Inclisiran injection

About inclisiran

Lipids, or fats, are easily stored in your body and serve as a source of energy. Cholesterol is a type of lipid that is made in your liver from the fatty foods that you eat. When the concentration of cholesterol in your blood is too high, it is called hypercholesterolaemia or hyperlipidaemia. Although a high level of cholesterol will not make you feel ill, if left untreated it can lead to narrowing of the arteries, called atherosclerosis (sometimes referred to as 'hardening of the arteries'). This increases the risk of heart and blood vessel diseases, such as heart attack and stroke.

There is also an inherited form of raised cholesterol called familial hypercholesterolaemia (FH). People who inherit one or two genes linked to FH are at greatly increased risk of heart attack and stroke, regardless of their other risk factors. If you have a strong family history of raised cholesterol or heart disease, you may need to get screened to check if you have FH. You can find out more from our separate leaflet, above.

Cholesterol is carried in the blood by particles called lipoproteins. When low-density lipoproteins (LDL cholesterol) carry cholesterol this is referred to as 'bad' cholesterol. Higher levels of LDL cholesterol in your blood cause the increased risk of cardiovascular disease.

Inclisiran (Leqvio®) injections lower the level of LDL cholesterol in your blood. Inclisiran is actually a small piece of RNA which is absorbed by liver cells after being injected. Inside the liver cells it interferes with the production of a protein called PCSK9. Reducing PCSK9 levels causes the liver cells to remove more LDL cholesterol from your blood.

In clinical trials, two doses of inclisiran injection lowered patients' LDL cholesterol by more than 50% compared to placebo injections. These lower LDL levels were maintained by continuing with treatment.

Inclisiran is used in combination with a cholesterol-lowering diet and is usually given in combination with other lipid-lowering medicines such as the statins (eg, simvastatin, atorvastatin). It is only licensed to be given alone (without statins) if you can't take statins.

Before starting treatment with inclisiran

Some medicines are not suitable for people with certain conditions, and sometimes a medicine may only be used if extra care is taken. For these reasons, before you start treatment with inclisiran it is important that your doctor knows:

• If you are pregnant, trying for a baby, or breastfeeding.

• If you have any problems with the way your kidneys work or if you are undergoing kidney dialysis treatment.

• If you have any problems with the way your liver works.

• If you have ever had an allergic reaction to any ingredients of the injection.

• If you are taking any other medicines. This includes any medicines you are taking which are available to buy without a prescription, as well as herbal and complementary medicines.

How inclisiran injections are given

• Before you start this treatment, read the manufacturer's printed information leaflet from inside your pack, as well as any information you are given by your doctor or nurse.

• Inclisiran injection will usually be given to you by a healthcare professional such as a doctor, nurse or pharmacist. It will be injected into the skin of your tummy (abdomen), or alternatively the skin of your upper arm or thigh.

• You will be given one dose initially, followed by a second dose after three months. After this you will only need an injection once every six months (twice-yearly).

• Your doctor will tell you when to arrange an appointment for you to have these injections. If you miss an appointment, you should contact your doctor's surgery to make another appointment as soon as possible so that you receive your injections on time.

• If you need to cancel an appointment you can still be given inclisiran injection for up to three months from the scheduled date. As long as you receive your dose within this time you can continue with your twice-yearly schedule.

• If you miss a dose by more than three months you will need to start your schedule again, with an initial dose followed by a second dose after three months and then every six months.

Getting the most from your treatment

• Try to keep all your regular appointments with your doctor. This is so your doctor can check on your progress. You may need blood tests from time to time to check that the treatment is working and to check your liver has not been affected by it.

• Let the person administering the injection know if you have any areas of skin that are damaged through sunburn, infection or other inflammation such as eczema. These areas of skin should not be used for injecting.

• Your doctor will give you advice about eating a healthy diet, cutting down on the amount of alcohol you normally drink, reducing the amount of salt in your diet, stopping smoking, and taking regular exercise. Following this advice will also help you to reduce your risk of developing heart and blood vessel disease.

• During treatment with inclisiran you should continue taking any other medicines that have been prescribed to lower your cholesterol levels.

Can inclisiran injections cause problems?

Along with their useful effects, most medicines can cause unwanted side-effects although not everyone experiences them. The table below contains the most common ones associated with inclisiran injections.The only reported side-effects of inclisiran injection involve a reaction at the injection site itself, including tenderness, redness or a rash. These are generally mild reactions but speak with your doctor or pharmacist if any of the following continue or become troublesome.

If you experience any other symptoms which you think may be due to this medicine, speak with your doctor or pharmacist.

How to store inclisiran injections

• You may be asked to collect inclisiran injections from your pharmacy and to store them until your scheduled appointments.

• Store inclisiran injections in their original packaging in a cool, dry place, away from direct heat and light.

• Keep all medicines out of the reach and sight of children.

Important information about all medicines