Monograph Details
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Infections & Infestations
> Viral infections
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INVIRASE CAPSULES |
| Manufacturer |
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Roche Laboratories |
| Legal Classification |
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Rx
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| Pharmacological Class |
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HIV protease inhibitor. |
| Generic Name |
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Saquinavir (as mesylate) 200mg; hard gel caps. |
| Also |
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• INVIRASE TABLETS
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| Indications |
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HIV infection (must use with ritonavir). |
| Children |
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<16yrs: not recommended. |
| Adults |
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Take within 2 hours after a meal. ≥16yrs: saquinavir 1g twice daily + ritonavir 100mg twice daily (taken at same time). |
| Contraindications |
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Severe hepatic impairment. Concomitant amiodarone, bepridil, cisapride, ergots, flecainide, midazolam, pimozide, propafenone, quinidine, rifampin, triazolam. Concomitant lovastatin, simvastatin, St. John's wort, garlic capsules: not recommended. |
| Precautions |
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Not bioequivalent to soft gel form of saquinavir; do not interchange. Hepatic impairment. Severe renal impairment. Hemophilia (monitor for spontaneous bleeding). Diabetes. Monitor clinical chemistry, triglycerides, and for hyperglycemia. Elderly. Pregnancy (Cat.B). Nursing mothers: not recommended. |
| Interactions |
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See Contraindications. Plasma levels reduced by efavirenz, nevirapine, rifabutin, possibly other enzyme inducers. Consider alternatives to CYP3A4 inducers (eg, carbamazepine, phenobarbital, phenytoin, dexamethasone): not recommended. Plasma levels increased by clarithromycin (see literature), indinavir, nelfinavir, lopinavir/ritonavir, ritonavir, delavirdine, itraconazole, ketoconazole. Antagonizes methadone, oral contraceptives. Potentiates CYP3A4 substrates (eg, calcium channel blockers, atorvastatin, pravastatin, fluvastatin, rosuvastatin, dapsone, warfarin, cyclosporine, tacrolimus, rapamycin, sildenafil, vardenafil, tadalafil); monitor their effects; may need reduced doses. Caution with antiarrhythmics (eg, systemic lidocaine), tricyclics, benzodiazepines, fentanyl, nefazodone, others (see literature). |
| Adverse Reactions |
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GI disturbances, headache, fatigue, paresthesia, weakness, lab abnormalities, depression, hyperglycemia, diabetes, fat redistribution, rash, pruritus. |
| Extra Text |
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Note: Register pregnant patients exposed to saquinavir by calling (800) 258-4263. See Norvir entry in this section for more information on ritonavir. |
| How Supplied |
Caps—270
Tabs—120 |
| Additional Resources |
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• Related Prescribing Note |
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