Atripla

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Atripla (efavirenz/emtricitabine/tenofovir disoproxil fumarate) is an antiviral medication that treats HIV, which causes acquired immunodeficiency syndrome (AIDS). Atripla is not a cure for HIV or AIDS. Common side effects of Atripla include:

• dizziness,
• trouble sleeping,
• drowsiness,
• unusual dreams, and
• trouble concentrating.

Side effects may begin 1-2 days after starting Atripla and usually go away in 2-4 weeks. Other side effects of Atripla include:

• tiredness,
• headache,
• nausea,
• vomiting,
• gas,
• upset stomach,
• diarrhea, and
• skin discoloration (such as small spots/freckles, darkening of the palms of the hands/soles of the feet), and
• changes in the shape or location of body fat (especially in your arms, legs, face, neck, breasts, and waist).

Tell your doctor if you have serious side effects of Atripla including:

• unexplained weight loss,
• persistent muscle aches or weakness,
• joint pain,
• numbness or tingling of the hands/feet/arms/legs,
• severe tiredness,
• vision changes,
• severe or persistent headaches,
• signs of infection (such as fever, chills, trouble breathing, cough, non-healing skin sores),
• signs of an overactive thyroid (such as irritability, nervousness, heat intolerance, fast/pounding/irregular heartbeat, bulging eyes, unusual growth in the neck or thyroid known as a goiter), or
• signs of a certain nerve problem known as Guillain-Barre Syndrome (such as difficulty breathing/swallowing/moving your eyes, drooping face, paralysis, slurred speech).

The adult dose of Atripla is one tablet once daily taken orally on an empty stomach. Dosing at bedtime may improve the tolerability of nervous system symptoms. Atripla may interact with acyclovir, ganciclovir, valacyclovir, valganciclovir, sertraline, methadone, adefovir, cidofovir, blood thinners, cholesterol medications, antibiotics, calcium channel blockers, seizure medicines, or other HIV medicines. Tell your doctor all medications you use. Atripla is not recommended for use during pregnancy. It may harm a fetus, especially if taken during the first 3 months of pregnancy. Women of childbearing age should have a pregnancy test before starting Atripla. Consult your doctor about using 2 forms of birth control (such as condoms with birth control pills) during treatment and for 3 months after the end of treatment. Atripla decreases effectiveness of hormonal birth control, so barrier protection must be used. If you become pregnant or think you may be pregnant, tell your doctor. Discuss other HIV treatment options during pregnancy to decrease risk of HIV transmission to the baby. It is unknown if this medication passes into breast milk. Because breast milk can transmit HIV, do not breastfeed.

Our Atripla (efavirenz/emtricitabine/tenofovir disoproxil fumarate) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

This medication may cause lactic acidosis (a build-up of lactic acid in the body, which can be fatal). Lactic acidosis can start slowly and get worse over time. Get emergency medical help if you have even mild symptoms of lactic acidosis, such as: muscle pain or weakness, numb or cold feeling in your arms and legs, trouble breathing, stomach pain, nausea with vomiting, fast or uneven heart rate, dizziness, or feeling very weak or tired.

Stop using this medication and call your doctor at once if you have any other serious side effects such as:

• signs of liver damage - nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
• urinating less than usual or not at all;
• fever, chills, body aches, flu symptoms;
• pale skin, feeling light-headed or short of breath, trouble concentrating;
• rapid heart rate, increased sweating, tremors in your hands, anxiety, feeling irritable, sleep problems (insomnia);
• diarrhea, unexplained weight loss, menstrual changes, impotence, loss of interest in sex;
• swelling in your neck or throat (enlarged thyroid);
• weakness or prickly feeling in your fingers or toes;
• problems with walking, breathing, speech, swallowing, or eye movement;
• severe lower back pain, loss of bladder or bowel control;
• unusual thoughts or behavior, anger, severe depression, thoughts of hurting yourself or others, hallucinations;
• severe blistering, peeling, and red skin rash; or
• seizure (convulsions).

Less serious side effects may include:

• mild nausea, vomiting, gas, upset stomach;
• headache, dizziness, drowsiness, strange dreams;
• darkened skin on the palms of your hands or the soles of your feet; or
• changes in the shape or location of body fat (especially in your arms, legs, face, neck, breasts, and waist).

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Atripla (Efavirenz, Emtricitabine, and Tenofovir Disoproxil Fumarate)

SIDE EFFECTS

Efavirenz, Emtricitabine and Tenofovir DF: The following adverse reactions are discussed in other sections of the labeling:

• Severe Acute Exacerbations of Hepatitis B [See BOXED WARNING, WARNINGS AND PRECAUTIONS].
• Lactic Acidosis/Severe Hepatomegaly with Steatosis [See WARNINGS AND PRECAUTIONS].
• QTc Prolongation [See WARNINGS AND PRECAUTIONS].
• Psychiatric Symptoms [See WARNINGS AND PRECAUTIONS].
• Nervous System Symptoms [See WARNINGS AND PRECAUTIONS].
• New Onset or Worsening Renal Impairment [See WARNINGS AND PRECAUTIONS].
• Rash [See WARNINGS AND PRECAUTIONS].
• Hepatotoxicity [See WARNINGS AND PRECAUTIONS].
• Bone Effects of Tenofovir DF [See WARNINGS AND PRECAUTIONS].
• Immune Reconstitution Syndrome [See WARNINGS AND PRECAUTIONS].
• Fat Redistribution [See WARNINGS AND PRECAUTIONS].
• Drug Interactions [See CONTRAINDICATIONS, WARNINGS AND PRECAUTIONS and DRUG INTERACTIONS].

