Cobicistat and darunavir

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

If you also take enteric-coated didanosine (Videx EC), take it 1 hour before or 2 hours after you take cobicistat and darunavir.

Taking this medication will not prevent you from passing HIV to other people. Do not have unprotected sex or share razors or toothbrushes. Talk with your doctor about safe ways to prevent HIV transmission during sex. Sharing drug or medicine needles is never safe, even for a healthy person.

Mild or moderate liver dysfunction (Child-Pugh A or B): No adjustment recommended.
Severe liver dysfunction (Child-Pugh C): Not recommended.

Safety and efficacy have not been established in patients younger than 18 years.

Consult WARNINGS section for additional precautions.

Administration advice:
-Administer with other antiretroviral agents.
-Administer didanosine 1 hour before or 2 hours after this drug (which is administered with food).
-Consult the manufacturer product information regarding missed doses.

Storage requirements:
-Store at 20C to 25C (68F to 77F); excursions permitted to 15C to 30C (59F to 86F).

Monitoring:
-General: HIV genotypic testing in antiretroviral therapy-experienced patients (before starting therapy)
-Hematologic: For bleeding in hemophiliacs (during therapy)
-Hepatic: Liver function (before starting and during therapy; more often in at-risk patients)
-Hypersensitivity: Patients with known sulfonamide allergy (after starting therapy)
-Metabolic: Serum phosphorus in patients with or at risk of renal dysfunction (when used with tenofovir)
-Renal: Estimated CrCl (before starting therapy); for renal safety (if serum creatinine increases more than 0.4 mg/dL from baseline); estimated CrCl, urine glucose, and urine protein (at baseline and routinely during therapy [when used with tenofovir])

Patient advice:
-Do not alter the dose or stop therapy without consulting physician.