Juvisync (sitagliptin/simvastatin) Tablets

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

 

Summary View

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.