TRIUMEQ- abacavir sulfate, dolutegravir sodium, lamivudine tablet, film coated

Land: USA

Språk: engelska

Källa: NLM (National Library of Medicine)

Aktiva substanser:

ABACAVIR SULFATE (UNII: J220T4J9Q2) (ABACAVIR - UNII:WR2TIP26VS), DOLUTEGRAVIR SODIUM (UNII: 1Q1V9V5WYQ) (DOLUTEGRAVIR - UNII:DKO1W9H7M1), LAMIVUDINE (UNII: 2T8Q726O95) (LAMIVUDINE - UNII:2T8Q726O95)

Tillgänglig från:

A-S Medication Solutions

INN (International namn):

ABACAVIR SULFATE

Sammansättning:

ABACAVIR 600 mg

Administreringssätt:

ORAL

Receptbelagda typ:

PRESCRIPTION DRUG

Terapeutiska indikationer:

TRIUMEQ is indicated for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults and in pediatric patients weighing at least 40 kg. Limitations of Use: TRIUMEQ is contraindicated in patients:   Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in individuals exposed to TRIUMEQ during pregnancy. Healthcare providers are encouraged to register patients by calling the Antiretroviral Pregnancy Registry (APR) at 1‑800‑258‑4263. Risk Summary Preliminary data from an observational study has identified a possible increased risk of neural tube defects when dolutegravir, a component of TRIUMEQ, is administered at the time of conception compared with non-dolutegravir-containing antiretroviral regimens. As defects related to closure of the neural tube occur from conception through the first 6 weeks of gestation, embryos exposed to dolutegravir from the time of conception through the first 6 weeks of gestation are at potential risk. In addition, 2

Produktsammanfattning:

Product: 50090-1606 NDC: 50090-1606-0 30 TABLET, FILM COATED in a BOTTLE

Bemyndigande status:

New Drug Application

Bipacksedel

A-S Medication Solutions
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MEDICATION GUIDE
TRIUMEQ (TRI-u-meck)
(abacavir, dolutegravir, and lamivudine tablets)
What is the most important information I should know about TRIUMEQ?
TRIUMEQ can cause serious side effects, including:
•
Serious allergic reactions (hypersensitivity reaction) that can cause
death have happened with
TRIUMEQ and other abacavir-containing products. Your risk of this
allergic reaction to abacavir 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 TRIUMEQ, call your
healthcare provider right away to find out if you should stop taking
TRIUMEQ.
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 TRIUMEQ because of an allergic reaction, never take
TRIUMEQ (abacavir, dolutegravir and
lamivudine) or any other medicine that contains abacavir or
dolutegravir (EPZICOM, TIVICAY,
TRIZIVIR, or ZIAGEN) again.
•
If you have an allergic reaction, dispose of any unused TRIUMEQ. Ask
your pharmacist how to
properly dispose of medicines.
•
If you take TRIUMEQ 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 TRIUMEQ for any other reason, even for a few days, and you
are not allergic to
TRIUMEQ, talk with your healthcare provider before taking it again.
Taking TRIUMEQ 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 TRIUMEQ again,
start taking it wh

Produktens egenskaper

TRIUMEQ- ABACAVIR SULFATE, DOLUTEGRAVIR SODIUM, LAMIVUDINE TABLET,
FILM COATED
A-S MEDICATION SOLUTIONS
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
TRIUMEQ SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR TRIUMEQ.
TRIUMEQ (ABACAVIR, DOLUTEGRAVIR, AND LAMIVUDINE TABLETS), FOR ORAL USE
INITIAL U.S. APPROVAL: 2014
WARNING: HYPERSENSITIVITY REACTIONS, AND EXACERBATIONS OF HEPATITIS B
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
HYPERSENSITIVITY REACTIONS
•
•
•
•
•
•
EXACERBATIONS OF HEPATITIS B
•
RECENT MAJOR CHANGES
Boxed Warning
05/2018
Indications and Usage (1)
11/2017
Dosage and Administration, Pregnancy Testing before Initiation of
TRIUMEQ (2.2)
09/2018
Dosage and Administration, Recommended Dosage (2.3)
11/2017
Warnings and Precautions, Hepatotoxicity (5.4)
11/2017
Warnings and Precautions, Lactic Acidosis and Severe Hepatomegaly with
Steatosis (5.5)
05/2018
Warnings and Precautions, Embryo-Fetal Toxicity (5.6)
09/2018
Warnings and Precautions, Risk of Adverse Reactions or Loss of
Virologic Response Due to Drug
Interactions (5.7)
11/2017
Warnings and Precautions, Related Products that are Not Recommended
(previous 5.8)
Removed - 11/2017
Warnings and Precautions, Fat Redistribution (previous 5.9)
Removed 05/2018
Warnings and Precautions, Myocardial Infarction (5.10)
05/2018
INDICATIONS AND USAGE
TRIUMEQ, a combination of dolutegravir (integrase strand transfer
inhibitor [INSTI]), abacavir, and lamivudine (both
nucleoside analogue reverse transcriptase inhibitors) is indicated for
the treatment of HIV-1 infection in adults and in
pediatric patients weighing at least 40 kg. (1)
Limitations of Use:
•
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)