"The U.S. Food and Drug Administration today announced that new safety information has been added to the label for the HIV antiviral drug Invirase (saquinavir), describing potentially life-threatening side effects on the heart when used with Norvi"...
INVIRASE in combination with ritonavir and other antiretroviral agents is indicated for the treatment of HIV-1 infection in adults (over the age of 16 years).
The following points should be considered when initiating therapy with INVIRASE:
- The twice daily administration of INVIRASE in combination with ritonavir is supported by safety data from the MaxCmin 1 trial [see ADVERSE REACTIONS] and pharmacokinetic data [see CLINICAL PHARMACOLOGY].
- The efficacy of INVIRASE with ritonavir has not been compared against the efficacy of antiretroviral regimens currently considered standard of care.
- The number of baseline primary protease inhibitor mutations affects the virologic response to INVIRASE/ritonavir.
DOSAGE AND ADMINISTRATION
INVIRASE must be used in combination with ritonavir because ritonavir significantly inhibits saquinavir's metabolism to provide increased plasma saquinavir levels.
- INVIRASE 1000-mg twice daily (5 x 200-mg capsules or 2 x 500-mg tablets) in combination with ritonavir 100-mg twice daily.
- Ritonavir should be taken at the same time as INVIRASE.
- INVIRASE and ritonavir should be taken within 2 hours after a meal.
- No additional ritonavir is recommended when INVIRASE is administered with lopinavir/ritonavir 400/100 mg twice daily.
- Pediatric dose recommendations that are both reliably effective and below thresholds of concern for QT and PR interval prolongation could not be determined.
Administration for Patients Unable to Swallow Capsules
Open the INVIRASE capsules and place the contents into an empty container. Add 15 mL of either sugar syrup or sorbitol syrup (for patients with Type 1 diabetes or glucose intolerance) OR 3 teaspoons of jam to the contents of INVIRASE capsules that are in the container. Stir with a spoon for 30 to 60 seconds. Administer the full amount prepared for each dose. Suspensions should be at room temperature before administering.
Dosage Forms And Strengths
Capsules: 200 mg Film-coated tablets: 500 mg
Storage And Handling
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.
Capsules Manufactured by: Roche Farma, S.A., Leganes, Spain Tablets Manufactured by: Roche Farma, S.A., Leganes, Spain. Distributed by: Genentech USA, Inc. A member of the Roche Group, 1 DNA Way, South San Francisco, CA 94080-4990. Revised: November 2012
Last reviewed on RxList: 12/18/2012
This monograph has been modified to include the generic and brand name in many instances.
Additional Invirase Information
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