Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Leqvio 284 mg solution for injection in pre filled syringe with needle guard
⚠ This medicine appears to have been discontinued
The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.
If you were prescribed this medicine, other products containing Inclisiran sodium may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
What it is and what it is used for
for
What Leqvio is and how it works Leqvio contains the active substance inclisiran. Inclisiran lowers levels of LDL-cholesterol ("bad" cholesterol), which can cause heart and blood circulation problems when levels are raised. Inclisiran works by interfering with RNA (genetic material in body cells) to limit the production of a protein called PCSK9. This protein can increase LDL-cholesterol levels and preventing its production helps to lower your LDL-cholesterol levels. What Leqvio is used for Leqvio is used in addition to your cholesterol-lowering diet if you are an adult with a high cholesterol level in your blood (primary hypercholesterolaemia, including heterozygous familial and non-familial, or mixed dyslipidaemia). Leqvio is given: together with a statin (a type of medicine that treats high cholesterol), sometimes combined with another cholesterol-lowering treatment if the maximum dose of the statin does not work well enough, or alone or together with other cholesterol-lowering medicines when statins do not work well or cannot be used. 2.
What you need to know before you take it
Leqvio
You must not be given Leqvio if you are allergic to inclisiran or any of the other ingredients of this medicine (listed in section 6). Warnings and precautions Talk to your doctor, pharmacist or nurse before you are given Leqvio: if you are receiving dialysis if you have severe liver disease 1
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if you have severe kidney disease
Children and adolescents Do not give this medicine to children and adolescents under 18 years of age, because there is no experience of using the medicine in this age group. Other medicines and Leqvio Tell your doctor, pharmacist or nurse if you are using, have recently used or might use any other medicines. Pregnancy and breast-feeding If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor, pharmacist or nurse for advice before you are given this medicine. The use of Leqvio should be avoided during pregnancy. It is not yet known whether Leqvio passes into human breast milk. Your doctor will help you to decide whether to continue breast-feeding or to start treatment with Leqvio. Your doctor will consider the potential benefits of treatment for you, compared with the health benefits and risks of breast-feeding for your baby. Driving and using machines Leqvio is not expected to affect your ability to drive or use machines. Leqvio contains sodium This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially "sodium-free". 3.
How to take it
The recommended dose of Leqvio is 284 mg given by injection under the skin (subcutaneous injection). The next dose is given after 3 months, followed by further doses every 6 months. Before starting Leqvio you should be on a diet to lower your cholesterol and it is likely that you will be taking a statin. You should stay on this cholesterol-lowering diet and keep taking the statin all the time you receive Leqvio. Leqvio is for injection under the skin of the abdomen; alternative injection sites include the upper arm or thigh. Leqvio will be given to you by a doctor, pharmacist or nurse (healthcare professional). If you receive more Leqvio than you should This medicine will be given to you by your doctor, pharmacist or nurse (healthcare professional). In the highly unlikely event that you are given too much (an overdose) the doctor or other healthcare professional will check you for side effects. If you miss your dose of Leqvio If you miss your appointment for your Leqvio injection, contact your doctor, pharmacist or nurse as soon as you can to arrange your next injection. If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse. 4.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. 2
Common (may affect up to 1 in 10 people) • Injection site reactions, such as pain, redness or rash. Reporting of side effects If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine. 5.
How to store it
Leqvio
Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date which is stated on the label and carton after EXP. The expiry date refers to the last day of that month. This medicine does not require any special storage conditions. Do not freeze. The doctor, pharmacist or nurse will check this medicine and will discard it if it contains particles. Medicines should not be disposed of via wastewater or household waste. Your doctor, pharmacist or nurse will throw away medicines no longer being used. These measures will help protect the environment. 6.
