Flotufolastat F 18

What is Flotufolastat F 18?

• Flotufolastat F 18 (Posluma) is a radioactive diagnostic agent for intravenous use.

What are the uses of this medicine?

Flotufolastat F 18 (Posluma) is used 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.

How does this medicine work?

• Flotufolastat F 18 binds to PSMA 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.

Who Should Not Use this medicine ?

• This medicine have no usage limitations.

What drug interactions can this medicine cause?

• Tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products.

Be sure to mention any of the following:

• androgen receptor antagonists

Is this medicine FDA approved?

• Initial U.S. Approval: 2023

How should this medicine be used?

• Instruct patients to drink water prior to administration of Posluma to ensure adequate hydration and to continue drinking and voiding frequently for the first few hours following administration to reduce radiation exposure.

Recommended dosage:

• Recommended amount of radioactivity of Posluma is 296 MBq (8 mCi) 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.

Administration:

• Posluma (flotufolastat F 18) injection is for intravenous use.
• Inspect Posluma visually for particulate matter and discoloration before administration.
• Do not use the drug if the solution contains particulate matter or is discolored.
• Use aseptic technique and radiation shielding when withdrawing and administering Posluma.
• Calculate the necessary volume to administer based on calibration time and required dose.
• The recommended maximum volume of undiluted Posluma is 5 mL.
• Posluma may be diluted with 0.9% Sodium Chloride Injection, USP.
• Assay the dose in a dose calibrator before administration.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As 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.

This medicine is available in fallowing brand namesː

• Posluma

What side effects can this medication cause?

The most common side effects of this medicine include:

• diarrhea, blood pressureincrease, and injection site pain.

Less common, but serious side effects may include:

• Radiation Risks

What special precautions should I follow?

• 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.
• Image interpretation errors can occur with Posluma PET. Negative image does not rule out the presence of prostate cancer and a positive image does not confirm the presence of prostate cancer.
• Posluma use contributes to a patient's overall long-term cumulative radiation exposure. Long-term cumulative radiation exposure is associated with an increased risk for cancer.
• Ensure safe handling to minimize radiation exposure to the patient and health care providers.
• 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.

What to do in case of emergency/overdose?

Management of overdosage:

• In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

• Overdose related information is also available online at poisonhelp.org/help.
• In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.
• 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.

Can this medicine be used in pregnancy?

• 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.

Can this medicine be used in children?

• The safety and effectiveness of Posluma have not been established in pediatric patients.

What are the active and inactive ingredients in this medicine?

Active ingredient:

• flotufolastat f-18

Inactive ingredients:

• citric acid monohydrate
• sodium hydroxide
• water
• sodium chloride

Who manufactures and distributes this medicine?

• Marketed by Blue Earth Diagnostics Ltd., Oxford, OX4 4GA, UK
• Posluma is a registered trademark of Blue Earth Diagnostics Ltd.

What should I know about storage and disposal of this medication?

• Store Posluma at 20°C to 25°C (68°F to 77°F).
• Store Posluma in the original container in radiation shielding.
• The expiration date and time are provided on the container label.
• Use Posluma within 10 hours from end of synthesis.
• Dispose of unused Posluma in compliance with applicable regulations.

• Dailymed label info on Flotufolastat F 18
• FDA Flotufolastat F 18

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