Intelence Side Effects

Generic Name: etravirine

Please note - some side effects for Intelence may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of Intelence - for the Consumer

Intelence

All medicines may cause side effects, but many people have no, or minor side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Intelence:

Diarrhea; headache; nausea; stomach pain; tingling or pain in the hands or feet; tiredness; vomiting

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); blurred vision or other vision changes; change in amount of urine; chest pain; dark urine; fainting; irregular heartbeat; memory loss; mood or mental changes (eg, confusion); numbness of the arms, legs, hands, or feet; pale stools; reddened, blistered, swollen, or peeling skin; seizures; severe or persistent dizziness or headache; severe stomach pain; shortness of breath; unusual tiredness or weakness; yellowing of the skin or eyes.

Intelence Side Effects - for the Professional

Intelence

The most common adverse events (incidence > 10%) of any intensity that occurred at a higher rate than placebo are rash and nausea. (6)

To report SUSPECTED ADVERSE REACTIONS, contact Tibotec Therapeutics at 1-877-REACH-TT or 1-877-732-2488 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Side Effects by Body System

General

The safety report of etravirine 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 30 weeks. The most common side effects reported with etravirine and BR, regardless of causality, were nausea and rash. A total of 2% of HIV-1-infected patients in Phase 3 trials receiving etravirine discontinued due to rash.

Dermatologic

Dermatologic side effects have included rash (16.9%, all intensities), regardless of causality. Side effects reported of at least moderate intensity have included rash (9.0%) and in less than 2% of patients, dry skin, face swelling, hyperhidrosis, lipohypertrophy, night sweats, and prurigo. Contact dermatitis, erythema, and pruritus have also been reported.

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 compared to men. Patients with a history of nonnucleoside reverse transcriptase inhibitor-related rash did not appear to be at increased risk.

Gastrointestinal

Gastrointestinal side effects have included nausea (13.9%, all intensities), regardless of causality. Side effects reported of at least moderate intensity have included diarrhea (5.2%), nausea (4.7%), abdominal pain (3.0%), vomiting (2.3%), and in less than 2% of patients, abdominal distension, constipation, dry mouth, flatulence, gastritis, gastroesophageal reflux disease, hematemesis, pancreatitis, retching, and stomatitis.

Cardiovascular

Cardiovascular side effects of at least moderate intensity have included hypertension (2.8%); in less than 2% of patients, angina pectoris, atrial fibrillation, and myocardial infarction; and in no more than 0.5%, angioneurotic edema and hemorrhagic stroke. Mild atrioventricular block has also been reported.

Hypersensitivity

Hypersensitivity side effects have included Stevens-Johnson syndrome, hypersensitivity reaction, and erythema multiforme in less than 0.1% of patients during clinical development. Erythema multiforme (no more than 0.5%, at least moderate intensity) has been reported in other trials.

Metabolic

Metabolic side effects of at least moderate intensity have included anorexia, diabetes mellitus, and dyslipidemia in less than 2% of patients and acquired lipodystrophy in no more than 0.5%. Elevated pancreatic amylase (Grade 2: 5.9%, Grade 3: 6.3%, Grade 4: 1.2%), lipase (Grade 2: 3.4%, Grade 3: 1.7%, Grade 4: 1.0%), total cholesterol (Grade 2: 18.0%, Grade 3: 5.8%), low density lipoprotein (Grade 2: 11.5%, Grade 3: 5.2%), triglycerides (Grade 2: 7.1%, Grade 3: 4.1%, Grade 4: 2.9%), and glucose levels (Grade 2: 13.1%, Grade 3: 2.5%) have been reported.

Hepatic

Hepatic side effects of at least moderate intensity have included cytolytic hepatitis, hepatic steatosis, hepatitis, and hepatomegaly in less than 2% of patients. Elevated alanine transaminase (ALT; Grade 2: 5.4%, Grade 3: 1.9%, Grade 4: 0.7%), aspartate transaminase (AST; Grade 2: 5.1%, Grade 3: 2.0%, Grade 4: 0.5%), and total bilirubin (1.2%) have been reported. Grade 2 or higher abnormalities representing a worsening from baseline of AST, ALT, and total bilirubin have been reported in 22.8%, 21.4%, and 5.7%, respectively, in patients coinfected with hepatitis B and/or C virus as compared to 5.5%, 6.1%, and 1.2% reported in non-coinfected patients.

Nervous system

Nervous system side effects of at least moderate intensity have included peripheral neuropathy (2.8%), headache (2.7%), and in less than 2% of patients, amnesia, convulsion, hypersomnia, hypoesthesia, paresthesia, somnolence, syncope, tremor, and vertigo.

Hematologic

Hematologic side effects of at least moderate intensity have included anemia and hemolytic anemia in less than 2% of patients. Decreased hemoglobin (Grade 2: 1.9%, Grade 3: 1.0%, Grade 4: 0.7%), neutrophils (Grade 2: 4.4%, Grade 3: 2.7%, Grade 4: 1.0%), and platelet count (Grade 2: 2.9%, Grade 3: 1.2%, Grade 4: 0.2%) have been reported.

Renal

Renal side effects of at least moderate intensity have included renal failure in less than 2% of patients. Elevated creatinine (Grade 2: 4.7%, Grade 3: 1.9%) has been reported.

Other

Other side effects of at least moderate intensity have included fatigue (3.3%) and sluggishness (less than 2%). Pyrexia has been reported.

Immunologic

Immunologic side effects of at least moderate intensity have included drug hypersensitivity and immune reconstitution syndrome in less than 2% of patients.

Respiratory

Respiratory side effects of at least moderate intensity have included bronchospasm and exertional dyspnea in less than 2% of patients. Pneumonia and nasopharyngitis have also been reported.

Psychiatric

Psychiatric side effects of at least moderate intensity have included abnormal dreams, anxiety, confusional state, disorientation, insomnia, nervousness, nightmares, and sleep disorders in less than 2% of patients.

Endocrine

Endocrine side effects of at least moderate intensity have included gynecomastia in less than 2% of patients.

Ocular

Ocular side effects of at least moderate intensity have included blurred vision in less than 2% of patients.

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