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Florbetapir F-18: Drug information

Florbetapir F-18: Drug information
(For additional information see "Florbetapir F-18: Patient drug information")

For abbreviations, symbols, and age group definitions used in Lexicomp (show table)
Brand Names: US
  • Amyvid
Pharmacologic Category
  • Radiopharmaceutical
Dosing: Adult

Note: Measure dose by a suitable radioactivity calibration system immediately prior to administration.

Radioimaging

Radioimaging: IV: 10 mCi (370 MBq); maximum: 50 mcg mass dose

Dosing: Kidney Impairment: Adult

There are no dosage adjustments provided in the manufacturer's labeling.

Dosing: Hepatic Impairment: Adult

There are no dosage adjustments provided in the manufacturer's labeling.

Dosing: Older Adult

Refer to adult dosing.

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.

1% to 10%: Central nervous system: Headache (2%)

<1%: Anxiety, back pain, claustrophobia, dizziness, dysgeusia, fatigue, flushing, increased blood pressure, injection site reaction (including injection site hemorrhage, injection site irritation, and injection site pain), insomnia, musculoskeletal pain, nausea, neck pain, pruritus, rash at injection site, sensation of cold, urticaria

Contraindications

There are no contraindications listed within the manufacturer's labeling.

Warnings/Precautions

Concerns related to adverse effects:

• Malignancy: Patients are exposed to some radiation during treatment; large cumulative amounts of radiation exposure may increase the risk of cancer.

Special handling:

• Radiopharmaceutical: Use appropriate precautions for handling, disposal, and minimizing exposure to patients and healthcare personnel. Use only under supervision of individuals with experience/training in the handling of radioactive materials approved by the applicable regulatory authority.

Other warnings/precautions:

• Experienced staff: Images should only be interpreted by specially trained personnel.

• Limitations: A positive scan does not establish a diagnosis of Alzheimer disease or other cognitive disorders. Safety and effectiveness have not been established for predicting the development of a neurological condition (eg, dementia) or monitoring responses to therapy. Image interpretation provides an estimate of the brain β-amyloid plaque density; it does not determine clinical diagnosis.

• Risk for misinterpretation and errors: The use of clinical information in the interpretation of images has not been evaluated and may lead to errors. Scan results are indicative of the brain neuritic amyloid plaque content only at the time of imaging. A negative scan result does not preclude the development of brain amyloid in the future.

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Solution, Intravenous:

Amyvid: 500-1900 MBQ/ML (1 ea) [contains alcohol, usp]

Generic Equivalent Available: US

No

Pricing: US

Solution (Amyvid Intravenous)

500-1900 mbq/ml (per each): $3,428.88

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Administration: Adult

IV: Administer as a single intravenous bolus in a total volume of 10 mL or less; do not dilute. Following injection, flush with NS to ensure full delivery of dose. Administer through a short IV catheter (≤1.5 inches) to minimize potential drug adsorption to the catheter (may adhere to longer tubing/catheters). Initiate 10-minute PET image 30 to 50 minutes after injection. Patient should remain supine with brain centered in the PET scanner field of view; stabilize head to reduce movement if necessary.

Radiopharmaceutical; use appropriate precautions for handling and disposal. Waterproof gloves should be worn and effective shielding should be used during handling and administration.

Use: Labeled Indications

Radioimaging: Radioactive agent for positron emission tomography (PET) imaging estimation of beta-amyloid neuritic plaque density in the brain of patients being evaluated for cognitive decline (eg, Alzheimer disease)

Medication Safety Issues
Sound-alike/look-alike issues:

Florbetapir F18 may be confused with Flutemetamol F 18

Other safety concerns:

Radiopharmaceutical: Use appropriate precaution for handling, disposal, and minimizing exposure to patients and healthcare personnel. Use under supervision of experienced personnel. Should be stored in original lead container or adequate radiation shield.

Metabolism/Transport Effects

None known.

Drug Interactions

There are no known significant interactions.

Reproductive Considerations

Evaluate pregnancy status prior to administration in females of reproductive potential.

Pregnancy Considerations

Animal reproduction studies have not been conducted. Radiopharmaceuticals have the potential to cause fetal harm.

Breastfeeding Considerations

It is not known if florbetapir F18 is present in breast milk.

According to the manufacturer, the decision to breastfeed during therapy should consider the risk of infant exposure, the benefits of breastfeeding to the infant, and the benefits of treatment to the mother; to minimize potential exposure to the infant, breast milk can be pumped and discarded, and alternate infant nutrition be used for 24 hours after drug administration.

Mechanism of Action

Florbetapir F18 binds to β-amyloid plaques; the F18 isotope produces a positron signal that is detected by a PET scanner.

Pharmacokinetics (Adult Data Unless Noted)

Distribution: <5% of total dose present in blood 20 minutes post administration; <2% of total dose present in blood 45 minutes post administration

Half-life elimination: Florbetapir F18: ~110 minutes

Excretion: Predominately through biliary/gastrointestinal tract

Brand Names: International
International Brand Names by Country
For country code abbreviations (show table)

  • (GB) United Kingdom: Amyvid;
  • (IT) Italy: Amyvid;
  • (JP) Japan: Amyvid;
  • (PR) Puerto Rico: Amyvid
  1. Amyvid (florbetapir F 18) [prescribing information]. Indianapolis, IN: Eli Lilly and Company; December 2019.
Topic 83331 Version 77.0

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