Invirase (Saquinavir) - Indications and Dosage

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INDICATIONS AND USAGE

INVIRASE in combination with ritonavir and other antiretroviral agents is indicated for the treatment of HIV infection. The twice daily administration of INVIRASE in combination with ritonavir is supported by safety data from the MaxCmin 1 study (see Table 7) and pharmacokinetic data (see Table 1). The efficacy of INVIRASE with ritonavir has not been compared against the efficacy of antiretroviral regimens currently considered standard of care.

Description of Clinical Studies

In a randomized, double-blind clinical study (NV14256) in ZDV-experienced, HIV-infected patients, INVIRASE in combination with HIVID was shown to be superior to either INVIRASE or HIVID monotherapy in decreasing the cumulative incidence of clinical disease progression to AIDS-defining events or death. Furthermore, in a randomized study (ACTG229/NV14255), patients with advanced HIV infection with history of prolonged ZDV treatment and who were given INVIRASE 600 mg tid + ZDV + HIVID experienced greater increases in CD₄ cell counts as compared to those who received INVIRASE + ZDV or HIVID + ZDV. It should be noted that HIV treatment regimens that were used in these initial clinical studies of INVIRASE are no longer considered standard of care.

Saquinavir gel capsule 1000 mg bid coadministered with ritonavir 100 mg bid was studied in a heterogeneous population of 148 HIV-infected patients (MaxCmin 1 study). At baseline 42 were treatment naïve and 106 were treatment experienced (of which 52 had an HIV RNA level <400 copies/mL at baseline). Results showed that 91/148 (61%) subjects achieved and/or sustained an HIV RNA level <400 copies/mL at the completion of 48 weeks.

DOSAGE AND ADMINISTRATION

INVIRASE must be used in combination with ritonavir, because it significantly inhibits saquinavir's metabolism to provide increased plasma saquinavir levels.

Adults (Over the Age of 16 Years)

INVIRASE 1000-mg bid (5 × 200-mg capsules or 2 × 500-mg tablets) in combination with ritonavir 100-mg bid.
Ritonavir should be taken at the same time as INVIRASE.
INVIRASE and ritonavir should be taken within 2 hours after a meal.

Concomitant Therapy: INVIRASE with Lopinavir/Ritonavir

When administered with lopinavir/ritonavir 400/100 mg bid, the appropriate dose of INVIRASE is 1000 mg bid (with no additional ritonavir).

Monitoring of Patients

Clinical chemistry tests, viral load, and CD₄ count should be performed prior to initiating INVIRASE therapy and at appropriate intervals thereafter. For comprehensive patient monitoring recommendations for other nucleoside analogues, physicians should refer to the complete product information for these drugs.

Dose Adjustment for Combination Therapy with INVIRASE

For serious toxicities that may be associated with INVIRASE, the drug should be interrupted. INVIRASE at doses less than 1000 mg with 100 mg ritonavir bid are not recommended since lower doses have not shown antiviral activity. For recipients of combination therapy with INVIRASE and ritonavir, dose adjustments may be necessary. These adjustments should be based on the known toxicity profile of the individual agent and the pharmacokinetic interaction between saquinavir and the coadministered drug (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 of nucleoside analogues.

HOW SUPPLIED

INVIRASE 200-mg capsules are light brown and green opaque capsules with ROCHE and 0245 imprinted on the capsule shell—bottles of 270 (NDC 0004-0245-15).

INVIRASE 500-mg film-coated tablets are light orange to greyish- or brownish-orange, oval cylindrical, biconvex tablets with ROCHE and SQV 500 imprinted on the tablet face—bottles of 120 (NDC 0004-0244-51).

The capsules and tablets should be stored at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature] in tightly closed bottles.

HIVID and VERSED are registered trademarks of Hoffmann-La Roche Inc.

KALETRA is a registered trademark of Abbott Laboratories.

Capsules Manufactured by:

F. Hoffmann-La Roche Ltd., Basel, Switzerland

Tablets Manufactured by:

Roche Farma, S.A., Leganes, Spain

Distributed by:

Roche Pharmaceuticals
Roche Laboratories Inc.
340 Kingsland Street
Nutley, New Jersey 07110-1199

27899380

10085696

Revised: July 2007

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