Flyrcado

Flyrcado (flurpiridaz F 18) is a radioactive diagnostic drug that may be used for positron emission tomography (PET) myocardial perfusion imaging (MPI) in adults with known or suspected coronary artery disease (CAD) to evaluate for heart blood flow blockages (myocardial ischemia) and a heart attack (myocardial infarction).

• Flyrcado may be used at rest or under stress testing (using medications or exercise).

Flyrcado's mechanism of action involves radioactive Flurpiridaz F 18 binding to heart tissue that has biologically active mitochondria. This shows on a PET MPI as a higher level of radioactivity in healthy heart tissue compared to heart tissue that has infarcted (died), making it easier to identify blockages or infarcted tissue.

Flyrcado gained FDA approval on 27 September 2024.

Flyrcado is administered via an intravenous (into the vein) injection by a healthcare professional.

You should be well hydrated before you are administered Flyrcado. Drink enough water to ensure adequate hydration before Flyrcado and continue drinking and urinating often during the first hours following administration to reduce radiation exposure.

The most common side effects of Flyrcado are:

• Shortness of breath
• Headache
• Angina or chest pain
• Fatigue or tiredness
• ECG changes (such as ST segment changes)
• Flushing
• Nausea
• Abdominal (stomach) pain
• Dizziness
• Heart palpitations (arrhythmias).

Serious side effects and warnings

There is a risk of serious side effects when Flyrcado is used with exercise or pharmacologic stress testing, including a risk of heart attack (myocardial infarction), arrhythmias, low blood pressure, airway narrowing (bronchoconstriction, stroke, and seizures. Your healthcare provider will monitor you for these risks and stress testing should be performed only in facilities where cardiac resuscitation equipment and trained staff are readily available.

Radiation risks. Flyrcado is a radioactive substance and safe handling practices should be followed to minimize radiation exposure to patients and health care providers.

These are not all the side effects of Flyrcado. See the Flyrcado Prescribing Information for a full list of side effects. To report suspected side effects, contact GE HealthCare at 1-800-654-0118 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Before being administered Flyrcado, tell your healthcare provider about all your medical conditions including if you:

• Have heart disease, angina, or arrhythmias
• Have a history of stroke or heart attack
• Have low blood pressure
• Have asthma or other lung conditions that affect your breathing
• Have epilepsy or a history of seizures
• Are pregnant or intend to become pregnant
• Are breastfeeding or intend to breastfeed.

Pregnancy

Talk to your healthcare provider if you are pregnant. Your unborn baby will be exposed to radiation if you undergo a radionuclide procedure, including one using Flyrcado, while pregnant. Flyrcado also contains alcohol (ethanol).

Breastfeeding

If you are breastfeeding, you should temporarily pump and discard breastmilk while you are being administered Flyrcado and for at least 8 hours after a Flyrcado dose to minimize radiation exposure to the breastfed infant.

When rest and stress imaging are conducted on the same day, the recommended administered activities are:

• Rest imaging: 93 MBq to 111 MBq (2.5 mCi to 3 mCi)
• Pharmacologic stress imaging: 222 MBq to 241 MBq (6 mCi to 6.5 mCi)
• Exercise stress imaging: 333 MBq to 352 MBq (9 mCi to 9.5 mCi)

When rest and stress imaging are conducted over two days, the recommended rest and stress administered activities, for both pharmacologic and exercise stress, are 93 MBq to 111 MBq (2.5 mCi to 3 mCi).

See the Flyrcado Prescribing Information for more information.

Active ingredients: flurpiridaz F 18 190 MBq to 2,050 MBq (5 mCi to 55 mCi) at end of synthesis and up to 2.3 mcg flurpiridaz.

Inactive ingredients: 45 mg hydroxypropyl-β-cyclodextrin (as a solubilizer and co-radiostabilizer), 35 mg L-(+)-ascorbic acid (as a radiostabilizer), 8.2 mg sodium hydroxide, and 55.2 mg anhydrous ethanol, in water for injection.

Flyrcado is a sterile, preservative-free, non-pyrogenic, clear, colorless to yellow radioactive solution. Each mL

The pH of the solution is between 5.5 and 8.

Flyrcado is available as a shielded multiple-dose vial with up to 30 mL fill volume containing 190 MBq/mL to 2,050 MBq/mL (5 mCi/mL to 55 mCi/mL) of flurpiridaz F 18 at the end of synthesis.

GE Health Care makes Flyrcado.