ivabradine (Corlanor)

Corlanor is a prescription medicine used:

• to treat adults who have chronic (lasting a long time) heart failure, with symptoms, to reduce their risk of hospitalization for worsening heart failure.
• to treat certain children 6 months of age and older who have stable heart failure, with symptoms, that is due to an enlarged heart (dilated cardiomyopathy).

Corlanor may cause serious side effects in adults and children, including:

• Increased risk of irregular or rapid heartbeat (atrial fibrillation or heart rhythm problems). Tell your doctor if you feel any of the following symptoms of an irregular or rapid heartbeat:
  • heart is pounding or racing (palpitations).
  • chest pressure.
  • worsened shortness of breath.
  • near fainting or fainting.
• Slower than normal heart rate (bradycardia). Tell your doctor if you have:
  • a slowing of heart rate, or
  • symptoms of a slow heart rate such as dizziness, fatigue, lack of energy.

In young children signs and symptoms of slow heart rate may include:

• poor feeding,
• difficulty breathing or
• turning blue.

The most common side effects of Corlanor are:

• increased blood pressure
• temporary brightness in part of your field of vision. This is usually caused by sudden changes in light (luminous phenomena). This brightness usually happens within the first 2 months of treatment with Corlanor and may go away during or after treatment with Corlanor. Be careful when driving or operating machinery where sudden changes in light can happen, especially when driving at night.

These are not all the side effects of Corlanor. Ask your doctor or pharmacist for more information. Call your doctor for medical advice about side effects.

Adult and pediatric patients greater than 40 kg

Starting dose is 2.5 (pediatrics and vulnerable adults) or 5 mg twice daily with food. After 2 weeks of treatment, adjust dose based on heart rate. The maximum dose is 7.5 mg twice daily.

Pediatric Patients less than 40 kg

Starting dose is 0.05 mg/kg twice daily with food. Adjust dose at two-week intervals by 0.05 mg/kg based on heart rate. Maximum dose is 0.2 mg/kg (patients 6 months to less than .1 year old) or 0.3 mg/kg (patients 1 years old and older), up to a total of 7.5 mg twice daily.

How should you take Corlanor?

• Take Corlanor exactly as your doctor tells you.
• Do not stop taking Corlanor without talking with your doctor.
• Corlanor comes as a tablet or as an oral solution.
  • Tablets: 5 mg, 7.5 mg
  • Oral Solution: 5 mg/5 mL
  • Tell your doctor if you have trouble swallowing tablets.
  • Your doctor may change your dose of Corlanor during treatment.
• If you are prescribed Corlanor oral solution, see the Instructions for Use that comes with your medicine for important information about how to prepare, and give or take a dose of Corlanor oral solution.
• Take Corlanor 2 times each day with food.
• If you miss a dose of Corlanor, do not give another dose. Give the next dose at the usual time.
• If you or your child take too much Corlanor, call your doctor or go to the nearest emergency room right away.

Avoid drinking grapefruit juice and taking St. John’s wort during treatment with Corlanor. These can affect the way Corlanor works and may cause serious side effects.

Cytochrome P450-based interactions

Avoid CYP3A4 inhibitors or inducers. Corlanor is primarily metabolized by CYP3A4. Concomitant use of CYP3A4 inhibitors increases ivabradine plasma concentrations and use of CYP3A4 inducers decreases them. Increased plasma concentrations may exacerbate bradycardia and conduction disturbances. The concomitant use of strong CYP3A4 inhibitors is contraindicated. Examples of strong CYP3A4 inhibitors include

• azole antifungals (e.g., itraconazole),
• macrolide antibiotics (e.g., clarithromycin, telithromycin),
• HIV protease inhibitors (e.g., nelfinavir), and
• nefazodone.

Avoid concomitant use of moderate CYP3A4 inhibitors when using Corlanor. Examples of moderate CYP3A4 inhibitors include

• diltiazem,
• verapamil, and
• grapefruit juice.

Avoid concomitant use of CYP3A4 inducers when using Corlanor. Examples of CYP3A4 inducers include

• St. John’s wort,
• rifampicin,
• barbiturates, and
• phenytoin.

Negative chronotropes

Negative chronotropes increase risk of bradycardia; monitor heart rate.

Most patients receiving Corlanor will also be treated with a beta-blocker. The risk of bradycardia increases with concomitant administration of drugs that slow heart rate (e.g., digoxin, amiodarone, beta-blockers). Monitor heart rate in patients taking Corlanor with other negative chronotropes.

Pacemakers in adults

Corlanor dosing is based on heart rate reduction, targeting a heart rate of 50 to 60 beats per minute in adults. Patients with demand pacemakers set to a rate ≥ 60 beats per minute cannot achieve a target heart rate < 60 beats per minute, and these patients were excluded from clinical trials. The use of Corlanor is not recommended in patients with demand pacemakers set to rates ≥ 60 beats per minute.

Corlanor may cause harm to an unborn baby. Females who are able to get pregnant:

• Must use effective birth control during treatment with Corlanor.
• Tell your doctor right away if you become pregnant during treatment with Corlanor.

Breastfeeding is not recommended.