Valheart Special Precautions

Chronic Stable Angina Pectoris: Ivabradine is indicated only for symptomatic treatment of chronic stable angina pectoris because ivabradine has no benefits on cardiovascular outcomes (e.g., myocardial infarction or cardiovascular death).
Measurement of Heart Rate: Given that the heart rate may fluctuate considerably over time, serial heart rate measurements, ECG or ambulatory 24-hour monitoring should be considered when determining resting heart rate before initiation of ivabradine treatment and in patients on treatment with ivabradine when titration is considered. This also applies to patients with a low heart rate, in particular when heart rate decreases below 50 bpm, or after dose reduction.
Cardiac Arrhythmias: Ivabradine is not effective in the treatment or prevention of cardiac arrhythmias and likely loses its efficacy when tachyarrhythmia occurs (e.g., ventricular or supraventricular tachycardia). Ivabradine is therefore not recommended in patients with atrial fibrillation or other cardiac arrhythmias that interfere with sinus node function.
Atrial fibrillation: In patients treated with ivabradine, the risk of developing atrial fibrillation is increased. It is recommended to regular clinically monitor patients for the occurrence of atrial fibrillation (sustained or paroxysmal), which should also include ECG monitoring if clinically indicated (e.g., in case of exacerbated angina, palpitations, irregular pulse). Patients should be informed of signs and symptoms of atrial fibrillation and be advised to contact their physician if these occur. Discontinue treatment with ivabradine if atrial fibrillation develops.
Atrial fibrillation has been more common in patients using concomitantly amiodarone or potent class I anti-arrhythmics. Concomitant use of ivabradine and amiodarone should be avoided. If combination is deemed necessary, close cardiac monitoring is required.
Bradycardia and Conduction Disturbances: Bradycardia, sinus arrest, and heart block have occurred with ivabradine. The rate of bradycardia was 6% per patient-year in patients treated with ivabradine (2.7% symptomatic; 3.4% asymptomatic) and 1.3% per patient-year in patients treated with placebo. Risk factors for bradycardia include sinus node dysfunction, conduction defects (e.g., first or second degree AV block, bundle branch block), ventricular dyssynchrony, and use of other negative chronotropes (e.g., digoxin, diltiazem, verapamil, amiodarone). Bradycardia may increase the risk of QT prolongation which may lead to severe ventricular arrhythmias, including torsade de pointes, especially in patients with risk factors such as use of QTc prolonging drugs.
Concurrent use of verapamil or diltiazem will increase ivabradine exposure, may themselves contribute to heart rate lowering, and should be avoided.
Avoid use of ivabradine in patients with second degree AV block unless a functioning demand pacemaker is present.
If during treatment, the resting heart rate drops below 50 bpm or the patient experiences symptoms related to bradycardia (e.g., dizziness, fatigue or hypotension), the dose must be titrated downward or treatment must be discontinued. Patients should be informed of signs and symptoms of bradycardia and be advised to contact their physician if these occur.
Chronic Heart Failure: Heart failure must be stable, in terms of clinical conditions and medications, before treatment with ivabradine is considered.
Chronic heart failure patients with intraventricular conduction defects (bundle branch block left, bundle branch block right) and ventricular dyssynchrony should be monitored closely.
Use in Hypertensive Patients: Events of blood pressure inadequately controlled were more frequently reported with ivabradine than with placebo (ivabradine 7.1% versus placebo 6.1%). In hypertensive patients requiring ivabradine treatment, monitor blood pressure regularly and reassess treatment of antihypertensive agents.
Stroke: The use of ivabradine is not recommended immediately after a stroke since no data is available in these situations.
Hepatic Impairment: Caution should be exercised when using ivabradine in patients with mild or moderate hepatic impairment. Ivabradine is contraindicated in patients with severe hepatic impairment (Child-Pugh C) as it has not been studied in this population and an increase in systemic exposure is anticipated.
Renal Impairment: Caution should be exercised when using ivabradine in patients with severe renal impairment (creatinine clearance <15 mL/min) since there is no available data in these patients.
Visual function: Ivabradine influences retinal function. There is no evidence of a toxic effect of long-term ivabradine treatment on the retina. Cessation of treatment should be considered if any unexpected deterioration in visual function occurs. Caution should be exercised in patients with retinitis pigmentosa.
Cardiac Devices: There is limited data in patients with implantable cardioverter defibrillator (ICD) or cardiac resynchronization therapy (CRT) taking ivabradine. If ivabradine treatment is deemed necessary for these patients, caution and close cardiac monitoring is recommended.
Effects on Ability to Drive and Use Machines: Ivabradine may cause transient luminous phenomena consisting mainly of phosphenes. The possible occurrence of such luminous phenomena should be taken into account when driving or using machines in situations where sudden variations in light intensity may occur, especially when driving at night.
Use in Children: The safety and efficacy of ivabradine in pediatric patients below 18 years of age have not been established.
Use in the Elderly: Ivabradine has only been studied in a limited number of patients ≥75 years of age. A lower starting dose is recommended in these patients.