Ivabradine

ATC code

C01EB17

Therapeutic class

Other cardiac preparations · Sinus node If current inhibitor

Forms

film-coated tablet

Brand names

Corlentor (ES) · Procoralan (EU) · Ivabradine Anpharm (EU) · Corlanor (US)

Overall confidence

high

Regulatory sources consulted

Symptomatic treatment of chronic stable angina pectoris in coronary artery disease adults with normal sinus rhythm and heart rate ≥ 70 bpm. Indicated: in adults unable to tolerate or with a contra-indication to the use of beta-blockers or in combination with beta-blockers in patients inadequately controlled with an optimal beta-blocker dose.
Treatment of chronic heart failure NYHA II to IV class with systolic dysfunction, in patients in sinus rhythm and whose heart rate is ≥ 75 bpm, in combination with standard therapy including beta-blocker therapy or when beta-blocker therapy is contraindicated or not tolerated.

Hypersensitivity to the active substance; Resting heart rate < 70 bpm prior to treatment (for angina); Cardiogenic shock; Acute myocardial infarction; Severe hypotension (< 90/50 mmHg); Severe hepatic insufficiency; Sick sinus syndrome; Sino-atrial block; 3rd degree AV-block; Pacemaker dependency; Unstable angina; Acute heart failure; Pregnancy, lactation and women of childbearing potential not using appropriate contraceptive measures; Concomitant use of strong cytochrome P450 3A4 inhibitors.

Major warning · Luminous phenomena (phosphenes): described as a transient enhanced brightness in a limited area of the visual field. Onset is typically within the first two months of treatment. Use with caution in patients with retinitis pigmentosa. — EMA
Major warning · Risk of Atrial Fibrillation: an increased risk of atrial fibrillation has been observed in patients treated with ivabradine. Regular clinical monitoring for the occurrence of atrial fibrillation should be performed. — EMA

HighKetoconazoleJ02AB02
Mechanism: Potent CYP3A4 inhibitor. Increases mean ivabradine exposure by 7- to 8-fold.
Recommendation: Concomitant use is contraindicated.
EMA SPC
HighVerapamilC08DA01
Mechanism: Moderate CYP3A4 inhibitor with additional heart rate-reducing properties.
Recommendation: Concomitant use is contraindicated.
EMA SPC
ModerateGrapefruit juice
Mechanism: CYP3A4 inhibitor. Ivabradine exposure was doubled following co-administration with grapefruit juice.
Recommendation: Grapefruit juice intake should be restricted during treatment with ivabradine.
EMA SPC

luminous phenomena (phosphenes) · bradycardia · headache · dizziness · blurred vision

atrial fibrillation · syncope · second-degree AV block · angioedema

FDA category: X

Contraindicated during pregnancy and lactation. Women of childbearing potential must use effective contraception during treatment.