1. Ranexa [package insert]. Foster City, CA: Gilead Sciences, Inc; December 2013.
  2. Chaitman BR, Pepine CJ, Parker JO, et al. Effects of ranolazine with atenolol, amlodipine, or diltiazem on exercise tolerance and angina frequency in patients with severe chronic angina: a randomized controlled trial. JAMA. 2004;291:309-316.
  3. Serruys PW, Unger F, Sousa JE, et al. Comparison of coronary-artery bypass surgery and stenting for the treatment of multivessel disease. N Engl J Med. 2001;344:1117-1124.
  4. Boden WE, O’Rourke RA, Teo KK, et al. Optimal medical therapy with or without PCI for stable coronary disease. N Engl J Med. 2007;356:1503-1516.
  5. Cohen DJ, Van Hout B, Serruys PW, et al. Quality of life after PCI with drug-eluting stents or coronary-artery bypass surgery. N Engl J Med. 2011;364:1012-1026.
  6. American Heart Association. Heart Disease and Stroke Statistics—2012 Update. Dallas, TX: American Heart Association; 2012.
  7. Gibbons RJ, Abrams J, Chatterjee K, et al. ACC/AHA 2002 guideline update for the management of patients with
    chronic stable angina: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Committee to Update the 1999 Guidelines for the Management of Patients with Chronic Stable Angina). 2002. Available at http://cardiosource.org/~/media/Images/ACC/Science and Quality/Practice
    Guidelines/s/stable_clean.ashx?w_nav=Search&WT.oss= Guidelines&WT.oss_r=7203&. Accessed June 4, 2012.
  8. Morrow DA, Boden WE. Stable ischemic heart disease. In: Bonow RO, Mann DL, Zipes DP, Libby P, eds. Braunwald’s Heart Disease: A Textbook of Cardiovascular Medicine.
    9th ed. Philadelphia, PA: Saunders Elsevier; 2012:1210-1254.
  9. Cannon CP, Braunwald E. Unstable angina and non-ST elevation myocardial infarction. In: Bonow RO, Mann DL, Zipes DP, Libby P, eds. Braunwald’s Heart Disease: A Textbook of Cardiovascular Medicine. 9th ed. Philadelphia, PA: Saunders Elsevier; 2012:1178-1209.
  10. Chestnut LG, Keller LR, Lambert WE, Rowe RD. Measuring heart patients’ willingness to pay for changes in angina symptoms. Med Decis Making. 1996;16(1):65-77.
  11. ACCF/AHA/AMA PCPI 2011 Performance Measures for Adults With Coronary Artery Disease and Hypertension: A Report of the American College of Cardiology Foundation/American Heart Association Task Force on Performance Measures and the American Medical Association Physician Consortium for Performance Improvement. J Am Coll Cardiol. 2011;58;316-336.
  12. Scirica BM, Morrow DA, Hod H, et al. Effect of ranolazine, an antianginal agent with novel electrophysiological properties, on the incidence of arrhythmias in patients with non–ST-segment elevation acute coronary syndrome:
    results from the Metabolic Efficiency With Ranolazine for Less Ischemia in Non–ST-Elevation Acute Coronary Syndrome–Thrombolysis in Myocardial Infarction 36 (MERLIN- TIMI 36) randomized controlled trial. Circulation. 2007;116:1647-1652.
  13. Thadani U, Ripley TL. Side effects of using nitrates to treat heart failure and the acute coronary syndromes, unstable angina and acute myocardial infarction. Expert Opinion Drug Saf. 2007;6:385-396.
  14. Gheorghiade M, Abraham WT, Albert NM, et al. Systolic blood pressure at admission, clinical characteristics, and outcomes in patients hospitalized with acute heart failure. JAMA. 2006;296:2217-2226.
  15. Rouleau JL, Roecker EB, Tendera M, et al. Influence of pretreatment systolic blood pressure on the effect of carvedilol in patients with severe chronic heart failure: the Carvedilol Prospective Randomized Cumulative Survival (COPERNICUS) study. J Am Coll Cardiol.
    2004;43:1423-1429.
  16. Yancy CW, Lopatin M, Stevenson LW, De Marco T, Fonarow GC. Clinical presentation, management, and in-hospital outcomes of patients admitted with acute decompensated heart failure with preserved systolic function: a report from the Acute Decompensated Heart Failure National Registry (ADHERE) Database. J Am Coll Cardiol. 2006;47:76-84.
  17. Morrow DA, Scirica BM, Karwatowska-Prokopczuk E, et al. Effects of ranolazine on recurrent cardiovascular events in patients with non-ST-elevation coronary syndromes: the MERLIN-TIMI 36 randomized trial. JAMA.
    2007;297:1775-1783.
  18. Stone PH, Gratsiansky NA, Blokhin A, Huang IZ, Meng L. Antianginal efficacy of ranolazine when added to treatment with amlodipine: the ERICA (Efficacy of Ranolazine in Chronic Angina) Trial. J Am Coll Cardiol. 2006;48:566-575.
  19. Data on file, Gilead Sciences, Inc.
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    monotherapy in patients with chronic severe angina. J Am Coll Cardiol. 2004;43:1375-1382.
  22. Stone PH, Chaitman B, Koren A, Crager M. Effects of ranolazine as monotherapy and combination therapy on rate pressure product at rest and during exercise: results from the MARISA and CARISA trials. Circulation. 2006;114:II 715. Abstract 3362.