Contents of the pack and other information
What Leqvio contains • The active substance is inclisiran. Each pre-filled syringe contains inclisiran sodium equivalent to 284 mg inclisiran in 1.5 ml solution. Each ml contains inclisiran sodium equivalent to 189 mg inclisiran. • The other ingredients are water for injections, sodium hydroxide (E524) (see section 2 "Leqvio contains sodium") and concentrated phosphoric acid (E338). What Leqvio looks like and contents of the pack Leqvio 284 mg solution for injection in pre-filled syringe is a clear, colourless to pale yellow solution, essentially free of particulates. Each pack contains one single-use pre-filled syringe with needle guard. Marketing Authorisation Holder Novartis Pharmaceuticals UK Limited 2nd Floor, The WestWorks Building White City Place 195 Wood Lane London W12 7FQ United Kingdom Manufacturer Novartis Pharmaceuticals UK Limited 2nd Floor, The WestWorks Building White City Place 195 Wood Lane London, W12 7FQ United Kingdom 3
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder: United Kingdom Novartis Pharmaceuticals UK Ltd. Tel: +44 1276 698370 This leaflet was last revised in 09/2025
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The following information is intended for healthcare professionals only: Leqvio® 284 mg solution for injection in pre-filled syringe Pre-filled syringe with needle guard inclisiran Healthcare professionals should refer to the Summary of Product Characteristics for full prescribing information. Indication (see section 4.1 of the SmPC) Leqvio is indicated in adults with primary hypercholesterolaemia (heterozygous familial and non-familial) or mixed dyslipidaemia, as an adjunct to diet: • in combination with a statin or statin with other lipid-lowering therapies in patients unable to reach LDL-C goals with the maximum tolerated dose of a statin, or • alone or in combination with other lipid-lowering therapies in patients who are statin-intolerant, or for whom a statin is contraindicated. Posology (see section 4.2 of the SmPC) The recommended dose is 284 mg inclisiran administered as a single subcutaneous injection: initially, again at 3 months, followed by every 6 months. Missed doses If a planned dose is missed by less than 3 months, inclisiran should be administered and dosing continued according to the patient's original schedule. If a planned dose is missed by more than 3 months, a new dosing schedule should be started – inclisiran should be administered initially, again at 3 months, followed by every 6 months. Treatment transition from monoclonal antibody PCSK9 inhibitors Inclisiran can be administered immediately after the last dose of a monoclonal antibody proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor. To maintain low-density lipoprotein cholesterol (LDL-C) lowering it is recommended that inclisiran is administered within 2 weeks after the last dose of a monoclonal antibody PCSK9 inhibitor. Special populations Elderly No dose adjustments are necessary in elderly patients (see section 5.2 of the SmPC). Hepatic impairment No dose adjustments are necessary for patients with mild (Child-Pugh class A) or moderate (Child-Pugh class B) hepatic impairment (see section 5.2 of the SmPC). No data are available in patients with severe hepatic impairment (Child-Pugh class C). Inclisiran should be used with caution in patients with severe hepatic impairment. Renal impairment No dose adjustments are necessary for patients with mild, moderate or severe renal impairment or patients with end stage renal disease (see section 5.2 of the SmPC). There is limited experience with inclisiran in patients with severe renal impairment. Inclisiran should be used with caution in these patients. See section 4.4 of the SmPC for precautions to take in case of haemodialysis. Paediatric population The safety and efficacy of inclisiran in children aged less than 18 years has not yet been established. No data are available.
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Method of administration (see section 4.2 of the SmPC) Subcutaneous use. Inclisiran is for subcutaneous injection into the abdomen; alternative injection sites include the upper arm or thigh. Injections should not be given into areas of active skin disease or injury such as sunburns, skin rashes, inflammation, or skin infections. Each 284 mg dose is administered using a single pre-filled syringe. Each pre-filled syringe is for single use only. Inclisiran is intended for administration by a healthcare professional. Contraindications (see section 4.3 of the SmPC) Hypersensitivity to the active substance or to any of the excipients. Special warnings and precautions (see section 4.4 of the SmPC) Haemodialysis The effect of haemodialysis on inclisiran pharmacokinetics has not been studied. Considering that inclisiran is eliminated renally, haemodialysis should not be performed for at least 72 hours after inclisiran dosing. Storage (see section 6.4 of the SmPC) This medicinal product does not require any special storage conditions. Do not freeze. Instructions for Use for Leqvio pre-filled syringe with needle guard This section contains information on how to inject Leqvio. After use
Before use Plunger head Plunger Needle guard wings
Expiry date Needle guard Viewing window Needle Needle cap
Important information you need to know before injecting Leqvio • •
Do not use the pre-filled syringe if any of the seals on the outer carton or the seal of the plastic tray are broken. Do not remove the needle cap until you are ready to inject. 6
• • •
Do not use if the pre-filled syringe has been dropped onto a hard surface or dropped after removing the needle cap. Do not try to re-use or take apart the pre-filled syringe. The pre-filled syringe has a needle guard that will be activated to cover the needle after the injection is finished. The needle guard will help to prevent needle stick injuries to anyone who handles the pre-filled syringe after injection.
Step 1. Inspect the pre-filled syringe You may see air bubbles in the liquid, which is normal. Do not try to remove the air.
