Riik: Ameerika Ühendriigid
keel: inglise
Allikas: NLM (National Library of Medicine)
MARAVIROC (UNII: MD6P741W8A) (MARAVIROC - UNII:MD6P741W8A)
A-S Medication Solutions
MARAVIROC
MARAVIROC 300 mg
ORAL
PRESCRIPTION DRUG
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: 50090-1486 NDC: 50090-1486-0 60 TABLET, FILM COATED in a BOTTLE
New Drug Application
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 Lugege kogu dokumenti
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 Lugege kogu dokumenti