LEVOSIMENDAN

Background and Date of Approval

Levosimendan was first approved for medical use on 22nd September 2000 by 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 strictly meant for in-hospital use and should be administered by your healthcare provider. Throughout your levosimendan injection treatment, your doctor will closely monitor your heart rate, blood pressure, and electrocardiogram (ECG) to measure your response. After you have finished the medication, your doctor will continue monitoring you for about 4-5 days and may adjust your dose when necessary. It is crucial to stick to your regular follow-up appointments to minimize the risk of side effects. For elderly patients, there are no dose adjustments done, but they require close monitoring. Levosimendan injection can cause a drop in potassium levels, so your doctor might prescribe potassium supplements to prevent this. Also, consider incorporating iron-rich foods into your diet, as this medication can lead to anemia. Remember to schedule a complete cholesterol screening (lipid profile test) at least once a year to keep track of your heart health. Additionally, keep an eye on your blood pressure, heart rate, and electrolyte levels. Always consult your doctor if you have any concerns before starting this medication. If you experience any side effects during or after treatment, be sure to inform your healthcare provider promptly.

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.

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Written By: P. Thirumal Reddy

Reviewed By: Dr. Tejashwin Adiga