Generic Name: Efavirenz, emtricitabine, tenofovir disoproxil fumarate, EFV/FTC/TDF
- Simplifies HIV treatment with one dose daily
- One tablet combines three of the most effective antiretroviral treatments for HIV
- Kidney function should be evaluated before starting Atripla
Atripla is prescribed for the treatment of HIV. It’s a combination drug that contains 600 milligrams (mg) of efavirenz (Sustiva), 200 mg of emtricitabine (Emtriva), and 300 mg of tenofovir disoproxil fumarate (Viread).
Read the FDA description of Atripla.
Two components of Atripla are emtricitabine and tenofovir disoproxil fumarate. These medications are nucleoside reverse transcriptase inhibitors (NRTIs). They block the effectiveness of the reverse transcriptase enzyme, which HIV needs to replicate in the body. Efavirenz is the third Atripla component. It’s a non-nucleoside transcriptase inhibitor (NNRTI). It also reduces the ability of HIV to replicate in the body.
Atripla is approved for use in adults and in children 12 years of age and older, who weigh at least 88 pounds. The adult dose is one tablet taken daily on an empty stomach, preferably at bedtime. Taking the tablet at bedtime helps minimize side effects. Each tablet contains:
- 600 mg of efavirenz
- 200 mg of emtricitabine
- 300 mg of tenofovir disoproxil fumarate
Atripla should not be given to patients with impaired kidney function (measured at creatine clearance of 50 mL/minute or less).
If rifampin is given at the same time, an additional 200 mg/day of efavirenz is recommended for patients weighing 50 kg or more.
According to the U.S. Food and Drug Administration, Atripla is not a cure for HIV. It’s meant to slow the progression of the virus.
This information is a summary. Before starting this medication, discuss questions with your healthcare provider and make sure you understand dosage instructions.
Before taking Atripla, make sure to tell your doctor if you:
- have an allergy to Atripla or to any of the medications contained in Atripla
- are abusing drugs or alcohol
- are pregnant or planning on becoming pregnant
- are taking medications for seizures
- have been diagnosed with a kidney disorder and/or are currently undergoing dialysis
- have experienced a life-threatening skin reaction, including Stevens-Johnson syndrome
- have hepatitis B (The FDA has not approved Atripla for use in treating hepatitis B.)
Some side effects of Atripla are not an emergency, while others can cause serious complications.
Possible Adverse and Emergency Side Effects
The following are severe and emergent side effects of Atripla. Contact your medical provider immediately if you experience:
- liver toxicity that affects your liver functioning. Symptoms of this condition include dark urine, decrease in appetite, fatigue, jaundice or yellowing skin, nausea, light-colored bowel movements, and tenderness over the liver.
- psychiatric problems, such as suicidal thoughts, aggressive behavior, delusions, and paranoia
- a rash that appears suddenly. Because a rash can be a life-threatening condition when taking Atripla, see your medical provider immediately.
- symptoms associated with an allergic reaction, such as hives, difficulty breathing, or sweating
- symptoms associated with lactic acid buildup or lactic acidosis. Symptoms include weakness, tiredness, difficulty breathing, stomach pain, feeling cold or feeling dizzy.
Possible Nonemergency Side Effects
The following side effects may occur but do not usually represent an emergency. Discuss them with your doctor if they continue or are bothersome.
- changes in the distribution of body fat, such as an increasing amount of fat on the neck
- high cholesterol and triglycerides
- immune reconstitution syndrome where the immune system experiences an inflammatory response due to the medication. This can cause other viruses in the blood to re-emerge, such as cytomegalovirus or tuberculosis.
- skin discolorations, such as the appearance of small freckles or spots
Atripla can affect bone density (from tenofovir component). Ask your physician if bone density monitoring should be part of your treatment plan. Your physician may want to add calcium and vitamin D supplements to your treatment, while you take Atripla.
Atripla and Kidney Impairment
Emtricitabine and tenofovir are mostly filtered out by the kidney, but efavirenz is not. Since Atripla is a fixed combination product, patients with estimated creatinine clearance below 50 mL/min should not receive Atripla.
A large decrease of kidney function and cases of acute kidney failure and Fanconi syndrome (kidney filtering damage with severely increased blood levels of phosphate) has been reported with the use of tenofovir.
It’s recommended that the estimated creatinine clearance should be evaluated in all patients before starting Atripla treatment and as clinically appropriate during therapy with Atripla. Patients at risk of kidney disease or reduced kidney function, or whose kidney function has been decreased while taking Hepsera (a treatment for Hepatitis B), are recommended to have estimated creatinine clearance, serum phosphorus, urine glucose, and urine protein before starting Atripla and be regularly monitored during Atripla treatment.
Atripla should not be used in patients who are currently being treated with a drug known to be potentially damaging to the kidney or who recently used such a drug. This could include high-dose or more than one nonsteroidal anti-inflammatory drugs (NSAIDs). Some patients with HIV, who had risk for kidney disease but appeared to be stable on tenofovir, who were then started on high dose or multiple NSAIDs, have had acute kidney failure. Some patients required hospitalization and dialysis. Alternatives to NSAIDs should be considered, if needed, in patients at risk for renal dysfunction.
Persistent or worsening bone pain, pain in extremities, fractures, and/or muscular pain or weakness may be manifestations of potential kidney damage and require an immediate evaluation of kidney function, in patients who are at risk.
This list may not describe all possible side effects. Call your doctor or healthcare provider for advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
Always tell your physician about any prescription medications or herbal remedies you are taking.
Medications that can adversely interact with Atripla include:
- antifungal medications, such as voriconazole (Vfend)
- antihistamines, such as astemizole (Hismanal)
- benzodiazepines, including midazolam (Dormicum, Hypnovel, Versed), and triazolam (Apo-Triazo, Halcion, Hypam, Trilam)
- calcium channel blockers, such as bepridil (Vascor)
- ergot derivatives used to treat migraines, including dihydroergotamine (Migranal), ergonovine (such as Ergotrate), ergotamine (Ergomar), and methylergonovine (Methergine)
- GI motility agents, such as cisapride (for example, Propulsid)
- medications containing lamivudine, including Combivir, Epivir, Epivir-HBV, Epzicom, and Trizivir
- neuroleptic medications, such as pimozide (Orap)
- nonsteroidal anti-inflammatory drugs (NSAIDS) like ibuprofen, naproxen and others should be avoided at high doses, and patients should not take multiple NSAIDS while taking Atripla (see important warning on Atripla and kidney impairment below).
- St. John’s wort
Atripla should be stored at room temperature—around 77 degrees Fahrenheit (25 degrees Celsius). Keep the medication tightly closed and in its original container.
Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
FDA WARNING: ATRIPLA CARRIES A BLACK BOX WARNING (MEANING THE MEDICATION HAS POTENTIALLY LETHAL SIDE EFFECTS) FOR ITS POTENTIAL TO CAUSE LACTIC ACIDOSIS OR SEVERE HEPATOMEGALY. THE WARNING ADVISES PEOPLE WHO TAKE ATRIPLA TO SUSPEND MEDICATION USE IF THEY SUSPECT THEY MAY BE EXPERIENCING A TOXIC REACTION.
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