subjects and younger subjects.

Florbetapir F 18- Amyvid - @- (Apr 2012) - Diagnostic agent

Drug Interaction

Indication

Adverse Reaction

Contra-Indications

Dosages/ Overdosage Etc

Patient Information

Pharmacology/ Pharmacokinetics

Pregnancy and lactation