SELZENTRY- maraviroc tablet, film coated SELZENTRY- maraviroc solution SELZENTRY- maraviroc kit

Country: Bandaríkin

Tungumál: enska

Heimild: NLM (National Library of Medicine)

Virkt innihaldsefni:

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

Fáanlegur frá:

ViiV Healthcare Company

INN (Alþjóðlegt nafn):

MARAVIROC

Samsetning:

MARAVIROC 25 mg

Stjórnsýsluleið:

ORAL

Gerð lyfseðils:

PRESCRIPTION DRUG

Ábendingar:

SELZENTRY 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 weighing at least 2 kg. Limitations of Use SELZENTRY 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 SELZENTRY 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 SELZENTRY during pregnancy from the APR and case reports are not sufficient to inform a drug-associated risk of birth defects and miscarriage. In animal reproduction studies, no evidence of adverse developmental outcomes was observed with

Vörulýsing:

SELZENTRY film-coated tablets are available as follows: 25-mg, 75-mg, 150-mg, and 300-mg tablets are blue, biconvex, oval, film-coated tablets debossed with “MVC 25”, “MVC 75”, “MVC 150”, or “MVC 300”, respectively, on one side and plain on the other. 25-mg tablets: Bottle of 120 tablets (NDC 49702-233-08). 75-mg tablets: Bottle of 120 tablets (NDC 49702-235-08). 150-mg tablets: Bottle of 60 tablets (NDC 49702-223-18). 300-mg tablets: Bottle of 60 tablets (NDC 49702-224-18). SELZENTRY film‑coated tablets should be stored at 20o C to 25o C (68o F to 77o F); excursions permitted between 15o C and 30o C (59o F and 86o F) [see USP Controlled Room Temperature]. SELZENTRY oral solution is a clear, colorless, strawberry-flavored liquid. Each mL of the solution contains 20 mg of maraviroc. It is supplied in a Convenience Combination Kit (NDC 49702-260-55) as follows: Bottle of 230 mL (NDC 49702-237-48). Each plastic bottle is packaged with one press-in bottle adapter, one 10–mL oral dosing syringe with 0.5–mL gradations, and one 3–mL oral dosing syringe with 0.5–mL gradations. The press-in bottle adapter and oral dosing syringes are not made with natural rubber latex. This product does not require reconstitution. SELZENTRY oral solution should be stored at 20o C to 25o C (68o F to 77o F); excursions permitted between 15o C and 30o C (59o F and 86o F) [see USP Controlled Room Temperature]. Discard any unused oral solution 60 days after first opening the bottle.

Leyfisstaða:

New Drug Application

Upplýsingar fylgiseðill

SELZENTRY- MARAVIROC SOLUTION
SELZENTRY- MARAVIROC
ViiV Healthcare Company
----------
MEDICATION GUIDE
SELZENTRY (sell-ZEN-tree)
(maraviroc)
tablets
SELZENTRY (sell-ZEN-tree)
(maraviroc)
oral solution
What is the most important information I should know about SELZENTRY?
SELZENTRY can cause serious side effects including serious liver
problems (liver toxicity). Some people
who take SELZENTRY can develop a severe rash or an allergic reaction
before liver problems happen and
may be life-threatening. Stop taking SELZENTRY 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
SELZENTRY and as needed during treatment with SELZENTRY.
What is SELZENTRY?
SELZENTRY 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 weighing at least 4.4 lb (2 kg).
HIV-1 is the virus that causes Acquired Immune Deficiency Syndrome
(AIDS).
Use of SELZENTRY is not recommended in people with dual/mixed- or
CXCR4-tropic HIV-1.
SELZENTRY should not be used in premature newborns or children
weighing less than 4.4 pounds (2 kg).
Do not take SELZENTRY if you have severe kidney problems or are on
hemodialysis and are also taking
certain other medications.
Before you take SELZENTRY, 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 SELZENTRY
may harm your un

Vara einkenni

SELZENTRY- MARAVIROC TABLET, FILM COATED
SELZENTRY- MARAVIROC SOLUTION
SELZENTRY- MARAVIROC
VIIV HEALTHCARE COMPANY
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
SELZENTRY SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR SELZENTRY.
SELZENTRY (MARAVIROC) TABLETS, FOR ORAL USE
SELZENTRY (MARAVIROC) ORAL SOLUTION
INITIAL U.S. APPROVAL: 2007
WARNING: HEPATOTOXICITY
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
•
•
INDICATIONS AND USAGE
SELZENTRY 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 weighing at least 2 kg. (1)
Limitations of Use:
•
DOSAGE AND ADMINISTRATION
•
•
Recommended Dosage in Adult Patients: (2.3)
Concomitant Medications
Dosage of
SELZENTRY
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
Administration_. (2)
Recommended Dosage in Pediatric Patients Weighing at Least 2 kg:
Administer twice daily. Dosage should
be based on body weight (kg) and concomitant medications and should
not exceed the recommended
adult dose. (2.4)
Recommended Dosage in Patients with Renal Impairment: Dose adjustment
may be necessary in adult
patients with renal impairment. (2.5)
DOSAGE FORMS AND STRENGTHS
•
•
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