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:

Physicians Total Care, Inc.

INN (International Name):

ABACAVIR SULFATE

Composition:

ABACAVIR SULFATE 600 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

EPZICOM Tablets, in combination with other antiretroviral agents, are indicated for the treatment of HIV-1 infection. Additional important information on the use of EPZICOM for treatment of HIV-1 infection: - EPZICOM is one of multiple products containing abacavir. Before starting EPZICOM, review medical history for prior exposure to any abacavir-containing product in order to avoid reintroduction in a patient with a history of hypersensitivity to abacavir. - In one controlled study (CNA30021), more patients taking ZIAGEN 600 mg once daily had severe hypersensitivity reactions compared with patients taking ZIAGEN 300 mg twice daily. - As part of a triple-drug regimen, EPZICOM Tablets are recommended for use with antiretroviral agents from different pharmacological classes and not with other nucleoside/nucleotide reverse transcriptase inhibitors. See WARNINGS, ADVERSE REACTIONS, and Description of Clinical Studies. There have been no clinical trials conducted with EPZICOM (see CLINICAL PHARMACOLOGY for informa

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: 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

Physicians Total Care, Inc.
----------
MEDICATION GUIDE
EPZICOM® (ep' zih com) Tablets
Generic name: abacavir (uH-BACK-ah-veer) sulfate and lamivudine
(la-MIV-yoo-deen)
Read the Medication Guide that comes with EPZICOM before you start
taking it and each time you get a
refill because there may be new information. This information does not
take the place of talking to your
doctor about your medical condition or your treatment. Be sure to
carry your EPZICOM Warning Card
with you at all times.
What is the most important information I should know about EPZICOM?
•
Serious Allergic Reaction to Abacavir. EPZICOM contains abacavir (also
contained in ZIAGEN®
and TRIZIVIR®). Patients taking EPZICOM may have a serious allergic
reaction
(hypersensitivity reaction) that can cause death. Your risk of this
allergic reaction is much higher
if you have a gene variation called HLA-B*5701 than if you do not.
Your doctor 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 doctor right away to
determine if you should
stop taking this medicine.
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.
If you stop EPZICOM because of an allergic reaction, NEVER take
EPZICOM (abacavir sulfate and
lamivudine) or any other abacavir-containing medicine (ZIAGEN and
TRIZIVIR) again. 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.
If you stop EPZICOM for any other reason, even for a few days, and you
are not allergic to EPZICOM,
talk with your doctor before taking it again. Taking EPZICOM again can
cause a serious a

Summary of Product characteristics

EPZICOM - ABACAVIR SULFATE AND LAMIVUDINE TABLET, FILM COATED
PHYSICIANS TOTAL CARE, INC.
----------
EPZICOM
(ABACAVIR SULFATE AND LAMIVUDINE)
TABLETS
WARNINGS
EPZICOM CONTAINS 2 NUCLEOSIDE ANALOGUES (ABACAVIR SULFATE AND
LAMIVUDINE) AND IS
INTENDED ONLY FOR PATIENTS WHOSE REGIMEN WOULD OTHERWISE INCLUDE THESE
2 COMPONENTS.
HYPERSENSITIVITY REACTIONS: SERIOUS AND SOMETIMES FATAL
HYPERSENSITIVITY REACTIONS HAVE
BEEN ASSOCIATED WITH ABACAVIR SULFATE, A COMPONENT OF EPZICOM.
HYPERSENSITIVITY TO
ABACAVIR IS A MULTI-ORGAN CLINICAL SYNDROME USUALLY CHARACTERIZED BY A
SIGN OR SYMPTOM IN 2
OR MORE OF THE FOLLOWING GROUPS: (1) FEVER, (2) RASH, (3)
GASTROINTESTINAL (INCLUDING NAUSEA,
VOMITING, DIARRHEA, OR ABDOMINAL PAIN), (4) CONSTITUTIONAL (INCLUDING
GENERALIZED MALAISE,
FATIGUE, OR ACHINESS), AND (5) RESPIRATORY (INCLUDING DYSPNEA, COUGH,
OR PHARYNGITIS).
DISCONTINUE EPZICOM AS SOON AS A HYPERSENSITIVITY REACTION IS
SUSPECTED.
PATIENTS WHO CARRY THE HLA-B*5701 ALLELE ARE AT HIGH RISK FOR
EXPERIENCING A
HYPERSENSITIVITY REACTION TO ABACAVIR. PRIOR TO INITIATING THERAPY
WITH ABACAVIR, SCREENING FOR
THE HLA-B*5701 ALLELE IS RECOMMENDED; THIS APPROACH HAS BEEN FOUND TO
DECREASE THE RISK
OF HYPERSENSITIVITY REACTION. SCREENING IS ALSO RECOMMENDED PRIOR TO
REINITIATION OF ABACAVIR
IN PATIENTS OF UNKNOWN HLA-B*5701 STATUS WHO HAVE PREVIOUSLY TOLERATED
ABACAVIR. HLA-
B*5701-NEGATIVE PATIENTS MAY DEVELOP A SUSPECTED HYPERSENSITIVITY
REACTION TO ABACAVIR;
HOWEVER, THIS OCCURS SIGNIFICANTLY LESS FREQUENTLY THAN IN
HLA-B*5701-POSITIVE PATIENTS.
REGARDLESS OF HLA-B*5701 STATUS, PERMANENTLY DISCONTINUE EPZICOM IF
HYPERSENSITIVITY
CANNOT BE RULED OUT, EVEN WHEN OTHER DIAGNOSES ARE POSSIBLE.
FOLLOWING A HYPERSENSITIVITY REACTION TO ABACAVIR, NEVER RESTART
EPZICOM OR ANY OTHER
ABACAVIR-CONTAINING PRODUCT BECAUSE MORE SEVERE SYMPTOMS CAN OCCUR
WITHIN HOURS AND
MAY INCLUDE LIFE-THREATENING HYPOTENSION AND DEATH.
REINTRODUCTION OF EPZICOM OR ANY OTHER ABACAVIR-CONTAINING PRODUCT,
EVEN IN PATIENTS
WHO HAVE NO IDENTIFIED HISTORY OR UNRECOGNI