Monograph Details
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Infections & Infestations
> Viral infections
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PREZISTA |
| Manufacturer |
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Tibotec, Inc. |
| Legal Classification |
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Rx
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| Pharmacological Class |
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Protease inhibitor. |
| Generic Name |
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Darunavir (as ethanolate) 300mg, 600mg; tabs. |
| Indications |
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With ritonavir: for treating HIV infection in antiretroviral treatment-experienced adult patients, in combination with other antiretroviral agents. |
| Children |
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Not recommended. |
| Adults |
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Take with food. 600mg twice daily with ritonavir 100mg twice daily. Severe hepatic impairment: not recommended. |
| Contraindications |
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Concomitant rifampin, carbamazepine, phenobarbital, phenytoin, ergots, St. John's wort, lovastatin, simvastatin, pimozide, midazolam, triazolam. |
| Precautions |
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Sulfonamide allergy. Hepatic impairment (eg, chronic hepatitis, cirrhosis): monitor liver enzymes; interrupt or discontinue therapy if liver dysfunction occurs or worsens. Severe renal impairment. Diabetes. Hemophilia: monitor for spontaneous bleeding. Fat redistribution. Immune reconstitution syndrome. Elderly. Pregnancy (Cat.B). Nursing mothers: not recommended. |
| Interactions |
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See Contraindications. Voriconazole: not recommended. Avoid protease inhibitors other than those studied (lopinavir/ritonavir, saquinavir; indinavir, atazanavir), dexamethasone, fluticasone. Potentiates trazodone, rifabutin, digoxin, atorvastatin, pravastatin, rosuvastatin, sildenafil, vardenafil, tadalafil (reduce their doses). Potentiates, and is potentiated by, indinavir, ketoconazole, itraconazole. Increases efavirenz levels. Antagonizes sertraline, paroxetine (monitor levels), ethinyl estradiol (use backup contraception). Antagonizes, and antagonized by, other CYP3A4 substrates (eg, carbamazepine, phenobarbital, phenytoin). Antagonized by efavirenz. Monitor antiarrhythmics (eg, bepridil, systemic lidocaine, quinidine, amiodarone), calcium channel blockers, warfarin, digoxin, immunosuppressants (eg, tacrolimus, cyclosporine), methadone (possible opiate withdrawal syndrome). Reduce concomitant clarithromycin dose in renal impairment. Separate dosing of didanosine. Others. |
| Adverse Reactions |
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GI upset, constipation, abdominal pain, headache; rash (discontinue if severe), drug-induced hepatitis, others. |
| Extra Text |
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Note: See Norvir entry for more information on ritonavir. To register pregnant patients exposed to darunavir/ritonavir call (800) 258-4263. |
| How Supplied |
Tabs 300mg—120
600mg—60 (available soon) |
| Additional Resources |
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• Related Prescribing Note |
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