Atripla (efavirenz/emtricitabine/tenofovir disoproxil fumarate)

ATRIPLA (efavirenz/emtricitabine/tenofovir disoproxil fumarate) – a combination of 2 nucleoside analog HIV-1 reverse transcriptase inhibitors and 1 non-nucleoside HIV-1 reverse transcriptase inhibitor commonly used to treat infection by the human immunodeficiency virus (HIV).

FDA approved uses: Atripla is indicated for use alone as a complete regimen or in combination with other antiretroviral agents to treat adult and pediatric (age 12 years or older) infections with the HIV-1 virus.

Available dosage forms: Tablet containing 600 mg of efavirenz, 200 mg of emtricitabine, and 300 mg of tenofovir disoproxil fumarate.

Usual dosage: For adults and pediatric patients aged 12 years and older who weigh at least 40 kg, one tablet once daily taken orally on an empty stomach, preferably at bedtime. Renal impairment: should not be administered to persons whose creatinine clearance is less than 50 ml/min. Dosage may need to be adjusted for patients who are prescribed rifampin.

Contraindications: Do not administer to patients with previously demonstrated hypersensitivity (e.g., Stevens-Johnson syndrome, erythema multiforme, or toxic skin eruptions) to efavirenz, a component of ATRIPLA. Use caution when coadministering with drugs that are CYP3A4 substrates, as life-threatening drug interactions may result.

Special Warnings: Immediate medical evaluation is recommended if serious psychiatric symptoms develop. Nervous system symptoms are frequent, usually begin 1-2 days after starting therapy and usually resolve in 2-4 weeks. Can cause new onset or worsening renal impairment, including acute renal failure and Fanconi syndrome. Fetal harm can occur is given in the first trimester. Use caution in patients with a history of seizure disorders.

Adverse reactions (side effects) of these medications: The most common side effects of Atripla include diarrhea, nausea, fatigue, headache, dizziness, depression, insomnia, abnormal dreams, and rash. Other adverse reactions seen in clinical trials or post-marketing include: Lactic acidosis/severe hepatomegaly with steatosis, severe acute worsening of Hepatitis B, decreases in bone mineral density, sinusitis, upper respiratory infections, nasopharyngitis, anxiety, and skin rashes.

Common drug interactions: A number of drugs have been reported to interact with Atripla. The nature of these interactions is varied, including increasing or decreasing the activity of Atripla; or increasing or decreasing the activity of the interacting drug. Components of Atripla are known to induce CYP3A and CYP2B6, and are also affected by CYP enzyme inducers. Thus, numerous drugs (including Phenobarbital, rifampin, and rifabutin) may interact with Atripla. A list of drugs reported to interact with Atripla includes, but is not limited to, acyclovir, ganciclovir, valacyclovir, valganciclovir, didanosine, tenofavir, atazanavir, fosamprinivir, indinavir, lopinavir/ritonavir,saquinavir, maraviroc, warfarin, carbamazepine, phenytoin, bupropion, sertraline, itraconazole, ketoconazole, posaconazole, clarithromycin, calcium channel blockers, statins, oral contraceptives, immunosuppressant drugs, and methadone.

Special instructions for patients: ATRIPLA is not a cure for HIV-1 infection and patients may continue to experience illnesses associated with HIV-1 infection, including opportunistic infections. Patients should remain under the care of a physician when using ATRIPLA. Patients should not share needles or other injection equipment. Do not share personal items that may have blood or other bodily fluids on them. Do not have any kind of sex without protection. Do not breastfeed while taking this medication. Atripla may cause redistribution of body fat. Notify doctor if disease worsens or unusual symptoms are experienced.

Full prescribing information may be found at the manufacturer‘s official website Atripla.com or at the U.S. Food and Drug Administration’s website at Atripla Info at Drugs@FDA

Tags: , , , ,

Comments are closed.