For additional safety information about SUSTIVA (efavirenz), EMTRIVA (emtricitabine), or VIREAD (tenofovir DF) in combination with other antiretroviral agents, consult the prescribing information for these products.

Adverse Reactions From Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

Clinical Trials In Adult Subjects

Study 934

Study 934 was an open-label active-controlled trial in which 511 antiretroviral-naïve subjects received either emtricitabine + tenofovir DF administered in combination with efavirenz (N=257) or zidovudine/lamivudine administered in combination with efavirenz (N=254).

The most common adverse reactions (incidence greater than or equal to 10%, any severity) occurring in Study 934 include diarrhea, nausea, fatigue, headache, dizziness, depression, insomnia, abnormal dreams, and rash. Adverse reactions observed in Study 934 were generally consistent with those seen in previous trials of the individual components (Table 1).

Table 1 : Selected Treatment-Emergent Adverse Reactions^a (Grades 2-4) Reported in ≥ 5% in Either Treatment Group in Study 934 (0-144 Weeks)

Study 073

In Study 073, subjects with stable, virologic suppression on antiretroviral therapy and no history of virologic failure were randomized to receive ATRIPLA or to stay on their baseline regimen. The adverse reactions observed in Study 073 were generally consistent with those seen in Study 934 and those seen with the individual components of ATRIPLA when each was administered in combination with other antiretroviral agents.

Efavirenz, Emtricitabine, or Tenofovir DF: In addition to the adverse reactions in Study 934 and Study 073, the following adverse reactions were observed in clinical trials of efavirenz, emtricitabine, or tenofovir DF in combination with other antiretroviral agents.

Efavirenz: The most significant adverse reactions observed in subjects treated with efavirenz were nervous system symptoms [See WARNINGS AND PRECAUTIONS], psychiatric symptoms [See WARNINGS AND PRECAUTIONS], and rash [See WARNINGS AND PRECAUTIONS].

Selected adverse reactions of moderate-to-severe intensity observed in greater than or equal to 2% of efavirenz-treated subjects in two controlled clinical trials included pain, impaired concentration, abnormal dreams, somnolence, anorexia, dyspepsia, abdominal pain, nervousness, and pruritus.

Pancreatitis has also been reported, although a causal relationship with efavirenz has not been established. Asymptomatic increases in serum amylase levels were observed in a significantly higher number of subjects treated with efavirenz 600 mg than in control subjects.

Emtricitabine and Tenofovir DF: Adverse reactions that occurred in at least 5% of treatment-experienced or treatment-naïve subjects receiving emtricitabine or tenofovir DF with other antiretroviral agents in clinical trials included arthralgia, increased cough, dyspepsia, fever, myalgia, pain, abdominal pain, back pain, paresthesia, peripheral neuropathy (including peripheral neuritis and neuropathy), pneumonia, rhinitis, and rash event (including rash, pruritus, maculopapular rash, urticaria, vesiculobullous rash, pustular rash, and allergic reaction).

Skin discoloration has been reported with higher frequency among emtricitabine-treated subjects; it was manifested by hyperpigmentation on the palms and/or soles and was generally mild and asymptomatic. The mechanism and clinical significance are unknown.

Clinical Trials in Pediatric Subjects

Efavirenz: Assessment of adverse reactions is based on three pediatric clinical trials in 182 HIV-1 infected pediatric subjects 3 months to 21 years of age who received efavirenz in combination with other antiretroviral agents for a median of 123 weeks. The type and frequency of adverse reactions in the three trials were generally similar to that of adult subjects with the exception of a higher incidence of rash, which was reported in 32% (59/182) of pediatric subjects compared to 26% of adults, and a higher frequency of Grade 3 or 4 rash reported in 3% (6/182) of pediatric subjects compared to 0.9% of adults [See WARNINGS AND PRECAUTIONS]. For additional information, please consult the SUSTIVA prescribing information.

Emtricitabine: In addition to the adverse reactions reported in adults, anemia and hyperpigmentation were observed in 7% and 32%, respectively, of pediatric subjects (3 months to less than 18 years of age) who received treatment with emtricitabine in the larger of two open-label, uncontrolled pediatric trials (N=116). For additional information, please consult the EMTRIVA prescribing information.

Tenofovir DF: In a pediatric clinical trial conducted in subjects 12 to less than 18 years of age, the adverse reactions observed in pediatric subjects who received treatment with tenofovir DF were consistent with those observed in clinical trials of tenofovir DF in adults [See WARNINGS AND PRECAUTIONS].