Indication

  • Ranexa (ranolazine) is indicated for the treatment of chronic angina.
  • Ranexa may be used with beta-blockers, nitrates, calcium channel blockers, anti-platelet therapy, lipid-lowering therapy, ACE inhibitors, and angiotensin receptor blockers.

IMPORTANT SAFETY INFORMATION

Contraindications

  • Ranexa is contraindicated in patients:
    • Taking strong inhibitors of CYP3A (e.g., ketoconazole, itraconazole, clarithromycin, nefazodone, nelfinavir, ritonavir, indinavir, and saquinavir).
    • Taking inducers of CYP3A (e.g., rifampin, rifabutin, rifapentine, phenobarbital, phenytoin, carbamazepine, and St John’s wort)
    • With liver cirrhosis

Warnings and Precautions

  • Ranexa blocks lKr 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. However, there is little experience with high doses (> 1000 mg twice daily) or exposure, with other QT-prolonging drugs, with potassium channel variants resulting in a long QT interval, in patients with a family history of (or congenital) long QT syndrome, or in patients with known acquired QT interval prolongation.
  • Acute renal failure has been observed in patients with severe renal impairment while on Ranexa. Monitor renal function after initiation and periodically in patients with moderate to severe renal impairment. Discontinue Ranexa if acute renal failure develops.

Adverse Reactions

  • The most common adverse reactions (> 4% and more common than with placebo) during treatment with Ranexa (ranolazine) were dizziness, headache, constipation, and nausea.

Dosage and Administration

  • Begin treatment with 500 mg twice daily and increase to the maximum recommended dose of 1000 mg twice daily, based on clinical symptoms. Ranexa should be swallowed whole; do not crush, break or chew.
  • Limit the dose of Ranexa to 500 mg twice daily in patients on moderate CYP3A inhibitors (e.g., diltiazem, verapamil, erythromycin, fluconazole, and grapefruit juice or grapefruit-containing products). See Drug Interactions for additional dosing considerations.

Drug Interactions

  • Inducers and strong inhibitors of CYP3A: Do not use Ranexa (see Contraindications).
  • Moderate CYP3A inhibitors: Limit Ranexa to 500 mg twice daily (see Dosage and Administration).
  • P-gp inhibitors (e.g., cyclosporine): Ranexa exposure increased; titrate Ranexa based on clinical response.
  • CYP3A substrates: Limit simvastatin to 20 mg once daily when used with Ranexa. Doses of other sensitive CYP3A substrates (e.g., lovastatin) and CYP3A substrates with narrow therapeutic range (e.g., cyclosporine, tacrolimus, sirolimus) may need to be reduced with Ranexa.
  • Drugs transported by P-gp (e.g., digoxin) or metabolized by CYP2D6 (e.g., tricyclic antidepressants and antipsychotics): Doses of these drugs may need to be reduced.
  • Drugs transported by OCT2: Limit metformin to 1700 mg per day when used with Ranexa 1000 mg twice daily. Monitor blood glucose and risks associated with high metformin exposure.

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