Patient Support

For more than a decade, Boehringer Ingelheim has helped to assist you in the care of HIV/AIDS patients by offering programs and support options designed to fit their needs.

The Viramune^® XR™ (nevirapine) extended-release tablets Co-Pay Savings Card offers qualified patients a $0 co-pay for their first VIRAMUNE XR (400 mg) prescription, and savings of up to $100 toward their monthly co-pay for up to 12 months on each VIRAMUNE XR prescription.

Click here for more information about the VIRAMUNE XR Co-Pay Savings Card

With the Vlife on Therapy™ program, we further our commitment to helping you improve HIV/AIDS patient treatment and care.

Click here for more information about the Vlife on Therapy™ program

Please see Important Safety Information below.

INDICATIONS AND USAGE

VIRAMUNE is indicated for use in combination with other antiretroviral (ARV) agents for the treatment of HIV-1 infection.

VIRAMUNE XR is indicated for use in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults.

Important Considerations:

• 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 > 250 cells/mm³ or in adult males with CD4+ cell counts > 400 cells/mm³ unless the benefit outweighs the risk.


• The 14-day lead-in period with immediate-release VIRAMUNE 200 mg daily dosing must be strictly followed; it has been demonstrated to reduce the frequency of rash.


• If rash persists beyond the 14-day lead-in period with immediate-release VIRAMUNE, do not begin dosing with VIRAMUNE XR^™. The lead-in dosing with 200 mg once-daily immediate-release VIRAMUNE should not be continued beyond 28 days, at which point an alternative regimen should be sought.


• Adult patients already on a regimen of immediate-release VIRAMUNE twice daily can be switched to
  VIRAMUNE XR^™ 400 mg once daily without the 14-day lead-in period of immediate-release VIRAMUNE.


• For patients who interrupt VIRAMUNE XR^™ dosing for more than 7 days, restart the recommended lead-in dosing with immediate-release VIRAMUNE using one 200 mg tablet daily for the first 14 days.

IMPORTANT SAFETY INFORMATION

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 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+ cell counts at initiation of therapy place patients at increased risk; women with CD4+ cell counts > 250 cells/mm³, including pregnant women receiving nevirapine in combination with other antiretrovirals for the treatment of HIV-1 infection, are at the greatest risk. However, hepatotoxicity associated with nevirapine use can occur in both genders, all CD4+ cell counts, and at any time during treatment. Hepatic failure has also been reported in patients without HIV taking nevirapine for post-exposure prophylaxis (PEP). Use of nevirapine for occupational and non-occupational PEP is contraindicated. Patients with signs or symptoms of hepatitis, or with increased transaminases combined with rash or other systemic symptoms, must discontinue nevirapine and seek medical evaluation immediately.


• SKIN REACTIONS: Severe, life-threatening skin reactions, including fatal cases, have occurred in patients treated with nevirapine. 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 nevirapine 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 immediate-release VIRAMUNE 200 mg daily dosing has been observed to decrease the incidence of rash and must be followed.


• MONITORING: Patients must be monitored intensively during the first 18 weeks of therapy with nevirapine 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 nevirapine following clinical hepatitis, or transaminase elevations combined with rash or other systemic symptoms, or following severe skin rash or hypersensitivity reactions. In some cases, hepatic injury has progressed despite discontinuation of treatment.


• CONTRAINDICATIONS: Nevirapine is contraindicated in patients with moderate or severe (Child-Pugh Class B or C, respectively) hepatic impairment or for use in occupational and non-occupational PEP.


• Patients taking nevirapine should not take St. John's wort or efavirenz. Please see full Prescribing Information for additional drug-to-drug interactions.


• Immune reconstitution syndrome has been reported in patients treated with combination ARV therapy, including nevirapine. Fat redistribution or accumulation of body fat has been reported in patients receiving ARV therapy. The mechanism and long-term consequences of this are unknown.


• Other less common side effects include nausea, fatigue, fever, headache, vomiting, diarrhea, abdominal pain, and myalgia.

Please consult full Prescribing Information, including boxed WARNING for VIRAMUNE XR.