Country: United States
Language: English
Source: NLM (National Library of Medicine)
MARAVIROC (UNII: MD6P741W8A) (MARAVIROC - UNII:MD6P741W8A)
A-S Medication Solutions
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 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
Product: 50090-6238 NDC: 50090-6238-0 60 TABLET, FILM COATED in a BOTTLE
New Drug Application
A-S Medication Solutions ---------- 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 unborn baby. Pregnancy Registry. There is a pregnancy Read the complete document
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._ • • 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 • • CONTRAINDICATIONS 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 ALLERG Read the complete document