Laboratory Abnormalities

Efavirenz, Emtricitabine and Tenofovir DF: Laboratory abnormalities observed in Study 934 were generally consistent with those seen in previous trials (Table 2).

Table 2 : Significant Laboratory Abnormalities Reported in ≥ 1% of Subjects in Either Treatment Group in Study 934 (0-144 Weeks)

Laboratory abnormalities observed in Study 073 were generally consistent with those in Study 934.

In addition to the laboratory abnormalities described for Study 934 (Table 2), Grade 3/4 laboratory abnormalities of increased bilirubin (greater than 2.5 x upper limit of normal (ULN)), increased pancreatic amylase (greater than 2.0 x ULN), increased or decreased serum glucose (less than 40 or greater than 250 mg/dL), and increased serum lipase (greater than 2.0 x ULN) occurred in up to 3% of subjects treated with emtricitabine or tenofovir DF with other antiretroviral agents in clinical trials.

Hepatic Events: In Study 934, 19 subjects treated with efavirenz, emtricitabine, and tenofovir DF and 20 subjects treated with efavirenz and fixed-dose zidovudine/lamivudine were hepatitis B surface antigen or hepatitis C antibody positive. Among these coinfected subjects, one subject (1/19) in the efavirenz, emtricitabine, and tenofovir DF arm had elevations in transaminases to greater than five times ULN through 144 weeks. In the fixed-dose zidovudine/lamivudine arm, two subjects (2/20) had elevations in transaminases to greater than five times ULN through 144 weeks. No HBV and/or HCV coinfected subject discontinued from the trial due to hepatobiliary disorders [See WARNINGS AND PRECAUTIONS].

Postmarketing Experience

The following adverse reactions have been identified during postapproval use of efavirenz, emtricitabine, or tenofovir DF. Because postmarketing reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Efavirenz

Cardiac Disorders

Palpitations

Ear and Labyrinth Disorders

Tinnitus, vertigo

Endocrine Disorders

Gynecomastia

Eye Disorders

Abnormal vision

Gastrointestinal Disorders

Constipation, malabsorption

General Disorders and Administration Site Conditions

Asthenia

Hepatobiliary Disorders

Hepatic enzyme increase, hepatic failure, hepatitis. A few of the postmarketing reports of hepatic failure, including cases in patients with no pre-existing hepatic disease or other identifiable risk factors, were characterized by a fulminant course, progressing in some cases to transplantation or death.

Immune System Disorders

Allergic reactions

Metabolism and Nutrition Disorders

Redistribution/accumulation of body fat [See WARNINGS AND PRECAUTIONS], hypercholesterolemia, hypertriglyceridemia

Musculoskeletal and Connective Tissue Disorders

Arthralgia, myalgia, myopathy

Nervous System Disorders

Abnormal coordination, ataxia, cerebellar coordination and balance disturbances, convulsions, hypoesthesia, paresthesia, neuropathy, tremor

Psychiatric Disorders

Aggressive reactions, agitation, delusions, emotional lability, mania, neurosis, paranoia, psychosis, suicide, catatonia

Respiratory, Thoracic and Mediastinal Disorders

Dyspnea

Skin and Subcutaneous Tissue Disorders

Flushing, erythema multiforme, photoallergic dermatitis, Stevens-Johnson syndrome

Emtricitabine: No postmarketing adverse reactions have been identified for inclusion in this section.

Tenofovir DF

Immune System Disorders

Allergic reaction, including angioedema

Metabolism and Nutrition Disorders

Lactic acidosis, hypokalemia, hypophosphatemia

Respiratory, Thoracic, and Mediastinal Disorders

Dyspnea

Gastrointestinal Disorders

Pancreatitis, increased amylase, abdominal pain

Hepatobiliary Disorders

Hepatic steatosis, hepatitis, increased liver enzymes (most commonly AST, ALT, gamma GT)

Skin and Subcutaneous Tissue Disorders

Rash

Musculoskeletal and Connective Tissue Disorders

Rhabdomyolysis, osteomalacia (manifested as bone pain and which may contribute to fractures), muscular weakness, myopathy

Renal and Urinary Disorders

Acute renal failure, renal failure, acute tubular necrosis, Fanconi syndrome, proximal renal tubulopathy, interstitial nephritis (including acute cases), nephrogenic diabetes insipidus, renal insufficiency, increased creatinine, proteinuria, polyuria

General Disorders and Administration Site Conditions

Asthenia

The following adverse reactions, listed under the body system headings above, may occur as a consequence of proximal renal tubulopathy: rhabdomyolysis, osteomalacia, hypokalemia, muscular weakness, myopathy, hypophosphatemia.

Read the entire FDA prescribing information for Atripla (Efavirenz, Emtricitabine, and Tenofovir Disoproxil Fumarate)

Read the Atripla User Reviews »

© Atripla Patient Information is supplied by Cerner Multum, Inc. and Atripla Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.