LEVOSIMENDAN

Background and Date of Approval

Levosimendan received regulatory approval for medical use on 22 September 2000 from the Sweden Medical Products Agency (MPA) for the management of acutely decompensated chronic heart failure (ADHF).

Uses

Levosimendan is used for the short-term management of acutely decompensated severe chronic heart failure (ADHF), which means when there is a sudden or gradual worsening of the symptoms of heart failure. This medication is used when the standard treatments haven't provided enough relief and you are still struggling to breathe or need to remove excess fluid from your body.

How is it administered?

Levosimendan is available as a 12.5mg injection. It is given only in a hospital setup by a healthcare provider. It is infused directly into your veins by your physician. Your physician will decide the dosage and frequency of this injection based on the severity of your disease and other factors.

Side Effects

Levosimendan can cause some side effects like any other drug. The most common side effects are headache, low blood pressure, and dizziness. Some of the common side effects are potassium deficiency, insomnia, abnormally fast heartbeats (atrial fibrillation), oxygen insufficiency, nausea, constipation, diarrhea, vomiting, and low blood counts (anemia).

Warnings

Do not take levosimendan if you are under 18 years old or if you have allergies to levosimendan or its components. Also, inform your healthcare provider if you have severe chronic kidney or liver disease or any specific heart condition; it is crucial to avoid this medication in these cases. Before taking this medication, inform your doctor if you are experiencing very low blood pressure (hypotension), have low blood counts (anemia), a significant decrease in blood volume, potassium deficiency, or an abnormally fast heartbeat. Always provide your doctor with a detailed medical history and a list of your current medications before starting this treatment.

Precautions

Before taking levosimendan, inform your doctor if you are pregnant or planning to conceive, as its effects on pregnancy are unknown. Breastfeeding is not recommended while using this medicine due to potential cardiovascular side effects on your baby. If you have lung disease or a severe liver disorder, inform your doctor before starting treatment. Additionally, if you have an alcohol addiction, let your doctor know, as the impact of alcohol content in the medication may be reduced. It is not advisable to consume alcohol during the treatment, and driving or operating heavy machinery is unsafe due to the alcohol content in the medicine. Always consult your doctor for personalized guidance.

Word of Advice

Levosimendan is restricted to in-hospital administration and must be given by a healthcare provider. During levosimendan injection therapy, your doctor will monitor your heart rate, blood pressure, and electrocardiogram (ECG) to assess your response. Following completion of the medication, monitoring will continue for approximately 4–5 days, with dose adjustments made as needed. Regular follow-up appointments are essential to reduce the risk of adverse effects. In elderly patients, no dose adjustment is required, though close monitoring remains necessary. Levosimendag injection may cause potassium level reduction, and your doctor may prescribe potassium supplements to counteract this. This medication can also lead to anaemia, so consider including iron-rich foods in your diet. A complete cholesterol screening (lipid profile test) should be scheduled at least annually to monitor cardiac health. Monitor your blood pressure, heart rate, and electrolyte levels regularly. Inform your doctor of any concerns before initiating this medication. Report any adverse effects occurring during or after treatment to your healthcare provider without delay.

References

As Kalceks, Health Products Regulatory Authority (HPRA), [Revised on Feb 2022], [Accessed on 21st Sept 2023], https://www.hpra.ie/img/uploaded/swedocuments/f255c6f4-40a8-4c0f-b034-e20069403900.pdf Orion Pharma, Sweden Medical Products Agency (MPA), [Revised on Jun 2010], [Accessed on 21st Sep 2023], https://www.simdax.com/siteassets/simdax-spc.pdf KD Tripathi, Essentials of Medical Pharmacology, Cardiovascular drugs, 8th edition, 2019, 568 Bertram G. Katzung, Drugs Used in Heart Failure, Lange’s Basic and Clinical Pharmacology, 14th Edition, 2018, 212-227.

Frequently Asked Questions

Is levosimendan injection indicated for children?

No, levosimendan injection should not be administered to children and adolescents under 18.

How long does the effect of levosimendan injection last?

The clinical effect of levosimendan injection lasts 7-10 days after the treatment.

What precautions should I take before taking levosimendan injection?

Your blood pressure and volume should be normal before taking this medication. Inform your doctor thoroughly about your medical history and all the medication you have taken.

What are the complications of levosimendan injection?

The most common side effects of levosimendan injection are headache, dizziness, and low blood pressure.

Should I follow any specific diet during the treatment with levosimendan injection?

Yes, It is recommended to eat a low-fat diet and iron-rich foods. Include omega-3 fatty acids and fibers in your diet. Avoid smoking and alcohol consumption.

Does levosimeden injection affect heart rate?

Yes, levosimendan injection significantly increases heart rate in a dose-dependent manner.

Available Brands 2

Written By: Muskan Patel, M.Pharm

Reviewed By: Dr. Vishwa Patel, MBBS