Amyvid

What Is Amyvid?

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.

What Are Side Effects of Amyvid?

Common side effects of Amyvid include:

• headache
• muscle or joint pain
• fatigue
• nausea
• anxiety
• feeling cold
• tiredness
• insomnia
• increased blood pressure
• injection site reactions
• back pain
• claustrophobia
• dizziness, and
• neck pain

Dosage for Amyvid

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.

What Drugs, Substances, or Supplements Interact with Amyvid?

Amyvid may interact with other drugs. Tell your doctor all medications and supplements you use.

Amyvid During Pregnancy and Breastfeeding

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.

Additional Information

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.

 

Amyvid Consumer Information

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Less serious side effects may include:

• headache;
• joint or muscle pain;
• nausea; or
• feeling tired.

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.

Read the entire detailed patient monograph for Amyvid (Florbetapir F 18 Injection)

 

Amyvid Professional Information

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)