EPZICOM- abacavir sulfate 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:

ViiV Healthcare Company

INN (International Name):

ABACAVIR SULFATE

Composition:

ABACAVIR 600 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

EPZICOM, in combination with other antiretroviral agents, is indicated for the treatment of human immunodeficiency virus type 1 (HIV‑1) infection. EPZICOM is contraindicated in patients: Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to EPZICOM 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 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 weeks’ gestation. The rate of miscarri

Product summary:

EPZICOM is available as tablets. Each tablet contains 600 mg of abacavir as abacavir sulfate and 300 mg of lamivudine. The tablets are orange, film-coated, modified capsule-shaped, and debossed with GS FC2 on one side with no markings on the reverse side. They are packaged as follows: Bottles of 30 tablets (NDC 49702-206-13). 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
EPZICOM (ep' zih com)
(abacavir and lamivudine tablets)
What is the most important information I should know about EPZICOM?
EPZICOM can cause serious side effects, including:
•
Serious allergic reactions (hypersensitivity reaction) that can cause
death have happened with
EPZICOM 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 EPZICOM, call your
healthcare provider right away to find out if you should stop taking
EPZICOM.
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 EPZICOM because of an allergic reaction, never take
EPZICOM (abacavir and
lamivudine) or any other abacavir-containing medicine (TRIUMEQ,
TRIZIVIR, or ZIAGEN)
again.
o
If you have an allergic reaction, dispose of any unused EPZICOM. Ask
your pharmacist how
to properly dispose of medicines.
o
If you take EPZICOM 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 EPZICOM for any other reason, even for a few days, and you
are not allergic to
EPZICOM, talk with your healthcare provider before taking it again.
Taking EPZICOM
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 EPZICOM again,
start taking it when you are
around medical help or people who can call a healthcare provider

Summary of Product characteristics

EPZICOM- ABACAVIR SULFATE AND LAMIVUDINE TABLET, FILM COATED
VIIV HEALTHCARE COMPANY
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
EPZICOM SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR EPZICOM.
EPZICOM (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
•
•
•
•
•
•
EXACERBATIONS OF HEPATITIS B
•
INDICATIONS AND USAGE
EPZICOM, a combination of abacavir and lamivudine, both nucleoside
analogue HIV-1 reverse
transcriptase inhibitors, is indicated in combination with other
antiretroviral agents for the treatment of
HIV-1 infection. (1)
DOSAGE AND ADMINISTRATION
•
•
•
•
DOSAGE FORMS AND STRENGTHS
Tablets: 600 mg of abacavir and 300 mg of lamivudine. (3)
CONTRAINDICATIONS
•
•
•
WARNINGS AND PRECAUTIONS
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)
EPZICOM IS CONTRAINDICATED IN PATIENTS WITH A PRIOR HYPERSENSITIVITY
REACTION TO
ABACAVIR AND IN HLA-B*5701-POSITIVE PATIENTS. (4)
DISCONTINUE EPZICOM AS SOON AS A HYPERSENSITIVITY REACTION IS
SUSPECTED.
REGARDLESS OF HLA-B*5701 STATUS, PERMANENTLY DISCONTINUE EPZICOM IF
HYPERSENSITIVITY CANNOT BE RULED OUT, EVEN WHEN OTHER DIAGNOSES ARE
POSSIBLE.
(5.1)
FOLLOWING A HYPERSENSITIVITY REACTION TO EPZICOM, NEVER RESTART
EPZICOM OR ANY
OTHER ABACAVIR-CONTAINING PRODUCT. (5.1)
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 EPZICOM. MONITOR
HEPATIC
FUNCTION CLOSELY IN THESE PAT