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U.S. Department of Health and Human Services

Safety

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Selzentry (maraviroc) Tablets

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) -- November 2008

 

The detailed view includes drug products with safety labeling changes to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, or PATIENT PACKAGE INSERT/MEDICATION GUIDE sections. Deletions or editorial revisions made to these sections are not included in this summary. Read about the new physician labeling format.


 

Summary View

 

Sections Modified

Summary of Changes to Contraindications and Warnings

WARNINGS AND PRECAUTIONS

  • Cardiovascular Events

ADVERSE REACTIONS

  • Clinical Trials Experience
    • Initial Section (see highlighted text)
    • Table 2 (updated to include 48 week data)
    • Less Common Adverse Events
      • Blood and Lymphatic System
        • marrow depression
        • hypoplastic anemia
      • Hepatobiliary Disorders
        • portal vein
          thrombosis
      • Infections and Infestations
        • endocarditis
        • infective myositis
        • treponema infections
      • Neoplasms benign, malignant and Unspecified (incl Cysts and Polyps)
        • anaplastic large cell lymphomas T- and null-cell types
        • bile duct neoplasms malignant
        • endocrine
          neoplasms malignant and unspecified
      • Nervous System Disorders
        • convulsions and epilepsy
        • tremor
          (excluding congenital)
    • Laboratory Abnormalities
      • Table 3

USE IN SPECIFIC POPULATIONS

  • Hepatic Impairment
    • Maraviroc is principally metabolized by the liver; therefore, caution should be exercised when administering this drug to patients with hepatic impairment, because maraviroc concentrations may be increased. Maraviroc has not been studied in subjects with severe hepatic impairment...

WARNINGS AND PRECAUTIONS

Cardiovascular Events:

...Eleven subjects (1.3%) who received Selzentry had cardiovascular events including myocardial ischemia and/or infarction during the Phase 3 studies [total exposure 609 patient-years (300 on once daily + 309 on twice daily Selzentry)], while no subjects who received placebo had such events (total exposure 111 patient-years)...