FORTOVASE is indicated for use in combination with other antiretroviral agents for the treatment of HIV infection.

This indication is based on studies that showed increased saquinavir concentrations and improved antiviral activity for FORTOVASE 1200 mg tid compared to INVIRASE 600 mg tid.In treatment-naive and treatment-experienced patients, the efficacy of FORTOVASE (with or without ritonavir coadministration) has not been compared against the efficacy of antiretroviral regimens currently considered standard of care.

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HIV Infections -- any state of infection accompanied by evidence of HIV in the body (positive test for HIV genome, cDNA, proteins, antigens, or antibodies); may be medically asymptomatic or symptomatic; use AIDS when appropriate.

FORTOVASE is contraindicated in patients with clinically significant hypersensitivity to saquinavir or to any of the components contained in the capsule.FORTOVASE should not be administered concurrently with terfenadine, cisapride, astemizole, pimozide, triazolam, midazolam, or ergot derivatives, because competition for CYP3A4 by saquinavir could result in inhibition of the metabolism of these drugs and create the potential for serious and/or life-threatening reactions, such as cardiac arrhythmias or prolonged sedation (see PRECAUTIONS: Drug Interactions).FORTOVASE is contraindicated in patients with severe hepatic impairment (see PRECAUTIONS: Hepatic Effects).FORTOVASE should not be administered concurrently with drugs listed in Table 4 (also see PRECAUTIONS: Drug Interactions, Table 5).Table 4 Drugs That Are Contraindicated With FORTOVASE Drug ClassDrugs Within Class That Are Contraindicated With FORTOVASE AntiarrhythmicsAmiodarone, bepridil, flecainide, propafenone, quinidine AntihistaminesAstemizoleNo longer marketed in the US., terfenadine Ergot DerivativesDihydroergotamine, ergonovine, ergotamine, methylergonovine Antimycobacterial AgentsRifampin GI Motility AgentCisapride NeurolepticsPimozide Sedative/HypnoticsTriazolam, midazolam If FORTOVASE is coadministered with ritonavir, the ritonavir label should be reviewed for additional contraindicated drugs.

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Hypersensitivity -- Altered reactivity to an antigen, which can result in pathologic reactions upon subsequent exposure to that particular antigen.

cardiac arrhythmia -- any variation from the normal rhythm or rate of the heart beat.

Sedation --

Hepatic impairment --

ALERT: Find out about medicines that should not be taken with FORTOVASE.

This statement is included on the product's bottle label.