DRUG INTERACTIONS -(summary)

Androgen deprivation therapy and other therapies targeting the androgen pathway Androgen deprivation therapy (ADT) and other therapies targeting the androgen pathway, such as androgen receptor antagonists, may result in changes in uptake of PYLARIFY in prostate cancer.

The effect of these therapies on performance of PYLARIFY PET has not been established.

BRIEF SUMMARY-

PIFLUFOLASTAT F 18-Injection -( May 2021) 

Indn-  For positron emission tomography imaging of  prostrate-specific membrane antigen-positive lesions in me with prostrate cancer 

Comp-  Injection: clear, colorless solution in a multiple-dose vial containing 37 MBq/mL to 2,960 MBq/mL (1 mCi/mL to 80 mCi/mL) of piflufolastat F 18 at calibration date and time.

 Recommended dose is 333 MBq (9 mCi) with an acceptable range of 296 MBq to 370 MBq (8 mCi to 10 mCi), administered as a bolus intravenous injection.     

ADR-  The most common reported adverse reactions are headache, dysgeusia, and fatigue.

CI-   None.

WARNINGS - 

­ • Risk of Image Misinterpretation:  drug  uptake can be seen in a variety of tumor types as well as in non-malignant processes and normal tissues. Image interpretation errors can occur 

 • Hypersensitivity Reactions: Monitor patients for hypersensitivity reactions, particularly patients with a history of allergy to other drugs and foods.

Pat Inform-

Adequate Hydration-                                                                                                   Instruct patients to drink a sufficient amount of water to ensure adequate hydration before their PET study and urge them to drink and urinate as often as possible during the first hours following the administration of , in order to reduce radiation exposure

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U.S. FDA APPROVED DRUGS SURING 2021                                          

Serial No 21

Name of the Drug-    PYLARIFY

Active Ingredient -   Piflufolast F 18 Injection

Pharmacological Classification-    For positron emission tomography imaging of                                                              prostrate-specific membrane antigen-positive                                                                lesions in me with prostrate cancer                                                                          

                                                                                                                                                  Date of Approval-          5/26/2021

HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the information needed to use                              PYLARIFY® safely and effectively.                                                                                 See full prescribing information for PYLARIFY. PYLARIFY® (piflufolastat F 18) injection, for intravenous use

Initial U.S. Approval: 2021

INDICATIONS AND USAGE-

­ PYLARIFY 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 prostatespecific antigen (PSA) level.

DOSAGE AND ADMINISTRATION-

­ • Recommended dose is 333 MBq (9 mCi) with an acceptable range of 296 MBq to 370 MBq (8 mCi to 10 mCi), administered as a bolus intravenous injection.                       

 • Initiate imaging approximately 60 minutes after PYLARIFY administration. The patient should void immediately prior to initiation of imaging. Image acquisition should start from mid-thigh and proceed to the skull vertex.

 • See full prescribing information for additional preparation, handling,

ADVERSE REACTIONS-

­­ The most common reported adverse reactions are headache, dysgeusia, and fatigue.

CONTRAINDICATIONS- 

­ None.

WARNINGS AND PRECAUTIONS- 

­ • Risk of Image Misinterpretation: PYLARIFY uptake can be seen in a variety of tumor types as well as in non-malignant processes and normal tissues. Image interpretation errors can occur with PYLARIFY ima

 • Hypersensitivity Reactions: Monitor patients for hypersensitivity reactions, particularly patients with a history of allergy to other drugs and foods.

 • Radiation Risk: Ensure safe drug handling to protect patients and health care workers from unintentional radiation exposure.

DOSAGE AND ADMINISTRATION-

­ • Recommended dose is 333 MBq (9 mCi) with an acceptable range of 296 MBq to 370 MBq (8 mCi to 10 mCi), administered as a bolus intravenous injection.                       

 • Initiate imaging approximately 60 minutes after PYLARIFY administration. The patient should void immediately prior to initiation of imaging. Image acquisition should start from mid-thigh and proceed to the skull vertex.

 • See full prescribing information for additional preparation, handling,

DOSAGE FORMS AND STRENGTHS-

­ Injection: clear, colorless solution in a multiple-dose vial containing 37 MBq/mL to 2,960 MBq/mL (1 mCi/mL to 80 mCi/mL) of piflufolastat F 18 at calibration date and time.

 PATIENT COUNSELING INFORMATION

Adequate Hydration-                                                                                                    Instruct patients to drink a sufficient amount of water to ensure adequate hydration before their PET study and urge them to drink and urinate as often as possible during the first hours following the administration of PYLARIFY, in order to reduce radiation exposure

Manufactured for: Progenics Pharmaceuticals, Inc. 331 Treble Cove Road Billerica, MA 01862

 CLINICAL PHARMACOLOGY-

1. Mechanism of Action-                                                                                             Piflufolastat F 18 binds to cells that express PSMA, including malignant prostate cancer cells, which usually overexpress PSMA. Fluorine-18 (F 18) is a ß+ emitting radionuclide that enables positron emission tomography.

2. Pharmacodynamics-                                                                                                    The relationship between piflufolastat F 18 plasma concentrations and image interpretation has not been studied.

3. Pharmacokinetics-                                                                                               Distribution-                                                                                                                   Following intravenous administration of piflufolastat F 18, blood levels decline in a biphasic fashion. The distribution half-life is 0.17 ± 0.044 hours and the elimination half-life is 3.47 ± 0.49 hours. Piflufolastat F 18 distributes to the kidneys (16.5% of administered activity), liver (9.3%), and lung (2.9%), within 60 minutes of intravenous administration.

Elimination-                                                                                                                       Elimination is by urinary excretion. In the first 8 hours post-injection, approximately 50% of administered radioactivity is excreted in the urine.

  USE IN SPECIFIC POPULATIONS

1. Pregnancy Risk Summary-

PYLARIFY is not indicated for use in females. There is no information on the risk of adverse developmental outcomes in pregnant women or animals with the use of piflufolastat F 18.

All radiopharmaceuticals, including PYLARIFY, have the potential to cause fetal harm depending on the fetal stage of development and the magnitude of the radiation dose.

2 Lactation Risk Summary-                                                                                            PYLARIFY is not indicated for use in females. There is no information on the presence of piflufolastat F 18 in human milk, the effect on the breastfed infant, or the effect on milk production.

3. Pediatric Use-                                                                                                             The safety and effectiveness of PYLARIFY in pediatric patients have not been established.

4. Geriatric Use-                                                                                                               Of the 593 patients in completed clinical studies of PYLARIFY, 355 (60%) were =65 years old, while 76 (12.8%) were =75 years old. The efficacy and safety of PYLARIFY appear similar in adult and  geriatric patients with prostate cancer, although the number of patients in the trials was not large enough to allow definitive comparison.

 OVERDOSAGE-                                                

In the event of an overdose of PYLARIFY, reduce the radiation absorbed dose to the patient where possible by increasing the elimination of the drug from the body using hydration and frequent bladder voiding.

A diuretic might also be considered. If possible, an estimate of the radiation effective dose administered to the patient should be made.