Lomitapide capsules

About lomitapide

Lipids, or fats, are made naturally in your body from the food you eat. They are easily stored in your body and serve as a source of energy. Cholesterol and triglycerides are types of lipid. If the concentration of these lipids in your blood becomes too high, it leads to a condition called hyperlipidaemia. If it is the concentration of cholesterol which has become too high, it is called hypercholesterolaemia.

Although a high blood concentration of lipids will not make you feel ill, it can cause a problem if it is left untreated. People with high lipid levels can develop small fatty patches called atheroma. These patches develop when excess fat is deposited on to the walls of blood vessels. Over time, these patches can make a blood vessel narrower and this is called atherosclerosis (sometimes referred to as 'hardening of the arteries'). The narrowing reduces the blood flow through the artery and increases the risk of a number of heart and blood vessel diseases, such as heart attack and stroke.

Some people are able to control high lipid levels by following a low-fat diet and taking regular exercise. Medicines like lomitapide are prescribed when additional help is needed. Lomitapide is prescribed for adults who have high cholesterol levels because of a condition that runs in their family, called homozygous familial hypercholesterolaemia (HoFH). It lowers the level of cholesterol in blood. It does this by blocking the action of a protein called 'microsomal triglyceride transfer protein'. This protein is involved in building particles of fat which are released into the bloodstream. By blocking its action, fewer cholesterol particles get into the blood. Lomitapide is usually given alongside other medicines to lower lipid levels.

Before taking lomitapide

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 taking lomitapide 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 liver works, or any problems with the way your kidneys work.

• If you have a bowel disease.

• If you have ever had an allergic reaction to a medicine.

• 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 to take lomitapide

• Before you start the treatment, read the manufacturer's printed information leaflet from inside the pack. It will give you more information about lomitapide and will provide you with a full list of the side-effects which you could experience from taking it.

• Take lomitapide exactly as your doctor tells you to. Take one dose a day at bedtime - this should be at least two hours after your evening meal. There are three strengths of lomitapide capsule available - 5 mg, 10 mg and 20 mg. You will be started on the lowest-strength capsule (5 mg) for a few weeks. Your dose will then be increased gradually, as needed.

• If you forget to take a dose one evening, miss it out completely but try to remember your next dose at the usual time. Do not 'double up' on the next evening to make up for missing the dose.

Getting the most from your treatment

• Try to keep your regular appointments with your doctor and hospital clinic. This is so that your doctors can check on your progress. You will need to have regular blood tests. These are to measure your lipid levels and also to check that your liver is working well.

• Your doctor will give you advice about eating a healthy diet, reducing the amount of salt in your diet, stopping smoking and taking regular exercise. Following this advice will help you to reduce your risk of developing heart and blood vessel disease, and is an important part of managing your condition.

• Treatment with lomitapide is usually long-term unless you experience an adverse effect. You should continue to take the capsules regularly.

• The capsules can interfere with the way your body absorbs some substances from your diet. As a result of this, your doctor may ask you to take some supplements. Vitamin E supplements are commonly required.

• Lomitapide can interfere with some medicines. If you buy any medicines, please check with a pharmacist that they are suitable for you to take alongside your prescribed medicines. Many medicines should not be taken within 12 hours of a dose of lomitapide.

• Drink plenty of fluids whilst taking lomitapide so as to avoid becoming dehydrated. This is especially important if you are suffering from side-effects like being sick (vomiting) or diarrhoea.

• Do not drink grapefruit juice while you are on lomitapide. This is because a chemical in grapefruit juice increases the amount of lomitapide in your bloodstream. This makes side-effects more likely.

• It is recommended that you do not drink alcohol while you are taking lomitapide. Drinking alcohol can increase the risk of damage to your liver.

• You must avoid getting pregnant while you are taking lomitapide. Make sure you have discussed with your doctor which types of contraception are suitable for you and your partner.

Can lomitapide cause problems?

Along with their useful effects, most medicines can cause unwanted side-effects although not everyone experiences them. The table below contains some of the most common ones associated with lomitapide. You will find a full list in the manufacturer's information leaflet supplied with your medicine. The unwanted effects often improve as your body adjusts to the new medicine, 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 the capsules, speak with your doctor or pharmacist for further advice.

How to store lomitapide

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

• Store in a cool, dry place, away from direct heat and light.

Important information about all medicines