MARAVIROC tablet, film coated

देश: संयुक्त राज्य

भाषा: अंग्रेज़ी

स्रोत: NLM (National Library of Medicine)

सक्रिय संघटक:

MARAVIROC (UNII: MD6P741W8A) (MARAVIROC - UNII:MD6P741W8A)

थमां उपलब्ध:

i3 Pharmaceuticals, LLC

प्रशासन का मार्ग:

ORAL

प्रिस्क्रिप्शन प्रकार:

PRESCRIPTION DRUG

चिकित्सीय संकेत:

Maraviroc is indicated in combination with other antiretroviral agents for the treatment of only CCR5‑tropic human immunodeficiency virus type 1 (HIV‑1) infection in adult and pediatric patients 2 years of age and older weighing at least 10 kg. Limitations of Use - Maraviroc is not recommended in patients with dual/mixed- or CXCR4-tropic HIV- 1 [see Microbiology (12.4)] . Maraviroc is contraindicated in patients with severe renal impairment or ESRD (creatinine clearance [CrCl] less than 30 mL per minute) who are concomitantly taking potent CYP3A inhibitors or inducers [see Warnings and Precautions (5.3)]. Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to Maraviroc during pregnancy. Physicians are encouraged to register patients by calling the Antiretroviral Pregnancy Registry (APR) at 1-800-258-4263. Risk Summary Limited data on the use of Maraviroc during pregnancy from the APR and case reports are not sufficient to

उत्पाद समीक्षा:

Maraviroc film-coated tablets are available as follows: 150-mg, and 300-mg tablets are blue, oval, film-coated tablets, debossed “I3” on one side and “24” and “25”, respectively, on the other side. 150-mg tablets: Bottle of 60 tablets (NDC 72319-024-02). 300-mg tablets: Bottle of 60 tablets (NDC 72319-025-02). Maraviroc film‑coated tablets should be stored at 20 o C to 25 o C (68 o F to 77 o F); excursions permitted between 15 o C and 30 o C (59 o F and 86 o F) [see USP Controlled Room Temperature].

प्राधिकरण का दर्जा:

Abbreviated New Drug Application

सूचना पत्रक

i3 Pharmaceuticals, LLC
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MEDICATION GUIDE
MEDICATION GUIDE
Maraviroc (mə-RAV-i-rok) tablets
What is the most important information I should know about Maraviroc?
Maraviroc can cause serious side effects including serious liver
problems (liver toxicity).
Some people who take Maraviroc can develop a severe rash or an
allergic reaction before liver
problems happen and may be life-threatening. Stop taking Maraviroc and
call your healthcare
provider right away if you get any of the following signs or symptoms
of liver problems:
•
an itchy rash on your body
(allergic reaction)
•
your skin or the white part of
your eyes turns yellow (jaundice)
•
dark or “tea-colored” urine
•
vomiting
•
pain, aching, or tenderness on the right side
of your stomach area
Your healthcare provider will do blood tests to check your liver
before you begin treatment
with Maraviroc and as needed during treatment with Maraviroc.
What are Maraviroc tablets?
Maraviroc tablet is a prescription Human Immunodeficiency Virus-1
(HIV-1) medicine given
with other HIV-1 medicines to treat CCR5-tropic HIV-1 infection in
adults and children 2
years of age and older weighing at least 22 lb (10 kg).
HIV-1 is the virus that causes Acquired Immune Deficiency Syndrome
(AIDS).
Use of Maraviroc is not recommended in people with dual/mixed- or
CXCR4-tropic HIV-1.
Maraviroc tablets should not be used in children weighing less than 22
pounds (10 kg).
Do not take Maraviroc if youhave severe kidney problems or are on
hemodialysis and are also
taking certain other medications.
Before you take Maraviroc, tell your healthcare provider about all of
your medical conditions,
including if you:
• have or have had liver problems including hepatitis B or C virus
infection.
• have heart problems.
• have kidney problems.
• have low blood pressure or take medicines to lower blood pressure.
• are pregnant or plan to become pregnant. It is not known if
Maraviroc may harm your unborn
baby.
Pregnancy Registry. There is a pregnancy registry for women wh

उत्पाद विशेषताएं

MARAVIROC- MARAVIROC TABLET, FILM COATED
I3 PHARMACEUTICALS, LLC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
MARAVIROC TABLETS
SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR MARAVIROC
TABLETS.
MARAVIROC TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 2007
WARNING: HEPATOTOXICITY
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
• HEPATOTOXICITY HAS BEEN REPORTED WHICH MAY BE PRECEDED BY SEVERE
RASH OR OTHER
FEATURES OF A SYSTEMIC ALLERGIC REACTION (E.G., FEVER, EOSINOPHILIA,
OR ELEVATED IGE). (
5.1)
• IMMEDIATELY EVALUATE PATIENTS WITH SIGNS OR SYMPTOMS OF HEPATITIS
OR ALLERGIC
REACTION. ( 5.1)
INDICATIONS AND USAGE
Maraviroc is a CCR5 co-receptor antagonist indicated in combination
with other antiretroviral agents for
the treatment of only CCR5-tropic HIV-1 infection in adults and
pediatric patients 2 years of age and older
weighing at least 10 kg. ( 1)
Limitations of Use:
• Not recommended in patients with dual/mixed- or CXCR4-tropic
HIV-1. ( 1)
DOSAGE AND ADMINISTRATION
• Prior to initiation of Maraviroc for treatment of HIV-1 infection,
test all patients for CCR5 tropism using a
highly sensitive tropism assay. ( 2.1)
• Maraviroc tablets are taken twice daily by mouth and may be taken
with or without food. Maraviroc must
be given in combination with other antiretroviral medications. ( 2.2)
Recommended Dosage in Adult Patients: ( 2.3)
Concomitant Medications
Dosage of Maraviroc
When given with potent cytochrome P450 (CYP)3A inhibitors
(with or without potent CYP3A inducers) including PIs (except
tipranavir/ritonavir) ( 2.3, 7.1)
150 mg twice daily
With NRTIs, tipranavir/ritonavir, nevirapine, raltegravir, and
other drugs that are not potent CYP3A inhibitors or CYP3A
inducers ( 2.3, 7.1)
300 mg twice daily
With potent and moderate CYP3A inducers including efavirenz
(without a potent CYP3A inhibitor) ( 2.3, 7.1)
600 mg twice daily
A more complete list of coadministered drugs is listed in Dosage and
Administrat