Ivabradine

What is Ivabradine?

Ivabradine (Corlanor) is a hyperpolarization-activated cyclic nucleotide-gated channel blocker used for the symptomatic management of stable heart-related chest pain and heart failure not fully managed by beta blockers.

What are the uses of this medicine?

This medicine is 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).

How does this medicine work?

• Ivabradine (eye vab' ra deen) is a small molecule inhibitor of the If ion current, a mixed Na+-K+ inward current that is a major determinant of the sinoatrial pacemaker rate.
• Ivabradine inhibits the If ion current and lowers heart rate but, unlike beta blockers, does not affect cardiac contractility.
• In large clinical trials in patients with heart failure in normal sinus rhythm, ivabradine lowered heart rate and decreased episodes of worsening of heart failure and need for hospitalization.

Who Should Not Use this medicine ?

This medicine cannot be used in patients with:

• symptoms of heart failure that recently worsened
• very low blood pressure (hypotension)
• certain heart conditions: sick sinus syndrome, sinoatrial block, or 3rd degree atrioventricular block
• a slow resting heart rate before treatment with Corlanor. Ask your doctor what a slow resting heart rate is for you.
• certain liver problems
• been prescribed any medicines that can increase the effects of Corlanor.

What drug interactions can this medicine cause?

• 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.
• 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.
• The use of Corlanor is not recommended in patients with demand pacemakers set to rates ≥ 60 beats per minute.

Is this medicine FDA approved?

• It was approved for use in the United States in 2015.

How should this medicine be used?

Recommended Dosage: 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 year old and older), up to a total of 7.5 mg twice daily.

Administration

• 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.
• ○ 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.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Tablets: 5 mg, 7.5 mg
• Oral Solution: 5 mg/5 mL (1 mg/mL)

This medicine is available in fallowing brand namesː

• Corlanor

What side effects can this medication cause?

The most common side effects of this medicine include:

• increased blood pressure
• temporary brightness in part of your field of vision.

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

• Harm to an unborn baby
• Increased risk of irregular or rapid heartbeat (atrial fibrillation or heart rhythm problems)
• Slower than normal heart rate (bradycardia)

What special precautions should I follow?

• Corlanor may cause fetal toxicity when administered to a pregnant woman based on findings in animal studies. Females should use effective contraception.
• Corlanor increases the risk of atrial fibrillation. Monitor patients for atrial fibrillation.
• Bradycardia, sinus arrest, and heart block have occurred with Corlanor. Monitor heart rate decreases and bradycardia symptoms during treatment.
• Not recommended in patients with 2nd degree AV block.

What to do in case of emergency/overdose?

• Overdose may lead to severe and prolonged bradycardia.

Management for overdosage:

• In the event of bradycardia with poor hemodynamic tolerance, temporary cardiac pacing may be required.
• Supportive treatment, including intravenous (IV) fluids, atropine, and intravenous beta-stimulating agents such as isoproterenol, may be considered.

Can this medicine be used in pregnancy?

• Based on findings in animals, Corlanor may cause fetal harm when administered to a pregnant woman.
• There are no adequate and well-controlled studies of Corlanor in pregnant women to inform any drug-associated risks.

Can this medicine be used in children?

• The safety and effectiveness of Corlanor have been established in pediatric patients (age 6 months to less than 18 years old)
• The safety and efficacy of Corlanor have not been established in patients less than 6 months of age.

What are the active and inactive ingredients in this medicine?

• Active ingredient: ivabradine
• Inactive ingredients:

Tablet: colloidal silicon dioxide, glycerol, hypromellose, lactose monohydrate, magnesium stearate, maize starch, maltodextrin, polyethylene glycol 6000, red iron oxide, titanium dioxide, yellow iron oxide Oral Solution: Maltitol and water

Who manufactures and distributes this medicine?

• Manufactured by: Amgen Inc. One Amgen Center Drive Thousand Oaks, California

What should I know about storage and disposal of this medication?

• Store Corlanor at room temperature between 68°F to 77°F (20°C to 25°C).
• Keep Corlanor ampules in the unopened child-resistant foil pouch until ready to use, to protect from light.
• Do not save or reuse any leftover Corlanor oral solution. Corlanor oral solution is sterile and does not contain a preservative.
• Keep Corlanor and all medicines out of the reach of children.

• Dailymed label info on Ivabradine
• FDA Ivabradine

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