Label Changes for:

Viramune (nevirapine) Tablets and Oral Suspension

June 2008

Changes have been made to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS and ADVERSE REACTIONS sections of the safety label.


Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) -- June 2008

 

The detailed view includes drug products with safety labeling changes to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, or PATIENT PACKAGE INSERT/MEDICATION GUIDE sections. Deletions or editorial revisions made to these sections are not included in this summary. Read about the new physician labeling format.


Summary View

 

Sections Modified Summary of Changes to Contraindications and Warnings

BOXED WARNING

  • Skin Reactions
  • Monitoring

CONTRAINDICATIONS

WARNINGS AND PRECAUTIONS

  • Hepatotoxicity and Hepatic Impairment
  • Skin Reactions
  • Drug Interactions
    • St. John's wort

ADVERSE REACTIONS

  • Clinical Trials in Pediatrics

DRUG INTERACTIONS

  • Table 4

USE IN SPECIFIC POPULATIONS

  • Pediatric Use
  • Hepatic Impairment

PATIENT COUNSELING INFORMATION

  • Hepatotoxicity and Skin Reactions
    • ...Patients should be instructed that if any rash occurs during the two-week lead-in period, the Viramune dose should not be escalated until the rash resolves...

MEDICATION GUIDE

  • Who should not take Viramune?
    • Do not take Viramune if you have severe liver problems.
  • How should I take Viramune?
    • ...Therefore, it is important to strictly follow the once daily dose for the first 14 days. If you have a skin rash during the first 14 days immediately contact your doctor and do not increase your dose to Viramune twice a day. The total duration of the once daily lead-in dosing period should not exceed 28 days at which point an alternative regimen may need to be started...

BOXED WARNING

Skin Reactions

...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...

Monitoring

Patients must be monitored intensively during the first 18 weeks of therapy with Viramune to detect potentially life-threatening hepatotoxicity or skin reactions...

CONTRAINDICATIONS

Viramune is contraindicated in patients with moderate or severe (Child Pugh Class B or C, respectively) hepatic impairment...

WARNINGS AND PRECAUTIONS

Hepatotoxicity and Hepatic Impairment

...Transaminases should be checked immediately if a patient experiences signs or symptoms suggestive of hepatitis and/or hypersensitivity reaction. Transaminases should also be checked immediately for all patients who develop a rash in the first 18 weeks of treatment...

...Nevirapine should not be administered to patients with moderate or severe (Child Pugh Class B or C, respectively) hepatic impairment...

Skin Reactions

...A patient experiencing a mild to moderate rash without constitutional symptoms during the 14-day lead-in period of 200 mg/day (150 mg/m2/day in pediatric patients) should not have their Viramune dose increased until the rash has resolved. The total duration of the once daily lead-in dosing period should not exceed 28 days at which point an alternative regimen should be sought...

Drug Interactions

Concomitant use of St. John's wort (Hypericum perforatum) or St. John's wort containing products and Viramune is not recommended. Co-administration of St. John’s wort with non-nucleoside reverse transcriptase inhibitors (NNRTIs), including Viramune, is expected to substantially decrease NNRTI concentrations and may result in sub-optimal levels of Viramune and lead to loss of virologic response and possible resistance to Viramune or to the class of NNRTIs.

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