FDA Approves Entresto

July 7, 2015 — The U.S. Food and Drug Administration today approved Entresto(sacubitril/valsartan) tablets for the treatment of heart failure. The drug has been shown to reduce the rate of cardiovascular death and hospitalization related to heart failure.

Entresto

Generic Name: sacubitril and valsartan
Date of Approval: July 7, 2015
Company: Novartis Pharmaceuticals Corporation

In clinical trials, Entresto was shown to significantly reduce the rate of heart failure deaths and hospitalizations compared to the ACE inhibitor enalapril.The U.S. Food and Drug Administration (FDA) has approved Entresto (sacubitril/valsartan), a neprilysin inhibitor and angiotensin receptor blocker (ARB) combination used to reduce the risk of hospitalization and cardiovascular death in patients with chronic heart failure. Entresto tablets are available in three dosage strengths administered twice daily, usually in conjunction with other heart failure therapies.

PATIENT INFORMATION

Read this Patient Information before you start treatment and each time you get a refill. There may be new information. This information does not take the place of talking with your doctor about your medical condition or your treatment.

IMPORTANT INFORMATION

Entresto can harm or cause death to your unborn baby. Talk to your doctor about other ways to treat heart failure if you plan to become pregnant. If you get pregnant during treatment, tell your doctor right away.

WHAT IS ENTRESTO?

Entresto is a prescription medicine used to reduce the risk of death and hospitalization in people with certain types of long-lasting (chronic) heart failure.It is usually used with other heart failure therapies, in place of an ACE inhibitor or other ARB therapy.Heart failure occurs when the heart is weak and cannot pump enough blood to your lungs and the rest of your body.It is not known if Entresto is safe and effective in children.

WHO SHOULD NOT TAKE ENTRESTO?

Do not take Entresto if you:

• are allergic to sacubitril or valsartan or any of the inactive ingredients. See the end of this Patient Information leaflet for a complete list of ingredients.
• have had an allergic reaction including swelling of your face, lips, tongue, throat or trouble breathing while taking a type of medicine called an angiotensin-converting enzyme (ACE) inhibitor or angiotensin II receptor blocker (ARB).
• take an ACE inhibitor medicine. Do not take Entresto for at least 36 hours before or after you take an ACE inhibitor medicine. Talk with your doctor or pharmacist before you start treatment if you are not sure if you take an ACE inhibitor medicine.
• have diabetes and take a medicine that contains aliskiren.

BEFORE TAKING ENTRESTO

Before you start treatment, tell your doctor about all of your medical conditions, including if you:

• have kidney or liver problems
• are pregnant or plan to become pregnant. See Important information.
• are breastfeeding or plan to breastfeed. It is not known if this medicine passes into your breast milk. You and your doctor should decide if you will take Entresto or breastfeed. You should not do both.

Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Using Entresto with other medicines can cause serious side effects. Especially tell your doctor if you take:

• potassium supplements or a salt substitute
• nonsteroidal anti-inflammatory drugs (NSAIDs)
• lithium
• other medicines for high blood pressure or heart problems such as an ACE inhibitor, ARB, or aliskiren Keep a list of your medicines to show your doctor and pharmacist when you get a new medicine.

HOW SHOULD I TAKE ENTRESTO?

• Take this medicine exactly as your doctor tells you to take it.
• Take your dose two times each day. Your doctor may change your dose during treatment.
• If you miss a dose, take it as soon as you remember. If it is close to your next dose, do not take the missed dose. Take the next dose at your regular time.
• If you overdose, call your doctor right away.

ENTRESTO SIDE EFFECTS

Entresto may cause serious side effects including:

• See Important information.
• Serious allergic reactions causing swelling of your face, lips, tongue, and throat (angioedema) that may cause trouble breathing and death. Get emergency medical help right away if you have symptoms of angioedema or trouble breathing. Do not take Entresto again if you have had angioedema during treatment. Black patients may have a higher risk of having angioedema during treatment. People who have had angioedema prior to treatment may have a higher risk of having angioedema during treatment. See Who should not take Entresto?
• Low blood pressure (hypotension). Low blood pressure may be more common if you also take water pills. Call your doctor if you become dizzy or lightheaded, or you develop extreme fatigue.
• Kidney problems. Your doctor will check your kidney function during your treatment.If you have changes in your kidney function tests, you may need a lower dose, or may need to stop treatment for a period of time.
• Increased amount of potassium in your blood. Your doctor will check your potassium blood level during treatment.

These are not all the possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

HOW SHOULD I STORE ENTRESTO?

• Store Entresto at room temperature between 68°F to 77°F (20°C to 25°C).
• Protect the tablets from moisture.
• Store the tablets in the original container.

Keep all medicines out of the reach of children.

GENERAL INFORMATION ABOUT THE SAFE AND EFFECTIVE USE OF ENTRESTO

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use this medicine for a condition for which it was not prescribed. Do not give it to other people, even if they have the same symptoms that you have. It may harm them.This Patient Information leaflet summarizes the most important information. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information that is written for health professionals.

WHAT ARE THE INGREDIENTS IN ENTRESTO?

Active ingredients: sacubitril and valsartan

Inactive ingredients: microcrystalline cellulose, low-substituted hydroxypropylcellulose, crospovidone, magnesium stearate (vegetable origin), talc, and colloidal silicon dioxide.
Film coat: hypromellose, titanium dioxide (E 171), Macrogol 4000, talc, iron oxide red (E 172). The film-coat for the 24 mg of sacubitril and 26 mg of valsartan tablet and the 97 mg of sacubitril and 103 mg of valsartan tablet also contains iron oxide black (E 172). The film-coat for the 49 mg of sacubitril and 51 mg of valsartan tablet contains iron oxide yellow (E 172).