Generic Name and Formulations:
Efavirenz 600mg, emtricitabine 200mg, tenofovir disoproxil fumarate 300mg; tabs.

Company:
Bristol-Myers Squibb and Gilead
Indications for ATRIPLA:
HIV-1 infection, use alone or in combination with other antiretroviral agents.

Adult:
Take on empty stomach. ≥12yrs and ≥40kg: 1 tab once daily (preferably at bedtime). Concomitant rifampin (≥50kg): give additional 200mg/day of efavirenz.

Children:
<12yrs: not recommended.

Pharmacological Class:
Non-nucleoside reverse transcriptase inhibitor + reverse transcriptase inhibitors (nucleoside + nucleotide analogue).

Contraindications:
Concomitant voriconazole.

Warnings/Precautions:
Risk of lactic acidosis or severe hepatomegaly with steatosis; suspend if occur. Assess CrCl prior to initiating therapy in all patients. Monitor CrCl, serum phosphorus, urine glucose and proteins prior to initiation and then periodically in patients at risk for renal impairment. Not for treating chronic hepatitis B virus; test for HBV before starting therapy and closely monitor patients co-infected with HBV and HIV during and for several months after stopping treatment (discontinuing therapy may exacerbate HBV infection). Women, obesity, prolonged nucleoside exposure, other risk factors for hepatic dysfunction: increased risk of toxicity. Hepatic or renal impairment (CrCl<50mL/min): not recommended. Monitor liver enzymes before and during treatment (esp. with underlying hepatic disease). History or risk of fractures, osteoporosis or bone loss: consider bone mineral density (BMD) assessment; Vit. D and calcium supplementation may be beneficial. History of seizures. Elderly. Women of childbearing potential should undergo pregnancy testing prior to initiation. Use effective methods of contraception (barrier and hormonal) during and for 12 weeks after discontinuing treatment. Pregnancy (Cat.D); avoid. Nursing mothers: not recommended.

Interactions:
See Contraindications. Avoid concomitant drugs that contain emtricitabine, efavirenz, tenofovir, or lamivudine. Avoid alcohol, atazanavir, posaconazole, boceprevir, adefovir dipivoxil or other NNRTIs, psychoactive, and/or hepatotoxic drugs. Potentiates didanosine toxicity (>60kg; reduce dose of didanosine); discontinue didanosine if toxicity develops. Potentiates, and is potentiated by ritonavir (monitor liver function and for adverse events). Tenofovir levels increased by lopinavir/ritonavir; discontinue if toxicity occurs. Efavirenz levels decreased by phenobarbital, carbamazepine, phenytoin, rifampin, rifabutin. May decrease levels of indinavir (may be ineffective, even with increased dose), amprenavir, atazanavir, bupropion, carbamazepine, phenytoin, phenobarbital, clarithromycin, calcium channel blockers (eg, diltiazem, felodipine, nicardipine, nifedipine, verapamil), itraconazole, ketoconazole, lopinavir (adjust dose), maraviroc, methadone, rifabutin (increase dose), raltegravir, sertraline, statins, progestins (eg, norelgestromin, levonorgestrel), immunosuppressants (eg, cyclosporine, sirolimus, tacrolimus). Efavirenz increases nelfinavir plasma levels. Antagonizes, and is antagonized by, saquinavir (do not use as sole protease inhibitor), telaprevir. Caution with drugs metabolized by, or that affect activity of, CYP2C9, CYP2C19, CYP3A4. Closely monitor warfarin, anticonvulsants (esp. phenytoin, phenobarbital, carbamazepine), rifabutin, immunosuppressants, methadone, others. Monitor drugs that decrease renal function or compete for renal tubular secretion (eg, acyclovir, adefovir dipivoxil, cidofovir, ganciclovir, valacyclovir, valganciclovir, aminoglycosides, high-dose or multiple NSAIDs). Efavirenz may cause false (+) cannabis screening test (CEDIA DAU multi-level THC assay).

Adverse Reactions:
Diarrhea, nausea, fatigue, headache, dizziness, depression, insomnia, abnormal dreams, rash (may be severe, eg, Stevens-Johnson; discontinue if occurs), hallucinations, other CNS and psychiatric effects, skin discoloration; fat redistribution, immune reconstitution syndrome, lactic acidosis, severe hepatomegaly with steatosis, hepatotoxicity, others.

Note:
Register pregnant patients exposed to Atripla by calling (800) 258-4263.

How Supplied:
Tabs—30