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Flurpiridaz F-18: Drug information

Flurpiridaz F-18: Drug information
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For additional information see "Flurpiridaz F-18: Patient drug information"

For abbreviations, symbols, and age group definitions show table
Brand Names: US
  • Flyrcado
Pharmacologic Category
  • Radiopharmaceutical
Dosing: Adult
Myocardial perfusion imaging

Myocardial perfusion imaging: Note: Administer a total of 2 doses (1 for rest imaging and 1 for either pharmacologic or exercise stress imaging). If performing a combined pharmacologic and exercise stress protocol, administer dose for pharmacologic stress.

If rest and stress imaging are performed on the same day, pharmacologic stress activity should be double the rest portion; and exercise stress activity should be triple the rest portion to provide adequate imaging.

One-day imaging:

Rest imaging: IV: 2.5 to 3 mCi (93 to 111 MBq). Time between rest and stress dose administration is ≥30 minutes (pharmacologic stress) or ≥60 minutes (exercise stress).

Stress imaging (pharmacologic): IV: 6 to 6.5 mCi (222 to 241 MBq).

Stress imaging (exercise): IV: 9 to 9.5 mCi (333 to 352 MBq).

Maximum total volume/day: 6.1 mL.

Two-day imaging:

Rest and stress (pharmacologic and exercise) imaging: IV: 2.5 to 3 mCi (93 to 111 MBq).

Maximum total volume/day: 6.1 mL.

Dosing: Kidney Impairment: Adult

There are no dosage adjustments provided in the manufacturer's labeling; however, pharmacokinetic differences were not seen in patients with kidney impairment ≥19 mL/minute; has not been studied in patients with end-stage kidney disease.

Dosing: Liver Impairment: Adult

There are no dosage adjustments provided in the manufacturer's labeling; however, pharmacokinetic differences were not seen in patients with mild impairment; has not been studied in patients with moderate to severe impairment.

Dosing: Older Adult

Refer to adult dosing.

Adverse Reactions

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

>10%:

Nervous system: Headache (15%)

Respiratory: Dyspnea (17%)

1% to 10%:

Cardiovascular: Angina pectoris (10%), cardiac arrhythmia (4%), cardiac conduction disorder (<2%), chest pain (8%), flushing (5%), hypotension (<2%), increased blood pressure (<2%), palpitations (<2%), ST segment changes on ECG (6%), syncope (<2%)

Dermatologic: Pruritus (<2%), skin rash (<2%)

Gastrointestinal: Abdominal pain (4%), diarrhea (<2%), dysgeusia (<2%), nausea (4%), vomiting (<2%), xerostomia (<2%)

Nervous system: Anxiety (<2%), dizziness (4%), fatigue (7%)

Neuromuscular & skeletal: Back pain (<2%)

Respiratory: Bronchospasm (<2%), cough (<2%), wheezing (<2%)

Contraindications

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

Warnings/Precautions

Concerns related to adverse effects:

• Cardiopulmonary events: Arrhythmias, bronchoconstriction, hypotension, myocardial infarction, seizure, and stroke have occurred due to pharmacologic agents and exercise used in conjunction with stress imaging. Appropriate measures for monitoring and resuscitation should be available during use.

• Malignancy: Flurpiridaz F18 administration contributes to the 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 minimize radiation exposure to the patient and health care providers.

Special handling:

• Radiopharmaceutical: Use appropriate precautions for handling, disposal, and minimizing exposure to patients and health care 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:

• Appropriate use: Patients should be adequately hydrated prior to dosing; instruct patients to void frequently following administration to decrease radiation exposure to the bladder. Myocardial imaging may be done while patients are at rest and/or under pharmacologic stress conditions.

Dosage Forms: US

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

Solution, Intravenous:

Flyrcado: 5 - 55 mCi/mL (190 - 2,050 MBq/mL) (1 ea) [contains alcohol, usp]

Generic Equivalent Available: US

No

Pricing: US

Solution (Flyrcado Intravenous)

5-55 mci/mL (per each): $600.00

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

For IV administration as a bolus over less than 10 seconds; flush with NS immediately following administration. Encourage patients to adequately hydrate prior to administration and continue hydration and voiding frequently for the first few hours following administration.

Rest imaging: Initiate positron emission tomography (PET) scan 5 minutes after flurpiridaz F18 dose and continue for 10 minutes using 3D mode. Separate rest and stress dose administration by ≥30 minutes (pharmacologic stress) or ≥60 minutes (exercise stress).

Pharmacologic stress: Administer flurpiridaz F18 dose at peak vasodilation for the stress agent prescribed via a different IV port. Initiate PET scan 5 minutes after flurpiridaz F18 dose and continue for 10 minutes using 3D mode; optionally, dynamic imaging may be started immediately prior to flurpiridaz F18 administration.

Exercise stress: Administer flurpiridaz F18 dose at ≥85% of age predicted maximum heart rate OR induction of ischemia. Continue exercise for 1 to 2 minutes after administration. If patient fails to meet heart rate or ischemia endpoints, then convert to pharmacologic stress method. Initiate PET scan about 15 to 25 minutes after flurpiridaz F18 dose, when respiration has begun to return to normal. Acquire images for 10 minutes using 3D mode.

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

Myocardial perfusion imaging: Positron emission tomography (PET) myocardial perfusion imaging (MPI) under rest or stress (pharmacologic or exercise) in adults with known or suspected coronary artery disease (CAD) to evaluate for myocardial ischemia and infarction.

Medication Safety Issues
Other safety concerns:

Radiopharmaceutical: Use appropriate precaution for handling, disposal, and minimizing exposure to patients and health care 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.

Pregnancy Considerations

Animal reproduction studies have not been conducted.

All radiopharmaceuticals have the potential to cause fetal harm. In addition, this product contains ethanol, which may be associated with adverse pregnancy outcomes.

Breastfeeding Considerations

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

According to the manufacturer, the decision to breastfeed should consider the risk of infant exposure, the benefits of breastfeeding to the infant, and the benefits of treatment to the mother. Patients may express and discard breast milk for a minimum of 8 hours after administration of flurpiridaz F18 to minimize exposure to the breastfed infant.

Mechanism of Action

Flurpiridaz F18 is an analog of the mitochondrial complex 1 (MC-1) inhibitor, pyridaben, which is extracted by the myocardium proportional to the blood flow and binds to heart tissue that has biologically active mitochondria. Therefore, radioactivity in viable myocardium is higher than in infarcted tissue.

Pharmacokinetics (Adult Data Unless Noted)

Duration: 1 hour (heart wall radioactivity).

Distribution: Liver, kidneys, brain, and heart wall.

Metabolism: Biotransformation to numerous polar metabolites.

Half-life elimination: Flourine-18: 109.8 minutes.

Excretion: Urine (63%); feces (30%).

  1. Flyrcado (flurpiridaz F18) [prescribing information]. Marlborouth, MA: GE Healthcare Inc; September 2024.
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