Considerations in special populations1
Use in chronic angina patients with diabetes
- No dose adjustment is required in patients with diabetes
- A population pharmacokinetic evaluation of data from angina patients and healthy subjects showed no effect of diabetes on Ranexa® pharmacokinetics
- Ranexa produced small reductions in HbA1c in patients with comorbid diabetes. The clinical significance of the HbA1c reductions is unknown
- Ranexa should not be considered a treatment for diabetes
Additional considerations for patients with chronic angina and type 2 diabetes:
- Limit the dose of metformin to 1700 mg/day when used with Ranexa 1000 mg twice daily
- Monitor blood glucose and risks associated with high metformin exposure
Use in chronic angina patients with heart failure
- Heart failure (NYHA Class I to IV) had no significant effect on Ranexa pharmacokinetics
- Ranexa had minimal effects on heart rate and blood pressure in patients with angina and heart failure (NYHA Class I to IV)
- No dose adjustment of Ranexa is required in patients with angina and heart failure
Use in chronic angina patients with renal impairment
- A pharmacokinetic study of Ranexa in subjects with severe renal impairment (CrCL<30 mL/min) was stopped when 2 of 4 subjects developed acute renal failure after receiving Ranexa 500 mg twice daily for 5 days (lead-in phase) followed by 1000 mg twice a day (1 dose in one subject and 11 doses in the other). Increases in creatinine, BUN, and potassium were observed in 3 subjects during the 500-mg lead-in phase. One subject required hemodialysis, while the other 2 subjects improved upon drug discontinuation. Monitor renal function periodically in patients with moderate to severe renal impairment. Discontinue Ranexa if acute renal failure develops
- In a separate study, Cmax was increased by between 40% and 50% in patients with mild, moderate, or severe renal impairment compared to patients with no renal impairment, suggesting a similar increase in exposure in patients with renal failure independent of the degree of impairment. The pharmacokinetics of ranolazine have not been assessed in patients on dialysis
Use in chronic angina patients with hepatic impairment
- Ranexa is contraindicated in patients with liver cirrhosis
- In a study of cirrhotic patients, the Cmax of ranolazine was increased by 30% in cirrhotic patients with mild (Child-Pugh Class A) hepatic impairment, but increased by 80% in cirrhotic patients with moderate (Child-Pugh Class B) hepatic impairment compared to patients without hepatic impairment
- This increase was not enough to account for the 3-fold increase in QT prolongation seen in cirrhotic patients with mild-to-moderate hepatic impairment
Use in geriatric patients with chronic angina
- Of the chronic angina patients treated with Ranexa in controlled studies, 496 (48%) were ≥ 65 years of age, and 114 (11%) were ≥ 75 years of age
- No overall differences in efficacy were observed between older and younger patients
- There were no differences in safety for patients ≥ 65 years of age compared with younger patients, but patients ≥ 75 years of age on Ranexa, compared with placebo, had a higher incidence of adverse events, serious adverse events, and drug discontinuations due to adverse events
- In general, dose selection for an elderly patient should usually start at the low end of the dosing range
Understand available dosing and recommendations regarding titration, as well as important treatment considerations.
See Dosing Information
Ranexa Clinical Trials
Review the CARISA and TERISA clinical trials to learn how Ranexa may help reduce the symptoms of chronic angina.
View Clinical Data
Ranexa Connect™ is a financial assistance resource for patients with a Ranexa prescription.
Ranexa Connect is pleased to announce iAssist, a program to help get your patients started on Ranexa faster. The program offers online patient enrollment, electronic signatures, as well as real-time pharmacy benefit check and eligibility for financial assistance.
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1. Ranexa [package insert]. Foster City, CA: Gilead Sciences, Inc.; January 2016.