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DRUG INTERACTIONS
Drugs That Are Mainly Metabolized by CYP3A4
Although specific studies have not been performed, coadministration with drugs that are mainly metabolized by CYP3A4 (eg, calcium channel blockers, dapsone, disopyramide, quinine, amiodarone, quinidine, warfarin, tacrolimus, cyclosporine, ergot derivatives, pimozide, carbamazepine, fentanyl, alfentanyl, alprazolam, nefazodone and triazolam) may have elevated plasma concentrations when coadministered with saquinavir; therefore, these combinations should be used with caution. If FORTOVASE is coadministered with ritonavir, the ritonavir label should be reviewed for additional drugs that should not be coadministered.
Inducers of CYP3A4
Coadministration with compounds that are potent inducers of CYP3A4 (eg, phenobarbital, phenytoin, dexamethasone, carbamazepine) may result in decreased plasma levels of saquinavir.
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OVERDOSAGE
Two cases of FORTOVASE overdosage have been received (one case with unknown amount of FORTOVASE, the second case 3.6 to 4 grams at once). No adverse events have been reported in both cases. There were 2 patients who had overdoses with INVIRASE. No acute toxicities or sequelae were noted in the first patient after ingesting 8 grams of INVIRASE as a single dose. The patient was treated with induction of emesis within 2 to 4 hours after ingestion. The second patient ingested 2.4 grams of INVIRASE in combination with 600 mg of ritonavir and experienced pain in the throat that lasted for 6 hours and then resolved.
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CONTRAINDICATIONS
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 Class | Drugs Within Class That Are Contraindicated With FORTOVASE |
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| Antiarrhythmics | Amiodarone, bepridil, flecainide, propafenone, quinidine |
| Antihistamines | Astemizole , terfenadine |
| Ergot Derivatives | Dihydroergotamine, ergonovine, ergotamine, methylergonovine |
| Antimycobacterial Agents | Rifampin |
| GI Motility Agent | Cisapride |
| Neuroleptics | Pimozide |
| Sedative/Hypnotics | Triazolam, midazolam |
If FORTOVASE is coadministered with ritonavir, the ritonavir label should be reviewed for additional contraindicated drugs.
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