POWDER HCP


FDA-APPROVED AND LABELED ACE INHIBITOR TREATMENT FOR PEDIATRIC HYPERTENSION IN PATIENTS OLDER THAN 1 MONTH

  • Trusted efficacy delivered with consistent potency.1
  • User-friendly solution provides everything needed for preparation.1
  • Oral solution provides consistent stability when stored as directed.1
  • Robust coverage and reimbursement support.

Dosing and administration

USER-FRIENDLY ENALAPRIL POWDER FOR ORAL SOLUTION

  • Adds convenience as everything is included for preparation.1
  • Streamlines procedures to ensure optimal efficiency and productivity.
  • Requires little time to prepare versus enalapril suspension preparation.

FDA-APPROVED DOSING1

Reconstitution of Epaned Powder for Oral Solution with 150 mL of the provided Ora-Sweet® SF diluent results in a 1 mg/mL Epaned Oral Solution.

Weight-based dosing for pediatric hypertension in patients over 1 month of age
The recommended starting dose is 0.08 mg/kg (up to 5 mg) once daily.
  • Dosage should be adjusted according to blood pressure response.
  • Doses above 0.58 mg/kg (or in excess of 40 mg) have not been studied in pediatric patients.
  • Epaned is not recommended in neonates or pediatric patients with glomular filtration rate < 30mL/min/1.73m2.

Dosing for adult hypertension
  • The recommended starting dosage is 5 mg daily up to a maximum of 40 mg daily as needed to help achieve blood pressure goals.
  • See full Prescribing Information for dosage adjustment for use with diuretics or renal impairment.


  • Dosing for adults with cardiac conditions
    The recommended starting dose is 2.5 mg twice daily up to a maximum of 20 mg twice daily for symptomatic heart failure and up to a maximum of 10 mg twice daily for asymptomatic left ventricular dysfunction.

    Oral solution for consistent dosing and convenience1,2
    • Stable for up to 60 days after reconstitution when stored according to label instructions.
    • Refrigeration not required because reconstituted Epaned Powder for Oral Solution can be stored at room temperature (25° C, 77° F); do not freeze.
    • No shaking necessary after reconstitution and prior to administration.
     

    See why Epaned is an affordable, accessible choice.  

    CO-PAY AND REIMBURSEMENT

    EPANED IS AFFORDABLE AND ACCESSIBLE

    Robust coverage and reimbursement support
    • Reimbursed by Medicaid in every state.
    • Covered by most commercial managed care plans.
    • Dedicated Prior Authorization Hotline (1-844-472-2032).
    • Co‐pay support and/or patient assistance available for qualifying patients.
     

    EPANED POWDER FOR ORAL SOLUTION PATIENTS WITH COMMERCIAL INSURANCE PAY NO MORE THAN $30 FOR AN EPANED PRESCRIPTION*

     
    • Automatic savings—applies electronic coupon to co-pay.
    • Completely paperless—no physician cards or coupons needed.
    • This program is for Epaned Powder for Oral Solution patients covered by commercial insurance.
     

    If you have commercial insurance, you’ll pay no more than $30 for your prescription with the Epaned co-pay programs up to $175. The automatic savings is instantly applied to your co-pay at the pharmacy. It’s completely paperless, so there are no cards, coupons, or forms.

    For eVoucherRx™ questions, please call: 800‐388‐2316 Relay Pharmacy Help Desk/Customer Support. To see a list of participating pharmacies for eVoucherRx, visit http://evoucherrx.relayhealth.com/storelookup.
    *See Epaned eVoucherRx™ program eligibility restrictions, terms, and conditions below.

    For Voucher On Demand™ questions, please call: 866-379-6389 Help Desk/Customer Support.

    How do I use the Epaned Powder for Oral Solution co-pay program?
    It’s easy. You don’t need any cards or coupons. Take your Epaned prescription to one of many participating pharmacies nationwide. When you pick up your prescription, you’ll get an automatic co‐pay reduction that ensures you’ll pay no more than $30 for Epaned up to $175. Qualifying patients will pay no more than $30 for an Epaned prescription up to $175. Savings depends on the amount of your co‐pay above $30.

    For patients without commercial insurance, there are other options for gaining access to Epaned Powder for Oral Solution:
    • Epaned is covered by Medicaid.
    • A patient assistance program is available for those who qualify.
     