- Do not use the pre-filled syringe if it looks damaged or if any of the solution for injection has leaked out of the pre-filled syringe. Step 2. Remove needle cap Firmly pull straight to remove the needle cap from the pre-filled syringe. You may see a drop of liquid at the end of the needle. This is normal. Do not put the needle cap back on. Throw it away. Do not remove the needle cap until you are ready to inject. Early removal of the needle cap prior to injection can lead to drying of the drug product within the needle, which can result in needle clogging. Step 3. Insert needle Gently pinch the skin at the injection site and hold the pinch throughout the injection. With the other hand insert the needle into the skin at an angle of approximately 45 degrees as shown.
Step 4. Start injection Continue to pinch the skin. Slowly press the plunger as far as it will go. This will make sure that a full dose is injected. Note: If you cannot depress the plunger following insertion of the needle, use a new pre-filled syringe.
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Step 5. Complete injection Confirm that the plunger head is between the needle guard wings as shown. This will make sure that the needle guard has been activated and will cover the needle after the injection is finished.
Step 6. Release plunger Keeping the pre-filled syringe at the injection site, slowly release the plunger until the needle is covered by the needle guard. Remove the pre-filled syringe from the injection site.
Step 7. Dispose of the pre-filled syringe Dispose of the pre-filled syringe in accordance with local requirements.
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Frequently asked questions about Leqvio 284 mg solution for injection in pre filled syringe with needle guard
How do I take Leqvio 284 mg solution for injection in pre filled syringe with needle guard?
Leqvio 284 mg solution for injection in pre filled syringe with needle guard comes as injection containing 284mg. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
What is the active substance in Leqvio 284 mg solution for injection in pre filled syringe with needle guard?
The active substance in Leqvio 284 mg solution for injection in pre filled syringe with needle guard is inclisiran sodium.
Are there equivalent medicines to Leqvio 284 mg solution for injection in pre filled syringe with needle guard?
Medicines with the same active substance, strength and form include: Leqvio 284 mg solution for injection in pre filled syringe. They are interchangeable only if your prescriber or pharmacist says so.
Where does this information come from?
This leaflet reproduces the patient information leaflet approved for Leqvio 284 mg solution for injection in pre filled syringe with needle guard, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Can I get Leqvio 284 mg solution for injection in pre filled syringe with needle guard without a prescription?
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
About this leaflet
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
- Source: electronic medicines compendium (emc), Datapharm
- Active substance: inclisiran sodium
- Official document: view the original leaflet on emc →
⚕For healthcare professionals — Summary of Product Characteristics (SmPC)Full SmPC: dosage, interactions, contraindications, warnings+
4.1. Therapeutic indications
Leqvio is indicated in adults with primary hypercholesterolaemia (heterozygous familial and non-familial) or mixed dyslipidaemia, as an adjunct to diet:
• in combination with a statin or statin with other lipid-lowering therapies in patients unable to reach LDL-C goals with the maximum tolerated dose of a statin, or
• alone or in combination with other lipid-lowering therapies in patients who are statin-intolerant, or for whom a statin is contraindicated.
4.2. Posology and method of administration
Posology
The recommended dose is 284 mg inclisiran administered as a single subcutaneous injection: initially, again at 3 months, followed by every 6 months.
Missed doses
If a planned dose is missed by less than 3 months, inclisiran should be administered and dosing continued according to the patient's original schedule.
If a planned dose is missed by more than 3 months, a new dosing schedule should be started – inclisiran should be administered initially, again at 3 months, followed by every 6 months.
Treatment transition from monoclonal antibody proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors
Inclisiran can be administered immediately after the last dose of a monoclonal antibody PCSK9 inhibitor. To maintain low-density lipoprotein cholesterol (LDL-C) lowering it is recommended that inclisiran is administered within 2 weeks after the last dose of a monoclonal antibody PCSK9 inhibitor.
Special populations
Elderly
No dose adjustments are necessary in elderly patients (see section 5.2).
Hepatic impairment
No dose adjustments are necessary for patients with mild (Child-Pugh class A) or moderate (Child-Pugh class B) hepatic impairment. No data are available in patients with severe hepatic impairment (Child-Pugh class C) (see section 5.2). Inclisiran should be used with caution in patients with severe hepatic impairment.
Renal impairment
No dose adjustments are necessary for patients with mild, moderate or severe renal impairment or patients with end-stage renal disease (see section 5.2). There is limited experience with inclisiran in patients with severe renal impairment. Inclisiran should be used with caution in these patients. See section 4.4 for precautions to take in case of haemodialysis.
Paediatric population
The safety and efficacy of inclisiran in children aged less than 18 years have not yet been established. No data are available.
