Source: FDA, National Drug Code (US) Revision Year: 2020
None.
Errors may occur in the Amyvid estimation of brain neuritic plaque density during image interpretation [see Clinical Studies (14)].
Image interpretation should be performed independently of the patient’s clinical information. The use of clinical information in the interpretation of Amyvid images has not been evaluated and may lead to errors. Other errors may be due to extensive brain atrophy that limits the ability to distinguish gray and white matter on the Amyvid scan as well as motion artifacts that distort the image.
Amyvid scan results are indicative of the brain neuritic amyloid plaque content only at the time of image acquisition and a negative scan result does not preclude the development of brain amyloid in the future.
Amyvid, similar to other radiopharmaceuticals, contributes to a patient’s overall long-term cumulative radiation exposure. Long-term cumulative radiation exposure is associated with an increased risk of cancer. Ensure safe handling to protect patients and health care workers from unintentional radiation exposure [see Dosage and Administration (2.1)].
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%) |
a Includes the terms blood pressure increased and hypertension.
b Includes the terms injection site haemorrhage, injection site irritation, and injection site pain.
c Includes the terms feeling cold and chills.
Other adverse reactions occurred at lower frequencies and included infusion site rash, dysgeusia, pruritus, urticaria, and flushing.
Pharmacodynamic drug-drug interaction studies have not been performed in patients to establish the extent, if any, to which concomitant medications may alter Amyvid image results.
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.
There are no available data on Amyvid use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. Animal reproduction studies have not been conducted with Amyvid to evaluate its effect on female reproduction and embryo-fetal development. All radiopharmaceuticals, including Amyvid, have a potential to cause fetal harm depending on the stage of fetal development and the magnitude of the radiopharmaceutical dose. If considering Amyvid administration to a pregnant woman, inform the patient about the potential for adverse pregnancy outcomes based on the radiation dose from the drug and the gestational timing of exposure.
The background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of adverse outcomes. The background risk in the U.S. general population of major birth defects is 2-4% and of miscarriage is 15-20% of clinically recognized pregnancies.
There are no data on the presence of Florbetapir F 18 Injection in human milk, the effects on the breastfed infant, or the effects of Florbetapir F 18 Injection on milk production. Lactation studies have not been conducted in animals. Exposure of Amyvid to a breastfed infant can be minimized by temporary discontinuation of breastfeeding [see Clinical Considerations]. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Amyvid and any potential adverse effects on the breastfed child from Amyvid or from the underlying maternal condition.
To decrease radiation exposure to the breastfed infant, advise a lactating woman to pump and discard breast milk for 24 hours (>10 half-lives of radioactive decay for the F 18 isotope) following administration of Amyvid.
Assess pregnancy status before administering Amyvid to a female of reproductive potential.
Amyvid is not indicated for use in pediatric patients.
Of 496 patients in completed clinical studies of Amyvid, 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.
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