SELZENTRY- maraviroc tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

A-S Medication Solutions

INN (International Name):

MARAVIROC

Composition:

MARAVIROC 300 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 patients 2 years of age and older weighing at least 10 kg. Limitations of Use: SELZENTRY is contraindicated in patients with severe renal impairment or ESRD (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 maraviroc. Durin

Product summary:

Product: 50090-1486 NDC: 50090-1486-0 60 TABLET, FILM COATED in a BOTTLE

Authorization status:

New Drug Application

Patient Information leaflet

A-S Medication Solutions
----------
MEDICATION GUIDE
SELZENTRY® (sell-ZEN-tree) SELZENTRY® (sell-ZEN-tree)
(maraviroc) (maraviroc)
tablets 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). An allergic
reaction may happen before liver problems occur. 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) • vomiting
• your skin or the white part of your eyes • pain, aching, or
tenderness on the right side
turns yellow (jaundice) of your stomach area
• dark or “tea-colored” urine
Your healthcare provider will do blood tests to check your liver
before you begin treatment with
SELZENTRY and as needed during treatment, and if you get a severe
rash, signs and symptoms of liver
problems, or an allergic reaction during treatment with SELZENTRY.
What is SELZENTRY?
SELZENTRY is a prescription HIV-1 (human Immunodeficiency Virus type
1) medicine used with other
antiretroviral medicines to treat CCR5-tropic HIV-1 infection in
people 2 years of age and older
weighing at least 22 lb. (10 kg). HIV-1 is the virus that causes AIDS
(Acquired Immune Deficiency
Syndrome).
Use of SELZENTRY is not recommended in people with dual/mixed or
CXCR4-tropic HIV-1.
The safety and effectiveness of SELZENTRY has not been established in
children younger than 2 years
of age.
Who should not take SELZENTRY?
Do not take SELZENTRY if you:
•
have severe kidney problems or are on hemodialysis and are also taking
certain other medications.
What should I tell my healthcare provider before taking SELZENTRY?
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 medic

Summary of Product characteristics

SELZENTRY- MARAVIROC TABLET, FILM COATED
A-S MEDICATION SOLUTIONS
----------
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._
•
•
RECENT MAJOR CHANGES
Indications and Usage (1)
Dosage and Administration:
Warnings and Precautions, Cardiovascular Events (5.3)
11/2016
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 patients 2 years of age and
older weighing at least 10 kg. (1)
Limitations of Use:
•
DOSAGE AND ADMINISTRATION
Prior to initiation of SELZENTRY, test all patients for CCR5 tropism
using a highly sensitive tropism assay. (2.1)
SELZENTRY tablets and oral solution are taken twice daily by mouth and
may be taken with or without food. SELZENTRY
must be given in combination with other antiretroviral medications.
(2.2)
Recommended Dosage in Adults: (2.3)
Concomitant Medications
Dosage of
SELZENTRY
When given with potent CYP3A inhibitors (with or without potent CYP3A
inducers) including PIs
(except tipranavir/ritonavir), delavirdine (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 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)_
Pediatric Patients Aged 2 Years and Older and Weighing at Least 10 kg:
Administer twice daily. Dosage should be based on
®
®
HEPATOTOXICITY HAS BEEN REPORTED WHICH MAY BE PRECEDED BY SEVERE RASH
OR OTHER FEATURES OF A
SYSTEMIC ALLERGI