Efavirenz at 400 mg compared to standard 600 mg dose has similar efficacy with fewer side effects. Chapter 3 methods for the analysis of efavirenz drug profile and literature survey 3. Side effects of atripla efavirenz, emtricitabine, and. Efavirenz in the therapy of hiv infection pubmed central pmc. Get emergency medical help if you have signs of an allergic reaction hives, difficult breathing, swelling in your face or throat or a severe skin reaction fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling. It is a nonnucleoside reverse transcriptase inhibitor nnrti and works by blocking the function of reverse transcriptase. Topics az slideshows images quizzes supplements medications. The most common side effects are fatigue see fact sheet 551, rash, nausea, dizziness, diarrhea, headache and insomnia. Atripla efavirenzemtricitabinetenofovir disoproxil fumarate is an antiviral medication that treats hiv, which causes acquired immunodeficiency syndrome. How to store efavirenz lamivudinetenofovir disoproxil fumarate 600mg300 mg300 mg tablets 6.
Sustiva efavirenz capsules and tablets rx only description sustiva efavirenz is a human immunodeficiency virus type 1 hiv1 specific, nonnucleoside, reverse transcriptase inhibitor nnrti. Join our mailing list oupblog twitter facebook youtube tumblr. Close monitoring of liver function is necessary while receiving this medicine. Conference reports, antiretrovirals, ias 7 kuala lumpur 20. Efavirenz 600 mg versus nevirapine all doses for three. Sustiva efavirenz dose, indications, adverse effects. For information regarding clinical recommendations see. Contact your doctor at once if you have any of these side effects, even if you have had them before. Stocrin helps most people with hiv infection, but it may have unwanted side effects.
I am experiencing severe psychological side effects depression, anxiety, mania, disturbed sleep from what i believe to be the efavirenz sustiva component of my. These side effects are more pronounced in the first 12 weeks of treatment. The content of this database of side effects adverse drug reactions is intended for educational and scientific research purposes only. Efavirenz is an antiviral medicine that prevents human immunodeficiency virus from multiplying in your body. What is the most important information i should know about efavirenz sustiva. Efavirenz is used in combination with other drugs at a dose of 600 mg once a day. This emedtv web page explores how the medication works to stop the hiv virus from multiplying and discusses possible offlabel efavirenz uses. Efavirenz is an antiviral medicine which is used in combination with other medicines to treat human immunodeficiency virus hiv infection. Efavirenz dosage for adults and larger children the recommended dose of efavirenz for treating adults and children weighing 88 pounds or more with hiv or aids is 600 mg once daily, preferably at bedtime.
Efavirenz can cause adverse effects of the central nervous system e. I have severe side effects after 6 months on efavirenz q. All interactions with efavirenz sustiva coadministered drug dose of drug dose of efavirenz. Common adverse effects of antiretroviral therapy for hiv disease. Other serious side effects include depression, thoughts of suicide, liver problems, and seizures. Efavirenz has been linked to early two to six weeks1 transient as well as late neuropsychiatric effects, which include increased risk of suicidal ideation,2 encephalopathy,3 catatonia,4 psychosis and ataxia. Also let your doctor know if you develop any other serious side effects, such as skin problems, flulike symptoms, a sore throat or other symptoms of infection such as a cough or fever, or. Efavirenz comes as a capsule and as a tablet to take by mouth. Efavirenzlamivudinetenofovir disoproxil fumarate 600mg300 mg300 mg tablets could cause. Efavirenz and neuropsychiatric effects southern african hiv. Inclusion or absence of a drug label on the aidsinfo site does not imply endorsement or lack thereof by aidsinfo. Efavirenz tablets, usp are a nonnucleoside reverse transcriptase inhibitor indicated in.
Question i have severe side effects after 6 months on efavirenz. Due to side effects of efavirenz especially on ageing population. Efavirenz is a human immunodeficiency virus type1 hiv1 specific, nonnucleoside. Advise patient that the longterm effects of efavirenz are unknownatthistime. Sustiva is available as capsules for oral administration containing either 50 mg, 100 mg.
What you need to know before you take efavirenz lamivudinetenofovir disoproxil fumarate 600 mg300 mg300 mg tablets. List of drug master files dmf of efavirenz active pharmaceutical ingredient api submitted to the u. Patients receiving benzodiazepines that are metabolized by these isoenzymes may experience decreased benzodiazepine serum concentrations if administered concurrently with efavirenz. Efavirenz is a synthetic nonnucleoside reverse transcriptase rt inhibitor with antiviral activity.
Nov 11, 2019 our sustiva efavirenz side effects drug center provides a comprehensive view of available drug information on the potential side effects when taking this medication. It would be best to add 50 mg more in combine pill for those who need tb treatment. Know efavirenz uses, side effects, dosage, contraindications, benefit. Sometimes they are serious, most of the time they are not. You can report side effects to fda at 1800fda1088 18003321088 or online. Efavirenz is used as part of combination therapy for people with hiv. Important information on the association of the cyp2b6 genotype and central nervous system side effects of efavirenz therapy. Review side effects, dosage, drug interactions, warnings and precautions, and pregnancy safety information. Except as otherwise noted, this work is licensed under a creative commons attributionnoncommercialshare alike 4. Atripla efavirenzemtricitabinetenofovir disoproxil.
