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Flurpiridaz F-18

FDA Drug Information • Also known as: Flyrcado

Brand Names
Flyrcado
Drug Class
Radioactive Diagnostic Agent [EPC]
Route
INTRAVENOUS
Dosage Form
INJECTION
Product Type
HUMAN PRESCRIPTION DRUG

Description

11 DESCRIPTION 11.1 Chemical Characteristics FLYRCADO (flurpiridaz F 18) injection is a radioactive diagnostic drug for intravenous use. The molecular formula of flurpiridaz F 18 is C 18 H 22 Cl 18 FN 2 O 3 , the molecular mass is 367.8, and the structural formula is: Chemically, flurpiridaz F 18 is 2- tert -butyl-4-chloro-5-[[4-(2-( 18 F)fluoranylethoxymethyl)phenyl]methoxy]pyridazin-3-one. FLYRCADO is a sterile, preservative-free, non-pyrogenic, clear, colorless to yellow radioactive solution. Each mL contains 190 MBq to 2,050 MBq (5 mCi to 55 mCi) of flurpiridaz F 18 at end of synthesis, up to 2.3 mcg flurpiridaz, and the following 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. The pH of the solution is between 5.5 and 8. Chemical Structure 11.2 Physical Characteristics Fluorine-18 decays by positron (β+) emission and has a half-life of 109.8 minutes. The principal photons useful for diagnostic imaging are the 511 keV gamma photons, resulting from the interaction of the emitted positron with an electron. Principal emission data for fluorine-18 are shown in Table 4. Table 4 – Principal Radiation Emission Data for Fluorine-18 Radiation/Emission % per Disintegration Mean Energy (keV) Positron 96.7 249.8 Gamma 193.5 511 11.3 External Radiation The point source air-kerma rate constant for fluorine-18 is 3.74E-17 Gy m 2 /(Bq s); this coefficient was formerly defined as the specific gamma-ray constant of 5.7 R/hr/mCi at 1 cm. The first half-value thickness of lead (Pb) for fluorine-18 gamma rays is approximately 6 mm. The relative reduction of radiation emitted by fluorine-18 that results from various thicknesses of lead shielding is shown in Table 5. The use of about 8 cm of Pb will decrease the radiation transmission (i.e., exposure) by a factor of about 10,000. Table 5 - Radiation...

What Is Flurpiridaz F-18 Used For?

1 INDICATIONS AND USAGE FLYRCADO is indicated for positron emission tomography (PET) myocardial perfusion imaging (MPI) under rest or stress (pharmacologic or exercise) in adult patients with known or suspected coronary artery disease (CAD) to evaluate for myocardial ischemia and infarction. FLYRCADO is a radioactive diagnostic drug indicated for positron emission tomography (PET) myocardial perfusion imaging (MPI) under rest or stress (pharmacologic or exercise) in adult patients with known or suspected coronary artery disease (CAD) to evaluate for myocardial ischemia and infarction. ( 1 )

Dosage and Administration

2 DOSAGE AND ADMINISTRATION Administer FLYRCADO via intravenous injection. ( 2.2 ) When rest and stress imaging are conducted on the same day, the recommended administered activities are ( 2.2 ): 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). ( 2.2 ) See full prescribing information for radiation safety, preparation, administration, imaging, and radiation dosimetry information. ( 2.1 , 2.2 , 2.3 , 2.4 ) 2.1 Radiation Safety – Drug Handling Handle FLYRCADO with appropriate safety measures to minimize radiation exposure [see Warnings and Precautions (5.2) ] . Use waterproof gloves and effective shielding, including lead-glass syringe shields, when handling and administering FLYRCADO. Radioactive drugs should be used by or under the control of healthcare providers who are qualified by specific training and experience in the safe use and handling of radionuclides, and whose experience and training have been approved by the appropriate governmental agency authorized to license the use of radionuclides. 2.2 Recommended Dosage, Preparation, and Administration Instructions Recommended Dosage The recommended activity for each type of examination is presented in Table 1. Administer two doses by intravenous injection, one for rest imaging and one 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. When rest and stress imaging are performed on the same day, the recommended minimum stress activity is 2-fold the rest activity for pharmacologic stress and 3-fold the rest activity for exercise stress to provide adequate image quality and obscure residual signal from the first acquisition. The recommended maximum total volume administered in one day is 6.1 mL. Table 1 – Recommended Administered Activities of FLYRCADO in Adults for Rest and Stress Imaging Using Pharmacologic or Exercise Stress in a 1-Day or 2-Day Protocol Length of Protocol Activity for Rest Imaging Activity for Stress Imaging Pharmacologic Exercise 1 day 93 MBq to 111 MBq (2.5 mCi to 3 mCi) 222 MBq to 241 MBq (6 mCi to 6.5 mCi) 333 MBq to 352 MBq (9 mCi to 9.5 mCi) 2 days 93 MBq to 111 MBq (2.5 mCi to 3 mCi) 93 MBq to 111 MBq (2.5 mCi to 3 mCi) 93 MBq to 111 MBq (2.5 mCi to 3 mCi) Patient Preparation Instruct patients to drink water to ensure adequate hydration prior to administration of FLYRCADO and to continue drinking and voiding frequently during the first hours following administration to reduce radiation exposure [see Warnings and Precautions (5.2) ] . Drug Preparation Use aseptic...

