Warnings/Precautions

All Proteases

New onset diabetes mellitus, exacerbation of pre-existing diabetes mellitus and hyperglycemia have been reported during post-marketing surveillance in HIV-infected patients receiving protease inhibitor therapy. Some patients required either initiation or dose adjustments of insulin or oral hypoglycemic agents for treatment of these events. In some cases diabetic ketoacidosis has occurred. In those patients who discontinued protease inhibitor therapy, hyperglycemia persisted in some cases. Because these events have been reported voluntarily during clinical practice, estimates of frequency cannot be made and a causal relationship between protease inhibitor therapy and these events has not been established.

There have been reports of increased bleeding, including spontaneous skin hematomas and hemarthrosis, in patients with hemophilia type A and B treated with protease inhibitors. In some patients additional factor VIII was given. In more than half of the reported cases, treatment with protease inhibitors was continued or reintroduced. A casual relationship has not been established.

Resistance/Cross-resistance

The potential for HIV cross-resistance between protease inhibitors has not been fully explored. Therefore, it is unknown what effect initial protease inhibitor therapy will have on the activity of subsequent protease inhibitors.

Viracept®

Patients with Phenylketonuria: Viracept® Oral Powder contains 11.2 mg phenylalanine per gram of powder.

Norvir^tm

Allergic reactions including urticaria, mild skin eruptions, bronchospasm, and angioedema have been reported. Rare cases of anaphylaxis and Stevens-Johnson syndrome have also been reported.

Hepatic transaminase elevations exceeding 5 times the upper limit of normal, clinical hepatitis, and jaundice have occurred in patients receiving Norvir^tm alone or in combination with other antiretroviral drugs (see Table V). There may be an increased risk for transaminase elevations in patients with underlying hepatitis B or C. Therefor, caution should be exercised when administering Norvir^tm to patients with pre-existing liver diseases, liver enzyme abnormalities, or hepatitis.

There have been postmarketing reports of hepatic dysfunction, including some fatalities. These have generally occurred in patients taking multiple concomitant medications and/or with advanced AIDS. A definitive causal relationship has not been established.

Crixivan®

Nephrolithiasis (kidney stones) may occur with Crixivan®. If signs and symptoms of nephrolithiasis, including flank pain with or without hematuria (including microscopic hematuria), occur, temporary interruption of therapy (e.g. 1-3 days) during the acute episode of nephrolithiasis may be considered. Adequate hydration is recommended in all patients treated with Crixivan®.