    *ELIGIBILITY RESTRICTIONS, TERMS, AND CONDITIONS

    By participating in this savings program, participants understand and agree that the information provided, as well as non-personally identifiable information obtained from the pharmacy, will be shared with the manufacturer and with any companies working with the manufacturer. Participants also affirm that they will not submit, and have not had submitted on their behalf, a claim for reimbursement or coverage for items purchased with this card under Medicaid, Medicare, TRICARE, or any other federal or state government healthcare program, or where prohibited by state law.

    • Offer applies to out‐of‐pocket expenses (co‐pay) greater than $30. Out‐of‐pocket expenses greater than $30 will be covered up to $175 per prescription. If your total out‐of‐pocket cost exceeds $175, you will be responsible for a $30 co‐pay plus any additional amount over $175. If your co‐pay is already $30 or less, this offer does not apply.
    • Offer applies only to Epaned Powder for Oral Solution patients and associated refills.
    • This offer is not valid for prescriptions paid in part or in full by any federally or state‐funded program, including but not limited to Medicaid, Medicare, Department of Veterans Affairs, Department of Defense, or TRICARE, and where prohibited by law.
    • For questions about eVoucherRx™, please call: 800‐388‐2316 Relay Pharmacy Help Desk/Customer Support.
    • For questions about Voucher On Demand™, please call: 866‐379‐6389 Change Healthcare Help Desk/Customer Support.
    • This savings program cannot be combined with any other coupon, certificate, voucher, or similar offer.
    • Offer good only in the USA at participating retail pharmacies and cannot be redeemed at government‐subsidized clinics. Void where taxed, restricted, or prohibited by law.
    • Offer not extended to clubs, groups, or organizations.
    • Participation in this program must comply with all applicable laws and contractual or other obligations as a pharmacy provider.
    • This is not an insurance program.
    • Participating patients and pharmacists understand and agree to comply with the Terms and Conditions of this offer as set forth herein.
    • Any step‐edits or prior authorizations required by the insurance plan still apply.
    • Silvergate Pharmaceuticals, Inc. reserves the right to modify or cancel this program at any time.
    • eVoucherRx™ and Voucher On Demand™ are not extended on prescriptions for patients:
      • who are cash‐paying customers.
      • using institution-based pharmacies to fill their prescriptions, or who are recipients of federal or state government health care.
      • who are filling their prescriptions at nonparticipating pharmacies.
eVoucherRx™ is a trademark of RelayHealth.
Voucher On Demand™ is a trademark of Change Healthcare.

IMPORTANT SAFETY INFORMATION

WARNING: FETAL TOXICITY
See full Prescribing Information for complete boxed warning.
  • When pregnancy is detected, discontinue EPANED as soon as possible.
  • Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus.

INDICATIONS

EPANED is an angiotensin-converting enzyme (ACE) inhibitor indicated for:
  • treatment of hypertension in adults and children older than 1 month, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions.
  • treatment of symptomatic heart failure.
  • treatment of asymptomatic left ventricular dysfunction, to decrease the rate of development of overt heart failure and reduce hospitalization for heart failure.

