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Amyvid

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Amyvid

Amyvid Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Amyvid (florbetapir F 18 injection) is a molecular imaging agent for Positron Emission Tomography (PET) imaging of the brain to estimate beta-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. Common side effects include headache, muscle or joint pain, fatigue, nausea, anxiety, feeling cold, and insomnia.

The recommended dose for Amyvid is 370 MBq (10 mCi), maximum 50 μg mass dose, administered as a single intravenous bolus in a total volume of 10 mL or less. Amyvid may interact with other drugs. Tell your doctor all medications and supplements you use. All radiopharmaceuticals, including Amyvid, have a potential to cause fetal harm. The likelihood of fetal harm depends on the stage of fetal development and the magnitude of the radiopharmaceutical dose. Tell your doctor if you are pregnant before Amyvid is administered. Because of the potential for radiation exposure to nursing infants from Amyvid, avoid use of the drug if breastfeeding or temporarily interrupt breastfeeding for 24 hours after exposure to Amyvid; consult your doctor.

Our Amyvid (florbetapir F 18 injection) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Amyvid FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.

In clinical studies, 555 patients were exposed to Amyvid. Amyvid caused no serious adverse reactions in the studies and the reported adverse reactions were predominantly mild to moderate in severity. The adverse reactions reported in more than one subject within the studies are shown in Table 2.

Table 2: Adverse Reactions Reported in Clinical Trials (N=555 patients)

Adverse Reactions N (Percent of patients)
Headache 10 (1.8%)
Musculoskeletal pain 4 (0.7%)
Blood pressure increaseda 4 (0.7%)
Nausea 4 (0.7%)
Fatigue 3 (0.5%)
Injection site reactionb 3 (0.5%)
Anxiety 2 (0.4%)
Back pain 2 (0.4%)
Claustrophobia 2 (0.4%)
Dizziness 2 (0.4%)
Feeling coldc 2 (0.4%)
Insomnia 2 (0.4%)
Neck pain 2 (0.4%)
aIncludes the terms blood pressure increased and hypertension.
bIncludes the terms injection site haemorrhage, injection site irritation, and injection site pain.
cIncludes the terms feeling cold and chills.

Other adverse reactions occurred at lower frequencies and included infusion site rash, dysgeusia, pruritis, urticaria, and flushing.

Read the entire FDA prescribing information for Amyvid (Florbetapir F 18 Injection) »

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Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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