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NEVIRAPINE MYLAN is a brand name for Nevirapine. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Nevirapine is indicated in combination with other anti-retroviral medicinal products for the treatment of HIV-1 infected adults, adolescents, and children three years and above and able to swallow tablets (see sections 4.2 and 4.4.). Prolonged-release tablets are not suitable for the 14-day lead-in phase for patients…
Verbatim from this product's MHRA label. Tap a section to expand.
Nevirapine should be administered by physicians who are experienced in the treatment of HIV infection. Posology Adults The recommended dose of nevirapine for patients initiating nevirapine therapy is one 200 mg immediate-release tablet daily for the first 14 days (this lead-in period should be used because it has been found to lessen the frequency of rash), followed by one 400 mg prolonged-release tablet once daily, in combination with at least two additional antiretroviral agents.
Patients currently on a nevirapine immediate-release twice daily regimen:
Patients already on a regimen of nevirapine immediate-release twice daily in combination with other antiretroviral agents can be switched to Nevirapine 400 mg prolonged-release tablets once daily in combination with other antiretroviral agents without a lead-in period of nevirapine immediate-release.
Nevirapine should be combined with at least two additional antiretroviral agents. For concomitantly administered therapy, the manufacturers recommended dose should be followed. If a dose is recognised as missed within 12 hours of when it was due, the patient should take the missed dose as soon as possible.
If a dose is missed and it is more than 12 hours later, the patient should only take the next dose at the usual time. g. 50 mg or 100 mg prolonged-release tablets, should be checked for their availability. Children less than three years old The safety and efficacy of nevirapine prolonged-release tablets in children aged less than 3 years has not been established.
No data are available. For patients less than 3 years, a nevirapine immediate-release oral suspension dosage form should be checked for availability (please refer to the respective Summary of Product Characteristics). Dose management considerations The total daily dose at any time during treatment should not exceed 400 mg for any patient.
Patients should be advised of the need to take Nevirapine every day as prescribed. Patients experiencing rash during the 14-day lead-in period of 200 mg/day should not initiate treatment with Nevirapine prolonged-release tablets until the rash has resolved.
4). The 200 mg once daily nevirapine immediate-release lead-in dosing regimen should not be continued beyond 28 days at which point in time an alternative treatment should be sought due to the possible risk of underexposure and resistance.
1486 (VERxVE) were rash, nausea, liver function test abnormal, headache, fatigue, hepatitis, abdominal pain, diarrhoea and pyrexia. There are no new adverse drug reactions for nevirapine prolonged- release tablets that have not been previously identified for nevirapine immediate- release tablets and oral suspension.
The nevirapine postmarketing experience has shown that the most serious adverse reactions are Stevens-Johnson syndrome/toxic epidermal necrolysis, serious hepatitis/hepatic failure, and drug rash with eosinophilia and systemic symptoms, characterised by rash with constitutional symptoms such as fever, arthralgia, myalgia and lymphadenopathy, plus visceral involvement, such as hepatitis, eosinophilia, granulocytopenia, and renal dysfunction.
4). Tabulated summary of adverse reactions The following adverse reactions which may be causally related to the administration of nevirapine prolonged-release tablets have been reported. 1486 with 1,068 patients exposed to nevirapine on a backbone of tenofovir/emtricitabine.
Frequency is defined using the following convention: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000) Table 1: Lead-in phase with nevirapine immediate-release tablets Blood and lymphatic system disorders Uncommon granulocytopenia Rare anaemia Immune system disorders Uncommon hypersensitivity (incl.
anaphylactic reaction, angioedema, urticaria), drug rash with eosinophilia and systemic symptoms, anaphylactic reaction Nervous system disorders Common headache Gastrointestinal disorders Common abdominal pain, nausea, diarrhoea Uncommon vomiting Hepatobiliary disorders Uncommon jaundice, hepatitis fulminant (which may be fatal) Rare hepatitis (incl.
2 %), angioedema, urticaria Musculoskeletal and connective tissue disorders Uncommon arthralgia, myalgia General disorders and administration site conditions Common fatigue, pyrexia Investigations Uncommon liver function test abnormal (alanine aminotransferase increased; transaminases increased; aspartate aminotransferase increased; gamma-glutamyltransferase increased; hepatic enzyme increased; hypertransaminasaemia), blood phosphorus decreased, blood pressure increased Table 2: Maintenance phase of nevirapine prolonged-release Blood and lymphatic system disorders Uncommon anaemia, granulocytopenia Immune system disorders Uncommon hypersensitivity (incl.
4. Special populations Elderly patients Nevirapine has not been specifically investigated in patients over the age of 65. Renal impairment In adult patients with renal dysfunction requiring dialysis an additional 200 mg dose of nevirapine immediate-release following each dialysis treatment is recommended.
