Adult Dosing
Treatment of HIV-1 infection
- 1 tablet PO daily on an empty stomach, usually at bedtime
Pediatric Dosing
Treatment of HIV-1 infection
12 yrs; 40 years: 1 tablet PO daily on an empty stomach, usually at bedtime
[Outline]
Renal Dose Adjustment (Based on CrCl)
- <50 mL/min: Contraindicated
Hepatic Dose Adjustment
- Hepatic impairment: Use with caution; dose adjustments not defined
- Women are more prone to lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, with the use of nucleoside analogs alone or in combination with other antiretrovirals [US Black Box Warning]; obesity and prolonged therapy with nucleoside are the associated risk factors
- Discontinue therapy on developing clinical or laboratory findings suggestive of lactic acidosis or pronounced hepatotoxicity
- Test all patients with HIV-1 for the presence of chronic Hepatitis B virus (HBV) before initiating antiretroviral therapy
- Not approved for the treatment of chronic HBV infection and the safety and efficacy of this drug have not been established in patients coinfected with HBV and HIV [US Black Box Warning]
- Severe acute exacerbations of Hepatitis B have occurred in patients after the discontinuation of therapy (US Black Box Warning)
- Exacerbations of hepatitis B were associated with liver decompensation and liver failure in patients infected with HBV and undergoing therapy with this drug
- Closely monitor hepatic function with clinical and laboratory follow-up for at least several months in patients who are coinfected with HIV-1 and HBV and also in patients with discontinued therapy [US Black Box Warning]. Initiate appropriate anti-hepatitis B therapy
- Avoid administration with adefovir dipivoxil
- Plasma concentrations of efavirenz are altered by substrates, inhibitors, or inducers of CYP3A. Therapy may alter plasma concentrations of drugs metabolized by CYP3A
- Avoid concomitant administration with emtricitabine, tenofovir DF, emtricitabine/tenofovir DF, efavirenz, drugs containing lamivudine, including lamivudine/zidovudine, lamivudine, abacavir sulfate/lamivudine, or abacavir sulfate/lamivudine/zidovudine
- Serious psychiatric adverse experiences such as depression, suicidal ideation, nonfatal suicide attempts, aggressive behavior, paranoid reactions, and manic reactions have occurred in treated patients. Factors associated with an increase in the occurrence of these psychiatric symptoms are history of injection drug use, psychiatric history, and receipt of psychiatric medication at study entry
- Rare postmarketing reports of death by suicide, delusions, and psychosis-like behavior have occurred. Assess the possibility that the psychiatric symptoms are related to the therapy and determine whether the risks of continued therapy outweigh the benefits
- CNS symptoms beginning during the first or second day of therapy and generally resolving after the first 2-4 weeks of therapy have occurred
- New onset or worsening renal impairment has occurred. Renal impairment, including cases of acute renal failure and fanconi syndrome (renal tubular injury with severe hypophosphatemia) has occurred with the use of tenofovir. Avoid treatment in patients with creatinine clearance <50 mL/min
- Calculate creatinine clearance in all patients prior to initiating therapy and as clinically appropriate during therapy. Routinely monitor calculated creatinine clearance and perform serum phosphorus in patients at risk for renal impairment, including patients having previous experience of renal events. Avoid concurrent use with nephrotoxic agent or in patients recently using nephrotoxic agent
- Potentially fetal harm has occurred on administering to pregnant women during the first trimester
- Perform pregnancy test before initiation of therapy
- Register patients in antiretroviral pregnancy registry to monitor fetal outcomes of pregnant women
- Discontinue therapy in patients having developed severe rash associated with blistering, desquamation, mucosal involvement or fever
- Monitor liver enzymes before and during therapy in patients with underlying hepatic disease, including hepatitis B or C infection, pre-existing hepatic dysfunction, patients with marked transaminase elevations, and patients treated with other medications associated with liver toxicity
- Assess potential benefits of therapy against the unknown risks of significant liver toxicity in patients with persistent elevations of serum transaminases >5x ULN
- Monitor Liver enzyme in patients without pre-existing hepatic dysfunction or other risk factors
- Monitor bone mineral density (BMD) for HIV-1 infected subjects having a history of pathologic bone fracture or having risk for osteopenia. Tenofovir component is associated with significant increases in biochemical markers of bone metabolism (serum bone-specific alkaline phosphatase, serum osteocalcin, serum C-telopeptide, and urinary N-telopeptide)
- Convulsions have occurred in patients receiving therapy having known medical history of seizures. Periodically monitor plasma levels in patients receiving concomitant anticonvulsant medications
- Immune reconstitution syndrome has occurred in patients treated with combination antiretroviral therapy
- Redistribution/accumulation of body fat is observed in patients treated with this drug
- Autoimmune disorders such as Graves disease, polymyositis, and Guillain-Barré syndrome may occur in the setting of immune reconstitution
Cautions: Use cautiously in
- Renal impairment
- Renal disease
- Concurrent use of nephrotoxic agents
- Hepatic impairment
- Hepatic disease
- Psychiatric disorder
- History of seizure
- History of drug abuse
- HBV or HCV co-infection
- Prolonged therapy with nucleoside
- Obesity
- Osteopenia
- History of pathologic fracture
Pregnancy Category:D
Breastfeeding: HIV-infected mothers should generally not breastfeed their infants. In countries in which no acceptable, feasible, sustainable and safe replacement feeding is available, exclusive breastfeeding for 6 months is recommended for HIV-infected mothers to reduce the risk of HIV transmission from the mother to the infant compared with mixed feeding. In these settings, abrupt weaning at 4 months does not reduce the risk of HIV transmission or produce an overall health benefit compared to continued breastfeeding, and increases the risk of infant death in HIV-infected infants. Extended antiretroviral prophylaxis in breastfed infants with antiretroviral reduces the rate of HIV transmission during breastfeeding by about half, but the optimal regimen and duration of prophylaxis has not yet been defined. efavirenz/emtricitabine/tenofovir has been successfully used as part of a regimen that decreases mother-to-child transmission. This information is based upon LactMed database (available at http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT last accessed 18 January 2011). Centers for disease control and prevention recommends mothers avoiding breast-feeding their infants as risk for postnatal transmission of HIV-1 infection exists. Manufacturer advises to instruct infected mothers to avoid breast-feeding during therapy because of both the potential for HIV-1 transmission and the potential for serious adverse reactions in nursing infants.
US Trade Name(s)
US Availability
Atripla (efavirenz/emtricitabine/tenofovir)
- TABS: 600 mg/200 mg/300 mg
Canadian Trade Name(s)
Canadian Availability
Atripla (efavirenz/emtricitabine/tenofovir)
- TABS: 600 mg/200 mg/300 mg
UK Trade Name(s)
UK Availability
Atripla (efavirenz/emtricitabine/tenofovir)
- TABS: 600 mg/200 mg/245 mg
Australian Trade Name(s)
Australian Availability
[Outline]
Pricing data from www.DrugStore.com in U.S.A.
- Atripla 600-200-300 MG TABS [Bottle] (BRISTOL-MYERS SQUIBB/GILEAD)
30 mg = $1878.96
90 mg = $5400.81
Warning: This pricing information is subject to change at the sole discretion of DS Pharmacy. For the most current and up-to-date pricing information, please visit drugstore.com.