Prior Auth Protocol

FDA Approved Indications:

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.

Health Net Approved Indications and Usage Guidelines:

Coverage is Not Authorized For:

Non-FDA approved indications, which are not listed in the Health Net Approved Indications and usage guidelines section unless there is sufficient documentation of efficacy and safety in the published literature

General Information:

According to the American College of Cardiology (ACC), the mainstay of anginal therapy includes beta-blockers, calcium channel blockers, long-acting nitrates and an antiplatelet agent (aspirin or Plavix).
Ranexa concentrations may increase if given concurrently with CYP3A inhibitors, resulting in increased adverse effects. Do not use Ranexa with strong CYP3A inhibitors, including ketoconazole, itraconazole, clarithromycin, nefazodone, nelfinavir, ritonavir, indinavir, and saquinavir.
Avoid co-administration of Ranexa and CYP3A inducers such as rifampin, rifabutin, rifapentin, phenobarbital, phenytoin, carbamazepine, and St. John's wort.
Ranexa produces small reductions in HbA1c in patients with diabetes, the clinical significance of which is unknown. Ranexa should not be considered a treatment for diabetes.

Therapeutic Alternatives:

Drug	Dosing Regimen	Dose Limit/ Maximum Dose
isosorbide dinitrate (Isordil^R)	5-40 mg PO BID to TID	240 mg/day
isosorbide mononitrate (Imdur^R)	30 - 120 mg PO QD	240 mg/day
metoprolol (Lopressor^R)	100 -400 mg PO QD (divided doses)	400 mg/day
amlodipine (Norvasc^R)	5 - 10 mg PO QD	10 mg/day

* Requires Prior Authorization

Recommended Dosing Regimen and Authorization Limit:

Drug	Dosing Regimen	Authorization Limit
Ranexa^R(ranolazine)	500 mg PO BID; titrate to maximum dose of 1000 mg PO BID Patients taking concurrent moderate CYP3A inhibitors (including diltiazem, verapamil, erythromycin) Limit dose to 500 mg PO BID	Length of benefit

Product Availability:

Extended-release tablet: 500 mg, 1000 mg

References:

Ranexa [Prescribing Information] Foster City, CA: Gilead Sciences; December 2013.
Micromedex^R Healthcare Series [Internet database]. Greenwood Village, Colo: Thomson Healthcare. Updated periodically. Accessed June 2015.
Fihn SD, Williams SV, Daley J, Gibbon RJ. Guidelines for the Management of Patients with Chronic Stable Angina: Treatment. Ann Intern Med. 2001; 135:616-632.
Fraker TD Jr, Fihn SD, 2002 Chronic Stable Angina Writing Committee, et al. 2007 chronic angina focused update of the ACC/AHA 2002 guidelines 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 Writing Group to develop the focused update of the 2002 guidelines for the management of patients with chronic stable angina. J Am Coll Cardiol 2007; 50:2264.
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.
Chaitman BR, Skettino SL, Parker JO, et al. Anti-ischemic effects and long-term survival during ranolazine monotherapy in patients with chronic severe angina. J Am Coll Cardiol 2004;43:1375-1382.