WARNING: LIFE-THREATENING (INCLUDING FATAL) HEPATOTOXICITY and SKIN REACTIONS
HEPATOTOXICITY:
Severe, life-threatening, and in some cases fatal hepatotoxicity, particularly in the first 18 weeks, has been reported in patients treated with VIRAMUNE. 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 initiation of therapy place patients at increased risk; women with CD4 counts >250 cells/mm3, including pregnant women receiving VIRAMUNE in combination with other antiretrovirals for the treatment of HIV infection, are at the greatest risk. However, hepatotoxicity associated with VIRAMUNE use can occur in both genders, all CD4 counts and at any time during treatment. Patients with signs or symptoms of hepatitis, or with increased transaminases combined with rash or other systemic symptoms, must discontinue VIRAMUNE and seek medical evaluation immediately [ see Warnings and Precautions ].
SKIN REACTIONS:
Severe, life-threatening skin reactions, including fatal cases, have occurred in patients treated with VIRAMUNE. These have included cases of Stevens-Johnson syndrome, toxic epidermal necrolysis, and hypersensitivity reactions characterized by rash, constitutional findings, and organ dysfunction. Patients developing signs or symptoms of severe skin reactions or hypersensitivity reactions must discontinue VIRAMUNE and seek medical evaluation immediately. Transaminase levels should be checked immediately for all patients who develop a rash in the first 18 weeks of treatment. The 14-day lead-in period with VIRAMUNE 200 mg daily dosing has been observed to decrease the incidence of rash and must be followed [ see Warnings and Precautions ].
MONITORING:
Patients must be monitored intensively during the first 18 weeks of therapy with VIRAMUNE to detect potentially life-threatening hepatotoxicity or skin reactions. Extra vigilance is warranted during the first 6 weeks of therapy, which is the period of greatest risk of these events. Do not restart VIRAMUNE following severe hepatic, skin or hypersensitivity reactions. In some cases, hepatic injury has progressed despite discontinuation of treatment.
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VIRAMUNE SUMMARY
VIRAMUNE is the brand name for nevirapine (NVP), a non-nucleoside reverse transcriptase inhibitor with activity against Human Immunodeficiency Virus Type 1 (HIV-1). Nevirapine is structurally a member of the dipyridodiazepinone chemical class of compounds.
VIRAMUNE (nevirapine) is indicated for use in combination with other antiretroviral agents for the treatment of HIV-1 infection.
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NEWS HIGHLIGHTS
Published Studies Related to Viramune (Nevirapine)
Lower risk of resistance after short-course HAART compared with zidovudine/single-dose nevirapine used for prevention of HIV-1 mother-to-child transmission. [2009.08.15]
BACKGROUND: Antiretroviral resistance after short-course regimens used to prevent mother-to-child transmission has consequences for later treatment. Directly comparing the prevalence of resistance after short-course regimens of highly active antiretroviral therapy (HAART) and zidovudine plus single-dose nevirapine (ZDV/sdNVP) will provide critical information when assessing the relative merits of these antiretroviral interventions... CONCLUSIONS: Our finding provides evidence that compared with ZDV/sdNVP, HAART reduces but does not eliminate nevirapine resistance.
Safety of Switching Nevirapine Twice Daily to Nevirapine Once Daily in Virologically Suppressed Patients. [2009.04.01]
BACKGROUND: The strategy of switching nevirapine (NVP) twice daily to once daily was evaluated... CONCLUSIONS: In patients on standard twice daily NVP-containing regimens for at least 12-18 weeks, per protocol analysis showed that switching to once daily NVP was not inferior to continued twice daily NVP in terms of the predefined noninferiority margin of 10% for hepatotoxicity.
Effects of concurrent administration of nevirapine on the disposition of quinine in healthy volunteers. [2009.04]
OBJECTIVES: Nevirapine and quinine are likely to be administered concurrently in the treatment of patients with HIV and malaria. Both drugs are metabolised to a significant extent by cytochrome P450 (CYP)3A4 and nevirapine is also an inducer of this enzyme. This study therefore evaluated the effect of nevirapine on the pharmacokinetics of quinine... CONCLUSIONS: Nevirapine significantly alters the pharmacokinetics of quinine. An increase in the dose of quinine may be necessary when the drug is co-administered with nevirapine.
Virologic, immunologic, clinical, safety, and resistance outcomes from a long-term comparison of efavirenz-based versus nevirapine-based antiretroviral regimens as initial therapy in HIV-1-infected persons. [2008.09]
CONCLUSIONS: EFV-based regimens as initial therapy resulted in a lower risk of VF and VF with resistance than did NVP-based regimens, although immunologic and clinical outcomes were similar.
The influence of lamivudine, stavudine and nevirapine on the pharmacokinetics of chlorpropamide in human subjects. [2008.07]
Diabetic patients tend to be prone to infections, and multiple drug therapy cannot be ruled out in the management of diabetes. The effect of three routinely prescribed antiretroviral (ARV) drugs on the pharmacokinetic profile of an antidiabetic drug, chlorpropamide, was investigated in 18 human subjects, who had recently been diagnosed positive for human immunodeficiency virus (HIV) infection...
Clinical Trials Related to Viramune (Nevirapine)
An Open-Label, Non-Randomized Trial to Evaluate the Tolerability and Safety of Viramune (Nevirapine) in Adult and Pediatric Patients With Progressive HIV Disease [Completed]
To provide access to Viramune and to evaluate the tolerance and safety of Viramune in
patients with progressive, symptomatic HIV disease who failed or are intolerant to currently
approved treatment for HIV-1 infection and who are unable to participate in another Viramune
controlled clinical trial and have a compelling need for anti-HIV treatment.
Study on the Effect of Kaletra + Nevirapine as Maintenance Bitherapy Compared to a Triple Therapy Including Kaletra + Analogues in HIV Patients [Completed]
The study aims to evaluate the changes in mitochondrial DNA (mDNA) by means of the
mDNA/nuclearDNA (nDNA) ratio as a marker of mitochondrial toxicity following the interruption
of nucleoside analogues.
An Open-Label Study in HIV+ Patients to Determine the Effects of Nevirapine (Viramune) on the Pharmacokinetics of Clarithromycin and Activity of Cytochrome 3A4. [Completed]
To evaluate the potential pharmacokinetic interaction between nevirapine and clarithromycin,
and to determine the effects of nevirapine on cytochrome P450 3A4 (CYP3A4) activity in vivo.
A Pharmacokinetic Study to Assess Nevirapine [Viramune] Levels in HIV Infected Patients With Impaired Hepatic Functions [Completed]
To evaluate the correlation between the degree of hepatic impairment based on liver biopsy
score (mi ld, moderate, severe) and plasma levels of nevirapine [Viramune] and its
metobolites
An Open-Label, Pilot Study to Evaluate the Development of Resistance to Nevirapine (BI-RG-587) in HIV-Infected Patients With CD4 Cell Count >= 500/mm3 [Completed]
Primary: To evaluate the rate of development of resistance to nevirapine in HIV-1 infected
individuals. To evaluate safety of nevirapine in HIV-1 infected individuals with CD4 counts
greater than or equal to 500 cells/mm3.
Secondary: To evaluate the effect of nevirapine on surrogate markers. The anti-HIV agent
nevirapine is associated with rapid emergence of resistance when administered alone or in
combination with zidovudine to HIV-infected patients with CD4 counts <= 400 cells/mm3. In
persons with less advanced HIV disease and less viral burden, the emergence of resistance may
be delayed, thus permitting evaluation for beneficial effect in a population where there is
currently no established therapy.
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Page last updated: 2009-10-20
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