Viramune Suspension Side Effects

Please note - some side effects for Viramune Suspension may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Side Effects by Body System - for Healthcare Professionals

Applies to: oral suspension; oral tablet; oral tablet, extended release

General

Serious adverse effects can occur with nevirapine. The most serious side effects have included hepatitis, hepatic failure, Stevens-Johnson syndrome, toxic epidermal necrolysis, and hypersensitivity reactions. Hepatitis/hepatic failure may be isolated or associated with signs of hypersensitivity which may include severe rash or rash accompanied by fever, general malaise, fatigue, muscle or joint aches, blisters, oral lesions, conjunctivitis, facial edema, eosinophilia, granulocytopenia, lymphadenopathy, or renal dysfunction.

The first 18 weeks of therapy with nevirapine are a critical period during which it is essential that patients be monitored intensively to detect potentially life-threatening hepatotoxicity or skin reactions. Nevirapine should not be restarted following clinical hepatitis, or transaminase elevations combined with rash or other systemic symptoms, or following severe skin rash or hypersensitivity reactions.

Dermatologic

Dermatologic side effects have included rash, the most common clinical toxicity. Rashes were usually mild to moderate, maculopapular erythematous cutaneous eruptions, with or without pruritus, located on the face, trunk, and extremities. Severe and life-threatening skin reactions, including fatal cases, have been reported. These have included cases of Stevens-Johnson syndrome, toxic epidermal necrolysis, and hypersensitivity reactions characterized by rash, constitutional findings, and organ dysfunction. Moderate or severe rash has been reported in up to 7% of patients. During one study, side effects of at least moderate intensity included rash (including rash, maculopapular rash, erythema nodosum, erythematous rash, papular rash, skin reaction, Stevens-Johnson syndrome, drug rash with eosinophilia and systemic symptoms, and allergic dermatitis) in 3% of patients using the immediate-release formulation and 3% of patients using the extended-release formulation.

Rash has occurred most often during the first 6 weeks of therapy. Utilization of the 14-day lead-in period with immediate-release nevirapine has been shown to reduce the frequency of rash.

During clinical trials, Grade 1 and 2 rashes were reported in 13% of patients taking immediate-release nevirapine during the first 6 weeks of therapy. Grade 3 and 4 rashes were reported in 2% of immediate-release nevirapine-treated patients.

Women tended to be at greater risk of nevirapine-associated rash.

Rash was reported in about half of patients with symptomatic hepatic side effects.

Hepatic

Risk of symptomatic hepatic events (regardless of severity) was greatest in the first 6 weeks and continued to be greater in the nevirapine groups compared to controls through 18 weeks of therapy.

Female gender and higher CD4+ cell counts at the start of therapy place patients at increased risk of hepatic events (including potentially fatal events). Women with CD4+ cell counts greater than 250 cells/mm3 (including pregnant women using nevirapine with other antiretrovirals to treat HIV-1 infection) are at greatest risk. However, nevirapine-associated hepatotoxicity can develop in both genders, all CD4+ cell counts, and at any time during therapy. Coinfection with hepatitis B or C and/or increased transaminases at the start of nevirapine therapy are associated with a greater risk of later symptomatic events (6 weeks or more after starting nevirapine) and asymptomatic increases in AST or ALT.

Rash was reported in about half of patients with symptomatic hepatic side effects. Fever and influenza-like symptoms accompanied some hepatic events.

Following the lead-in period, the incidence of any hepatic event was 9% with the immediate-release formulation and 6% with the extended-release formulation. Symptomatic hepatic events (anorexia, jaundice, vomiting) were reported in 3% and 2% of patients using the immediate-release and extended-release formulations, respectively. Grade 3 or 4 ALT/AST elevation was 7% with the immediate-release formulation and 6% with the extended-release formulation.

Grade 2 elevated SGPT/ALT (2.6 to 5 times ULN) was reported in 10% of patients using the immediate-release formulation and 9% of patients using the extended-release formulation. Grade 3 elevated SGPT/ALT (5.1 to 10 times ULN) was reported in 4% of patients using the immediate-release formulation and 3% of patients using the extended-release formulation. Grade 4 elevated SGPT/ALT (greater than 10 times ULN) was reported in 4% of patients using the immediate-release formulation and 2% of patients using the extended-release formulation.

