LOJUXTA 5 mg HARD CAPSULES

Introduction

Package Leaflet: Information for the User

Lojuxta 5 mg hard capsules

Lojuxta 10 mg hard capsules

Lojuxta 20 mg hard capsules

lomitapide

This medicine is subject to additional monitoring, which will allow for quick identification of new safety information. You can help by reporting any side effects you may get. The last section of this leaflet includes information on how to report side effects.

Read all of this leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.

• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What is Lojuxta and what is it used for
2. What you need to know before you take Lojuxta
3. How to take Lojuxta

1. Possible side effects

1. Storage of Lojuxta

1. Contents of the pack and other information

1. What is Lojuxta and what is it used for

Lojuxta contains the active substance lomitapide. Lomitapide is a ‘lipid-modifying agent’ that works by blocking the action of ‘microsomal triglyceride transfer protein’. This protein is located inside the cells of the liver and intestine, where it helps to combine fatty substances into larger particles that then enter the bloodstream. By blocking this protein, the medicine reduces the level of fats and cholesterol (lipids) in the blood.

Lojuxta is used to treat adult patients with a very high level of cholesterol due to a genetic disorder (homozygous familial hypercholesterolaemia or HoFH). This condition is usually inherited from both parents, who may also have high cholesterol that they have inherited from their parents. The patient’s ‘bad’ cholesterol level is very high from a very early age. ‘Bad’ cholesterol can cause heart attacks, strokes, or other events at a young age. Lojuxta is used together with a low-fat diet and other lipid-lowering treatments to reduce cholesterol levels. Lojuxta can reduce blood levels of:

• low-density lipoprotein cholesterol (LDL) (‘bad’ cholesterol)
• total cholesterol
• apolipoprotein B, a protein that carries ‘bad’ cholesterol into the blood
• triglycerides (fat carried into the blood)

2. What you need to know before you take Lojuxta

Do not take Lojuxta

• if you are allergic to lomitapide or any of the other ingredients of this medicine (listed in section 6).
• if you have liver problems or unexplained abnormal results in liver function tests
• if you have intestinal problems or cannot absorb food from your intestine
• if you take more than 40 mg of simvastatin per day (another medicine used to lower cholesterol, see section “Other medicines and Lojuxta”)
• if you take any of the following medicines that affect how lomitapide is broken down in the body:

• itraconazole, ketoconazole, fluconazole, voriconazole, posaconazole (for fungal infections)
• telithromycin, clarithromycin, erythromycin (for bacterial infections)
• indinavir, nelfinavir, saquinavir, ritonavir (for HIV infection)

• diltiazem, verapamil (for high blood pressure or angina) and dronedarone (to regulate heart rhythm)

• if you are pregnant, think you may be pregnant, or plan to become pregnant (see section 2 “Pregnancy and breastfeeding”).

Warnings and precautions

Tell your doctor or pharmacist before you start taking Lojuxta if:

• you have had liver problems, including those that occurred while taking other medicines. These capsules can cause side effects that can also be symptoms of liver problems. These side effects are listed in section 4 and you must tell your doctor immediatelyif you have experienced any of these signs or symptoms, as they may be caused by liver damage. Your doctor will perform a blood test to check your liver before you start taking these capsules, if your dose is increased, and regularly during treatment. These blood tests will help your doctor adjust your dose. If your tests reveal any liver problems, your doctor may decide to reduce your dose or stop treatment.

In some cases, you may experience loss of fluids/dehydration, for example, due to vomiting, nausea, and diarrhea. It is essential to avoid dehydration by drinking enough liquid (see section 4).

Children and adolescents

No trials have been conducted in children and adolescents under 18 years of age. Therefore, the use of this medicine is not recommended in children and adolescents.

