INCLISIRAN
Background and Date of Approval
Inclisiran received US Food and Drug Administration approval on December 22, 2021 for lowering low-density lipoprotein cholesterol. It is a proprotein convertase subtilisin kexin type-9 [PCSK-9] class medication.
Uses
Inclisiran is used to lower high cholesterol levels in your blood (primary hypercholesterolaemia, including heterozygous familial and non-familial, or mixed dyslipidemia) together with a statin or a cholesterol-lowering diet.
How is it administered?
Inclisiran will be administered to you by a healthcare professional in a hospital setting. It is usually administered as a subcutaneous injection into the abdomen, upper arm, or thigh. Your doctor will decide the dose, route of administration, and frequency based on your disease condition and other factors. The second dose is given after 3 months and the subsequent dose every 6 months. It is available in the dose of 284mg.
Side Effects
The common side effects that are likely to occur while you are on the treatment with Inclisiran Injection are injection site reactions like redness, rash and pain, arthralgia, bronchitis, fever, chills and headache . If you experience any allergic reactions and serious adverse reactions, report to your doctor immediately.
Warnings
It is not recommended to use this medication if you are allergic to the active compound Inclisiran or its components. It is not recommended to use during pregnancy and breastfeeding, it is advised to consult your physician regarding further queries. It is not recommended for use in children and adolescents below 18 years.
Precautions
You should be taking a statin and following a diet to reduce your cholesterol before beginning this therapy. For the duration that you are receiving inclisiran, you should continue taking the statin and adhering to this cholesterol-lowering diet. Do not stop taking this medicine without consulting your doctor. Talk to your doctor if you have kidney disorders, breathing problems, liver disorders, heart problems, intolerance to sugars before taking this medicine. Inform your physician or pharmacist of any additional medications you are taking, have recently taken, or may take, including over-the-counter medications and herbal remedies.
Word of Advice
Inclisiran works best when combined with lifestyle modifications and other cholesterol-lowering therapies. Maintain a balanced diet low in saturated and trans fats, exercise regularly, keep a healthy weight, and avoid smoking. Continue taking your regular statin medications as prescribed, since inclisiran is effective only alongside these therapies. Do not stop inclisiran without advice from your healthcare professional, even if your symptoms improve. Follow your doctor's guidance and have your cholesterol levels checked regularly. This monitoring helps assess inclisiran's effectiveness and allows your doctor to adjust your treatment plan if needed. If a dose is missed for more than three months, your doctor will need to establish a new dosing regimen.
References
Novartis Pharmaceuticals Corporation , US Food and Drug Administration, [ Revised on July 2023] [ Accessed on 05-03-2024 ], https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/214012s009lbl.pdf Novartis Pharmaceuticals UK Ltd. Electronic medicines compendium (emc), [ Revised on November 2022] [ Accessed on 05-03-2024], https://www.medicines.org.uk/emc/files/pil.12039.pdf Leqvio, Novartis Pharmaceuticals Ltd, https://www.leqvio.com/
Frequently Asked Questions
Can Inclisiran be used during pregnancy or breastfeeding?
The safety of Inclisiran during pregnancy and breastfeeding has not been established. It is important to consult with a healthcare provider before using Inclisiran if you are pregnant, planning to become pregnant, or breastfeeding.
How often do I need to have my cholesterol levels checked while taking Inclisiran?
Your healthcare provider will determine how often you need to have your cholesterol levels checked based on your individual health status and treatment response. Regular monitoring of cholesterol levels is typically recommended during Inclisiran therapy.
Can I stop taking my other cholesterol-lowering medications if I start Inclisiran?
It is important to follow your healthcare provider's instructions regarding the use of other cholesterol-lowering medications while taking Inclisiran. Inclisiran may be used in addition to other medications to achieve optimal cholesterol control.
What should I do if I miss a dose of Inclisiran?
If you miss a dose of Inclisiran, contact your healthcare provider to reschedule the missed dose. Usually inclisiran is given at an interval of 3 months. It is important to maintain the prescribed dosing schedule to ensure the effectiveness of Inclisiran therapy in lowering LDL cholesterol levels.
What are the common side effects of Inclisiran?
Common side effects of Inclisiran may include injection site reactions (such as pain, redness, or swelling), flu-like symptoms (such as fever, chills, or body aches), and headache. These side effects are usually mild and temporary.