RUKOBIA (fostemsavir) dosing and drug interactions
Prescribe RUKOBIA as part of an optimized ARV regimen
RUKOBIA should be taken exactly as prescribed
The recommended dosing schedule for RUKOBIA is 600 mg twice daily, with or without food. No dose adjustments are required for patients with renal or hepatic impairment, regardless of severity.
One 600 mg tablet
Do not chew, crush, or split.
Tablet shown is not actual size.
No adjustments for renal
or hepatic impairment,
regardless of severity
With or without food
Taken twice daily
Drug-drug interaction (DDI) profile
Established and other potentially significant drug interactions*
Recommendations are based on drug interaction trials or predicted interactions due to the expected magnitude of interaction and potential for serious adverse events or loss of efficacy.
| Concomitant Drug Class: Drug Name |
Effect on Concentration of Temsavir and/or Concomitant Drug | Clinical Comment |
|---|---|---|
| Androgen receptor inhibitor: Enzalutamide |
↓ Temsavir | Coadministration is contraindicated due to potential for loss of therapeutic effect to RUKOBIA. |
| Anticonvulsants: Carbamazepine Phenytoin |
↓ Temsavir | |
| Antimycobacterial: Rifampin |
↓ Temsavir | |
| Antineoplastic: Mitotane |
↓ Temsavir | |
| Herbal product: St John's wort (Hypericum perforatum) |
↓ Temsavir | |
| Hepatitis C virus direct-acting antivirals: Grazoprevir Voxilaprevir |
↑ Grazoprevir ↑ Voxilaprevir |
Coadministration may increase exposures of grazoprevir or voxilaprevir; however, the magnitude of increase in exposure is unknown. Increased exposures of grazoprevir may increase the risk of ALT elevations. Use an alternative HCV regimen if possible. |
| Oral contraceptive: Ethinyl estradiol |
↑ Ethinyl estradiol | Ethinyl estradiol daily dose should not exceed 30 mcg. Caution is advised particularly in patients with additional risk factors for thromboembolic events. |
| Statins: | ||
| Rosuvastatin | ↑ Rosuvastatin | Use the lowest possible starting dose for statins and monitor for statin-associated adverse events. |
| Atorvastatin | ↑ Atorvastatin | |
| Fluvastatin | ↑ Fluvastatin | |
| Pitavastatin | ↑ Pitavastatin | |
| Simvastatin | ↑ Simvastatin | |
↑=increase, ↓=decrease.
*This table is not all inclusive.
ALT=alanine transaminase; ARV=antiretroviral; HCV=hepatitis C virus; HIV-1=human immunodeficiency virus type-1.
FSTWCNT230027