Other medicines and Lojuxta

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Other medicines may affect how Lojuxta works. Do not take any of the following medicines with Lojuxta:

• certain medicines for bacterial, fungal, or HIV infections (see section 2 “Do not take Lojuxta”)
• certain medicines for high blood pressure, angina, or to regulate heart rhythm (see section 2 “Do not take Lojuxta”)

You should also tell your doctor or pharmacist if you are taking any of the following medicines, as your dose of Lojuxta may need to be changed:

• medicines that lower cholesterol (e.g., atorvastatin)

• combined oral contraceptives (e.g., ethinylestradiol, norgestimate)
• glucocorticoids (e.g., beclometasone, prednisolone) which are corticosteroid medicines used to treat inflammation in diseases such as severe asthma or arthritis
• medicines to treat cancer (e.g., bicalutamide, lapatinib, methotrexate, nilotinib, pazopanib, tamoxifen) or nausea/vomiting with cancer treatment (e.g., fosaprepitant)

• medicines to reduce the activity of the immune system (e.g., ciclosporin, tacrolimus)
• medicines to treat bacterial or fungal infections (e.g., nafcillin, acitromycin, roxithromycin, clotrimazole)

• medicines to prevent blood clots (e.g., cilostazol, ticagrelor)

• medicines to treat angina, a chest pain caused by the heart (e.g., ranolazine)
• medicines to lower blood pressure (e.g., amlodipine, lacidipine)
• medicines to regulate heart rhythm (e.g., amiodarone)
• medicines to treat epilepsy (e.g., phenobarbital, carbamazepine, phenytoin)
• medicines to treat diabetes (e.g., pioglitazone, linagliptin)
• medicines to treat tuberculosis (e.g., isoniazid, rifampicin)
• tetracycline antibiotics to treat infections such as those of the urinary tract
• medicines to treat anxiety and depression disorders (e.g., alprazolam, fluoxetine, fluvoxamine)
• antacids (e.g., ranitidine, cimetidine)
• aminoglutethimide, a medicine used to treat Cushing's syndrome
• medicines to treat extensive acne (e.g., isotretinoin)
• paracetamol to treat pain

• medicines to treat cystic fibrosis (e.g., ivacaftor)

• medicines to treat urinary incontinence (e.g., propiverine)
• medicines to treat low sodium levels in the blood (e.g., tolvaptan)
• medicines to treat excessive daytime sleepiness (e.g., modafinil)
• certain herbal medicines:

• St. John's Wort (for depression)
• Ginkgo (to improve memory)

• Goldenseal (for inflammation and infection)

Lojuxta may affect how other medicines work. Tell your doctor or pharmacist if you are taking any of the following medicines:

• oral contraceptives (see section 2 “Pregnancy and breastfeeding”)
• other medicines used to lower cholesterol, such as:

• statins, such as simvastatin. The risk of liver damage increases if this medicine is used at the same time as statins.

Muscle pain (myalgia) or weakness (myopathy) may occur. Contact your doctor immediatelyif you experience any muscle pain, muscle tenderness, or unexplained weakness.You should not take more than 40 mg of simvastatin if you are taking Lojuxta (see section 2 “Do not take Lojuxta”)

• warfarin and other coumarin anticoagulants to thin the blood (e.g., warfarin)

• medicines to treat cancer (e.g., everolimus, imatinib, lapatinib, nilotinib, topotecan)
• medicines to reduce the activity of the immune system (e.g., sirolimus)
• medicines to treat HIV (e.g., maraviroc)

• medicines to prevent blood clots (e.g., dabigatran etexilate)

• medicines to treat angina, a chest pain caused by the heart (e.g., ranolazine)
• medicines to lower blood pressure (e.g., talinolol, aliskiren, ambrisentan)
• medicines to regulate heart rhythm (e.g., digoxin)

• medicines to treat diabetes (e.g., saxagliptin, sitagliptin)
• medicines to treat gout (e.g., colchicine)

• medicines to treat low sodium levels in the blood (e.g., tolvaptan)
• antihistamines to treat hay fever (e.g., fexofenadine)

Taking Lojuxta with food, drinks, and alcohol

• Do not drink any type of grapefruit juice.

• Alcohol consumption is not recommended during treatment with Lojuxta.

