Flyrcado

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 technique and radiation shielding to withdraw and administer FLYRCADO. Calculate the necessary volume to administer based on calibration time and activity using a suitably calibrated instrument. Visually inspect FLYRCADO for particulate matter and discoloration prior to administration and do not use if either is observed. Ensure the correct syringe is used and has adequate volume (at least 1 mL to 2 mL) so that the activity in the syringe can be administered without excessive dead volume loss. Measure patient dose using a dose calibrator immediately before administration. Do not use and discard FLYRCADO 8 hours after end of synthesis or when the activity falls below the activity requirement at the time of injection, whichever is earlier. FLYRCADO may be diluted aseptically with 0.9% Sodium Chloride Injection, USP. Diluted product should be used within 8 hours after end of synthesis or when the activity falls below the activity requirement at the time of injection, whichever is earlier. Dispose of unused product in a safe manner and in compliance with applicable regulations. Administration Instructions Administer FLYRCADO via intravenous injection as a bolus lasting less than 10 seconds and immediately follow with a flush of 0.9% Sodium Chloride Injection, USP. The minimum time between rest and stress dose administration is: 30 minutes when using pharmacologic stress 60 minutes when using exercise stress When using pharmacologic stress, administer FLYRCADO at the time of peak vasodilation according to the prescribing information for the stress agent, using an intravenous port different from the one used for the stress agent. When using exercise stress, administer FLYRCADO after the patient reaches at least 85% of their age-predicted maximum heart rate or exhibits ischemic signs or symptoms. The patient should then continue to exercise for approximately 1 minute to 2 minutes after the injection. If the patient cannot achieve the target heart rate, the examination may be converted to pharmacologic stress. 2.3 Image Acquisition Instructions For rest and stress imaging, image reconstruction should include attenuation correction. Rest Imaging Begin the PET acquisition 5 minutes after FLYRCADO administration and acquire images for 10 minutes using a scanner in 3D mode. Pharmacologic Stress Imaging Begin the PET acquisition 5 minutes after FLYRCADO administration and acquire images for 10 minutes using a scanner in 3D mode. Optionally, dynamic imaging may be performed, starting immediately prior to the injection of FLYRCADO. Exercise Stress Imaging Once the patient has been positioned on the scanner and respiration has begun to return to normal, begin image acquisition (about 15 minutes to 25 minutes after administration of FLYRCADO). Acquire images for 10 minutes using a scanner in 3D mode. 2.4 Radiation Dosimetry Table 2 shows the estimated radiation absorbed doses per unit of injected activity. Table 2 – Estimated Radiation Absorbed Doses in Organs/Tissues from Intravenous Administration of FLYRCADO in Adults Organ Absorbed Dose per Unit of Administered Activity (mGy/MBq) Rest Pharmacologic Stress The pharmacologic stress agent used was adenosine. Exercise Stress Adrenals 0.016 0.016 0.014 Bone surfaces 0.019 0.019 0.02 Brain 0.025 0.022 0.011 Breasts 0.009 0.009 0.01 Gallbladder Wall 0.017 0.018 0.015 Gastrointestinal Tract Stomach Wall 0.04 0.033 0.024 Small Intestine Wall 0.013 0.012 0.014 Upper Large Intestine Wall 0.013 0.012 0.014 Lower Large Intestine Wall 0.012 0.011 0.014 Heart Wall 0.048 0.09 0.039 Kidneys 0.066 0.057 0.027 Liver 0.039 0.044 0.015 Lungs 0.011 0.012 0.012 Muscle 0.01 0.01 0.012 Ovaries 0.012 0.012 0.014 Pancreas 0.016 0.016 0.015 Red Marrow 0.016 0.018 0.015 Salivary Glands 0.035 0.076 0.007 Skin 0.008 0.008 0.009 Spleen 0.016 0.012 0.013 Testes 0.009 0.009 0.011 Thymus 0.011 0.012 0.013 Thyroid 0.032 0.036 0.014 Urinary Bladder Wall 0.023 0.021 0.016 Uterus 0.012 0.012 0.014 Total Body 0.012 0.012 0.012 Effective Dose (mSv/MBq) 0.019 0.019 0.015 The whole-body effective dose resulting from the administration of maximal activity of FLYRCADO of 111 MBq at rest, 241 MBq during pharmacological stress, and 352 MBq during exercise stress is, respectively, 2.1 mSv, 4.6 mSv, and 5.3 mSv. Under the same conditions, the absorbed dose to the target organ (heart wall) is 5.3 mGy, 22 mGy, and 14 mGy for each administered activity, respectively. The use of a CT scan to calculate attenuation correction for the reconstruction of FLYRCADO PET images (as done in PET/CT imaging) will add radiation exposure.

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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.