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MYLAN-NEVIRAPINE is a brand name for Nevirapine, supplied as a tablet. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: AND CLINICAL USE ...........................................................................3 CONTRAINDICATIONS ................................................................................................4 WARNINGS AND PRECAUTIONS ..............................................................................5…
Verbatim from this product's HC label. Tap a section to expand.
Serious Warnings and Precautions MYLAN-NEVIRAPINE should not be initiated in adult females, including pregnant women, with CD4+ cell counts > 250 cell/mm3 and in adult males with CD4 cell counts > 400 cells/mm3 unless the benefit outweighs the risk.
Severe, life-threatening, and in some cases fatal hepatotoxicity, particularly in the first 18 weeks, has been reported in patients treated with nevirapine. An increased risk of hepatic adverse events is associated with female gender and higher CD4 counts (see, General and Hepatic/Biliary/Pancreatic sections below).
Severe, life-threatening skin reactions, including fatal cases, have been reported with nevirapine treatment, occurring almost exclusively during the first 6 weeks of therapy. These have included cases of Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and hypersensitivity syndrome characterized by rash, constitutional findings, and organ dysfunction (see ADVERSE REACTIONS, Adverse Drug Reaction Overview).
Patients should be carefully monitored during the first 18 weeks of treatment. Patients developing signs or symptoms of severe skin reactions or hypersensitivity reactions (including, but not limited to, severe rash or rash accompanied by fever, general malaise, fatigue, muscle or joint aches, blisters, oral lesions, conjunctivitis, facial edema, and/or hepatitis, eosinophilia, granulocytopenia, lymphadenopathy, and renal dysfunction) must permanently discontinue Mylan-Nevirapine and seek medical evaluation immediately (see Guidelines for the MANAGEMENT OF RASH EVENTS, WARNINGS AND PRECAUTIONS and ADVERSE REACTIONS).
General Women and patients with higher CD4 counts are at increased risk of hepatic adverse events. The first 18 weeks of therapy with nevirapine are a critical period during which intensive monitoring of patients is required to detect potentially life-threatening hepatic events and skin reactions.
The optimal frequency of monitoring during this time period has not been established, however it may be prudent to conduct clinical and laboratory monitoring more often than once per month; for example, liver function tests at baseline, prior to dose escalation and at two weeks post dose escalation.
After the initial 18 week period, frequent clinical and laboratory monitoring should continue throughout treatment. The greatest risk of hepatic events 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.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Resistant virus emerges rapidly and uniformly when nevirapine is administered as monotherapy. Therefore, nevirapine should always be administered in combination with other antiretroviral agents for the treatment of HIV- 1 infection.
MYLAN-NEVIRAPINE Product Monograph Page 6 of 62 When discontinuing an antiretroviral regimen containing nevirapine , the longer half-life of nevirapine should be taken into account; if antiretrovirals with shorter half-lives than nevriapine are stopped concurrently, low plasma concentrations of nevirapine alone may persist for a week or longer and virus resistance may subsequently develop.
When administering nevirapine as part of a multi-drug antiretroviral treatment regimen, the complete product information for each therapeutic component should be consulted before initiation of treatment. Patients receiving nevirapine or any other antiretroviral therapy may continue to develop opportunistic infections and other complications of HIV infection, and therefore should remain under close clinical observation by physicians experienced in the treatment of patients with associated HIV diseases.
Nevirapine therapy has not been shown to reduce the risk of horizontal transmission of HIV-1 to others. Hepatic/Biliary/Pancreatic Severe, life-threatening, and in some cases fatal hepatotoxicity, including fulminant and cholestatic hepatitis, hepatic necrosis and hepatic failure, have been reported in patients treated with nevirapine.
In some cases, patients presented with non-specific prodromal signs or symptoms of hepatitis and progressed to hepatic failure. These events are often associated with rash. Female gender and higher CD4 counts at the initiation of therapy place patients at greater risk of hepatic adverse events.
Based on serious and life- threatening hepatotoxicity observed in controlled and uncontrolled studies, nevirapine should not be initiated in adult females with CD4+ cell counts greater than 250 cells/mm3, including pregnant women receiving chronic treatment for HIV infection, or in adult males with CD4+ cell counts greater than 400 cells/mm3 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.
NEVIRAPINE should not be restarted following severe hepatic, skin or hypersensitivity reactions. In clinical trials, the risk of hepatic events regardless of severity was greatest in the first 6 weeks of therapy. The risk continued to be greater in the nevirapine groups compared to controls through 18 weeks of treatment.
However, hepatic events may occur at any time during treatment. In some cases, patients presented with non-specific, prodromal signs or symptoms of fatigue, malaise, anorexia, nausea, jaundice, liver tenderness or hepatomegaly, with or without initially abnormal serum transaminase levels.
Some of these events have progressed to hepatic failure with transaminase elevation, with or without hyperbilirubinemia, prolonged partial thromboplastin time, or eosinophilia. Rash and fever accompanied some of these hepatic events.
Patients with signs or symptoms of hepatitis must be advised to discontinue nevirapine and immediately seek medical evaluation, which should include liver function tests. In rare instances […]