Flurpiridaz F 18

Flurpiridaz F 18 is a radioactive diagnostic drug indicated for positron emission tomography (PET) myocardial perfusion imaging under rest or stress (pharmacologic or exercise) in adults with known or suspected coronary artery disease to evaluate for myocardial ischemia and infarction. 

• Flurpiridaz F 18 is available under the following different brand names: Flyrcado.

Common side effects of Flurpiridaz F 18 include:

• dyspnea
• headache
• angina pectoris 
• chest pain 
• fatigue
• ST segment changes
• flushing 
• nausea
• abdominal pain 
• dizziness
• arrhythmia

Serious side effects of Flurpiridaz F 18 include:

• exercise or pharmacologic stress testing, including risk of myocardial infarction (MI), arrhythmia, hypotension, bronchoconstriction, stroke, and seizure

Rare side effects of Flurpiridaz F 18 include:

• none 

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, coordination loss, unsteady, very stiff muscles, high fever, profuse sweating, or tremors.
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights.
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheadedness, or passing out.

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult dosage

Injectable solution

• 190-2,050 MBq/mL (5-55 mCi/mL) at the end of synthesis in a shielded multiple-dose vial with up to 30 mL fill volume

Myocardial perfusion imaging

Adult dosage

• Administer 2 doses by IV injection, 1 for rest imaging and 1 for stress imaging, using either pharmacologic or exercise stress, in either a 1-day or 2-day protocol
• If performing a combined exercise/pharmacologic stress protocol, administer the recommended activity for pharmacologic stress
• Rest and stress imaging were performed on the same day
  • Pharmacologic stress: Minimum stress activity is 2-folding the rest-activity
  • Exercise stress: Minimum stress activity is 3-folding the rest-activity
  • Maximum 1-day total volume: 6.1 mL
• Dosage (1-day regimen)
  • Rest imaging: 93-111 MBq (2.5-3 mCi)
  • Pharmacologic stress imaging: 222-241 MBq (6-6.5 mCi)
  • Exercise stress imaging: 333-342 MBq (9-9.5 mCi)
• Dosage (2-day regimen)
  • Rest, pharmacologic, and exercise stress imaging: 93-111 MBq (2.5-3 mCi)

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Flurpiridaz F 18 has no noted severe interactions with any other drugs
• Flurpiridaz F 18 has no noted serious interactions with any other drugs
• Flurpiridaz F 18 has no noted moderate interactions with any other drugs
• Flurpiridaz F 18 has no noted minor interactions with any other drugs

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all the products you use. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your healthcare professional or doctor for additional medical advice, health questions, or concerns.

Contraindications

• none

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Flurpiridaz F 18?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Flurpiridaz F 18?”

Cautions

• Risks associated with exercise or pharmacologic stress
  • Patients evaluated with exercise or pharmacologic stress may experience serious adverse reactions (e.g., MI, arrhythmia, hypotension, bronchoconstriction, stroke, seizure)
  • Perform stress testing in a setting where cardiac resuscitation equipment and trained staff are readily available
  • When pharmacologic stress is selected as an alternative to exercise, perform the procedure under the pharmacologic stress agent’s prescribing information
• Radiation risks
  • Contributes to 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 patients and healthcare providers
  • Advise patients to hydrate before and after administration and to void frequently after administration

Pregnancy and Lactation

• Data are unavailable on use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes
• All radiopharmaceuticals have the potential to cause fetal harm depending on the stage of development and the magnitude of the radiation dose
• If considering administration to a pregnant woman, inform the patient about the potential for adverse pregnancy outcomes based on radiation dose and gestational timing of exposure
• Contains ethanol (a maximum daily dose of 337 mg anhydrous ethanol); a lower limit of safety for ethanol use during pregnancy has not been established
• Published studies have demonstrated that ethanol is associated with fetal harm including central nervous system abnormalities, behavioral disorders, and impaired intellectual development
• Inform the patient about the potential for adverse pregnancy outcomes associated with ethanol exposure during pregnancy
• Lactation
  • Data are unavailable regarding the presence of flurpiridaz F 18 or its metabolites in human milk or animal milk, its effects on breastfed infants, or milk production
  • Based on clinical guidelines, exposure to breastfed infants can be minimized by advising a lactating woman to discontinue breastfeeding temporarily and to pump and discard breast milk for at least 8 hours after administration