Label Changes for:

Juvisync (sitagliptin/simvastatin) Tablets, 100mg/10mg, 100 mg/20 mg, 100mg/40mg, 50mg/10mg, 50 mg/20 mg, and 50mg/40mg

September 2012

Changes have been made to the CONTRAINDICATIONS, WARNINGS, PRECAUTIONS and ADVERSE REACTIONS sections of the safety label.

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – September 2012

 

4 CONTRAINDICATIONS

  • JUVISYNC is contraindicated in the following conditions:
  • Concomitant administration of strong CYP3A4 inhibitors 
  • added ..... boceprevir, telaprevir

5 WARNINGS AND PRECAUTIONS

5.2 Myopathy/Rhabdomyolysis

Drug Interactions

  • added ..... boceprevir, telaprevir
  • Caution should be used when treating Chinese patients with JUVISYNC 100 mg/40 mg or 50 mg/40 mg per day coadministered with lipid-modifying doses of niacin-containing products
  • Table 1:  boceprevir, telaprevir added
5.4 Renal Impairment
  • A dosage adjustment is recommended in patients with moderate renal .....impairment

6 ADVERSE REACTIONS

6.2 Postmarketing Experience
  • added ..... arthralgia; pain in extremity; back pain;

8 USE IN SPECIFIC POPULATIONS

8.6 Renal Impairment
  • JUVISYNC is not recommended for use in patients with severe renal impairment or ESRD [see Dosage and Administration (2.2)].

MEDICATION GUIDE

Do not take JUVISYNC if you take:

  • certain hepatitis C virus protease inhibitors, including:
    • boceprevir
    • telaprevir

How should I take JUVISYNC?

  • Your doctor may change your dose or discontinue JUVISYNC based on the results of your blood tests.
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