DRUG INTERACTIONS-(summary)

 Androgen deprivation therapy (ADT) and other therapies targeting the androgen pathway, such as androgen receptor antagonists, can result in changes in uptake of flotufolastat F 18 in prostate cancer.

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

BRIEF SUMMARY

FLOTUFOLASTAT-F 18- (May 2023)

Indication-   To  Use with positron emission tomographic                                                                 imaging in certain patients with prostrate                                                                       cancer   

Dose- 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  in a multiple-dose vial. 

ADR- 

 The most common adverse reactions (=0.4%) are diarrhea, blood pressure increase, and injection site pain. 

CI-  None.

WARNINGS 

 Risk of Image Misinterpretation: Image interpretation errors can occur  in patients with suspected recurrence of prostate cancer. .

Pat Inform- Adequate Hydration- Instruct patients to drink a sufficient amount of water to ensure adequate hydration  and urge them to drink and urinate as often as possible during the first hours following  administration to reduce radiation exposure

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U.S.  APPROVED DRUGS DURING 2023                                        

Serial No 21

Name-                          POSLUMA

Acive  Ingredient -      FLOTULASTAT  F 18

Pharmacological clssificiation-        To  Use with positron emission tomographic                                                                 imaging in certain patients with prostrate                                                                       cancer                                                                                                                                                                                                                           

 Date of Approval-         5/25/2023

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.

ADVERSE REACTIONS-

 The most common adverse reactions (=0.4%) are diarrhea, blood pressure increase, and injection site pain. 

CONTRAINDICATIONS

 None.

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.

• 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.

se reactions (=0.4%) are diarrhea, blood pressure increase, and injection site pain. 

DOSAGE AND ADMINISTRATION-

 administered as an intravenous bolus injection.

 • Initiate imaging approximately 60 minutes after administration. Scanning should start from mid-thigh and proceed to base of skull

 • See full prescribing information for additional preparation, handling, administration, imaging, and radiation dosimetry information.

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. 

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 POSLUMA, in order to reduce radiation exposure

. Marketed by Blue Earth Diagnostics Ltd., Oxford, OX4 4GA, UK POSLUMA® is a registered trademark of Blue Earth Diagnostics Ltd. © 2023 Blue Earth Diagnostics Ltd. – all rig

CLINICAL PHARMACOLOGY

1. Mechanism of action-

Flotufolastat F 18 binds to PSMA (IC50 = 4.4 nM) expressed on cells, including prostate cancer cells, and is internalized. Prostate cancer cells usually overexpress PSMA. Fluorine-18 is a ß+ emitting radionuclide that can be detected using positron emission tomography.

2. Pharmacodynamics The relationship between flotufolastat F 18 plasma concentrations and image interpretation has not been fully characterized.

3. Pharmacokinetics -

Distribution -Following intravenous administration, flotufolastat F 18 distributes to liver (15.8% of administered activity), heart blood pool (7.4%), and kidneys (3.2%) and is cleared from the blood.

Elimination Metabolism- Flotufolastat F 18 does not undergo metabolism up to 50 minutes post injection.

Excretion-

 Elimination is by urinary excretion. Approximately 7% of the administered activity was excreted in the urine in the first 2 hours post-injection with approximately 15% excreted by 4.5 hours post-injection. 

8 USE IN SPECIFIC POPULATIONS

1 Pregnancy Risk Summary

POSLUMA is not indicated for use in females. There are no available data on the use of POSLUMA in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Animal reproduction studies have not been conducted with flotufolastat F

 Radioactive drugs, including POSLUMA, 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

POSLUMA is not indicated for use in females. There are no data on the presence of flotufolastat 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 POSLUMA have not been established in pediatric patients.

4. Geriatric Use Among the total number of patients receiving POSLUMA in clinical studies of prostate cancer, 463 (62%) were 65 years of age and older, while 118 (16%) were 75 years of age and older 

No overall differences in safety or effectiveness were observed between these patients and younger adult patients

 OVERDOSAGE-

In the event of an overdose of POSLUMA, maintain hydration of the patient and frequent voiding to minimize radiation exposure. A diuretic might also be considered. If possible, an estimate of the radiation effective dose administered to the patient should be made.