However, Atripla has not been evaluated in the presence of food. Administration of efavirenz with a high-fat meal increased the mean maximum plasma concentrations significantly compared with the fasted state. Atripla is contraindicated in patients with previously demonstrated hypersensitivity to any of the components of the product.
Tenofovir DF and efavirenz have not been studied in patients younger than 3 years of age or weighing less than 13 kg Atripla is not recommended for pediatric administration. Atripla should not be administered concurrently with midazolam, triazolam, or ergot derivatives, because competition for CYP3A4 liver enzymes by efavirenz could result in inhibitor of metabolism of these drugs and create the potential for serious adverse events, including cardiac arrhythmias and respiratory depression.
Atripla should not be coadministered with voriconazole, because efavirenz significantly decreases voriconazole plasma concentrations. Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogues alone or in combination with other antiretrovirals.
Hepatic function should be monitored closely for at least several months in patients who discontinue Atripla and are coinfected with HIV and HBV. If appropriate, initiation of HBV therapy may be warranted. Severe acute exacerbations of HBV have been reported in patients who have discontinued emtricitabine or tenofovir DF.
Because of the nature of the fixed-dose combination tablet, Atripla should not be used in combination with the individual component medications efavirenz, emtricitabine, and tenofovir DF. In addition, because of similarities between emtricitabine and lamivudine, Atripla should not be coadministered with drugs containing lamivudine, including the brand medications Combivir, Epivir, Epzicom, or Trizivir.
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Tenofovir DF, emtricitabine, and efavirenz vs. New England Journal of Medicine 3 : January 19, Integrase Strand Transfer Inhibitor dolutegravir. Integrase Strand Transfer Inhibitor elvitegravir. Latency-Reversing Agents. Maturation Inhibitors. Non-Nucleoside Reverse Transcriptase Inhibitor doravirine. Non-Nucleoside Reverse Transcriptase Inhibitor efavirenz. Non-Nucleoside Reverse Transcriptase Inhibitor rilpivirine. Nucleoside Reverse Transcriptase Inhibitor abacavir, lamivudine.
Nucleoside Reverse Transcriptase Inhibitor abacavir, lamivudine, zidovudine. Nucleoside Reverse Transcriptase Inhibitor emtricitabine, tenofovir alafenamide. Nucleoside Reverse Transcriptase Inhibitor lamivudine. Nucleoside Reverse Transcriptase Inhibitor lamivudine, zidovudine. Nucleoside Reverse Transcriptase Translocation Inhibitors. Pharmacokinetic Enhancer cobicistat.
Pharmacokinetic Enhancer ritonavir. Post-attachment Inhibitor. Protease Inhibitors PIs. Protease Inhibitor atazanavir. Protease Inhibitor darunavir. Protease Inhibitor lopinavir.
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Latency-Reversing Agents. Maturation Inhibitors. Non-Nucleoside Reverse Transcriptase Inhibitor doravirine. Non-Nucleoside Reverse Transcriptase Inhibitor efavirenz. Non-Nucleoside Reverse Transcriptase Inhibitor rilpivirine. Nucleoside Reverse Transcriptase Inhibitor abacavir, lamivudine. Nucleoside Reverse Transcriptase Inhibitor abacavir, lamivudine, zidovudine.
Nucleoside Reverse Transcriptase Inhibitor emtricitabine, tenofovir alafenamide. Nucleoside Reverse Transcriptase Inhibitor lamivudine. Nucleoside Reverse Transcriptase Inhibitor lamivudine, zidovudine.
Nucleoside Reverse Transcriptase Translocation Inhibitors. Pharmacokinetic Enhancer cobicistat. Pharmacokinetic Enhancer ritonavir. Post-attachment Inhibitor. Protease Inhibitors PIs. Protease Inhibitor atazanavir. Protease Inhibitor darunavir. Protease Inhibitor lopinavir. Skin and Mucus Membrane Products.
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Drug Image s : Click to enlarge. Chemical Image: Click to enlarge. Approval: Among reported cases of hepatic failure, a few occurred in patients with no pre-existing hepatic disease.
Dosing at bedtime may improve tolerability. NSS are not predictive of onset of psychiatric symptoms. Prior to initiation and during use of ATRIPLA, assess serum creatinine, estimated creatinine clearance, urine glucose, and urine protein in all patients. Monitor for evidence of tenofovir toxicity. Mineralization Defects Cases of osteomalacia associated with proximal renal tubulopathy, manifested as bone pain or pain in extremities and which may contribute to fractures, have been reported in association with TDF use [see Adverse Reactions 6.
