HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use POSLUMA ® safely and effectively. See full prescribing information for POSLUMA. POSLUMA (flotufolastat F 18) injection, for intravenous use Initial U.S. Approval: 2023 ----------------------------- INDICATIONS AND USAGE -------------------------- POSLUMA is a radioactive diagnostic agent indicated for positron emission tomography (PET) of prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer: • with suspected metastasis who are candidates for initial definitive therapy • with suspected recurrence based on elevated serum prostate-specific antigen (PSA) level. (1) ------------------------- DOSAGE AND ADMINISTRATION -------------------- • Recommended amount of radioactivity of POSLUMA is 296 MBq (8 mCi) administered as an intravenous bolus injection. (2.2) • Initiate imaging approximately 60 minutes after administration. Scanning should start from mid-thigh and proceed to base of skull. (2.4) • See full prescribing information for additional preparation, handling, administration, imaging, and radiation dosimetry information. (2.3, 2.4) ---------------------- DOSAGE FORMS AND STRENGTHS --------------------- Injection: 296 MBq/mL to 5,846 MBq/mL (8 mCi/mL to 158 mCi/mL) as flotufolastat F 18 gallium in approximately 25 mL at end of synthesis in a multiple-dose vial. (3)
----------------------------- CONTRAINDICATIONS -------------------------------- None. (4) ------------------------ WARNINGS AND PRECAUTIONS ----------------------- • Risk of Image Misinterpretation: Image interpretation errors can occur with POSLUMA imaging. Interpretation of POSLUMA PET may differ depending on imaging readers in patients with suspected recurrence of prostate cancer. Consider multidisciplinary consultation and histopathological confirmation. (5.1, 14.2) • Radiation risk: POSLUMA contributes to a patient’s long-term cumulative radiation exposure. Ensure safe handling to protect patients and health care workers from unintentional radiation exposure. (2.1, 5.2) ------------------------------- ADVERSE REACTIONS ------------------------------ The most common adverse reactions (≥0.4%) are diarrhea, blood pressure increase, and injection site pain. (6.1) To report SUSPECTED ADVERSE REACTIONS, contact Blue Earth Diagnostics Ltd at 1-844-POSLUMA (1-844-767-5862) or FDA at 1-800- FDA-1088 or www.fda.gov/medwatch . See 17 for PATIENT COUNSELING INFORMATION Revised: 5/2023
FULL PRESCRIBING INFORMATION: CONTENTS* HIGHLIGHTS OF PRESCRIBING INFORMATION 1 INDICATIONS AND USAGE 2 DOSAGE AND ADMINISTRATION 2.1 Radiation Safety - Drug Handling 2.2
8.5
Geriatric Use
10 OVERDOSAGE 11 DESCRIPTION
11.1 Chemical Characteristics 11.2 Physical Characteristics 11.3 External Radiation 12 CLINICAL PHARMACOLOGY 12.1 Mechanism of action 12.2 Pharmacodynamics 12.3 Pharmacokinetics 13 NONCLINICAL TOXICOLOGY
Recommended Dose and Administration Instructions
2.3 2.4 2.5 2.6
Patient Preparation Image Acquisition
Image Display and Interpretation
Radiation Dosimetry 3 DOSAGE FORMS AND STRENGTHS 4 CONTRAINDICATIONS 5 WARNINGS AND PRECAUTIONS 5.1 Risk of Image Misinterpretation 5.2 Radiation Risks 6 ADVERSE REACTIONS 6.1 Clinical Trials Experience 7 DRUG INTERACTIONS 8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy 8.2 Lactation 8.4 Pediatric Use
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
14 CLINICAL STUDIES
14.1 Imaging Prior to Initial Definitive Therapy of Prostate Cancer 14.2 Imaging for Suspected Recurrence of Prostate Cancer 16 HOW SUPPLIED/STORAGE AND HANDLING 17 PATIENT COUNSELING INFORMATION *Sections or subsections omitted from the full prescribing information are not listed.
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Reference ID: 5180081
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