TRIZIVIR- abacavir sulfate, lamivudine, and zidovudine 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), ZIDOVUDINE (UNII: 4B9XT59T7S) (ZIDOVUDINE - UNII:4B9XT59T7S)

Available from:

ViiV Healthcare Company

INN (International Name):

ABACAVIR SULFATE

Composition:

ABACAVIR 300 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

TRIZIVIR is indicated in combination with other antiretrovirals or alone for the treatment of human immunodeficiency virus type 1 (HIV‑1) infection. Limitations of Use: TRIZIVIR is contraindicated in patients: Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to TRIZIVIR 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, lamivudine, or zidovudine compared with the background rate for birth defects of 2.7% in the Metropolitan Atlanta Congenital Defects Program (MACDP) reference population (see Data) . The APR uses the MACDP as the U.S. reference population for birth defects in the general population. The MACDP evaluates women and infants from a limited geographic area and does not include outcomes for births that occurred at less than 20 w

Product summary:

TRIZIVIR is available as tablets. Each tablet contains 300 mg of abacavir as abacavir sulfate, 150 mg of lamivudine, and 300 mg of zidovudine. The tablets are blue‑green capsule-shaped, film‑coated, and imprinted with GX LL1 on one side with no markings on the reverse side. They are packaged as follows: Bottles of 60 tablets (NDC 49702-217-18). Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) (see USP Controlled Room Temperature).

Authorization status:

New Drug Application

Patient Information leaflet

ViiV Healthcare Company
----------
MEDICATION GUIDE
TRIZIVIR (TRY-zih-veer)
(abacavir, lamivudine, and zidovudine tablets)
What is the most important information I should know about TRIZIVIR?
TRIZIVIR can cause serious side effects, including:
•
Serious allergic reactions (hypersensitivity reaction) that can cause
death have happened with
TRIZIVIR 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 TRIZIVIR, call your
healthcare provider right away to find out if you should stop taking
TRIZIVIR.
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 TRIZIVIR because of an allergic reaction, never take
TRIZIVIR (abacavir, lamivudine and
zidovudine) or any other abacavir-containing medicine (EPZICOM,
TRIUMEQ, or ZIAGEN) again.
o
If you have an allergic reaction, dispose of any unused TRIZIVIR. Ask
your pharmacist how to
properly dispose of medicines.
o
If you take TRIZIVIR 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.
o
If you stop TRIZIVIR for any other reason, even for a few days, and
you are not allergic to
TRIZIVIR, talk with your healthcare provider before taking it again.
Taking TRIZIVIR again can
cause a serious allergic or life-threatening reaction, even if you
never had an allergic reaction to it
before.
If your healthcare provider tells you that you can take TRIZIVIR
again, start taking it when you are
around medical help or peo

Summary of Product characteristics

TRIZIVIR- ABACAVIR SULFATE, LAMIVUDINE, AND ZIDOVUDINE TABLET, FILM
COATED
VIIV HEALTHCARE COMPANY
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
TRIZIVIR SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR TRIZIVIR.
TRIZIVIR (ABACAVIR, LAMIVUDINE, AND ZIDOVUDINE TABLETS), FOR ORAL USE
INITIAL U.S. APPROVAL: 2000
WARNING: HYPERSENSITIVITY REACTIONS, HEMATOLOGIC TOXICITY, MYOPATHY,
LACTIC ACIDOSIS AND SEVERE HEPATOMEGALY WITH STEATOSIS, AND
EXACERBATIONS
OF HEPATITIS B
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
HYPERSENSITIVITY REACTIONS
•
•
•
•
•
•
HEMATOLOGIC TOXICITY
•
MYOPATHY
•
LACTIC ACIDOSIS AND SEVERE HEPATOMEGALY WITH STEATOSIS
•
EXACERBATIONS OF HEPATITIS B
•
INDICATIONS AND USAGE
TRIZIVIR, a combination of abacavir, lamivudine, and zidovudine, each
nucleoside analogue HIV-1 reverse
transcriptase inhibitors, is indicated in combination with other
antiretroviral agents for the treatment of
HIV‑1 infection. (1)
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)
TRIZIVIR IS CONTRAINDICATED IN PATIENTS WITH A PRIOR HYPERSENSITIVITY
REACTION TO
ABACAVIR AND IN HLA-B*5701-POSITIVE PATIENTS. (4)
DISCONTINUE TRIZIVIR AS SOON AS A HYPERSENSITIVITY REACTION IS
SUSPECTED.
REGARDLESS OF HLA-B*5701 STATUS, PERMANENTLY DISCONTINUE TRIZIVIR IF
HYPERSENSITIVITY CANNOT BE RULED OUT, EVEN WHEN OTHER DIAGNOSES ARE
POSSIBLE.
(5.1)
FOLLOWING A HYPERSENSITIVITY REACTION TO TRIZIVIR, NEVER RESTART
TRIZIVIR OR ANY
OTHER ABACAVIR-CONTAINING PRODUCT. (5.1)
HEMATOLOGIC TOXICITY, INCLUDING NEUTROPENIA AND ANEMIA, HAS BEEN
ASSOCIATED WITH
THE USE OF ZIDOVUDINE, A COMPONENT OF TRIZIVIR. (5.2)
SYMPTOMATIC MYOPATHY ASSOCIATED WITH PROLONGED USE OF ZIDOVUDINE.
(5.3)
LAC