POSLUMA Dosage & Rx Info | Uses, Side Effects

Posluma Generic Name & Formulations

Legal Class

General Description

Flotufolastat F 18 (296–5846 MBq/mL [8–158 mCi/mL]); per ~25mL; soln for IV inj.

Pharmacological Class

Radioactive diagnostic agent.

How Supplied

Multi-dose vial (25mL)—1

Storage

Store Posluma at 20°C to 25°C (68°F to 77°F) [see USP Controlled Room Temperature]. 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.

Manufacturer

Blue Earth Diagnostics, Inc.

Generic Availability

Mechanism of Action

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.

Posluma Indications

Indications

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 or with suspected recurrence based on elevated serum PSA level.

Posluma Dosage and Administration

Adult

Give as IV bolus inj. 296MBq (8mCi); max volume 5mL (undiluted). Follow with NaCl 0.9% IV flush. Acquire images ~60mins after inj. The radiation absorbed dose from 296MBq (8mCi) dose is 4.1mSv.

Children

Not established.

Posluma Contraindications

Not Applicable

Posluma Boxed Warnings

Not Applicable

Posluma Warnings/Precautions

Warnings/Precautions

Risk of radiation exposure. Should only be used by trained and experienced physicians in the safe use and handling of radioactive materials to minimize radiation exposure. Risk for image misinterpretation and other errors; clinical correlation recommended. Contributes to patient's overall long-term cumulative radiation exposure. Advise to hydrate prior to and post-inj; void frequently after. Pregnancy, nursing mothers: not indicated for females.

Posluma Pharmacokinetics

See Literature

Posluma Interactions

Interactions

Androgen deprivation therapy (ADT) and other therapies targeting the androgen pathway may affect flotufolastat F 18 uptake.

Posluma Adverse Reactions

Adverse Reactions

Diarrhea, BP increase, inj site pain.

Posluma Clinical Trials

Clinical Trials

The approval of Posluma was based on data from the LIGHTHOUSE study (ClinicalTrials.gov Identifier: NCT04186819), a phase 3, prospective, open-label, single-arm trial that included patients with prostate cancer who were candidates for initial definitive therapy. All study participants received a single dose of Posluma. Three central readers blinded to clinical information interpreted the scans for lesions considered positive for prostate cancer in pelvic lymph nodes.

The LIGHTHOUSE study demonstrated high specificity for the detection of pelvic lymph nodes (overall specificity of 96%) as compared with histopathology standard of truth in men with PSMA-positive lesions prior to radical prostatectomy. The overall sensitivity of Posluma was reported to be 24% by majority read.

Posluma was also investigated in the SPOTLIGHT study (ClinicalTrials.gov Identifier: NCT04186845), which included patients with biochemical evidence of recurrent prostate cancer. All patients received a single dose of Posluma. Three central readers blinded to clinical information interpreted each scan for the presence and location of lesions considered positive for prostate cancer.

Results showed an overall detection rate of 83% (322/389) based on the majority read from the 3 blinded PET readers. Among patients with prior prostatectomy, the detection rates were: 64% (77/121) for PSA level less than 0.5ng/mL; 76% (51/67) for PSA level 0.5 to less than 1ng/mL; 93% (42/44) for PSA 1 to less than 2ng/mL; and 97% (152/156) for PSA level greater than or equal 2ng/mL.

Posluma

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