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Indications and safety

Important Information

SIMDAX® is indicated for the short-term treatment of acutely decompensated severe chronic heart failure (ADHF) in situations where conventional therapy is not sufficient, and in cases where inotropic support is considered appropriate.

Important safety information

  • SIMDAX® is contraindicated in patients with: - A known hypersensitivity to levosimendan or to any of the excipients - Severe hypotension and tachycardia - Significant mechanical obstructions affecting ventricular filling or outflow or both - Severe renal impairment (creatinine clearance <30 ml/min) and severe hepatic impairment - A history of torsades de pointes

  • Caution is advised in patients with low baseline systolic or diastolic blood pressure or those at risk for a hypotensive episode. More conservative dosing regimens are recommended for these patients. Physicians should tailor the dose and duration of therapy to the condition and response of the patient.

  • Severe hypovolaemia should be corrected prior to levosimendan infusion. If excessive changes in blood pressure or heart rate are observed, the rate of infusion should be reduced or the infusion discontinued.

  • Non-invasive monitoring for at least 4-5 days after the end of infusion is recommended. Monitoring is recommended to continue until the blood pressure reduction has reached its maximum and the blood pressure starts to increase again, and may need to be longer than 5 days if there are any signs of continuing blood pressure decrease, but can be shorter than 5 days if the patient is clinically stable. In patients with mild to moderate renal or mild to moderate hepatic impairment an extended period of monitoring may be needed.

  • SIMDAX® should be used cautiously in patients with mild to moderate hepatic impairment. Impaired hepatic function may lead to prolonged exposure to the active metabolites, which may result in a more pronounced and prolonged haemodynamic effect.

  • SIMDAX® infusion may cause a decrease in serum potassium concentration. Thus, low serum potassium concentrations should be corrected prior to the administration of SIMDAX® and serum potassium should be monitored during treatment. As with other medicinal products for heart failure, infusions of SIMDAX® may be accompanied by decreases in haemoglobin and haematocrit and caution should be exercised in patients with ischaemic cardiovascular disease and concurrent anaemia.

  • SIMDAX® infusion should be used cautiously in patients with tachycardia, atrial fibrillation with rapid ventricular response or potentially life-threatening arrhythmias.

  • Experience with repeated administration of SIMDAX® is limited.

  • Experience with concomitant use of vaso­active agents, including inotropic agents (except digoxin), is limited. Benefit and risk should be assessed for the individual patient.

  • Simdax should be used cautiously and underclose ECG monitoring in patients with ongoing coronary ischaemia, long QTc interval regardless of aetiology, or when given concomitantly with medicinal products that prolong the QTc interval.

  • The use of levosimendan in cardiogenic shock has not been studied. No information is available on the use of Simdax in the following disorders: restrictive cardiomyopathy, hypertrophic cardiomyopathy, severe mitral valve insufficiency, myocardial rupture, cardiac tamponade, and right ventricular infarction.

  • SIMDAX® should not be administered to children as there is very limited experience of use in children and adolescents under 18 years of age.

  • Limited experience is available on the use of SIMDAX® in patients with heart failure after surgery, and in severe heart failure in patients awaiting heart transplantation.

  • The most frequent adverse events with SIMDAX® are ventricular tachycardia, atrial fibrillation, hypotension, ventricular extrasystoles, tachycardia and headache.

  • Other common (< 1/10, > 1/100) adverse events include hypokalaemia, insomnia, dizziness, cardiac failure, myocardial ischaemia, extrasystoles, nausea, constipation, diarrhoea, vomiting and haemoglobin decreased.