Call your doctor for medical advice about side effects. Tell your healthcare provider or pharmacist if you notice any side effects while taking atripla. Pdf documents can be viewed with the free adobe reader. Concerns regarding the use of efavirenz in patients with a history of mental illness may predispose clinicians to not offer this agent to psychiatrically ill populations in spite of the convenience of once daily dosing, which can result in improved adherence in these atrisk populations. May 03, 2019 these are not all the possible side effects of efavirenz. To avoid dizziness after taking efavirenz, take it before you go to sleep. Taking sustiva with alcohol, medicine for mental health problems, or certain street drugs can worsen side effects like drowsiness. Jan 05, 2016 i have severe side effects after 6 months on efavirenz. Efavirenz was approved for medical use in the united states in 1998. Jul 25, 20 efavirenz at 400 mg compared to standard 600 mg dose has similar efficacy with fewer side effects. Efavirenz can commonly cause a rash that is usually not serious. Caution patient to use a condom and to avoid sharing needles or donating blood to prevent spreading the aids virus to others.
This medicine can lower, but not fully prevent, the risk of spreading hiv to others. If we found that trials were similar enough to combine, we performed a. It only prevents the virus from multiplying in your body. Pdf neuropsychiatric side effects of efavirenz therapy. More severe side effects are hallucinations, sleeplessness and depression.
The nnrti efavirenz has long been one of the most frequently. The effects of coadministration of efavirenz on the auc and c max are summarized in table 1 effect of efavirenz on other drugs and table 2 effect of other drugs on efavirenz. Taking efavirenz at bedtime may make certain side effects less bothersome. Efavirenz should be used in combination with other hiv medications as part of an hiv cocktail this is known as highly active antiretroviral. Get emergency medical help if you have signs of an allergic reaction hives, difficult breathing, swelling in your face or throat. I have severe side effects after 6 months on efavirenz. If any of the side effects become serious, or if you notice any side effects not listed in this leaflet, please tell your health care provider. Taking sustiva with food increases the amount of medicine in your body, which may increase the frequency of side effects. Impact of pharmacogenetics on cns side effects related to efavirenz article in pharmacogenomics 1410. 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.
However, growing concern about its adverse effects has sometimes led to efavirenz being replaced by other drugs in the initial treatment. How to take efavirenz lamivudinetenofovir disoproxil fumarate 600mg300 mg300 mg tablets. Serious side effects of efavirenz include serious mental health problems, liver problems, and severe rash. Drug information on sustiva efavirenz includes side effects, uses, drug interactions, dosage, drug pictures, overdose symptoms, and what to avoid. Pharmacokinetic and pharmacodynamic comparison of once. Pdf psouth africa has the highest proportion of hivpositive people in the world. Our sustiva efavirenz side effects drug center provides a comprehensive view of available drug information on the potential side effects when taking this medication. Administration at bedtime especially in first 24 weeks reduces cns effects. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Efavirenz may cause serious psychiatric symptoms including confusion, feeling sad or hopeless, suicidal thoughts, anxiety, paranoia, hallucinations, trouble speaking or moving, or unusual behavior. Efavirenz is 1,4dihydro2h3,1benzoxazin2one substituted at the 4 position by cyclopropylethynyl and trifluoromethyl groups s configuration and at the 6 position by chlorine.
Efavirenz is associated with causing neuropsychiatric sideeffects npses, with almost 50% of patients experiencing at. Efavirenz side effects, dosage, interactions drugs. Nov 11, 2019 this is not a complete list of side effects and others may occur. A nonnucleoside reverse transcriptase inhibitor with activity against hiv, it is used with other antiretrovirals for combination therapy of hiv infection. Risk of adverse reactions or loss of virologic response due to drug interactions. Tablet containing 600 mg of efavirenz, 200 mg of emtricitabine and.
Additional side effects are inflammation of the pancreas, allergic reaction including swelling of the face, lips, tongue, or throat, shortness of breath, pain, stomach pain. Drug information on efavirenz for patients and consumers. Taking sustiva at bedtime may make some side effects less bothersome. We discuss the prevalence, types and specificities of its side effects. Efavirenz does not reduce the risk of transmission of hiv to others through sexual contact or blood contamination. These side effects may go away during treatment as your body adjusts to the medicine. Occasionally patients report disabling side effects which persist beyond this induction period, necessitating switching from efavirenz. Efavirenz should be used with caution with oxidized benzodiazepines including alprazolam. Efavirenzlamivudinetenofovir whopar part 3 july 2016.
