Product Dossier

IVABRADINE-WGR

Product Dossier for IVABRADINE-WGR (ivabradine, GM Pharma). ARTG record, PBS listing, PBAC outcomes — compiled by arcimedes.

What it is

IVABRADINE-WGR contains ivabradine as hydrochloride and is available as 5 mg and 7.5 mg tablets.

Approved indications

— Symptomatic treatment of chronic stable angina due to atherosclerotic coronary artery disease in patients with normal sinus rhythm and heart rate at or above 70 bpm, who are unable to tolerate or have a contraindication to the use of beta-blockers, or in combination with atenolol 50 mg once daily when angina is inadequately controlled. — Treatment of symptomatic chronic heart failure of NYHA Classes II or III with documented left ventricular ejection fraction (LVEF) ≤ 35% in adult patients in sinus rhythm and with heart rate at or above 77 bpm, in combination with optimal standard chronic heart failure treatment.

Dosing overview

For chronic stable angina, the starting dose should not exceed 5 mg twice daily in patients aged below 75 years. After three to four weeks of treatment, if the patient remains symptomatic, the dose is well tolerated and resting heart rate remains above 60 bpm, the dose may be increased to a higher dose, with maintenance not exceeding 7.5 mg twice daily. For chronic heart failure, the recommended starting dose is 5 mg twice daily when heart rate is at or above 77 bpm. After two weeks of treatment and during ongoing treatment, the dose should be reviewed and adjusted according to heart rate if necessary.

Key safety warnings

If during treatment heart rate decreases below 50 bpm at rest or the patient experiences symptoms related to bradycardia such as dizziness, fatigue or hypotension, the dose must be titrated downward to the lowest dose (2.5 mg twice daily). Treatment must be discontinued if heart rate remains below 50 bpm or symptoms of bradycardia persist despite dose reduction. If there is no improvement in symptoms of angina three months after start of treatment, IVABRADINE-WGR should be discontinued. Discontinuation should also be considered if there is only limited symptomatic response and when there is no clinically relevant reduction in resting heart rate within three months.

Regulatory history

IVABRADINE-WGR was first registered on the ARTG on 11 January 2018, with two entries: the 5 mg tablet (ARTG 285498) and the 7.5 mg tablet (ARTG 285486).