Side Effects (Adverse Reactions)

6 ADVERSE REACTIONS The following serious adverse reactions are described elsewhere in the labeling: Risks Associated with Exercise or Pharmacologic Stress [see Warnings and Precautions (5.1) ] Most common adverse reactions occurring during FLYRCADO PET MPI under rest and stress (pharmacologic or exercise) (incidence ≥ 2%) are dyspnea, headache, angina pectoris, chest pain, fatigue, ST segment changes, flushing, nausea, abdominal pain, dizziness, and arrhythmia. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact GE HealthCare at 1-800-654-0118 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience 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. The safety of FLYRCADO was evaluated in 1,600 subjects in clinical studies, including 1,575 (98%) subjects with known or suspected coronary artery disease and 25 (2%) healthy subjects. All 1,600 subjects were dosed under rest conditions, with a mean dose of 102 MBq (2.8 mCi) FLYRCADO. A total of 1,568 (98%) subjects were also dosed under stress (exercise or pharmacologic) conditions, with a mean activity of 252 MBq (6.8 mCi) FLYRCADO by intravenous route. The demographic characteristics of the study population were 31% female, mean age 62 years (range 19 years to 90 years), 81% White, 11% Black or African American, 1% Asian, and 7% other or unreported race, and 10% Hispanic or Latino, 81% Not Hispanic or Latino, and 9% unreported ethnicity. Stress testing procedures are associated with serious adverse reactions [see Warnings and Precautions (5.1) ] . Adverse reactions occurring in ≥2% subjects receiving FLYRCADO during PET MPI under rest and stress (pharmacologic or exercise) are presented in Table 3. Table 3. Adverse Reactions Reported in ≥2% of Subjects During FLYRCADO PET MPI Under Rest and Stress (Pharmacologic or Exercise) Adverse Reaction FLYRCADO PET MPI Under Rest and Stress (Pharmacologic or Exercise) N=1,600 Includes 32 subjects who received only one dose at rest. % Dyspnea 17 Headache 15 Angina pectoris 10 Chest pain 8 Fatigue 7 ST segment changes 6 Flushing 5 Nausea 4 Abdominal pain 4 Dizziness 4 Arrhythmia 4 Adverse reactions occurring during FLYRCADO PET MPI under rest and stress (pharmacologic or exercise) in <2% of subjects included diarrhea, palpitations, back pain, cardiac conduction disturbance, rash, dysgeusia, cough, hypotension, anxiety, vomiting, pruritus, bronchospasm, dry mouth, blood pressure elevation, syncope, and wheezing.

Contraindications

4 CONTRAINDICATIONS None. None ( 4 )

Pregnancy and Breastfeeding

8.1 Pregnancy Risk Summary There are no data on use of flurpiridaz F 18 in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes. All radiopharmaceuticals, including FLYRCADO, have the potential to cause fetal harm depending on the fetal stage of development and the magnitude of the radiation dose. If considering FLYRCADO administration to a pregnant woman, inform the patient about the potential for adverse pregnancy outcomes based on the radiation dose from flurpiridaz F 18 and the gestational timing of exposure. FLYRCADO contains ethanol (a maximum daily dose of 337 mg anhydrous ethanol). The 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. If considering FLYRCADO administration to a pregnant woman, inform the patient about the potential for adverse pregnancy outcomes associated with ethanol exposure during pregnancy. The background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.

How Supplied

16 HOW SUPPLIED/STORAGE AND HANDLING How Supplied FLYRCADO (flurpiridaz F 18) injection is a clear, colorless to yellow solution containing 190 MBq/mL to 2,050 MBq/mL (5 mCi/mL to 55 mCi/mL) of flurpiridaz F 18 at end of synthesis, supplied in a shielded multiple-dose vial (NDC 0407-8787-01) with up to 30 mL fill volume. Storage and Handling Store FLYRCADO at 2°C to 30°C (36°F to 86°F); excursions to -20°C (-4°F) (up to 2 hours) or to 50°C (122°F) (up to 8 hours) may be permitted. Store FLYRCADO within radiation shielding. The product does not contain a preservative. Do not use and discard FLYRCADO 8 hours after end of synthesis or when the activity falls below the radioactivity requirement at the time of injection, whichever is earlier. The expiration date and time are provided on the shield label. Dispose of the product in accordance with all federal, state, and local laws and institutional requirements. This preparation is for use by persons licensed by the Nuclear Regulatory Commission or the relevant regulatory authority of an Agreement State.

About This Information

This drug information is sourced from FDA-approved labeling via the openFDA database. It is intended for educational and reference purposes only. This is not medical advice. Always consult your healthcare provider before making decisions about medication. Drug information may be updated by the FDA; check with your pharmacist for the most current information.

What are side effects?

Side effects are unwanted reactions that can occur when taking a medication. They range from mild (headache, nausea) to severe (allergic reactions, organ damage). Not everyone experiences side effects, and severity varies. Report any concerning side effects to your doctor.

What are drug interactions?

Drug interactions occur when a medication is affected by another drug, food, or supplement. Interactions can make medications less effective or cause dangerous side effects. Always tell your doctor about all medications and supplements you take.