Intelence Side Effects

Generic name: etravirine

Note: This document contains side effect information about etravirine. Some of the dosage forms listed on this page may not apply to the brand name Intelence.

Some side effects of Intelence may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to etravirine: oral tablet

Get emergency medical help if you have any of these signs of an allergic reaction while taking etravirine (the active ingredient contained in Intelence) hives; difficult breathing; swelling of your face, lips, tongue, or throat.

In rare cases, etravirine can cause a condition that results in the breakdown of skeletal muscle tissue, leading to kidney failure. Call your doctor right away if you have unexplained muscle pain, tenderness, or weakness especially if you also have fever, unusual tiredness, and dark colored urine.

Stop using etravirine and call your doctor at once if you have:

• swelling, rapid weight gain, little or no urinating;

• confusion, seizure;

• nausea, upper stomach pain, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);

• the first sign of any type of skin rash, no matter how mild;

• severe skin reaction -- fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain, followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.

Etravirine may increase your risk of certain infections or autoimmune disorders by changing the way your immune system works. Symptoms may occur weeks or months after you start treatment with etravirine. Tell your doctor if you have:

• signs of a new infection--fever, night sweats, swollen glands, mouth sores, diarrhea, stomach pain, weight loss;

• chest pain (especially when you breathe), dry cough, wheezing, feeling short of breath;

• cold sores, sores on your genital or anal area;

• rapid heart rate, feeling anxious or irritable, weakness or prickly feeling, problems with balance or eye movement;

• trouble speaking or swallowing, severe lower back pain, loss of bladder or bowel control; or

• swelling in your neck or throat (enlarged thyroid), menstrual changes, impotence, loss of interest in sex.

Common side effects may include:

• upset stomach, constipation, heartburn, dry mouth;

• numbness or tingly feeling in your hands or feet;

• blurred vision, dizziness, drowsiness, unusual dreams; 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.

For Healthcare Professionals

Applies to etravirine: oral tablet

General

The safety report of etravirine (the active ingredient contained in Intelence) is based on 599 HIV-1-infected, treatment-experienced patients receiving 200 mg twice daily in combination with background regimen (BR). The median exposure was 52.3 weeks. Discontinuation due to side effects occurred in 5.2% of patients using etravirine. The most common side effects of moderate to severe intensity reported with etravirine and BR, regardless of causality, were peripheral neuropathy and rash. A total of 2.2% of HIV-1-infected patients in Phase 3 trials receiving etravirine discontinued due to rash.

Dermatologic

During clinical trials, rash generally was mild to moderate, occurred chiefly in the second week of therapy, and was infrequent after the fourth week. Rash usually resolved within 1 to 2 weeks on continued use of the drug. The incidence of rash was higher in women taking etravirine (the active ingredient contained in Intelence) (at least moderate severity: 15%) compared to men (at least moderate severity: 9.5%). Discontinuation due to rash occurred in 5% of women compared to 1.9% of men. Patients with a history of nonnucleoside reverse transcriptase inhibitor-related rash did not appear to be at increased risk.

Erythema multiforme has been reported in no more than 0.5% of patients in other trials.

Very common (10% or more): Rash (all intensities: 16.9%; at least moderate intensity: 10%)
Common (1% to 10%): Less than 2% (at least moderate intensity): Dry skin, face swelling, hyperhidrosis, lipohypertrophy, night sweats, prurigo
Uncommon (0.1% to 1%): Erythema multiforme (at least moderate intensity: up to 0.5%)
Rare (less than 0.1%): Stevens-Johnson syndrome, erythema multiforme
Frequency not reported: Contact dermatitis, erythema, pruritus
Postmarketing reports: Toxic epidermal necrolysis (fatal cases)

Gastrointestinal

Common (1% to 10%): Elevated pancreatic amylase (Grade 2: 7%; Grade 3: 7%; Grade 4: 2%), elevated lipase (Grade 2: 4%; Grade 3: 2%; Grade 4: 1%); Less than 2% (at least moderate intensity): Abdominal distension, constipation, dry mouth, flatulence, gastritis, gastroesophageal reflux disease, hematemesis, pancreatitis, retching, stomatitis
Frequency not reported: Nausea, diarrhea, abdominal pain, vomiting

Nervous system

Common (1% to 10%): Peripheral neuropathy (at least moderate intensity: 4%); Less than 2% (at least moderate intensity): Amnesia, convulsion, disturbance in attention, hypersomnia, hypoesthesia, paresthesia, somnolence, syncope, tremor, vertigo
Frequency not reported: Headache

Hypersensitivity

Common (1% to 10%): Drug hypersensitivity (at least moderate intensity: less than 2%)
Postmarketing reports: Severe hypersensitivity reactions (including drug rash with eosinophilia and systemic symptoms [DRESS] and cases of hepatic failure)

Cardiovascular

Common (1% to 10%): Less than 2% (at least moderate intensity): Angina pectoris, atrial fibrillation, myocardial infarction
Uncommon (0.1% to 1%): Angioneurotic edema (at least moderate intensity: up to 0.5%), hemorrhagic stroke (at least moderate intensity: up to 0.5%)
Frequency not reported: Hypertension, mild atrioventricular block

Angioneurotic edema and hemorrhagic stroke have been reported in no more than 0.5% of patients in other trials.

