Adults: Levosimendan is for use in hospital only. It should be given where adequate monitoring facilities are available and the staff have experience with inotropic agents.
Method of administration: Levosimendan has to be diluted before use. The infusion is for intravenous use only, and it can be given by the peripheral or the central route.
Posology: The dose and the length of treatment should be individualised according to the patient's clinical condition and response. Treatment starts with a loading dose of 6 to 12 microgram/kg infused over 10 minutes, followed by a continuous infusion of 0.1 microgram/kg/min. The lower loading dose of 6 microgram/kg is recommended for patients who are already on intravenous vasodilators or inotropes or both when the infusion starts. Higher loading doses within this range give a stronger haemodynamic response, but they may bring a transient rise in adverse reactions. Assess the patient's response with the loading dose, or within 30 to 60 minutes of a dose adjustment, and as clinically indicated. If the response seems excessive (hypotension, tachycardia), the infusion rate may be decreased to 0.05 microgram/kg/min or stopped. If the initial dose is tolerated and a greater haemodynamic effect is needed, the rate can be raised to 0.2 microgram/kg/min. For patients with acute decompensation of severe chronic heart failure, the recommended duration of infusion is 24 hours. No signs of tolerance or rebound have been seen after Levosimendan infusion is stopped. Haemodynamic effects last for at least 24 hours and may be seen up to 9 days after a 24-hour infusion ends. Experience of repeated administration of Levosimendan is limited. Experience with vasoactive agents used at the same time, including inotropic agents (except digoxin), is also limited. In the REVIVE programme, a lower loading dose (6 micrograms/kg) was given to patients who were on baseline concomitant vasoactive agents.
Monitoring of treatment: In line with current medical practice, ECG, blood pressure and heart rate must be monitored during treatment, and urine output measured. Monitoring of these parameters is recommended for at least 3 days after the infusion ends, or until the patient is clinically stable. In patients with mild to moderate renal or mild to moderate hepatic impairment, monitoring is recommended for at least 5 days.
Elderly: No dose adjustment is required for elderly patients.
Renal impairment: Levosimendan must be used with caution in patients with mild to moderate renal impairment. It should not be used in patients with severe renal impairment (creatinine clearance <30 ml/min).
Hepatic impairment: Levosimendan must be used with caution in patients with mild to moderate hepatic impairment, although no dose adjustment appears necessary for them. It should not be used in patients with severe hepatic impairment.
Children: Levosimendan should not be given to children and adolescents under 18 years of age.
