Fostemsavir is a novel anti-HIV-1 drug. As a gp120-directed attachment inhibitor, its unique mechanism of action provides a crucial treatment option for patients with multiply drug-resistant HIV infections.

Indications for Fostemsavir

Core Target Population

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

High Treatment Experience: Patients who have previously received multiple anti-HIV regimens and experienced failure of their current treatment due to drug resistance, intolerance, or safety issues.

Multiply Drug-Resistant HIV-1 Infection: Patients whose HIV-1 has developed extensive resistance to existing antiviral drugs, requiring reliance on drug combinations with novel mechanisms of action.

Specifications and Properties of Fostemsavir

Dosage Form and Strength

Dosage Form: Extended-release tablets. Each tablet contains 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: Including colloidal silicon dioxide, hydroxypropyl cellulose, hypromellose, etc. The film coating layer contains iron oxide red/yellow, polyethylene glycol, and other components.

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

Administration Method

Swallow Whole: The tablets must be swallowed whole. They should not be chewed, crushed, or broken, as this would destroy the extended-release structure.

Dietary Impact: Can be taken with food or on an empty stomach. A high-fat meal may increase absorption (but no deliberate adjustment of diet is required).

Storage Methods 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 Reminder: If the tablets have an abnormal odor or show changes in physical properties (such as discoloration, cracking), do not use them.