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Please click here or scroll for FULL INDICATION
& IMPORTANT SAFETY INFORMATION
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| WARNING: FETAL TOXICITY |
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When pregnancy is detected, discontinue ENTRESTO as soon as possible |
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Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus |
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Please click here or scroll for FULL INDICATION
& IMPORTANT SAFETY INFORMATION |
| WARNING: FETAL TOXICITY |
| • |
When pregnancy is detected, discontinue ENTRESTO as soon as possible |
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Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus |
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Have a
heart-to-heart
about the ACC/AHA/HFSA*
Treatment Guideline Update. |
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Have a
heart-to-heart
about the ACC/AHA/HFSA*
Treatment Guideline Update. |
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Dear Dr. %%first_name%% %%last_name%%,
As you may know, ENTRESTO® (sacubitril/valsartan) is now a guideline-recommended treatment for heart failure with reduced ejection fraction (HFrEF), having received a strong Class I recommendation as an alternative to an ACEi or ARB. The guideline specifically advises doctors to switch chronic HFrEF patients with mild to moderate symptoms (NYHA Class II-III) who are otherwise tolerating an ACEi or ARB to ENTRESTO to further reduce mortality and morbidity.1
Now you have the opportunity to discuss this new guideline update either by visiting the ENTRESTO booth at an upcoming conference or by attending an online webinar led by medical experts who can help you put the guideline recommendation into practice.
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ATTEND A CONFERENCE IN PERSON.
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Meet with experts who will be on hand to answer your questions.
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ACC's 66th Annual Scientific Session & Expo
March 17th-19th, 2017
Washington, DC
Booth #1919
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ACP - American College of
Physicians Annual Internal
Medicine Meeting
San Diego Convention Center
San Diego, CA
March 30th-April 1st, 2017
Booth TBD
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Watch, listen, interact, and have your questions answered by the nation's leading cardiologists using any internet-capable device.
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TO REGISTER
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1.
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Log on to: www.entrestospeakerdirect.com and enter the access code: SCHEDULE
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2.
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Select a program of your choice
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3.
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Receive a confirmation and reminders via e-mail
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For assistance, please call 1-800-531-6204 or e-mail admin@directconnectsupport.com.
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This is a promotional speaker program and is not accredited for CME. The speakers involved in the program are presenting on behalf of Novartis Pharmaceuticals Corporation.
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| *ACC=American College of Cardiology, AHA=American Heart Association, HFSA=Heart Failure Society of America. |
Please see accompanying full Prescribing Information, including Boxed WARNING.
INDICATION
ENTRESTO is indicated to reduce the risk of cardiovascular death and hospitalization for heart failure in patients with chronic heart failure (NYHA Class II-IV) and reduced ejection fraction.
ENTRESTO is usually administered in conjunction with other heart failure therapies, in place of an ACE inhibitor or other ARB.
IMPORTANT SAFETY INFORMATION |
| WARNING: FETAL TOXICITY |
| • |
When pregnancy is detected, discontinue ENTRESTO as soon as possible |
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Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus |
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ENTRESTO is contraindicated in patients with hypersensitivity to any component. ENTRESTO is contraindicated in patients with a history of angioedema related to previous angiotensin-converting enzyme (ACE) inhibitor or angiotensin receptor blocker (ARB) therapy.
ENTRESTO is contraindicated with concomitant use of ACE inhibitors. Do not administer within 36 hours of switching from or to an ACE inhibitor. ENTRESTO is contraindicated with concomitant use of aliskiren in patients with diabetes.
Angioedema: ENTRESTO may cause angioedema. Angioedema associated with laryngeal edema may be fatal. ENTRESTO has been associated with a higher rate of angioedema in Black patients and in patients with a prior history of angioedema. If angioedema occurs, discontinue ENTRESTO immediately, provide appropriate therapy, and monitor for airway compromise. ENTRESTO must not be re-administered.
Hypotension: ENTRESTO lowers blood pressure and may cause symptomatic hypotension. Patients with an activated renin-angiotensin system, such as volume- and/or salt-depleted patients (e.g., those being treated with high doses of diuretics), are at greater risk. Correct volume or salt depletion prior to administration of ENTRESTO or start at a lower dose. If hypotension persists despite dose adjustment of diuretics, concomitant antihypertensive drugs, and treatment of other causes of hypotension (e.g., hypovolemia) reduce the dosage or temporarily discontinue ENTRESTO. Permanent discontinuation of therapy is usually not required.
Impaired Renal Function: Decreases in renal function may be anticipated in susceptible individuals treated with ENTRESTO. In patients whose renal function depends upon the activity of the renin-angiotensin-aldosterone system (e.g., patients with severe congestive heart failure), treatment with ACE inhibitors and angiotensin receptor antagonists has been associated with oliguria, progressive azotemia and, rarely, acute renal failure and death. Closely monitor serum creatinine, and down-titrate or interrupt ENTRESTO in patients who develop a clinically significant decrease in renal function.
ENTRESTO may increase blood urea and serum creatinine levels in patients with bilateral or unilateral renal artery stenosis. In patients with renal artery stenosis, monitor renal function. Avoid use with aliskiren in patients with renal impairment (eGFR <60 mL/min/1.73 m2).
In patients who are elderly, volume-depleted (including those on diuretic therapy), or with compromised renal function, concomitant use of non-steroidal anti-inflammatory drugs (NSAIDs), including COX-2 inhibitors, with ENTRESTO may result in worsening of renal function, including possible acute renal failure. These effects are usually reversible. Monitor renal function periodically.
Hyperkalemia: Hyperkalemia may occur with ENTRESTO. Monitor serum potassium periodically and treat appropriately, especially in patients with risk factors for hyperkalemia such as severe renal impairment, diabetes, hypoaldosteronism, or a high potassium diet. Dosage reduction or interruption of ENTRESTO may be required.
Concomitant use of potassium-sparing diuretics (e.g., spironolactone, triamterene, amiloride), potassium supplements, or salt substitutes containing potassium may lead to increases in serum potassium.
ARBs: Avoid use of ENTRESTO with an ARB, because ENTRESTO contains the angiotensin II receptor blocker valsartan.
Lithium: Increases in serum lithium concentrations and lithium toxicity have been reported during concomitant administration of lithium with angiotensin II receptor antagonists. Monitor serum lithium levels during concomitant use with ENTRESTO.
Common Adverse Events: In a clinical trial, the most commonly observed adverse events with ENTRESTO vs enalapril, occurring at a frequency of at least 5% in either group, were hypotension (18%, 12%), hyperkalemia (12%, 14%), cough (9%, 13%) dizziness (6%, 5%) and renal failure/acute renal failure (5%, 5%).
Sincerely,
The ENTRESTO Team
References: 1. Yancy CW, Jessup M, Bozkurt B, et al. 2016 ACC/AHA/HFSA focused update on new pharmacological therapy for heart failure: an update of the 2013 ACCF/AHA guideline for the management of heart failure: a report of the American College of Cardiology Foundation/American Heart Association Task Force on Clinical Practice Guidelines and the Heart Failure Society of America. [published online ahead of print May 20, 2016]. Circulation. doi:10.1161/CIR.0000000000000435
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ENTRESTO and the ENTRESTO logo are registered trademarks of Novartis AG.
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Novartis Pharmaceuticals Corporation
One Health Plaza
East Hanover, New Jersey 07936
©2016 Novartis
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