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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:

As a complete regimen or in combination with other antiretroviral agents for the treatment of HIV-1 infection in patients weighing ≥40kg.

Adults and Children:

<40kg: not established. Take on empty stomach. ≥40kg: 1 tab once daily (preferably at bedtime). Concomitant rifampin (≥50kg): give additional 200mg/day of efavirenz.

Contraindications:

Concomitant voriconazole, elbasvir/grazoprevir.

Boxed Warning:

Post-treatment exacerbation of Hepatitis B.

Warnings/Precautions:

Test for HBV before starting antiretroviral therapy. Discontinuation of emtricitabine and/or tenofovir disoproxil may be associated with severe acute exacerbations of hepatitis B. Closely monitor patients co-infected with HBV and HIV for several months after stopping treatment; if appropriate, anti-HBV therapy may be warranted (esp. in those with advanced liver disease or cirrhosis). Underlying hepatic disease (including coinfection with hepatitis B or C). Monitor LFTs prior to and during therapy; consider discontinuing if serum transaminases elevated to >5XULN or, discontinue if accompanied by hepatitis or hepatic decompensation. Suspend therapy if lactic acidosis or pronounced hepatotoxicity (eg, hepatomegaly, steatosis) occurs. Monitor CrCl, serum creatinine, urine glucose, urine protein in all patients, and serum phosphorus (in chronic kidney disease) prior to and during therapy. Discontinue if significant renal dysfunction or Fanconi syndrome occurs. 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. Embryo-fetal toxicity. Potential risk of neural tube defects: perform pregnancy testing prior to initiation. Females of reproductive potential should use effective contraception (barrier and hormonal) during and for 12 weeks after discontinuing treatment. Pregnancy (1st trimester), nursing mothers: not recommended.

Pharmacological Class:

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

Interactions:

See Contraindications. Concomitant atazanavir ± ritonavir, posaconazole, boceprevir, simeprevir, sofosbuvir/velpatasvir, sofosbuvir/velpatasvir/voxilaprevir, glecaprevir/pibrentasvir, atovaquone/proguanil, other NNRTIs: not recommended. Additive CNS effects with alcohol, psychoactive drugs. 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. May antagonize or be antagonized by phenobarbital, phenytoin, carbamazepine (consider alternative), rifabutin (increase dose), rifampin (see Adults and Children); monitor. May antagonize indinavir (may be ineffective, even with increased dose), amprenavir, saquinavir, bupropion, CCBs (eg, diltiazem, felodipine, nicardipine, nifedipine, verapamil), itraconazole (consider alternative), ketoconazole, lopinavir (adjust dose), maraviroc, methadone (monitor), raltegravir, sertraline, statins, progestins (eg, norelgestromin, levonorgestrel), immunosuppressants (eg, cyclosporine, sirolimus, tacrolimus; monitor). Avoid concomitant or recent use of nephrotoxic agents (eg, high-dose or multiple NSAIDs). Monitor drugs that decrease renal function or compete for renal tubular secretion (eg, acyclovir, adefovir dipivoxil, cidofovir, ganciclovir, valacyclovir, valganciclovir, aminoglycosides, NSAIDs). Concomitant drugs with a known risk for Torsade de Pointes (eg, clarithromycin, artemether/lumefantrine); consider alternatives. Monitor warfarin. Efavirenz may cause false (+) urine cannabinoid screening assay.

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


Data provided by MPR.

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