Metabolic

Acquired lipodystrophy has been reported in no more than 0.5% of patients in other trials.

Very common (10% or more): Elevated total cholesterol (Grade 2: 20%), elevated glucose levels (Grade 2: 15%), elevated low density lipoprotein (Grade 2: 13%)
Common (1% to 10%): Elevated triglycerides (Grade 2: 9%; Grade 3: 6%; Grade 4: 4%), elevated total cholesterol (Grade 3: 8%), elevated low density lipoprotein (Grade 3: 7%), elevated glucose levels (Grade 3: 4%); Less than 2% (at least moderate intensity): Anorexia, diabetes mellitus, dyslipidemia
Uncommon (0.1% to 1%): Acquired lipodystrophy (at least moderate intensity: up to 0.5%)

Hepatic

Very common (10% or more): Worsening from baseline of AST (at least moderate intensity: 27.8% coinfected patients), worsening from baseline of ALT (at least moderate intensity: 25% coinfected patients)
Common (1% to 10%): Worsening from baseline of ALT (at least moderate intensity: 7.5% non-coinfected patients), worsening from baseline of total bilirubin (at least moderate intensity: 7.1% coinfected patients), worsening from baseline of AST (at least moderate intensity: 6.7% non-coinfected patients), elevated ALT (Grade 2: 6%; Grade 3: 3%; Grade 4: 1%), elevated AST (Grade 2: 6%; Grade 3: 3%), worsening from baseline of total bilirubin (at least moderate intensity: 1.8% non-coinfected patients); Less than 2% (at least moderate intensity): Cytolytic hepatitis, hepatic steatosis, hepatitis, hepatic failure, hepatomegaly
Uncommon (0.1% to 1%): Elevated AST (Grade 4: less than 1%)

Grade 2 or higher abnormalities representing a worsening from baseline of AST, ALT, and total bilirubin have been reported in 27.8%, 25%, and 7.1%, respectively, in patients coinfected with hepatitis B and/or C virus as compared to 6.7%, 7.5%, and 1.8% reported in non-coinfected patients.

Hematologic

Common (1% to 10%): Decreased neutrophils (Grade 2: 5%; Grade 3: 4%; Grade 4: 2%), decreased platelet count (Grade 2: 3%; Grade 3: 1%), decreased hemoglobin (Grade 2: 2%), decreased white blood cell count (Grade 2: 2%; Grade 3: 1%; Grade 4: 1%), hemolytic anemia (at least moderate intensity: less than 2%)
Uncommon (0.1% to 1%): Decreased hemoglobin (Grade 3: less than 1%; Grade 4: less than 1%), decreased platelet count (Grade 4: less than 1%)
Frequency not reported: Anemia

Renal

Common (1% to 10%): Elevated creatinine (Grade 2: 6%; Grade 3: 2%), acute renal failure (at least moderate intensity: less than 2%)

Other

Common (1% to 10%): Sluggishness (at least moderate intensity: less than 2%)
Frequency not reported: Fatigue, pyrexia

Immunologic

Common (1% to 10%): Immune reconstitution syndrome (at least moderate intensity: less than 2%)
Frequency not reported: Autoimmune disorders in the setting of immune reconstitution (e.g., Graves' disease, polymyositis, Guillain-Barre syndrome)

Respiratory

Common (1% to 10%): Bronchospasm (at least moderate intensity: less than 2%), exertional dyspnea (at least moderate intensity: less than 2%)

Psychiatric

Common (1% to 10%): Less than 2% (at least moderate intensity): Abnormal dreams, anxiety, confusional state, disorientation, nervousness, nightmares, sleep disorders
Frequency not reported: Insomnia

Endocrine

Common (1% to 10%): Gynecomastia (at least moderate intensity: less than 2%)

Ocular

Common (1% to 10%): Blurred vision (at least moderate intensity: less than 2%)

Musculoskeletal

Rare (less than 0.1%): Severe myopathy (including articular pain, muscular pain, weakness, stiffness, increased creatine kinase; at least 1 case)
Postmarketing reports: Rhabdomyolysis

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