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

Along with its needed effects, etravirine (the active ingredient contained in Intelence) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking etravirine:

More common
  • Rash
Less common
  • Blurred vision
  • burning, numbness, tingling, or painful sensations
  • dizziness
  • headache
  • nervousness
  • pounding in the ears
  • slow or fast heartbeat
  • unsteadiness or awkwardness
  • weakness in the arms, hands, legs, or feet
Rare
  • Blistering, peeling, or loosening of the skin
  • chills
  • cough
  • diarrhea
  • fever
  • hives
  • hoarseness
  • irritation
  • itching
  • joint pain, stiffness, or swelling
  • muscle pain
  • red skin lesions, often with a purple center
  • red, irritated eyes
  • redness of the skin
  • shortness of breath
  • sore throat
  • sores, ulcers, or white spots in the mouth or on the lips
  • swelling of the eyelids, face, lips, hands, or feet
  • tightness in the chest
  • trouble with breathing or swallowing
  • unusual tiredness or weakness
  • wheezing

Some side effects of etravirine may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common
  • Nausea
Less common
  • Stomach pain
  • vomiting

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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