Generic name: saquinavir
Dosage form: Soft Gelatin Capsules
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FORTOVASE (saquinavir) soft gelatin capsules and INVIRASE (saquinavir mesylate) capsules are not bioequivalent and cannot be used interchangeably. When using saquinavir as the sole protease inhibitor in an antiviral regimen, FORTOVASE is the recommended formulation. INVIRASE may be considered only if it is combined with ritonavir, which significantly inhibits saquinavir's metabolism to provide plasma saquinavir levels at least equal to those achieved with FORTOVASE at the recommended dose of 1200 mg tid (see CLINICAL PHARMACOLOGY: Drug Interactions).
Adults (Over the Age of 16 Years)
FORTOVASE Administered Without Ritonavir:
- FORTOVASE 1200-mg tid (6 × 200-mg capsules)
- FORTOVASE should be taken with a meal or up to 2 hours after a meal
FORTOVASE Administered With Ritonavir:
- FORTOVASE 1000-mg bid (5 × 200-mg capsules) in combination with ritonavir 100-mg bid
- Ritonavir should be taken at the same time as FORTOVASE
- FORTOVASE and ritonavir should be taken within 2 hours after a meal
When used in combination with nucleoside analogues, the dosage of FORTOVASE should not be reduced as this will lead to greater than dose proportional decreases in saquinavir plasma levels.
Patients should be advised that FORTOVASE, like other protease inhibitors, is recommended for use in combination with active antiretroviral therapy. Greater activity has been observed when new antiretroviral therapies are begun at the same time as FORTOVASE. As with all protease inhibitors, adherence to the prescribed regimen is strongly recommended. Concomitant therapy should be based on a patient's prior drug exposure.
Monitoring of Patients
Clinical chemistry tests, viral load, and CD4 count should be performed prior to initiating FORTOVASE therapy and at appropriate intervals thereafter. For comprehensive patient monitoring recommendations for other antiretroviral therapies, physicians should refer to the complete product information for these drugs.
Dose Adjustment for Combination Therapy with FORTOVASE
For serious toxicities that may be associated with FORTOVASE, the drug should be interrupted. For recipients of combination therapy with FORTOVASE and other antiretroviral agents, dose adjustment of the other antiretroviral agents should be based on the known toxicity profile of the individual drug. FORTOVASE dose adjustments may be required with some other antiretroviral agents (see PRECAUTIONS: Drug Interactions). Physicians should refer to the complete product information for these drugs for comprehensive dose adjustment recommendations and drug-associated adverse reactions.
More about Fortovase (saquinavir)
- Other brands: Invirase