Label Changes for:
Ranexa (ranolazine) Extended-Release Tablets
November 2008
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) -- 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
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CONTRAINDICATIONS
WARNINGS AND PRECAUTIONS
ADVERSE REACTIONS
- Clinical Trials Experience (see highlighted text)
- ...Doses above 1000 mg twice daily are poorly tolerated...
- ...Dizziness may be dose-related...
- The following additional adverse reactions occurred at an incidence of 0.5 to 2.0% in patients treated with Ranexa...
- Cardiac Disorders
- Vascular Disorders
- hypotension
- orthostatic hypotension
- Other (<0.5%) but potentially medically important adverse reactions observed more frequently in Ranexa than placebo treatment...
- A large clinical trial in acute coronary syndrome patients was unsuccessful in demonstrating a benefit for Renexa...
- Laboratory Abnormalities
- Ranexa produces small reductions in hemoglobin A1c...
- Ranexa produces elevations of serum creatinine by 0.1 mg/dL, regardless of previous renal function...
DRUG INTERACTIONS
- Effects of Ranolazine on Other Drugs
- Initial Section
- Drugs Metabolized by CYP3A
- ...Dose adjustments of simvastatin are not required when Ranexa is co-administered with simvastatin.
USE IN SPECIFIC POPULATIONS
- Pregnancy
- In animal studies, ranolazine at exposures 1.5 (rabbit) to 2 (rat) times the usual human exposure...
- Use in Patients with Hepatic Impairment
- Use in Patients with Heart Failure
NONCLINICAL TOXICOLOGY
- Carcinogenesis, Mutagenesis, Impairment of Fertility
PATIENT COUNSELING INFORMATION
- Patients should be advised...
- to inform their physician if they are receiving...P-gp inhibitors (e.g., cyclosporine)...
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CONTRAINDICATIONS
Ranexa is contraindicated in patients:
- Taking strong inhibitors of CYP3A [see Drug Interactions (7.1)]
- Taking inducers of CYP3A [see Drug Interactions (7.1)]
- With clinically significant hepatic impairment [see Use in Specific Populations (8.6)]
WARNINGS AND PRECAUTIONS
QT Interval Prolongation:
Ranolazine blocks IKr and prolongs the QTc interval in a dose-related manner.
Clinical experience in an acute coronary syndrome population did not show an increased risk of proarrhythmia or sudden death [see Clinical Studies (14.2)]. However, there is little experience with high doses (> 1000 mg twice daily) or exposure, other QT-prolonging drugs, or potassium channel variants resulting in a long QT interval.
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