Drug Detail:Fostemsavir (Fostemsavir [ fos-tem-sa-vir ])
Drug Class: Miscellaneous antivirals
Usual Adult Dose for HIV Infection
600 mg orally twice a day
Use: In combination with other antiretroviral agent(s), for the treatment of HIV-1 infection in heavily treatment-experienced patients with multidrug-resistant HIV-1 infection failing their current antiretroviral regimen due to resistance, intolerance, or safety considerations
Renal Dose Adjustments
Renal dysfunction: No adjustment recommended.
Liver Dose Adjustments
Mild to severe liver dysfunction (Child-Pugh A, B, or C): No adjustment recommended.
Precautions
CONTRAINDICATIONS:
- Previous hypersensitivity to this drug or any of the ingredients
- Coadministration with strong CYP450 3A inducers (may significantly decrease temsavir [the active moiety of this drug] plasma levels, which may result in loss of virologic response) including, but not limited to, enzalutamide, carbamazepine, phenytoin, rifampin, mitotane, St. John's wort
Safety and efficacy have not been established in patients younger than 18 years.
Consult WARNINGS section for additional precautions.
Dialysis
Hemodialysis: No adjustment recommended.
Other Comments
Administration advice:
- Administer with or without food.
- Swallow tablets whole; do not chew, crush, or split.
- Consult the manufacturer product information regarding missed doses.
Storage requirements:
- Store at 20C to 25C (68F to 77F); excursions permitted between 15C and 30C (59F and 86F).
General:
- The tablets may have a slight vinegar-like odor.
Monitoring:
- Hepatic: Liver chemistries in patients coinfected with HBV and/or HCV
Patient advice:
- Read the US FDA-approved patient labeling (Patient Information).
- Notify healthcare provider at once of any signs/symptoms of infection.
- Consult healthcare provider if symptoms such as dizziness, lightheadedness, abnormal heart rhythm, or loss of consciousness occur.
- Do not miss or skip doses as resistance may develop.