Commonly reported side effects of efavirenz include. When the side effects were examined individually, efv probably caused more. Taking this drug with food results in an increase of efavirenz concentration in the blood and thus lead to the side effects. Combining two nnrtis has not been shown to be beneficial. Identification of the substancemixture and of the companyundertaking product name. Monitor patients closely for excessive side effects. Taking efavirenz with food increases drug levels and may increase side effects. Efavirenz fda label capsule gelatin coated, tablet film. Contact your health care provider right away if you have any of the following symptoms that could be signs of mental health problems. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about.
For commercial use or customized versions, please contact biobyte solutions gmbh disclaimer. Several fdaapproved drug labels may be available for efavirenz. Pharmacogenetics of efavirenz and central nervous system side effects. Common side effects of efavirenzemtricitabinetenofovir are tiredness, dizziness, gastrointestinal distress, and skin discoloration. These include serious mental health problems, liver problems, and severe rash. What efavirenzlamivudinetenofovir disoproxil fumarate 600 mg300 mg300 mg tablets is. Sustiva efavirenz side effects, images, uses, dosage.
Rash, usually in the first 2 weeks, is the most common sideeffect. Efavirenz api dmfs us drug master file dmf details. Efavirenz fda label capsule gelatin coated, tablet. Efavirenz can cause serious, lifethreatening side effects. Pdf the nonnucleoside analogue inhibitor of the reverse transcriptase, efavirenz efv, has become. For information regarding clinical recommendations see drug interactions 7. Increased efavirenz effects and decreased voriconazole effects. It is not intended as a substitute for professional medical advice, diagnosis or treatment. The effects of coadministration of efavirenz on the c max, auc, and c min are summarized in table 7 effect of efavirenz on other drugs and table 8 effect of other drugs on efavirenz. Recommended dosage for efavirenzemtricitabinetenofovir is one tablet at or before bedtime. Efavirenz is a type of antihiv drug from a class of drugs commonly called nonnukes. What are the possible side effects of efavirenz sustiva.
Sustiva, efavirenz dosing, indications, interactions. Highlights of prescribing information nss are frequent nss. Side effects of sustiva efavirenz, warnings, uses rxlist. Get emergency medical help if you have signs of an allergic reaction hives, difficult breathing, swelling in your face or throat or a severe skin reaction fever, sore throat, burning eyes, skin pain. Impact of pharmacogenetics on cns side effects related to. Efavirenz is for adults and children who are at least 3 months old and weigh at least 8 pounds. This is not a complete list of side effects and others may occur. Find patient medical information for efavirenz oral on webmd including its uses, side effects and safety, interactions, pictures, warnings and user ratings. Rilpivirine versus efavirenz for initial therapy in treatment. Taking the pill in the evening, just before bedtime, improves the tolerability of central nervous system side effects. Get medical help right away if you have any very serious side effects, including. Sustiva is available as capsules for oral administration containing either 50 mg, 100 mg, or 200 mg of efavirenz and the following inactive ingredients. Efavirenz sustiva catie canadas source for hiv and.
Efavirenz is associated with neuropsychiatric effects including dizziness, abnormal dreams, insomnia, hallucination and euphoria. Additional side effects are inflammation of the pancreas, allergic reaction including swelling of the face, lips, tongue, or throat, shortness of breath, pain, stomach pain, weakness and indigestion. Some people see changes in body fat see fact sheet 553. The side effects of efavirenz, most especially the central nervous system. Aidsinfo provides the following drug label solely as an example of the labels available for efavirenz. Efavirenz at 400 mg compared to standard 600 mg dose has.
All topics, cd4 and viral load, changing treatment, side effects. Review side effects, dosage, drug interactions, warnings and. The effects of tdfassociated changes in bmd and biochemical markers on longterm bone health. American and european guidelines recommend the use of efv in combination with two nrtis as the. See below for a comprehensive list of adverse effects. It is usually taken once a day with plenty of water on an empty stomach at least 1 hour before or 2 hours after a meal. We will combine data for outcomes from studies that meet the. Efavirenz binds directly to the human immunodeficiency virus type 1 hiv1 rt, an rnadependent dna polymerase, blocking its function in viral dna replication. Efavirenz is used for the treatment of hiv or aids in adults and children age three months and older. Atripla efavirenz, emtricitabine, and tenofovir disoproxil.
Drug profile efavirenz is in a class of medications called nonnucleoside reverse transcriptase inhibitors nnrtis. Efavirenz side effects get emergency medical help if you have signs of an allergic reaction hives, difficult breathing, swelling in your face or throat or a severe skin reaction fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling. Member benefits favorites membership favorites join aafp. Some side effects may occur that usually do not need medical attention. The most prominent effect of efavirenz at steadystate is induction of cyp3a and cyp2b6 see. The most common side effects of efavirenz include dizziness, difficulty falling asleep, trouble concentrating and rash.
Currently, efavirenz efv is widely prescribed as part of antiretroviral therapy art. A randomized crossover study to compare efavirenz and. See the aidsinfo fact sheet on hiv medicines and side effects for more information. Feb 18, 2019 some side effects of efavirenz may occur that usually do not need medical attention.