• It may be necessary to adjust your dose of Lojuxta if you consume peppermint oil or bitter oranges.
• To reduce the risk of stomach problems, while taking this medicine, you should follow a low-fat diet. Consult your doctor to find out what you can eat while taking Lojuxta.

Pregnancy and breastfeeding

Do not take this medicine if you are pregnant, think you may be pregnant, or plan to become pregnant, as it may harm the unborn baby. If you become pregnant while taking this medicine, tell your doctor immediately and stop taking the capsules.

Pregnancy

• Before starting treatment, you must confirm that you are not pregnant and that you are using an effective contraceptive method, as advised by your doctor. If you are using the oral contraceptive pill and experience an episode of diarrhea or vomiting that lasts for more than 2 days, you should use an alternative contraceptive method (e.g., condom, diaphragm) for the 7 days following the resolution of symptoms.
• If, after starting treatment with Lojuxta, you decide to become pregnant, tell your doctor, as your treatment may need to be changed.

Breastfeeding

• It is not known whether Lojuxta is excreted in breast milk. Tell your doctor if you are breastfeeding or about to start breastfeeding. Your doctor will advise you to either stop taking Lojuxta or stop breastfeeding.

Driving and using machines

Your treatment may affect your ability to drive or use machines. If you feel dizzy during treatment, do not drive or use machines until you feel better.

Lojuxta contains lactose and sodium

If your doctor has told you that you have an intolerance to some sugars, consult your doctor before taking the medicine.

This medicine contains less than 1 mmol of sodium (23 mg) per capsule; this is essentially ‘sodium-free’.

3. How to take Lojuxta

Follow the instructions for administration of this medicine exactly as told by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again. These capsules must be prescribed by a doctor who is specialized in the treatment of lipid disorders and who will also monitor you regularly.

The recommended initial dose is one 5 mg capsule per day. Your doctor may gradually increase your dose over time, up to a maximum of 60 mg per day. Your doctor will tell you:

• what dose to take and for how long.
• when to increase or decrease your dose.

Do not change it yourself.

• Take this medicine once a day at bedtime with a glass of water, at least 2 hours after dinner (see section 2 “Lojuxta with food, drinks, and alcohol”).
• Do not take this medicine with food, as taking these capsules with food can cause stomach problems (see section 2 “Lojuxta with food, drinks, and alcohol”).
• If you take another medicine that lowers cholesterol by binding to bile acids, such as colesevelam or colestyramine, take the bile acid-binding medicine at least 4 hours before or 4 hours aftertaking Lojuxta.

Due to the risk of interactions with other medicines, your doctor may change the time of day you take your medicines. Another possibility is that your doctor may reduce your dose of Lojuxta. Tell your doctor about any changes in the medicines you are taking.

You also need to take daily supplements of vitamin E and essential fatty acids (omega-3 and omega-6) while taking this medicine. The usual dose you need to take is indicated below. Ask your doctor or dietitian how to get these supplements. See section 2 “Lojuxta with food, drinks, and alcohol”.

Daily amount

• UI - international units, mg - milligrams

If you take more Lojuxta than you should

Tell your doctor or pharmacist immediately.

If you forget to take Lojuxta

Take your normal dose at the usual time the next day. Do not take a double dose to make up for forgotten doses.

If you stop taking Lojuxta

If you stop taking this medicine, your cholesterol may rise again. You should contact your doctor before stopping this medicine.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Serious side effects:

• abnormal results in blood tests of liver function have been reported (may affect up to 1 in 10 people). Signs and symptoms of liver problems are, among others:

• nausea
• vomiting

• stomach pain

• muscle pain
• fever
• yellowing of the skin or the whites of the eyes
• feeling more tired than usual

• feeling like you have the flu

Tell your doctor immediatelyif you experience any of these symptoms, as your doctor may decide to stop treatment.

