corlanor

Corlanor (ivabradine) works by affecting your heart"s electrical activity in order to slow the heart rate.

Corlanor is a prescription medicine used in certain people with chronic heart failure, to help lower the risk of needing to be hospitalized when symptoms get worse.

Corlanor is not for use if you already have heart failure symptoms that recently got worse before starting this medicine.

Important information

You should not use Corlanor if you have severe liver disease, very low blood pressure or heart rate, a serious heart condition such as "sick sinus syndrome" or "AV block" (unless you have a pacemaker), or if you depend on a pacemaker to regulate your heart rate.

You also should not take Corlanor if your heart failure symptoms recently got worse, if your resting heart rate is less than 60 bpm, or your blood pressure is less than 90 over 50.

Do not use Corlanor if you are pregnant. It could harm the unborn baby or lead to premature birth.

Many drugs can interact with ivabradine, and some drugs should not be used together. Tell your doctor about all medicines you use, and those you start or stop using during your treatment with Corlanor.

Before taking this medicine

You should not use Corlanor if you are allergic to ivabradine, or if you have:

• a serious heart condition such as "sick sinus syndrome" or "AV block" (unless you have a pacemaker);

• heart failure symptoms that recently got worse;

• severe liver disease;

• if your resting heart rate is less than 60 beats per minute;

• if your blood pressure is lower than 90 over 50; or

• if you depend on a pacemaker to regulate your heart rate.

Some medicines can cause unwanted or dangerous effects when used with Corlanor. Your doctor may need to change your treatment plan if you use any of the following drugs:

• imatinib;

• isoniazid;

• nefazodone;

• an antibiotic - clarithromycin, telithromycin;

• antifungal medicine - itraconazole, ketoconazole, posaconazole, voriconazole;

• heart medication - nicardipine, quinidine; or

• antiviral medicine to treat hepatitis C or HIV/AIDS - atazanavir, boceprevir, cobicistat, delavirdine, fosamprenavir, indinavir, nelfinavir, ritonavir, saquinavir, telaprevir.

To make sure Corlanor is safe for you, tell your doctor if you have:

• other heart problems not being treated with Corlanor;

• liver disease;

• high or low blood pressure;

• if you have a pacemaker; or

• if you take other heart medicine or blood pressure medication, such as amiodarone, digoxin, diltiazem, or verapamil.

Do not use Corlanor if you are pregnant. It could harm the unborn baby or lead to premature birth. In animal studies, Corlanor caused miscarriage, heart and blood vessel problems, and infant death. However, it is not known whether these effects would occur in humans.

Use effective birth control to prevent pregnancy during treatment. Tell your doctor right away if you become pregnant while taking Corlanor.

It is not known whether ivabradine passes into breast milk or if it could harm a nursing baby. You should not breast-feed while using Corlanor.

How should I take Corlanor?

Take Corlanor exactly as prescribed by your doctor. Follow all directions on your prescription label. Your doctor may occasionally change your dose to make sure you get the best results. Do not use this medicine in larger or smaller amounts or for longer than recommended.

Corlanor is usually taken 2 times per day with meals. Avoid eating grapefruit or drinking grapefruit juice with this medicine.

You may also need to take another medicine called a beta-blocker. Use all medications as directed by your doctor. Read the medication guide or patient instructions provided with each medication. Do not change your doses or medication schedule without your doctor"s advice.

Corlanor can cause a temporary brightness in your vision, especially during the first 2 months of treatment. This can make you see halos around lights, see colors within lights, or see multiple images while looking at an object. You may also see kaleidoscope colors or flashes of movement in certain parts of your vision. Sudden bright light can make these vision changes more noticeable. These effects usually go away as you continue taking Corlanor or after you stop taking it.

While using Corlanor, you may need frequent medical tests. Your heart function may need to be checked using an electrocardiograph or ECG (sometimes called an EKG).

Store at room temperature away from moisture and heat.

Corlanor dosing information

Usual Adult Dose of Corlanor for Congestive Heart Failure:

Initial dose: 5 mg orally twice a day with meals
Maximum dose: 7.5 mg orally twice a day

Comments:
-In patients with a history of conduction defects or in patients whom bradycardia could lead to hemodynamic compromise, start with 2.5 mg orally twice a day.
-Assess after 2 weeks and adjust dose to maintain tolerability and achieve resting heart rate between 50 and 60 beats per minute (bpm); if resting heart rate is greater than 60 bpm, increase by 2.5 mg twice daily to a maximum of 7.5 mg twice daily; if resting heart rate is less than 50 bpm or bradycardia signs and symptoms occur, decrease by 2.5 mg twice daily (discontinue if current dose is 2.5 mg orally twice a day).

Use: To reduce worsening heart failure hospitalization risk in patients with stable, symptomatic chronic heart failure and left ventricular ejection fraction (LVEF) at or below 35%, who are in sinus rhythm with resting heart rate at or above 70 bpm and are either unable to tolerate or have a contraindication to beta-blockers.

What happens if I miss a dose?

Skip the missed dose and take the medicine when it is time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while taking Corlanor?

Avoid taking an herbal supplement containing St. John"s wort at the same time you are taking Corlanor.

Grapefruit and grapefruit juice may interact with ivabradine and lead to unwanted side effects. Avoid the use of grapefruit products while taking Corlanor.

Avoid sudden changes in the intensity of light around you, such as going outside in sunlight after being in a dark place. Allow your eyes time to adjust slowly to the light.

Corlanor may cause dizziness or vision changes, which could impair your thinking or reactions. Be careful if you drive (especially at night) or do anything that requires you to be alert and able to see clearly.

Corlanor side effects

Get emergency medical help if you have any signs of an allergic reaction to Corlanor: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• very slow heartbeats with dizziness, tiredness, or a lack of energy;

• a light-headed feeling, like you might pass out;

• shortness of breath that is worse than usual; or

• chest tightness, racing or pounding heartbeats, fluttering in your chest.

Common Corlanor side effects may include:

• slow heart rate;

• high blood pressure (severe headache, blurred vision, pounding in your neck or ears); or

• your eyes may be more sensitive to light.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

See also: Side effects (in more detail)

What other drugs will affect Corlanor?

Many drugs can interact with ivabradine, and some drugs should not be used together. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide. Tell your doctor about all medicines you use, and those you start or stop using during your treatment with Corlanor. Give a list of all your medicines to any healthcare provider who treats you.