Fostemsavir is a novel anti-HIV-1 drug. As a gp120-directed attachment inhibitor, its unique mechanism provides an important treatment option for patients with multiply drug-resistant HIV infection.

Indications for Fostemsavir

Core Target Population

In combination with other antiretroviral drugs, Fostemsavir is indicated for adult patients who meet the following criteria:

Extensive treatment experience: Patients who have previously received multiple anti-HIV regimens and whose current treatment has failed due to drug resistance, intolerance, or safety issues.

Multiply drug-resistant HIV-1 infection: Patients whose virus has developed extensive resistance to existing antiviral drugs and who require a combination of drugs with novel mechanisms of action.

Dosage Form, Strength and Properties of Fostemsavir

Dosage Form and Strength

Dosage form: Extended-release tablets, each containing 600 mg of Fostemsavir (equivalent to 725 mg of fostemsavir tromethamine salt).

Appearance: Beige, oval-shaped, film-coated tablets with a biconvex design. One side is engraved with the marking "SV1V7".

Composition

Active ingredient: Fostemsavir tromethamine salt.

Excipients: Include colloidal silicon dioxide, hydroxypropyl cellulose, hypromellose, etc. The film coating contains iron oxide red/yellow, polyethylene glycol, etc.

Odor: May have a slight vinegar-like odor, which is a normal phenomenon.

Administration Method

Swallow whole: The tablets must be swallowed whole; chewing, crushing, or breaking them is not allowed, as this will destroy the extended-release structure.

Effect of food: Can be taken with or without food. A high-fat meal may increase absorption (but no deliberate adjustment is required).

Storage Method for Fostemsavir

Environmental Requirements

Temperature: Store at 20°C to 25°C (68°F to 77°F). Brief exposure to temperatures between 15°C and 30°C (59°F and 86°F) is permitted.

Packaging: The original bottle is equipped with a child-resistant cap and contains 60 tablets. Do not transfer the tablets to other containers after opening the original packaging.

Precautions

Moisture and light protection: Keep the container tightly closed and away from moisture and direct sunlight.

Expiration date management: Regularly check the expiration date of the drug. Expired drugs should be disposed of as medical waste.

Special note: If the tablets have an abnormal odor or show changes in physical properties (such as discoloration, cracking), use of the drug should be discontinued.