2. In paediatric patients with renal dysfunction who are undergoing dialysis it is recommended that following each dialysis treatment patients receive an additional dose of nevirapine oral suspension or immediate-release tablets representing 50 % of the recommended daily dose of nevirapine oral suspension or immediate-release tablets which would help offset the effects of dialysis on nevirapine clearance.
Nevirapine prolonged-release tablets have not been studied in patients with renal dysfunction and nevirapine immediate-release formulation should be used. 3). 2). Nevirapine prolonged-release tablets have not been studied in patients with hepatic impairment and nevirapine immediate-release formulation should be used.
Method of administration For oral use. The prolonged-release tablets shall be taken with liquid, and should not be broken or chewed. Nevirapine can be taken with or without food. 1. Readministration to patients who have required permanent discontinuation for severe rash, rash accompanied by constitutional symptoms, hypersensitivity reactions, or clinical hepatitis due to nevirapine.
Patients with severe hepatic impairment (Child-Pugh C) or pre-treatment ASAT or ALAT > 5 ULN until baseline ASAT/ALAT are stabilised < 5 ULN. 4). Coadministration with herbal preparations containing St. 5). 1). Nevirapine should not be used as the sole active antiretroviral, as monotherapy with any antiretroviral has shown to result in viral resistance.
The first 18 weeks of therapy with nevirapine are a critical period which requires close monitoring of patients to disclose the potential appearance of severe and life-threatening skin reactions (including cases of Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN)) and serious hepatitis/hepatic failure.
1. Readministration to patients who have required permanent discontinuation for severe rash, rash accompanied by constitutional symptoms, hypersensitivity reactions, or clinical hepatitis due to nevirapine. Patients with severe hepatic impairment (Child-Pugh C) or pre-treatment ASAT or ALAT > 5 ULN until baseline ASAT/ALAT are stabilised < 5 ULN.
4). Coadministration with herbal preparations containing St. 5).
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Patients who interrupt nevirapine dosing for more than 7 days should restart the recommended dosing regimen using the two week lead-in period of nevirapine immediate-release. There are toxicities that require interruption of nevirapine therapy, see section
anaphylactic reaction, angioedema, urticaria), drug rash with eosinophilia and systemic symptoms, anaphylactic reaction Nervous system disorders Common headache Gastrointestinal disorders Common abdominal pain, nausea, vomiting, diarrhoea Hepatobiliary disorders Common hepatitis (incl.
1486. 1486 (n= 1,068). 1486 (n= 505). 4). 4). The following […]
The greatest risk of hepatic and skin reactions occurs in the first 6 weeks of therapy. However, the risk of any hepatic event continues past this period and monitoring should continue at frequent intervals. e. a concentration ≥ 50 copies/ml - at the initiation of nevirapine.
As serious and life threatening hepatotoxicity has been observed in controlled and uncontrolled studies predominantly in patients with a plasma HIV-1 viral load of 50 copies/ml or higher, nevirapine should not be initiated in adult females with CD4 cell counts greater than 250 cells/mm3 or in adult males with CD4 cell counts greater than 400 cells/mm3, who have a detectable plasma HIV-1 RNA unless the benefit outweighs the risk.
In some cases, hepatic injury has progressed despite discontinuation of treatment. Patients developing signs or symptoms of hepatitis, severe skin reaction or hypersensitivity reactions must discontinue nevirapine and seek medical evaluation immediately.
3). 2). Cutaneous reactions Severe and life-threatening skin reactions, including fatal cases, have occurred in patients treated with nevirapine mainly during the first 6 weeks of therapy. These have included cases of Stevens-Johnson syndrome, toxic epidermal necrolysis and hypersensitivity reactions characterised by rash, constitutional findings and visceral involvement.
Patients should be intensively monitored during the first 18 weeks of treatment. Patients should be closely monitored if an isolated rash occurs. Nevirapine must be permanently discontinued in any patient experiencing severe rash or a rash accompanied by constitutional symptoms (such as fever, blistering, oral lesions, conjunctivitis, facial oedema, muscle or joint aches, or general malaise), including Stevens-Johnson syndrome, or toxic epidermal necrolysis.
4. Nevirapine administration above the recommended dose might increase the frequency and seriousness of skin reactions, such as Stevens-Johnson syndrome and toxic epidermal necrolysis. Rhabdomyolysis has been observed in patients experiencing skin and/or liver reactions associated with use of nevirapine.
Concomitant prednisone use (40 mg/day for the first 14 days of nevirapine immediate-release administration) has been shown not to decrease the incidence of […]