NEVIRAPINE tablet, extended release

Maa: Yhdysvallat

Kieli: englanti

Lähde: NLM (National Library of Medicine)

Aktiivinen ainesosa:

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

Saatavilla:

Aurobindo Pharma Limited

Antoreitti:

ORAL

Prescription tyyppi:

PRESCRIPTION DRUG

Käyttöaiheet:

Nevirapine extended-release tablets are 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: Based on serious and life-threatening hepatotoxicity observed in controlled and uncontrolled trials, nevirapine extended-release tablets are not recommended to be initiated, unless the benefit outweighs the risk, in: - 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)] . Nevirapine extended-release tablets are 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-exp

Tuoteyhteenveto:

Nevirapine Extended-Release Tablets USP 400 mg are light yellow to yellow, oval, biconvex tablets debossed with “L” on one side and “55” on the other side.         Bottles of 30                           NDC 65862-933-30         Bottles of 90                           NDC 65862-933-90         Bottles of 500                         NDC 65862-933-05         Bottles of 1,000                      NDC 65862-933-99 Storage Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Store in a safe place out of the reach of children.

Valtuutuksen tilan:

Abbreviated New Drug Application

Pakkausseloste

Aurobindo Pharma Limited
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MEDICATION GUIDE
Nevirapine Extended-Release Tablets USP
(ne vir' a peen)
What is the most important information I should know about nevirapine
extended-release tablets?
Nevirapine extended-release tablets 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.
Nevirapine extended-release tablets can cause serious side effects,
including:
•
Severe liver problems. Some people taking nevirapine extended-release
tablets 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 nevirapine
extended-release tablets than men.
•
People who have abnormal liver test results before starting nevirapine
extended-release tablets
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 nevirapine
extended-release tablets 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 nevirapine extended-release tablets 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
treatment with nevirapi

Valmisteyhteenveto

NEVIRAPINE - NEVIRAPINE TABLET, EXTENDED RELEASE
AUROBINDO PHARMA LIMITED
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
NEVIRAPINE EXTENDED-
RELEASE TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR NEVIRAPINE
EXTENDED-RELEASE TABLETS.
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 NEVIRAPINE
EXTENDED-RELEASE TABLETS. DISCONTINUE IMMEDIATELY IF CLINICAL
HEPATITIS OR
TRANSAMINASE ELEVATIONS COMBINED WITH RASH OR OTHER SYSTEMIC SYMPTOMS
OCCUR. DO
NOT RESTART NEVIRAPINE EXTENDED-RELEASE TABLETS 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
NEVIRAPINE EXTENDED-RELEASE TABLETS 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
Nevirapine extended-release tablets are 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,
nevirapine extended-release tablets are not recommended to be
initiated, unless the benefit outweighs
the risk, in:
adult females with C