ABACAVIR solution

Nazione: Stati Uniti

Lingua: inglese

Fonte: NLM (National Library of Medicine)

Principio attivo:

ABACAVIR SULFATE (UNII: J220T4J9Q2) (ABACAVIR - UNII:WR2TIP26VS)

Commercializzato da:

Camber Pharmaceuticals, Inc.

INN (Nome Internazionale):

ABACAVIR SULFATE

Composizione:

ABACAVIR 20 mg in 1 mL

Via di somministrazione:

ORAL

Tipo di ricetta:

PRESCRIPTION DRUG

Indicazioni terapeutiche:

Abacavir oral solution in combination with other antiretroviral agents, is indicated for the treatment of human immunodeficiency virus (HIV-1) infection. Abacavir oral solution is 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)]. • with moderate or severe hepatic impairment [see Use in Specific Populations (8.6)]. Teratogenic effects: Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to abacavir 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 compared with the background rate for birth defects of 2.7% in the Metropolitan Atlanta Congenital Defects Program (MACDP) reference pop

Dettagli prodotto:

Abacavir oral solution USP is a clear yellowish, strawberry-banana flavored liquid filled in 250 cc HDPE opaque bottles. Each mL of the solution contains abacavir sulfate USP equivalent to 20 mg of abacavir. They are supplied in: Bottles of 240 mL with Induction Sealing FSE Wad (NDC 31722-562-24). This product does not require reconstitution. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. DO NOT FREEZE. May be refrigerated.

Stato dell'autorizzazione:

Abbreviated New Drug Application

Foglio illustrativo

Camber Pharmaceuticals, Inc.
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MEDICATION GUIDE
Abacavir oral solution
(ah-BAH-kah-veer)
What is the most important information I should know about abacavir
oral solution?
Abacavir can cause serious side effects, including:
• Serious allergic reaction (hypersensitivity reaction) that can
cause death have happened with abacavir
oral solution 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 oral solution, call
your healthcare provider right away to find out if you should stop
taking abacavir oral solution.
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 oral solution because of an allergic reaction,
never take abacavir oral solution or any
other abacavir-containing medicine (EPZICOM®, TRIUMEQ®, and
TRIZIVIR®) again.
• If you have an allergic reaction, dispose of any unused abacavir
oral solution. Ask your pharmacist how
to properly dispose of medicines.
• If you take abacavir oral solution 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 oral solution for any other reason, even for
a few days, and you are not allergic to
abacavir, talk with your healthcare provider before taking it again.
Taking abacavir oral solution 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 yo

Scheda tecnica

ABACAVIR - ABACAVIR SOLUTION
CAMBER PHARMACEUTICALS, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ABACAVIR ORAL SOLUTION SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR ABACAVIR ORAL
SOLUTION.
ABACAVIR ORAL SOLUTION
INITIAL U.S. APPROVAL: 1998
WARNING: HYPERSENSITIVITY REACTIONS, AND LACTIC ACIDOSIS AND SEVERE
HEPATOMEGALY WITH STEATOSIS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED
WARNING._HYPERSENSITIVITY REACTIONS
• SERIOUS AND SOMETIMES FATAL HYPERSENSITIVITY REACTIONS HAVE
OCCURRED WITH ABACAVIR. (5.1)
• HYPERSENSITIVITY TO ABACAVIR IS A MULTI-ORGAN CLINICAL SYNDROME.
(5.1)
• PATIENTS WHO CARRY THE HLA-B*5701 ALLELE ARE AT HIGHER RISK OF
EXPERIENCING A HYPERSENSITIVITY REACTION
TO ABACAVIR. (5.1)
• ABACAVIR IS CONTRAINDICATED IN PATIENTS WITH A PRIOR
HYPERSENSITIVITY REACTION TO ABACAVIR AND IN HLA-
B*5701-POSITIVE PATIENTS.(4)
• DISCONTINUE ABACAVIR AS SOON AS A HYPERSENSITIVITY REACTION IS
SUSPECTED. REGARDLESS OF HLA-B*5701
STATUS, PERMANENTLY DISCONTINUE ABACAVIR IF HYPERSENSITIVITY CANNOT BE
RULED OUT, EVEN WHEN OTHER
DIAGNOSES ARE POSSIBLE. (5.1)
• FOLLOWING A HYPERSENSITIVITY REACTION TO ABACAVIR, NEVER RESTART
ABACAVIR ORAL SOLUTION OR ANY OTHER
ABACAVIR-CONTAINING PRODUCT. (5.1)
LACTIC ACIDOSIS AND SEVERE HEPATOMEGALY WITH STEATOSIS
• LACTIC ACIDOSIS AND SEVERE HEPATOMEGALY WITH STEATOSIS, INCLUDING
FATAL CASES, HAVE BEEN REPORTED WITH
THE USE OF NUCLEOSIDE ANALOGUES. (5.2)
RECENT MAJOR CHANGES
Warnings and Precautions, Related Products that are Removed
Not Recommended (5.6) 03/2017
INDICATIONS AND USAGE
Abacavir oral solution, a nucleoside analogue human immunodeficiency
virus (HIV-1) reverse transcriptase inhibitor, is
indicated in combination with other antiretroviral agents for the
treatment of HIV-1 infection. (1)
DOSAGE AND ADMINISTRATION
• Before initiating abacavir, screen for the HLA-B*5701 allele.
(2.1)
• Adults: 600 mg daily, administered