ABACAVIR AND LAMIVUDINE tablet, film coated

Land: USA

Sprog: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv bestanddel:

ABACAVIR SULFATE (UNII: J220T4J9Q2) (ABACAVIR - UNII:WR2TIP26VS), LAMIVUDINE (UNII: 2T8Q726O95) (LAMIVUDINE - UNII:2T8Q726O95)

Tilgængelig fra:

Burel Pharmaceuticals, LLC

Indgivelsesvej:

ORAL

Recept type:

PRESCRIPTION DRUG

Terapeutiske indikationer:

Abacavir and lamivudine tablets, in combination with other antiretroviral agents, are indicated for the treatment of human immunodeficiency virus type 1 (HIV-1) infection. Abacavir and lamivudine tablets are contraindicated in patients: • who have the HLA-B*5701 allele [see Warnings and Precautions (5.1)]. • with prior hypersensitivity reaction to abacavir [see Warnings and Precautions (5.1)] or lamivudine. • with moderate or severe hepatic impairment [see Use in Specific Populations (8.7)]. Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to abacavir and lamivudine during pregnancy. Healthcare providers are encouraged to register patients by calling the Antiretroviral Pregnancy Registry (APR) at 1-800-258-4263. Risk Summary Available data from the APR show no difference in the overall risk of birth defects for abacavir or lamivudine compared with the background rate for birth defects of 2.7% in the Metropolitan Atl

Produkt oversigt:

Abacavir and Lamivudine Tablets USP  contain 600 mg of abacavir as abacavir sulfate and 300 mg of lamivudine. The tablets are white to off-white, modified oval shaped, film-coated tablet debossed with "Y" on one side and "98" on other side.         Bottles of 30                                       NDC 35573-402-30 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

Autorisation status:

Abbreviated New Drug Application

Indlægsseddel

ABACAVIR AND LAMIVUDINE - abacavir and lamivudine tablet, film coated
Burel Pharmaceuticals, LLC
----------
MEDICATION GUIDE
Abacavir and Lamivudine Tablets USP
(a bak' a vir and la miv' ue deen)
What is the most important information I should know about abacavir
and lamivudine tablets?
Abacavir and lamivudine tablets can cause serious side effects,
including:
•
Serious allergic reactions (hypersensitivity reaction) that can cause
death have happened with
abacavir and lamivudine tablets and other abacavir-containing
products. Your risk of this allergic
reaction is much higher if you have a gene variation called
HLA-B*5701. Your healthcare provider
can determine with a blood test if you have this gene variation.
If you get a symptom from 2 or more of the following groups while
taking abacavir and lamivudine tablets,
call your healthcare provider right away to find out if you should
stop taking abacavir and lamivudine tablets.
Symptom(s)
Group 1
Fever
Group 2
Rash
Group 3
Nausea, vomiting, diarrhea, abdominal (stomach area) pain
Group 4
Generally ill feeling, extreme tiredness, or achiness
Group 5
Shortness of breath, cough, sore throat
A list of these symptoms is on the Warning Card your pharmacist gives
you. Carry this Warning Card with
you at all times.
If you stop abacavir and lamivudine tablets because of an allergic
reaction, never take abacavir and
lamivudine tablets or any other abacavir-containing medicine (TRIUMEQ,
TRIZIVIR, or ZIAGEN) again.
•
If you have an allergic reaction, dispose of any unused abacavir and
lamivudine tablets. Ask your
pharmacist how to properly dispose of medicines.
•
If you take abacavir and lamivudine tablets or any other
abacavir-containing medicine again after you
have had an allergic reaction, within hours you may get
life-threatening symptoms that may include
very low blood pressure or death.
•
If you stop abacavir and lamivudine tablets for any other reason, even
for a few days, and you are not
allergic to abacavir and lamivudine tablets, talk with your healthcare
pro

Produktets egenskaber

ABACAVIR AND LAMIVUDINE - ABACAVIR AND LAMIVUDINE TABLET, FILM COATED
BUREL PHARMACEUTICALS, LLC
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ABACAVIR AND
LAMIVUDINE TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR ABACAVIR
AND LAMIVUDINE TABLETS.
ABACAVIR AND LAMIVUDINE TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 2004
WARNING: HYPERSENSITIVITY REACTIONS AND EXACERBATIONS OF HEPATITIS B
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
HYPERSENSITIVITY REACTIONS
SERIOUS AND SOMETIMES FATAL HYPERSENSITIVITY REACTIONS HAVE OCCURRED
WITH ABACAVIR-
CONTAINING PRODUCTS. (5.1)
HYPERSENSITIVITY TO ABACAVIR IS A MULTI-ORGAN CLINICAL SYNDROME. (5.1)
PATIENTS WHO CARRY THE HLA-B*5701 ALLELE ARE AT A HIGHER RISK OF
EXPERIENCING A
HYPERSENSITIVITY REACTION TO ABACAVIR. (5.1)
ABACAVIR AND LAMIVUDINE IS CONTRAINDICATED IN PATIENTS WITH A PRIOR
HYPERSENSITIVITY
REACTION TO ABACAVIR AND IN HLA-B*5701-POSITIVE PATIENTS. (4)
DISCONTINUE ABACAVIR AND LAMIVUDINE AS SOON AS A HYPERSENSITIVITY
REACTION IS
SUSPECTED. REGARDLESS OF HLA-B*5701 STATUS, PERMANENTLY DISCONTINUE
ABACAVIR AND
LAMIVUDINE IF HYPERSENSITIVITY CANNOT BE RULED OUT, EVEN WHEN OTHER
DIAGNOSES ARE
POSSIBLE. (5.1)
FOLLOWING A HYPERSENSITIVITY REACTION TO ABACAVIR AND LAMIVUDINE,
NEVER RESTART
ABACAVIR AND LAMIVUDINE OR ANY OTHER ABACAVIR-CONTAINING PRODUCT.
(5.1)
EXACERBATIONS OF HEPATITIS B
SEVERE ACUTE EXACERBATIONS OF HEPATITIS B HAVE BEEN REPORTED IN
PATIENTS WHO ARE
CO-INFECTED WITH HEPATITIS B VIRUS (HBV) AND HUMAN IMMUNODEFICIENCY
VIRUS (HIV-1)
AND HAVE DISCONTINUED LAMIVUDINE, A COMPONENT OF ABACAVIR AND
LAMIVUDINE.
MONITOR HEPATIC FUNCTION CLOSELY IN THESE PATIENTS AND, IF
APPROPRIATE, INITIATE ANTI-
HEPATITIS B TREATMENT. (5.2)
RECENT MAJOR CHANGES
Warnings and Precautions, Use with Interferon- and Removed
Ribavirin-Based Regimens (previous 5.4) 05/2019
INDICATIONS AND USAGE
Abacavir and lamivudine tablets, a combination of abacavir and
lamivudine, both nu