Amyvid
Generic: FLORBETAPIR F 18
Basic Information
Manufacturer
Eli Lilly and Company
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
INTRAVENOUS
FDA Set ID
bb5a5043-0f51-11df-8a39-0800200c9a66
Indications & Usage
1 INDICATIONS AND USAGE AMYVID 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 AMYVID is a radioactive diagnostic drug 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 ( 1 )
Adverse Reactions
6 ADVERSE REACTIONS Most common adverse reactions (incidence ≥ 0.4%) were headache, musculoskeletal pain, increased blood pressure, nausea, fatigue, injection site reaction, anxiety, back pain, claustrophobia, dizziness, feeling cold, insomnia, and neck pain.
( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Eli Lilly and Company at 1-800-545-5979 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
6.1 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.
The safety of AMYVID was evaluated in 555 adult subjects who received AMYVID by intravenous injection in clinical trials.
Table 2 shows adverse reactions reported in ≥ 0.4% of subjects from the clinical trials.
Table 2: Adverse Reactions Reported in ≥ 0.4% of Adult Subjects Who Received AMYVID in Clinical Trials a Includes the terms blood pressure increased and hypertension.
b Includes the terms injection site hemorrhage, injection site irritation, and injection site pain.
c Includes the terms feeling cold and chills.
Adverse Reaction AMYVID N=555 % Headache 1.8 Musculoskeletal pain 0.7 Blood pressure increased a 0.7 Nausea 0.7 Fatigue 0.5 Injection site reaction b 0.5 Anxiety 0.4 Back pain 0.4 Claustrophobia 0.4 Dizziness 0.4 Feeling cold c 0.4 Insomnia 0.4 Neck pain 0.4 Adverse reactions that occurred in <0.4% of subjects included infusion site rash, dysgeusia, pruritus, urticaria, and flushing.
( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Eli Lilly and Company at 1-800-545-5979 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
6.1 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.
The safety of AMYVID was evaluated in 555 adult subjects who received AMYVID by intravenous injection in clinical trials.
Table 2 shows adverse reactions reported in ≥ 0.4% of subjects from the clinical trials.
Table 2: Adverse Reactions Reported in ≥ 0.4% of Adult Subjects Who Received AMYVID in Clinical Trials a Includes the terms blood pressure increased and hypertension.
b Includes the terms injection site hemorrhage, injection site irritation, and injection site pain.
c Includes the terms feeling cold and chills.
Adverse Reaction AMYVID N=555 % Headache 1.8 Musculoskeletal pain 0.7 Blood pressure increased a 0.7 Nausea 0.7 Fatigue 0.5 Injection site reaction b 0.5 Anxiety 0.4 Back pain 0.4 Claustrophobia 0.4 Dizziness 0.4 Feeling cold c 0.4 Insomnia 0.4 Neck pain 0.4 Adverse reactions that occurred in <0.4% of subjects included infusion site rash, dysgeusia, pruritus, urticaria, and flushing.