Atripla is a threedrug fixeddose combination product containing 600 mg of efavirenz efv, 200 mg of emtricitabine ftc, and 300 mg of tenofovir disoproxil fumarate tdf. Darunavir is a pi, recently approved for treatmentexperienced patients with. Based on data from the single trial, a randomized, doubleblind to week 96. Sustiva is available as capsules for oral administration containing either 50 mg, 100 mg. Efavirenz efv, sold under the brand names sustiva among others, is an antiretroviral medication used to treat and prevent hivaids. Viread oral powder should be mixed in a container with 2 to 4 ounces of soft food not requiring chewing e. Efavirenz is associated with a low rate of serum enzyme elevations during therapy and is an uncommon, but well established cause of clinically apparent acute liver injury. Pdf documents can be viewed with the free adobe reader. Sustiva may not have these effects in every patient. Fixed combinations if using efavirenzemtricitabinetenofovir df atripla, consider that lactic acidosis and severe hepatomegaly with steatosis, including fatalities, have been reported in patients receiving hiv nucleoside reverse transcriptase inhibitors nrtis in conjunction with other antiretrovirals. Highlights of prescribing information 3 prs 16 weeks 16. Highlights of prescribing information these highlights do. Refer to the ribavirin tablet prescribing information for the correct ribavirin dosage for patients with crcl less than or equal to 50 ml per minute.
You can report side effects to fda at 1800fda1088 18003321088 or online. Efavirenz tablets 200 mg is indicated for the treatment of hiv1 infection in combination. Easy to read fda package insert, drug facts, dosage and administration, and adverse effects for sustiva efavirenz. To learn more about possible side effects of symfi, read the drug label or package insert or talk to your health care provider or pharmacist.
Highlights of prescribing information these highlights do not include all the information needed to use zyban safely and effectively. Nnrtis delavirdine, efavirenz, etravirine, nevirapine. Highlights of prescribing information these highlights do not include all the information needed to use benefix safely and effectively. Atripla is a threedrug fixeddose combination product containing 600 mg of efavirenz. Every month, 7143 specialty physicians nationwide answered questionnaires and provided a chart audit on the next four chronic hcv patients seen. Highlights of prescribing information reported cases. Read this patient information before you start taking sustiva and each time you get a refill. For dosage and full prescribing information, read accompanying package insert. It may be used for prevention after a needlestick injury or other potential exposure. Highlights of prescribing information nss are frequent.
Viread oral powder should be measured only with the supplied dosing scoop. Sustiva must not be used as a single agent to treat hiv1 infection or added on as a sole agent to a failing regimen. Risk of acute bronchospasm in patients with chronic lung disease acute bronchospasm has been observed in patients with asthma and copd using afrezza. Tivicay is a human immunodeficiency virus type 1 hiv1 integrase strand transfer inhibitor insti indicated in combination with. Symfi contains a combination of efavirenz, lamivudine, and tenofovir. Zyban bupropion hydrochloride sustainedrelease tablets. It i s recommended that sustiva be taken on an empty stomach, preferably at bedtime. Tenofovir disoproxil fumarate lamivudine efavirenz. Our findings suggest that a reduced dose of 400 mg efavirenz is noninferior to the standard dose of 600 mg, when combined with tenofovir and emtricitabine during 48 weeks in artnaive adults with hiv1 infection. These consequences can result in suboptimal treatment of the targeted disease states, damage to vital. Highlights of prescribing information these highlights do not include all the information needed to use kaletra safely and effectively.
The changes in the package insert reflect drug interactions, adverse event information, and precautions. Most hiv drugs have little or no impact on the effectiveness of hormonal contraceptives, with the possible exception of sustiva efavirenz. Tenofovir disoproxil fumaratelamivudineefavirenz 600mg300mg300mg tablets should be avoided with concurrent use of a nephrotoxic medicinal product e. Adverse events related to the study drug were more frequent with 600 mg efavirenz than with 400 mg.
The sustiva efavirenz package insert has been updated to include drugdrug interaction information regarding coadministration of efavirenz with rifampin, diltiazem, itraconazole, voriconazole, atorvastatin, pravastatin, simvastatin, pimozide and bepridil. To learn more about possible side effects of efavirenz, read the drug label or package insert or talk to your health care provider or pharmacist. Your doctor has prescribed efavirenz for you because you have hiv infection. If alcohol or mind or moodaltering drugs are used with efavirenz, it. Mavyret is contraindicated with atazanavir and rifampin. Edurant package insert pdf drug information on rilpivirine tablet film coated for health care professionals. Update information on hepatotoxicity in dosage and administration, warnings and precautions, adverse reactions and patient information sections.
Sustiva efavirenz capsules and tablets rx only description sustiva efavirenz is a human immunodeficiency virus type 1 hiv1 specific, nonnucleoside, reverse transcriptase inhibitor nnrti. No dose adjustment is suggested but caution is advised in patients with moderate hepatic impairment. When voriconazole is coadministered with sustiva, voriconazole maintenance dose should be increased to 400 mg every 12 hours and sustiva dose should be decreased to 300 mg once daily using the capsule formulation. Interactions between antiepileptics and antiretrovirals.
