Ivabradine

Ivabradine is a prescription medication used to treat Chronic Heart Failure.  

• Ivabradine is available under the following different brand names: Corlanor

Adult and pediatric dosage

Tablet

• 5mg (scored and can be divided into equal halves to provide a 2.5-mg dose)
• 7.5mg

Oral solution

• 5mg/5mL

Heart Failure

Adult dosage

• Initial: 5 mg orally twice daily with meals
• After 2 weeks, assess patient and adjust dose to achieve a resting heart rate of 50-60 bpm (see dose adjustment section below)
• Thereafter, adjust dose as needed based on resting heart rate and tolerability; not to exceed 7.5 mg twice daily

Pediatric dosage

• Children younger than 6 months: Safety and efficacy not established
• Children 6 months or older:
  • Weighing less than 40 kg (oral solution)
  • Initial: 0.05 mg/kg orally twice daily with meals
  • Assess patient at 2-week intervals and adjust dose by 0.05 mg/kg to target HR reduction of at least 20% based on tolerability
  • Maximum dose aged 6 months to younger than 1 year: Not to exceed 0.2 mg/kg twice daily
  • Maximum dose age 1 year and older: 0.3 mg/kg twice daily; not to exceed 7.5 mg twice daily
  • Weighing 40 kg or over (oral tablets)
  • Initial: 2.5 mg orally twice daily with meals
  • Assess patient at 2-week intervals and adjust dose by 2.5 mg to target HR reduction of at least 20%, based on tolerability; not to exceed 7.5 mg twice daily

Dosage Considerations – Should be Given as Follows: 

• See "Dosages"

Common side effects of Ivabradine include:

• temporary brightness in vision (especially during the first 2 months of treatment), 
• slow or irregular heartbeats, 
• high blood pressure, and 
• increased sensitivity to light

Serious side effects of Ivabradine include:

• hives, 
• difficulty breathing, 
• swelling of the face, lips, tongue, or throat, and
• fast or pounding heartbeats, 
• fluttering in the chest, 
• shortness of breath, 
• sudden dizziness, 
• very slow heartbeats, 
• severe headache, 
• blurred vision, 
• pounding in the neck or ears, 
• racing heartbeats with dizziness, 
• tiredness, 
• lack of energy, 
• chest tightness, 
• shortness of breath that is worse than usual, 
• feeding problems, and
• lips or fingernails that turn blue

Rare side effects of Ivabradine include:

• none 

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them.  Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider or pharmacist first

• Ivabradine has severe interactions with at least 23 other drugs. 
• Ivabradine has serious interactions with at least 57 other drugs.
• Ivabradine has moderate interactions with at least 24 other drugs.
• Ivabradine has minor interactions with no other drugs.

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drugs interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use.  Keep a list of all your medications with you, and share this information with your doctor and pharmacist.  Check with your health care professional or doctor for additional medical advice, or if you have health questions, concerns.

Contraindications

• Acute decompensated heart failure
• Clinically significant hypotension 
• Sick sinus syndrome, sinoatrial block, or third-degree AV block (unless a functioning demand pacemaker is present)
• Clinically significant bradycardia
• Severe hepatic impairment
• Pacemaker dependence (heart rate maintained exclusively by the pacemaker)
• Concomitant use of strong CYP3A4 inhibitors

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Ivabradine?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Ivabradine?”

Cautions

Increases the risk of atrial fibrillation; regularly monitor cardiac rhythm and discontinue drug if atrial fibrillation develops

May cause fetal toxicity when administered to a pregnant woman; inform women of childbearing potential to use effective contraception

• Bradycardia and conduction disturbances
  • Bradycardia, sinus arrest, and heart block reported
  • Bradycardia may increase risk of QT prolongation which may lead to severe ventricular arrhythmias, including torsade de pointes, especially in patients with risk factors
  • Risk factors for bradycardia include sinus node dysfunction, conduction defects (eg, first or second-degree AV block, bundle-branch block), ventricular dyssynchrony, and use of other negative chronotropes (eg, beta-blockers, clonidine, digoxin, diltiazem, verapamil, amiodarone)
  • Bradycardia and first-degree heart block were observed in pediatric patients; bradycardia was managed through dose titration, but did not result in study drug discontinuation
  • Avoid use in patients with second-degree AV block unless a functioning demand pacemaker is present
• Pacemakers
  • Dosing is based on heart rate reduction, targeting a heart rate of 50-60 bpm
  • Patients with demand pacemakers set to a rate ≥60 bpm cannot achieve a target heart rate <60 bpm, and these patients were excluded from clinical trials
  • Not recommended in patients with demand pacemakers set to rates ≥60 bpm
• Drug interactions overview
  • Coadministration of verapamil or diltiazem with ivabradine increases ivabradine systemic exposure and should be avoided
  • Concomitant use with negative chronotropes (eg, digoxin, amiodarone, beta-blockers) may increase the risk of bradycardia; monitor heart rate in patients taking ivabradine with other negative chronotropes
  • Coadministration with CYP3A4 inhibitors and inducers
  • Primarily metabolized by CYP3A4
  • Coadministration of CYP3A4 inhibitors increases ivabradine plasma concentrations
  • Increased plasma concentrations may exacerbate bradycardia and conduction disturbances
  • Contraindicated with strong CYP3A4 inhibitors
  • Avoid use with moderate CYP3A4 inhibitors
  • Avoid use with CYP3A4 inducers; coadministration may decrease ivabradine plasma concentrations

Pregnancy and Lactation

• May cause fetal toxicity when administered to a pregnant woman, based on findings in animal studies
• There are no adequate and well-controlled studies in pregnant women to inform any drug-associated risks
• Advise females of childbearing potential to use effective contraception
• Unknown if distributed in human breast milk
• Animal studies have shown, however, that ivabradine is present in rat milk
• Because of potential risk to breastfed infants, breastfeeding is not recommended