ABACAVIR AND LAMIVUDINE tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Teva Pharmaceuticals USA, Inc.

INN (International Name):

ABACAVIR SULFATE

Composition:

ABACAVIR 600 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 tablets 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 Atlanta Congenital De

Product summary:

Abacavir and Lamivudine Tablets USP, 600 mg/300 mg are available as follows: Each tablet contains 600 mg of abacavir as abacavir sulfate, USP and 300 mg of lamivudine, USP and is a yellow, film-coated, convex, capsule-shaped tablet debossed “5382” on one side of the tablet and "TV" on the other side, in bottles of 30 (NDC 0093-5382-56). Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

Teva Pharmaceuticals USA, Inc.
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MEDICATION GUIDE
MEDICATION GUIDE
Abacavir (a bak' a vir) and Lamivudine (la miv' ue deen) Tablets
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 provider before taking them again. Taking
abacavir and lam

Summary of Product characteristics

ABACAVIR AND LAMIVUDINE- ABACAVIR AND LAMIVUDINE TABLET, FILM COATED
TEVA PHARMACEUTICALS USA, INC.
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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 TABLETS ARE CONTRAINDICATED IN PATIENTS WITH A
PRIOR
HYPERSENSITIVITY REACTION TO ABACAVIR AND IN HLA-B*5701-POSITIVE
PATIENTS. (4)
DISCONTINUE ABACAVIR AND LAMIVUDINE TABLETS AS SOON AS A
HYPERSENSITIVITY REACTION IS
SUSPECTED. REGARDLESS OF HLA-B*5701 STATUS, PERMANENTLY DISCONTINUE
ABACAVIR AND
LAMIVUDINE TABLETS IF HYPERSENSITIVITY CANNOT BE RULED OUT, EVEN WHEN
OTHER
DIAGNOSES ARE POSSIBLE. (5.1)
FOLLOWING A HYPERSENSITIVITY REACTION TO ABACAVIR AND LAMIVUDINE
TABLETS, NEVER
RESTART ABACAVIR AND LAMIVUDINE TABLETS 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
TABLETS.
MONITOR HEPATIC FUNCTION CLOSELY IN THESE PATIENTS AND, IF
APPROPRIATE, INITIATE ANTI-
HEPATITIS B TREATMENT. (5.2)
INDICATIONS AND USAGE
Abacavir and lamivudine tablets, a combination of abacavir and
lamivudine, both nucleoside analogue HIV-
1 reverse transcriptase inhibitors, are indicated in