Grade 2 elevated SGOT/AST (2.6 to 5 times ULN) was reported in 9% of patients using the immediate-release formulation and 6% of patients using the extended-release formulation. Grade 3 elevated SGOT/AST (5.1 to 10 times ULN) was reported in 2% of patients using the immediate-release formulation and 3% of patients using the extended-release formulation. Grade 4 elevated SGOT/AST (greater than 10 times ULN) was reported in 2% of patients using the immediate-release formulation and 1% of patients using the extended-release formulation.

Grade 2 elevated total bilirubin (1.6 to 2.5 times ULN) was reported in less than 1% of patients using the immediate-release formulation and 1% of patients using the extended-release formulation. Grade 3 elevated total bilirubin (2.6 to 5 times ULN) was reported in 1% of patients using the immediate-release formulation and 1% of patients using the extended-release formulation. Grade 4 elevated total bilirubin (greater than 5 times ULN) was reported in less than 1% of patients using the immediate-release formulation and 1% of patients using the extended-release formulation.

Hepatic side effects have included symptomatic hepatic events (regardless of severity; up to 11%), asymptomatic transaminase elevations (AST or ALT greater than 5 times ULN; up to 9%), and elevated ALT (greater than 250 units/L; up to 14%), AST (greater than 250 units/L; up to 8%), and bilirubin (greater than 2.5 mg/dL; 2%). During one study, side effects of at least moderate intensity included clinical hepatitis (including hepatitis, hepatotoxicity, acute hepatitis, liver disorder, toxic hepatitis, hepatic failure, jaundice) in 3% of patients using the immediate-release formulation and 2% of patients using the extended-release formulation. Severe, life-threatening, and in some cases fatal, hepatotoxicity (including fulminant and cholestatic hepatitis, hepatic necrosis, and hepatic failure) has been reported. In some cases, patients presented with nonspecific prodromal signs or symptoms of hepatitis (including fatigue, malaise, anorexia, nausea, jaundice, liver tenderness or hepatomegaly, with or without initially abnormal transaminase levels). Some events (particularly those with rash and other symptoms) progressed to hepatic failure with transaminase elevation, with or without hyperbilirubinemia, hepatic encephalopathy, prolonged partial thromboplastin time, or eosinophilia. Patients without HIV using nevirapine for postexposure prophylaxis have reported serious hepatotoxicity, including hepatic failure. In controlled studies, liver enzyme abnormalities (AST, ALT, gamma-glutamyltransferase) occurred more frequently in patients receiving nevirapine. Asymptomatic elevations in gamma-glutamyltransferase were reported frequently. Elevated alkaline phosphatase has been reported. Elevated SGPT/ALT, SGOT/AST, and total bilirubin have been reported with the immediate-release and extended-release formulations. Jaundice, fulminant and cholestatic hepatitis, hepatic necrosis, and hepatic failure have also been reported during postmarketing experience.

Hematologic

Grade 2 decreased neutrophils (750 to 999/mm3) was reported in 7% of patients using the immediate-release formulation and 4% of patients using the extended-release formulation. Grade 3 decreased neutrophils (500 to 749/mm3) was reported in 3% of patients using the immediate-release formulation and 2% of patients using the extended-release formulation. Grade 4 decreased neutrophils (less than 500/mm3) was reported in 1% of patients using the immediate-release formulation and less than 1% of patients using the extended-release formulation.

Hematologic side effects of moderate or severe intensity have included granulocytopenia (up to 2%). Decreased neutrophils (less than 750/mm3; up to 13%), hemoglobin (less than 8 g/dL; up to 3%), and platelets (less than 50,000/mm3; up to 1%) have been reported. Decreased neutrophils have been reported with the immediate-release and extended-release formulations. Anemia, neutropenia, and eosinophilia have been reported during postmarketing experience.