Rash [see Warnings and Precautions 5. Hepatotoxicity [see Warnings and Precautions 5. Psychiatric Symptoms [see Warnings and Precautions 5. Nervous System Symptoms [see Warnings and Precautions 5. Embryo-Fetal Toxicity [see Warnings and Precautions 5. Convulsions [see Warnings and Precautions 5. Immune Reconstitution Syndrome [see Warnings and Precautions 5. Fat Redistribution [see Warnings and Precautions 5.
Clinical Trials in Pediatric Subjects Efavirenz: Assessment of adverse reactions is based on three pediatric clinical trials in HIV-1 infected pediatric subjects who received EFV in combination with other antiretroviral agents for a median of weeks.
Laboratory Abnormalities Efavirenz, Emtricitabine and Tenofovir DF: Laboratory abnormalities observed in Study were generally consistent with those seen in previous trials Table 2. Increasing the indinavir dose to mg every 8 hours does not compensate for the increased indinavir metabolism due to EFV. Patients should be monitored for tenofovir-associated adverse reactions. Discontinue didanosine in patients who develop didanosine-associated adverse reactions.
Higher didanosine concentrations could potentiate didanosine-associated adverse reactions, including pancreatitis, and neuropathy. The combination should be avoided. Alternative anticonvulsant treatment should be used. Increases in bupropion dosage should be guided by clinical response, but the maximum recommended dose of bupropion should not be exceeded. Efavirenz has the potential to decrease plasma concentrations of ketoconazole. Consider doubling the rifabutin dose in regimens where rifabutin is given 2 or 3 times a week.
The potential exists for reduction in plasma concentrations of the calcium channel blocker. Dose adjustments should be guided by clinical response refer to the full prescribing information for the calcium channel blocker. Efavirenz had no effect on ethinyl estradiol concentrations, but progestin levels norelgestromin and levonorgestrel were markedly decreased. Decreased exposure of etonogestrel may be expected. There have been postmarketing reports of contraceptive failure with etonogestrel in EFV-exposed patients.
These immunosuppressants are not anticipated to affect exposure of EFV. Dose adjustments of the immunosuppressant may be required. Close monitoring of immunosuppressant concentrations for at least 2 weeks until stable concentrations are reached is recommended when starting or stopping treatment with ATRIPLA. Patients should be monitored for signs of withdrawal and their methadone dose increased as required to alleviate withdrawal symptoms.
Risk Summary There are retrospective case reports of neural tube defects in infants whose mothers were exposed to EFV-containing regimens in the first trimester of pregnancy. Data Human Data Efavirenz: There are retrospective postmarketing reports of findings consistent with neural tube defects, including meningomyelocele, all in infants of mothers exposed to EFV-containing regimens in the first trimester.
Animal Data Efavirenz: Effects of EFV on embryo-fetal development have been studied in three nonclinical species cynomolgus monkeys, rats, and rabbits. Its molecular formula is C 14 H 9 ClF 3 NO 2 and its structural formula is: Efavirenz is a white to slightly pink crystalline powder with a molecular mass of It has the following structural formula: TDF is a white to off-white crystalline powder with a solubility of Patients with Hepatic Impairment Efavirenz: A multiple-dose trial showed no significant effect on EFV pharmacokinetics in subjects with mild hepatic impairment Child-Pugh Class A compared with controls.
The pharmacokinetics of ritonavir mg q12h are unaffected by concurrent EFV. Subjects received didanosine buffered tablets. Prezista Prescribing Information. Subjects received didanosine enteric-coated capsules. Keep container tightly closed. Forward-looking statements in this press release should be evaluated together with the many risks and uncertainties that affect Bristol-Myers Squibb's business, including those identified in Bristol-Myers Squibb's Annual Report on Form K for the year ended December 31, and in our Quarterly Reports on Form Q, particularly under "Item 1A.
Risk Factors", Bristol-Myers Squibb undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. This press release includes forward-looking statements, within the meaning of the Private Securities Litigation Reform Act of , that are subject to risks, uncertainties and other factors, including the risk that physicians in Canada may not see advantages of ATRIPLA over other antiretrovirals and may therefore be reluctant to prescribe the product.
These risks, uncertainties and other factors could cause actual results to differ materially from those referred to in the forward-looking statements. The reader is cautioned not to rely on these forward-looking statements. These and other risks are described in detail in the Gilead's Annual Report on Form K for the year ended December 31, and its Quarterly Report on Form Q for the first and second quarters of , as filed with the U.
Securities and Exchange Commission. All forward-looking statements are based on information currently available to Gilead and Gilead assumes no obligation to update any such forward-looking statements. Press Releases. About Gilead Sciences Gilead Sciences is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need. Gilead Forward-Looking Statement This press release includes forward-looking statements, within the meaning of the Private Securities Litigation Reform Act of , that are subject to risks, uncertainties and other factors, including the risk that physicians in Canada may not see advantages of ATRIPLA over other antiretrovirals and may therefore be reluctant to prescribe the product.
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