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ATRIPLA
Viral infections
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Drug Name:

ATRIPLA Rx

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

Company:
Bristol-Myers Squibb and Gilead

Therapeutic Use:

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.

Contraindications:

Concomitant voriconazole.

Warnings/Precautions:

Not for treating chronic HBV infection; test for HBV before starting therapy and closely monitor patients co-infected with HBV and HIV for several months after stopping treatment (discontinuing therapy may exacerbate HBV infection); if appropriate, initiate anti-hepatitis B therapy may be warranted. Underlying hepatitis B or C, marked LFT elevations, or use of hepatotoxic drugs; monitor for hepatotoxicity. Consider monitoring LFTs in those without pre-existing hepatic dysfunction or other risks. Suspend therapy if lactic acidosis or hepatotoxicity (eg, hepatomegaly, steatosis) occurs. Monitor CrCl (in all patients), serum phosphorus, urine glucose and urine protein prior to initiation and periodically during therapy in patients at risk for renal impairment. Promptly evaluate if serious psychiatric symptoms occur. History of seizures. History of pathologic fracture or risk factors of osteoporosis or bone loss: consider monitoring bone mineral density (BMD); calcium/vitamin D supplement may be beneficial. Moderate or severe hepatic or renal impairment (CrCl<50mL/min): not recommended. Pregnancy (Cat.D); avoid. Obtain negative pregnancy test before initiation. Use effective contraception (barrier and hormonal) during and for 12 weeks after discontinuing treatment. Nursing mothers: not recommended.

Interactions:

See Contraindications. Avoid concomitant drugs that contain emtricitabine, tenofovir DF, tenofovir alafenamide, efavirenz (unless for dose adjustment), or lamivudine. Avoid atazanavir ± ritonavir, posaconazole, boceprevir, simeprevir, adefovir dipivoxil, sofosbuvir/velpatasvir. Additive CNS effects with alcohol, psychoactive drugs. Caution with drugs metabolized by, or that affect activity of, CYP2C9, CYP2C19, CYP3A4, CYP2B6. Potentiates didanosine levels; monitor closely; discontinue or reduce didanosine dose if toxicity develops. Concomitant ritonavir: monitor liver function and toxicity. Tenofovir levels increased by lopinavir/ritonavir, darunavir + ritonavir, ledipasvir/sofosbuvir; monitor and discontinue if toxicity occurs. Antagonized by phenobarbital, carbamazepine, phenytoin, rifampin (see Adult), rifabutin. May antagonize indinavir (may be ineffective, even with increased dose), amprenavir, atazanavir, saquinavir, bupropion, CCBs (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), antimalarials. Closely monitor warfarin, anticonvulsants (decreased levels of phenytoin, phenobarbital, carbamazepine), rifabutin, immunosuppressants, methadone, others. Avoid concomitant or recent use of nephrotoxic agents. 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). Concomitant drugs with a known risk for Torsade de Pointes (eg, clarithromycin); consider alternatives. Efavirenz may cause false (+) cannabis screening test (CEDIA DAU multi-level THC assay).

Pharmacological Class:

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

Adverse Reactions:

Diarrhea, nausea, fatigue, headache, dizziness, depression, insomnia, abnormal dreams, rash (may be severe, eg, Stevens-Johnson; discontinue if occurs); CNS and psychiatric effects, decreased BMD, new onset or worsening renal impairment, immune reconstitution syndrome, QT prolongation, fat redistribution.

Note:

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

Generic Availability:

NO

How Supplied:

Tabs—30

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