Hypersensitivity

Hypersensitivity side effects have included allergic reactions (including anaphylaxis, angioedema, bullous eruptions, ulcerative stomatitis, and urticaria) during postmarketing experience. Hypersensitivity syndrome and hypersensitivity reactions with rash associated with constitutional findings such as fever, blistering, oral lesions, conjunctivitis, facial edema, muscle or joint aches, general malaise, fatigue, or significant hepatic abnormalities plus hepatitis, eosinophilia, granulocytopenia, lymphadenopathy, and/or renal dysfunction have also been reported during postmarketing experience.

Metabolic

Grade 2 elevated LDL (160 to 190 mg/dL) was reported in 13% of patients using the immediate-release formulation and 13% of patients using the extended-release formulation. Grade 3 elevated LDL (greater than 190 mg/dL) was reported in 4% of patients using the immediate-release formulation and 4% of patients using the extended-release formulation.

Grade 2 elevated cholesterol (240 to 300 mg/dL) was reported in 16% of patients using the immediate-release formulation and 16% of patients using the extended-release formulation. Grade 3 elevated cholesterol (greater than 300 mg/dL) was reported in 4% of patients using the immediate-release formulation and 2% of patients using the extended-release formulation.

Grade 2 elevated triglycerides (500 to 750 mg/dL) was reported in 2% of patients using the immediate-release formulation and 3% of patients using the extended-release formulation. Grade 3 elevated triglycerides (751 to 1200 mg/dL) was reported in 2% of patients using the immediate-release formulation and 1% of patients using the extended-release formulation. Grade 4 elevated triglycerides (greater than 1200 mg/dL) was reported in less than 1% of patients using the immediate-release formulation and less than 1% of patients using the extended-release formulation.

Grade 2 elevated alkaline phosphatase (2.6 to 5 times ULN) was reported in 4% of patients using the immediate-release formulation and 2% of patients using the extended-release formulation. Grade 3 elevated alkaline phosphatase (5.1 to 10 times ULN) was reported in less than 1% of patients using the immediate-release formulation and 1% of patients using the extended-release formulation.

Metabolic side effects have included hyperlactatemia, unspecified metabolic alterations, and elevated total cholesterol. Elevated LDL, cholesterol, triglycerides, and alkaline phosphatase have been reported with the immediate-release and extended-release formulations. Redistribution/accumulation of body fat including central obesity, dorsocervical fat enlargement, peripheral wasting, facial wasting, breast enlargement, and "cushingoid appearance" have been observed in patients receiving antiretroviral therapy. Acute porphyria has been reported. Redistribution/accumulation of body fat and decreased serum phosphorus have been reported during postmarketing experience.

Gastrointestinal

Gastrointestinal side effects of moderate or severe intensity have included nausea (up to 9%), diarrhea (up to 2%), and abdominal pain (up to 2%). Anorexia has been reported. Vomiting has been reported during postmarketing experience.

Other

Fever and influenza-like symptoms accompanied some hepatic events.

Other side effects of moderate or severe intensity have included fatigue (up to 5%). Fever, asthenia, and influenza-like symptoms have been reported. Fever and drug withdrawal (as a result of drug interactions) have been reported during postmarketing experience.

Nervous system

Nervous system side effects of moderate or severe intensity have included headache (up to 4%). Neuropathy has been reported. Somnolence and paresthesia have been reported during postmarketing experience.

Musculoskeletal

Musculoskeletal side effects of moderate or severe intensity have included myalgia (up to 1%). Arthromyalgia and arthritis have been reported. Rhabdomyolysis associated with skin and/or liver reactions and arthralgia have been reported during postmarketing experience.

Immunologic

Immunologic side effects have included immune reconstitution syndrome.

Respiratory

Respiratory side effects have rarely included dry cough, dyspnea, and interstitial pulmonary infiltration.

Psychiatric

Psychiatric side effects have included depression.

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date, and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This information does not endorse drugs, diagnose patients, or recommend therapy. This drug information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug of drug combination is safe, effective, or appropriate for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of information provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse, or pharmacist.