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ATRIKLA

Atrikla® (efavirenz 600mg/emtricitabine 200mg/tenofovir disoproxil fumarate 300mg) is indicated for use alone as a complete regimen or in combination with other antiretroviral agents for the treatment of HIV infection in adults and pediatric patients 12 years of age and older.

BOXED WARNING:

LACTIC ACIDOSIS/SEVERE HEPATOMEGALY WITH STEATOSIS and POST TREATMENT EXACERBATION OF HEPATITIS B.

Lactic acidosis and severe hepatomegaly with steatosis, Inc luding fatal cases, have been reported with the use of nucleoside analogs, Inc luding tenofovir disoproxil fumarate, a component of ATRIKLA, in combination with other antiretrovirals.

Atrikla is not approved for the treatment of chronic hepatitis B virus (HBV) infection and the safety and efficacy of Atrikla have not been established in patients coinfected with HBV and HIV-1. Severe acute exacerbations of hepatitis B have been reported in patients who have discontinued Emtrisa or Biread, which are components of Atrikla. Hepatic function should be monitored closely with both clinical and laboratory follow-up for at least several months in patients who are coinfected with HIV-1 and HBV and discontinue Atrikla. If appropriate, initiation of anti-hepatitis B therapy may be warranted.

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BROBUST

Brobust® (cobicistat 150 mg) is a CYP3A inhibitor indicated to increase systemic exposure of atazanavir or darunavir once daily in combination with other antiretroviral agents in the treatment of HIV-1 infection.

Limitations of Use:

Brobust is not interchangeable with ritonavir. Do not use Brobust with other protease inhibitors or darunavir 600 mg twice daily. Brobust and ritonavir may result in different drug interactions when used with concomitant medications.

Contraindictions:

Coadministration: Do not use with drugs highly dependent on CYP3A for clearance and for which elevated plasma concentrations are associated with serious and/or life-threatening events. Do not use with drugs that strongly induce CYP3A as this may lead to a loss of therapeutic effect of atazanavir or darunavir and development of resistance.

Use with the following drugs is contraindicated: alfuzosin, dronedarone, rifampin, dihydroergotamine, ergotamine, methylergonovine, cisapride, lovastatin, simvastatin, pimozide, sildenafil for pulmonary arterial hypertension, triazolam, oral midazolam, and St. John’s wort. When coadminstered with atazanavir, irinotecan, nevirapine, and indinavir are also contraindicated.