Method of administration
Subcutaneous use.
Inclisiran is for subcutaneous injection into the abdomen; alternative injection sites include the upper arm or thigh. Injections should not be given into areas of active skin disease or injury such as sunburns, skin rashes, inflammation or skin infections.
Each 284 mg dose is administered using a single pre-filled syringe. Each pre-filled syringe is for single use only.
Inclisiran is intended for administration by a healthcare professional.
4.3. Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
4.4. Special warnings and precautions for use
Haemodialysis
The effect of haemodialysis on inclisiran pharmacokinetics has not been studied. Considering that inclisiran is eliminated renally, haemodialysis should not be performed for at least 72 hours after inclisiran dosing.
Sodium content
This medicinal product contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially “sodium-free”.
4.5. Interaction with other medicinal products and other forms of interaction
Inclisiran is not a substrate for common drug transporters and, although in vitro studies were not conducted, it is not anticipated to be a substrate for cytochrome P450. Inclisiran is not an inhibitor or inducer of cytochrome P450 enzymes or common drug transporters. Therefore, inclisiran is not expected to have clinically significant interactions with other medicinal products. Based on the limited data available, clinically meaningful interactions with atorvastatin, rosuvastatin or other statins are not expected.
4.6. Fertility, pregnancy and lactation
Pregnancy
There are no or limited amount of data from the use of inclisiran in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see section 5.3). As a precautionary measure, it is preferable to avoid the use of inclisiran during pregnancy.
Breast-feeding
It is unknown whether inclisiran/metabolites are excreted in human milk. Available pharmacodynamic/toxicological data in animals have shown excretion of inclisiran in milk (see section 5.3). A risk to the newborns/infants cannot be excluded.
A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from Leqvio therapy, taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.
Fertility
No data on the effect of inclisiran on human fertility are available. Animal studies did not show any effects on fertility (see section 5.3).
4.7. Effects on ability to drive and use machines
Leqvio has no or negligible influence on the ability to drive and use machines.
4.8. Undesirable effects
Summary of the safety profile
The only adverse reactions associated with inclisiran were adverse reactions at the injection site (8.2%).
Tabulated list of adverse reactions
Adverse reactions are presented by system organ class (Table 1). Frequency categories are defined as: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000) and not known (cannot be estimated from the available data).
Table 1 Adverse reactions reported in patients treated with inclisiran
System organ class
Adverse reaction
Frequency category
General disorders and administration site conditions
Adverse reactions at the injection site1
Common
1 See section “Description of selected adverse reactions”
Description of selected adverse reactions
Adverse reactions at the injection site
Adverse reactions at the injection site occurred in 8.2% and 1.8% of inclisiran and placebo patients, respectively, in the pivotal studies. The proportion of patients in each group who discontinued treatment due to adverse reactions at the injection site was 0.2% and 0.0%, respectively. All of these adverse reactions were mild or moderate in severity, transient and resolved without sequelae. The most frequently occurring adverse reactions at the injection site in patients treated with inclisiran were injection site reaction (3.1%), injection site pain (2.2%), injection site erythema (1.6%), and injection site rash (0.7%).
Special populations
Elderly
Of the 1,833 patients treated with inclisiran in the pivotal studies, 981 (54%) were 65 years of age or older, while 239 (13%) were 75 years of age or older. No overall differences in safety were observed between these patients and younger patients.
Immunogenicity
In the pivotal studies 1,830 patients were tested for anti-drug antibodies. Confirmed positivity was detected in 1.8% (33/1,830) of patients prior to dosing and in 4.9% (90/1,830) of patients during the 18 months of treatment with inclisiran. No clinically significant differences in the clinical efficacy, safety or pharmacodynamic profiles of inclisiran were observed in the patients who tested positive for anti-inclisiran antibodies.
Laboratory values
In the phase III clinical studies, there were more frequent elevations of serum hepatic transaminases between >1x the upper limit of normal (ULN) and ≤3x ULN in patients on inclisiran (ALT: 19.7% and AST: 17.2%) than in patients on placebo (ALT: 13.6% and AST: 11.1%). These elevations did not progress to exceed the clinically relevant threshold of 3x ULN, were asymptomatic and were not associated with adverse reactions or other evidence of liver dysfunction.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
4.9. Overdose
No clinically relevant adverse reactions were observed in healthy volunteers who received inclisiran at doses up to three times the therapeutic dose. No specific treatment for inclisiran overdose is available. In the event of an overdose, the patient should be treated symptomatically, and supportive measures instituted as required.
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Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.