Symfi lo efavirenz, lamivudine and tenofovir disoproxil fumarate is indicated as a complete regimen for the treatment of human immunodeficiency virus type 1 hiv1 infection in adult and pediatric patients weighing at least 35 kg. Ask your doctor or pharmacist about medicines that should not be taken with sustiva. Comprehensive, uptodate information on hivaids treatment and prevention from the university of california san francisco. Refer to the prescribing information for velpatasvirsofosbuvir voxilaprevir for more information. Lower dose efavirenz should be recommended as part of routine care. Drugdrug interactions with hiv antiretroviral therapy. Kaletra lopinavir and ritonavir tablet, for oral use kaletra lopinavir and ritonavir oral solution initial u. The drugdrug interactions between pitavastatin and darunavirritonavir drvr as well as pitavastatin and efavirenz efv were examined in an openlabel, parallelarm, pharmacokinetic pk study in hivuninfected healthy volunteers. Lack of pharmacokinetic interactions between pitavastatin. Efv, 200 mg of emtricitabine ftc, and 300 mg of tenofovir disoproxil. Revised 42010 based on package insert dated 32010 a feeling of strangeness and losing touch with reality an exaggerated feeling of wellbeing agitation or anxiety. Data derived by ipsos healthcare from july 16, 2018march 2019.
It is generally recommended for use with other antiretrovirals. Efavirenz, lamivudine, and tenofovir are antiviral medicines that prevents human immunodeficiency virus human immunodeficiency virus hiv from multiplying in your body hiv is the virus that can cause acquired immunodeficiency syndrome aids. Other compounds that are substrates of cyp3a or cyp2b6 may have decreased plasma concentrations when coadministered with sustiva. Bristolmyers squibb receives us fda snda approval for use.
The most prominent effect of efavirenz at steadystate is induction of cyp3a and cyp2b6. Efavirenztenofovir dfemtricitabine atripla treatment. Zithromax is a macrolide antibacterial drug indicated for mild to moderate infections caused by designated, susceptible bacteria. Duration oftherapy is based on recovery from neutropenia or immunosuppression. The fda approved changes to the sustiva efavirenz package insert to. Product monograph pr atripla efavirenzemtricitabine tenofovir. Highlights of prescribing information reported cases of.
Sustiva is a prescription medicine used in combination with other medicines to treat hiv1 infection. Efavirenz lamivudine tenofovir disoproxil fumarate. Composition and packaging section of the product monograph. The recommended dosage of atripla in adults and pediatric patients weighing at least 40 kg is one tablet once daily taken orally on an empty stomach. Efavirenz, lamivudine and tenofovir disoproxil fumarate tablets 400 mg300 mg300 mg 30s count ndc3334236207 efavirenz, lamivudine and tenofovir disoproxil fumarate tablets 400 mg300 mg300 mg 90s count ndc3334236210 efavirenz, lamivudine and tenofovir. Efavirenz sustiva treatment national hiv curriculum. Drugdrug interactions are often a serious complication of taking multiple medications and account for 3% to 5% of all inhospital medication errors. The recommended dosage of sustiva efavirenz is 600 mg orally, once daily, in combination with a protease inhibitor andor nucleoside analogue reverse transcriptase inhibitors nrtis. Efavirenz has been shown in vivo to induce cyp3a and cyp2b6.
Update contraindications and patient information sections with drugdrug interaction information on elbasvir and grazoprevir. For more information, see the section what should i tell my doctor before taking sustiva. These are not all the possible side effects of efavirenz. Efavirenz, lamivudine and tenofovir fda prescribing. Peel back the cover from the clear plastic vial adapter package. One level scoop delivers 1 g of powder, which contains 40 mg of tdf. Equilibrate the refrigerated vial of noxafilposaconazoleinjectionto room temperature. For the 2 x 5 ml syringe package, the contents of both syringes must be injected to receive the 500 mg. Highlights of prescribing information these highlights do not include all the information needed to use mavyret safely and effectively. Patient information sustiva efavirenz capsules sustiva. Acute bacterial exacerbations of chronic bronchitis in adults acute bacterial sinusitis in adults uncomplicated skin and skin structure infections in adults urethritis and cervicitis in adults genital ulcer disease in men. Efavirenz is a nonnucleoside reverse transcriptase inhibitor used in combination with other agents in the therapy of human immunodeficiency virus hiv infection.
Johns wort may decrease concentrations of glecaprevir and pibrentasvir. Some efavirenz drug interactions may be overcome by altering doses of the. Review side effects, dosage, drug interactions, warnings and. Symfi efavirenz, lamivudine, and tenofovir patient. These highlights do not include all the information needed to use ampyra safely and effectively. We investigated the effect of efavirenz treatment on the results of drug screening tests of urine samples obtained from 100 patients infected with hu.