ADDITIONAL IMPORTANT SAFETY INFORMATION

  • Epaned is contraindicated in patients who are hypersensitive to enalapril or any component of reconstituted Epaned Powder for Oral Solution.
  • Epaned is contraindicated in patients with a history of hypersensitivity related to previous treatment with an ACE inhibitor.
  • Epaned is contraindicated in patients with hereditary or idiopathic angioedema.
  • Do not co-administer aliskiren with Epaned in patients with diabetes.
  • Head and Neck Angioedema: Angioedema of the face, extremities, lips, tongue, glottis, and/or larynx, including some fatal reactions, have been reported in patients treated with ACE inhibitors, including Epaned, at any time during treatment. Epaned should be promptly discontinued and appropriate therapy and monitoring provided until complete and sustained resolution of signs and symptoms of angioedema has occurred. Patients with a history of angioedema may be at increased risk of angioedema while receiving an ACE inhibitor.
  • Anaphylactoid Reactions during Dialysis: Sudden and potentially life-threatening anaphylactoid reactions have occurred in some patients dialyzed with high-flux membranes treated concomitantly with an ACE inhibitor. In such patients, dialysis must be stopped immediately, and aggressive therapy for anaphylactoid reactions must be initiated. In these patients, consideration should be given to using a different type of dialysis membrane or a different class of antihypertensive agent. Anaphylactoid reactions have also been reported in patients undergoing low-density lipoprotein apheresis with dextran sulfate absorption.
  • Intestinal Angioedema has been reported in patients treated with ACE inhibitors.
  • Hypotension: Epaned can cause symptomatic hypotension, sometimes complicated by oliguria, progressive azotemia, acute renal failure, or death. Patients at risk of excessive hypotension include those with the following conditions or characteristics: heart failure with systolic blood pressure below 100 mmHg, ischemic heart disease, cerebrovascular disease, hyponatremia, high-dose diuretic therapy, renal dialysis, or severe volume and/or salt depletion of any etiology. These patients should be started under close medical supervision and closely followed for the first 2 weeks of treatment with Epaned and whenever the dose of Epaned and/or a diuretic is increased. Symptomatic hypotension is also possible in patients with severe aortic stenosis or hypertrophic cardiomyopathy.
  • Surgery/Anesthesia: In patients undergoing major surgery or during anesthesia with agents that produce hypotension, Epaned may block angiotensin II formation secondary to compensatory renin release.
  • Hepatic Failure: Rarely, ACE inhibitors have been associated with a syndrome that starts with cholestatic jaundice and progresses to fulminant hepatic necrosis and (sometimes) death. Patients who develop jaundice or marked elevations of hepatic enzymes should discontinue the ACE inhibitor and receive appropriate medical follow-up.
  • Impaired Renal Function: Monitor renal function in patients treated with Epaned. Changes in renal function, including acute renal failure, can be caused by drugs that inhibit the renin-angiotensin system. Consider withholding or discontinuing therapy in patients who develop a clinically significant decrease in renal function on Epaned.
  • Hyperkalemia: Serum potassium should be monitored in patients receiving Epaned. Drugs that inhibit the renin-angiotensin system can cause hyperkalemia. Risk factors for the development of hyperkalemia include renal insufficiency, diabetes mellitus, and the concomitant use of potassium-sparing diuretics, potassium supplements, and/or potassium-containing salt substitutes.
  • Adverse Reactions (where rate on enalapril exceeds the rate on placebo by at least 0.2%) occurring in greater than 1% of patients with hypertension treated with enalapril in controlled trials include: fatigue, orthostatic effects, asthenia, cough, and rash. Adverse reactions reported in clinical trials of heart failure were similar to those seen in clinical trials for hypertension. In patients treated for heart failure, there was an increased incidence of hypotension and dizziness.

    See full Prescribing Information for further information, including non-steroidal anti-inflammatory agents and other Adverse Reactions.
  • In patients who are elderly, volume-depleted (as on diuretic therapy), or with compromised renal function, use of NSAIDs, including selective cyclooxygenase-2 (COX-2) inhibitors, with ACE inhibitors, including enalapril, may result in deterioration of renal function, including renal failure. Monitor renal function periodically in patients receiving enalapril and NSAID therapy.
  • Dual inhibition of the renin-angiotensin system (RAS): Dual blockade of the RAS with angiotensin receptor blockers, ACE inhibitors, or aliskiren is associated with increased risks of hypotension, hyperkalemia and changes in renal function, (including acute renal failure) compared to monotherapy. Closely monitor BP, renal function and electrolytes.
  • Avoid use of aliskiren with Epaned in patients with renal impairment.
  • Epaned attenuates potassium loss caused by thiazide-type diuretics. Potassium-sparing diuretics, potassium supplements, or potassium-containing salt substitutes may lead to significant increases in serum potassium.
  • Lithium toxicity has been reported in patients receiving enalapril and lithium concomitantly. Monitor serum lithium levels frequently if lithium is concomitantly administered with Epaned.
  • Nitritoid reactions have been reported rarely in patients with injectable gold (sodium aurothiomalate) and concomitant enalapril therapy.
  • mTOR Inhibitors: Patients taking concomitant mTOR inhibitor (e.g., temisirolimus, sirolimus, everolimus) therapy may be at increased risk for angioedema.
  • Epaned is not recommended in neonates and in pediatric patients with glomerular filtration rate < 30 mL/min/1.73 m2.
View full Prescribing Information for additional Important Safety Information, including BOXED WARNING.

To report SUSPECTED ADVERSE REACTIONS, contact Silvergate Pharmaceuticals at 1-855-379-0383, or FDA at 1-800-FDA-1088 or www.fda.gov/Safety/MedWatch.