"Aug. 11, 2011 -- The FDA has approved Gilead's Complera, the second complete HIV treatment in a single, once-daily pill.
Complera is a combination of Truvada (which combines the nucleoside reverse transcriptase inhibitors Emtriva and "...
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If overdose occurs, the patient should be monitored for evidence of toxicity, including monitoring of vital signs and observation of the patient's clinical status; standard supportive treatment should then be applied as necessary. Administration of activated charcoal may be used to aid removal of unabsorbed efavirenz. Hemodialysis can remove both emtricitabine and tenofovir DF (refer to detailed information below), but is unlikely to significantly remove efavirenz from the blood.
Some patients accidentally taking 600 mg twice daily have reported increased nervous system symptoms. One patient experienced involuntary muscle contractions.
Limited clinical experience is available at doses higher than the therapeutic dose of emtricitabine. In one clinical pharmacology trial single doses of emtricitabine 1200 mg were administered to 11 subjects. No severe adverse reactions were reported.
Hemodialysis treatment removes approximately 30% of the emtricitabine dose over a 3-hour dialysis period starting within 1.5 hours of emtricitabine dosing (blood flow rate of 400 mL/min and a dialysate flow rate of 600 mL/min). It is not known whether emtricitabine can be removed by peritoneal dialysis.
Tenofovir Disoproxil Fumarate
Limited clinical experience at doses higher than the therapeutic dose of tenofovir DF 300 mg is available. In one trial, 600 mg tenofovir DF was administered to 8 subjects orally for 28 days, and no severe adverse reactions were reported. The effects of higher doses are not known.
Tenofovir is efficiently removed by hemodialysis with an extraction coefficient of approximately 54%. Following a single 300 mg dose of tenofovir DF, a 4-hour hemodialysis session removed approximately 10% of the administered tenofovir dose.
ATRIPLA is contraindicated in patients with previously demonstrated clinically significant hypersensitivity (e.g., Stevens-Johnson syndrome, erythema multiforme, or toxic skin eruptions) to efavirenz, a component of ATRIPLA.
For some drugs, competition for CYP3A by efavirenz could result in inhibition of their metabolism and create the potential for serious and/or life-threatening adverse reactions (e.g., cardiac arrhythmias, prolonged sedation, or respiratory depression). Drugs that are contraindicated with ATRIPLA are listed in Table 1.
Table 1 : Drugs That Are Contraindicated or Not
Recommended for Use WithATRIPLA
|Drug Class: Drug Name||Clinical Comment|
|Antifungal: voriconazole||Efavirenz significantly decreases voriconazole plasma concentrations, and coadministration may decrease the therapeutic effectiveness of voriconazole. Also, voriconazole significantly increases efavirenz plasma concentrations, which may increase the risk of efavirenz-associated side effects. Because ATRIPLA is a fixed-dose combination product, the dose of efavirenz cannot be altered. [See CLINICAL PHARMACOLOGY Tables 5 and 6]|
|Ergot derivatives (dihydroergotamine, ergonovine, ergotamine, methylergonovine)||Potential for serious and/or life-threatening reactions such as acute ergot toxicity characterized by peripheral vasospasm and ischemia of the extremities and other tissues.|
|Benzodiazepines: midazolam, triazolam||Potential for serious and/or life-threatening reactions such as prolonged or increased sedation or respiratory depression.|
|Calcium channel blocker: bepridil||Potential for serious and/or life-threatening reactions such as cardiac arrhythmias.|
|GI motility agent: cisapride||Potential for serious and/or life-threatening reactions such as cardiac arrhythmias.|
|Neuroleptic: pimozide||Potential for serious and/or life-threatening reactions such as cardiac arrhythmias.|
|St. John's wort (Hypericum perforatum)||May lead to loss of virologic response and possible resistance to efavirenz or to the class of nonnucleoside reverse transcriptase inhibitors (NNRTIs).|
Last reviewed on RxList: 4/29/2013
This monograph has been modified to include the generic and brand name in many instances.
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