VIRAMUNE- nevirapine tablet, extended release

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

NEVIRAPINE (UNII: 99DK7FVK1H) (NEVIRAPINE - UNII:99DK7FVK1H)

Available from:

Boehringer Ingelheim Pharmaceuticals, Inc.

INN (International Name):

NEVIRAPINE

Composition:

NEVIRAPINE 400 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

VIRAMUNE XR is indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus (HIV-1) infection in adults and pediatric patients 6 years of age or older with a body surface area (BSA) of 1.17 m2 or greater [see Clinical Studies (14.1, 14.2)] . Limitations of Use: - adult females with CD4+ cell counts greater than 250 cells/mm3 or - adult males with CD4+ cell counts greater than 400 cells/mm3 [see Warnings and Precautions (5.1)]. VIRAMUNE XR is contraindicated: - in patients with moderate or severe (Child-Pugh Class B or C, respectively) hepatic impairment [see Warnings and Precautions (5.1) and Use in Specific Populations (8.7)] . - for use as part of occupational and non-occupational post-exposure prophylaxis (PEP) regimens [see Warnings and Precautions (5.1)] . Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to nevirapine during pregnancy. Healthcare providers are encouraged to register pat

Product summary:

VIRAMUNE XR tablets, 400 mg, are yellow, oval, biconvex tablets, debossed with "V04" on one side and the Boehringer Ingelheim symbol on the other side. VIRAMUNE XR 400 mg tablets are supplied in bottles of 30 (NDC 0597-0123-30). Storage Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Store in a safe place out of the reach of children.

Authorization status:

New Drug Application

Patient Information leaflet

Boehringer Ingelheim Pharmaceuticals, Inc.
----------
MEDICATION GUIDE
VIRAMUNE® (VIH-RAH-MUNE)
(NEVIRAPINE)
ORAL SUSPENSION
VIRAMUNE® (VIH-RAH-
MUNE)
(NEVIRAPINE)
TABLETS
VIRAMUNE XR® (VIH-RAH-
MUNE)
(NEVIRAPINE)
EXTENDED-RELEASE TABLETS
This Medication Guide has been approved by the U.S. Food and Drug
Administration
Revised: June 2022
What is the most important information I should know about VIRAMUNE?
VIRAMUNE can cause severe liver and skin problems that may lead to
death. These problems can
happen at any time during treatment, but your risk is higher during
the first 18 weeks of treatment.
VIRAMUNE can cause serious side effects, including:
•
Severe liver problems. Some people taking VIRAMUNE may develop severe
liver problems that
can lead to liver failure and the need for a liver transplant, or
death. If you have liver problems,
you may get a rash.
•
Women have a higher risk of developing liver problems during treatment
with
VIRAMUNE than men.
•
People who have abnormal liver test results before starting VIRAMUNE
and people with
hepatitis B or C also have a greater risk of getting liver problems.
People who have higher CD4+ cell counts when they begin VIRAMUNE have
a higher
risk of liver problems, especially:
•
Women with CD4+ counts higher than 250 cells/mm3. This group has the
highest risk.
•
Men with CD4+ counts higher than 400 cells/mm3.
Stop taking VIRAMUNE and call your doctor right away if you have any
of the following
symptoms of liver problems with or without a skin rash:
•
dark (tea colored) urine
•
light-colored bowel
movements (stools)
•
feeling sick to your stomach
(nausea)
•
pain or tenderness on your
right side below your ribs
•
loss of appetite
•
yellowing of your skin
or whites of your eyes
•
fever
•
feel unwell or like you
have the flu
•
tiredness
•
Severe skin reactions and rash. Some skin reactions and rashes may be
severe, life-threatening,
and in some people, may lead to death. Most severe skin reactions and
rashes happen in the first 6
weeks of treatme

Summary of Product characteristics

VIRAMUNE- NEVIRAPINE TABLET, EXTENDED RELEASE
BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
VIRAMUNE XR SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR VIRAMUNE XR.
VIRAMUNE XR® (NEVIRAPINE) EXTENDED-RELEASE TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 1996
WARNING: LIFE-THREATENING (INCLUDING FATAL) HEPATOTOXICITY AND SKIN
REACTIONS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
FATAL AND NON-FATAL HEPATOTOXICITY HAVE BEEN REPORTED IN PATIENTS
TAKING VIRAMUNE
XR. DISCONTINUE IMMEDIATELY IF CLINICAL HEPATITIS OR TRANSAMINASE
ELEVATIONS
COMBINED WITH RASH OR OTHER SYSTEMIC SYMPTOMS OCCUR. DO NOT RESTART
VIRAMUNE XR
AFTER RECOVERY. (5.1)
FATAL AND NON-FATAL SKIN REACTIONS, INCLUDING STEVENS-JOHNSON
SYNDROME, TOXIC
EPIDERMAL NECROLYSIS, AND HYPERSENSITIVITY REACTIONS, HAVE BEEN
REPORTED.
DISCONTINUE IMMEDIATELY IF SEVERE SKIN REACTIONS, HYPERSENSITIVITY
REACTIONS, OR ANY
RASH WITH SYSTEMIC SYMPTOMS OCCUR. CHECK TRANSAMINASE LEVELS
IMMEDIATELY FOR ALL
PATIENTS WHO DEVELOP A RASH IN THE FIRST 18 WEEKS OF TREATMENT. DO NOT
RESTART
VIRAMUNE XR AFTER RECOVERY. (5.2)
MONITORING DURING THE FIRST 18 WEEKS OF THERAPY IS ESSENTIAL. EXTRA
VIGILANCE IS
WARRANTED DURING THE FIRST 6 WEEKS OF THERAPY, WHICH IS THE PERIOD OF
GREATEST RISK
OF THESE EVENTS. (5.1, 5.2)
INDICATIONS AND USAGE
VIRAMUNE XR is an NNRTI indicated in combination with other
antiretroviral agents for the treatment of
human immunodeficiency virus (HIV-1) infection in adults and pediatric
patients 6 years of age or older
with a BSA of 1.17 m or greater. (1)
Limitations of Use:
Based on serious and life-threatening hepatotoxicity observed in
controlled and uncontrolled trials,
VIRAMUNE XR is not recommended to be initiated, unless the benefit
outweighs the risk, in:
adult females with CD4 cell counts greater than 250 cells/mm
adult males with CD4 cell counts greater than 400 cells/mm (1, 5.1)
DOSAGE AND ADMINISTRATION
The 1