Other side effects have also been reported, such as:

Very common (may affect more than 1 in 10 people):

• diarrhea

• nausea and vomiting
• stomach pain, discomfort, or bloating
• decreased appetite
• indigestion
• flatulence
• constipation
• weight loss

Common (may affect up to 1 in 10 people):

• inflammation of the stomach and intestines that causes diarrhea and vomiting
• regurgitation (food comes back into the mouth)
• belching

• feeling of incomplete defecation (bowel movement), urgent need to have a bowel movement
• rectal bleeding (anus) or blood in the stool
• dizziness, headache, migraine

• fatigue, lack of energy, or general weakness
• enlarged, damaged, or fatty liver
• purple discoloration of the skin, solid lumps on the skin, rash, yellow bumps on the skin
• changes in blood clotting tests
• changes in blood cell counts

• decreased levels of potassium, carotene, vitamin E, and vitamin K in the blood
• muscle spasms

Uncommon (may affect up to 1 in 100 people):

• flu or cold, fever, inflammation of the nasal passages, cough
• low red blood cell count (anemia)
• dehydration, dry mouth
• increased appetite
• burning or tingling sensation of the skin
• swelling of the eye
• ulcer or painful spots in the throat
• vomiting blood
• dry skin
• blistering
• excessive sweating
• joint or muscle pain, pain in hands or feet
• muscle pain
• blood or protein in the urine
• chest pain
• changes in walking (gait)

• abnormal results in liver function tests

Not known (cannot be estimated from the available data)

• hair loss (alopecia)
• muscle pain (myalgia)
• loss of fluids that can cause headache, dry mouth, dizziness, tiredness, or loss of consciousness (dehydration)

Reporting of side effects

If you experience any side effects, tell your doctor or pharmacist, even if they are not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Lojuxta

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 on the carton after 'EXP'. The expiry date is the last day of the month stated.

Store below 30°C.

Keep the bottle tightly closed to protect from moisture.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and further information

Composition of Lojuxta

• The active substance is lomitapide.

Lojuxta 5 mg: one hard capsule contains lomitapide mesylate equivalent to 5 mg of lomitapide.

Lojuxta 10 mg: one hard capsule contains lomitapide mesylate equivalent to 10 mg of lomitapide.

Lojuxta 20 mg: one hard capsule contains lomitapide mesylate equivalent to 20 mg of lomitapide.

• The other ingredients are: pregelatinized starch, sodium starch glycolate (Type A), microcrystalline cellulose, lactose monohydrate, colloidal anhydrous silica, and magnesium stearate (see section 2 'Lojuxta contains lactose and sodium').

Capsule shells:

• The shell of the 5 mg and 10 mg capsules contains gelatin, titanium dioxide (E171), and red iron oxide (E172).
• The shell of the 20 mg capsules contains gelatin and titanium dioxide (E171).
• All capsules have black edible printing ink.

Appearance of Lojuxta and package contents

• Lojuxta 5 mg is a hard capsule with an orange cap and orange body, with '5 mg' printed on the body and 'A733' printed on the cap with black ink.
• Lojuxta 10 mg is a hard capsule with an orange cap and white body, with '10 mg' printed on the body and 'A733' printed on the cap with black ink.
• Lojuxta 20 mg is a hard capsule with a white cap and white body, with '20 mg' printed on the body and 'A733' printed on the cap with black ink.

The pack sizes are:

28 capsules

Marketing authorisation holder

Chiesi Farmaceutici S.p.A.

Via Palermo 26/A

43122 Parma

Italy

Manufacturer

Amryt Pharmaceuticals DAC

45 Mespil Road

Dublin 4

Ireland

You can request more information about this medicine by contacting the local representative of the marketing authorisation holder:

Date of last revision of this leaflet: January 2025

Other sources of information

This medicine has been authorised under 'exceptional circumstances'. This means that due to the rarity of this disease, it has not been possible to obtain complete information on this medicine. The European Medicines Agency will review any new information that becomes available every year and this leaflet will be updated as necessary.

Detailed information on this medicine is available on the European Medicines Agency website: https://www.ema.europa.eu.