Summary of Product Characteristics: Information for the User

Lojuxta 5 mg Hard Capsules

Lojuxta 10 mg Hard Capsules

Lojuxta 20 mg Hard Capsules

Lomitapida

This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. You can help us by reporting any side effects you experience. The final part of section 4 includes information on how to report these side effects.

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

• Keep this leaflet, as 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 even if their symptoms are the same as yours. It may harm them.
• If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

1. Possible side effects

1. Storage of Lojuxta

1. Contents of the pack and other information

Lojuxta contains the active ingredient called lomitapida. Lomitapida is a «lipid-modifying agent» that acts by blocking the action of the «microsomal triglyceride transfer protein». This protein is located within liver and intestinal cells, where it participates in combining fatty substances into larger particles that then enter the circulation. By blocking this protein, the medication reduces the level of fats and cholesterol (lipids) in the blood.

Lojuxta is used to treat adult patients with extremely high cholesterol levels due to a genetic disease (familial hypercholesterolemia homozygous or HoFH). This disease is usually inherited from both parents, who in turn inherited high cholesterol from their parents. The patient's level of «bad» cholesterol is very high from a very early age. Bad cholesterol can produce heart attacks, strokes, or other events at a young age. Lojuxta is used in conjunction with a low-fat diet and other lipid-lowering treatments to decrease cholesterol levels. Lojuxta may decrease the levels in the blood of:

• low-density lipoprotein cholesterol (LDL) (bad cholesterol)
• total cholesterol
• apolipoprotein B, a protein that transports bad cholesterol into the blood
• triglycerides (fatty substances transported into the blood)

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 abnormal liver function test results.
• 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:

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take Lojuxta if:

• you have had liver problems, including those experienced while taking other medicines. These capsules may cause side effects that are also symptoms of liver problems. These side effects are listed in section 4 and you must inform your doctorimmediatelyif you have experienced any of these signs or symptoms, as they may be caused by liver damage. Your doctor will make a blood test to examine your liver before starting to take these capsules, if you increase your dose and regularly during treatment. These blood tests will help your doctor adjust your dose. If your tests show any liver problem, your doctor may decide to reduce your dose or stop treatment.

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

Children and adolescents

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

Other medicines and Lojuxta

Inform your doctor or pharmacist if you are taking, have taken recently or may need to take any other medicine.

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

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

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

• cholesterol-lowering medicines (e.g., atorvastatin)

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

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

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

• medicines used to treat angina, a chest pain caused by the heart (e.g., ranolacina)
• medicines used to lower blood pressure (e.g., amlodipine, lacidipine)
• medicines used to regulate heart rhythm (e.g., amiodarone)

• medicines used to treat epilepsy (e.g., phenobarbital, carbamazepine, phenytoin)
• medicines used to treat diabetes (e.g., pioglitazone, linagliptin)

• medicines used to treat tuberculosis (e.g., isoniazid, rifampicin)
• tetracycline antibiotics used to treat infections such as urinary tract infections
• medicines used 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 used to treat extensive acne (e.g., isotretinoin)
• paracetamol used to treat pain

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

• medicines used to treat urinary incontinence (e.g., propiverina)
• medicines used to treat low sodium levels in the blood (e.g., tolvaptan)
• medicines used to treat excessive daytime sleepiness (e.g., modafinil)

• some herbal medicines:

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

• Goldenseal (for inflammation and infection)

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

• combined 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 you use this medicine at the same time as statins. They may cause muscle pain (myalgia) or weakness (myopathy).Get in touch with your doctor immediatelyif you experience any muscle pain, tenderness, or unexplained weakness.You should not take more than 40 mg of simvastatin if you take Lojuxta (see section 2 “Do not take Lojuxta”)

• anticoagulant coumarins to thin the blood (e.g., warfarin)

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

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

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

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

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

Lojuxta with food, drinks, and alcohol

• Do not drink any type of grapefruit juice.

• It is not recommended to consume alcohol during treatment with Lojuxta.

• You may need to adjust your Lojuxta dose if you consume peppermint essential oil or bitter orange oil.
• To reduce the risk of stomach problems, while taking this medicine, you should follow a low-fat diet. Consult your doctor to know 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 intend to become pregnant, as it may harm the fetus. If you become pregnant while taking this medicine, inform your doctor immediately and stop taking the capsules.

Pregnancy

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

Breastfeeding

• It is unknown whether Lojuxta is excreted in breast milk. Inform your doctor if you are breastfeeding or are about to start. Your doctor will advise you to stop taking Lojuxta or to interrupt 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 them before taking the medicine.

This medicine contains less than 1 mmol of sodium (23 mg) per capsule; it is essentially “sodium-free”.

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again. These capsules must be prescribed by a doctor specializing in the treatment of lipid disorders 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 inform you:

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

Do not change it on your own.

• Take this medication 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 medication with food, as taking these capsules with food may cause stomach problems (see section 2 "Lojuxta with food, drinks, and alcohol").
• If you take another medication that reduces cholesterol by binding to bile acids, such as colesevelam or colestiramine, take the medication that binds to bile acids at least4 hours before or 4 hours aftertaking Lojuxta.

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

You also need to take daily vitamin E and essential fatty acid (omega-3 and omega-6) supplements while taking this medication. The normal daily dose you need to take is indicated below. Ask your doctor or dietitian how to obtain these supplements. See section 2 "Lojuxta with food, drinks, and alcohol".

Daily Amount

* IU - international units, mg - milligrams

If you take more Lojuxta than you should

Inform 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 compensate for the missed doses.

If you interrupt treatment with Lojuxta

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

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

Severe side effects:

• Abnormal values in blood tests for liver function (may affect up to 1 in 10 people). The signs and symptoms of liver problems include:

• Nausea
• Vomiting

• Stomach pain
• Muscle pain
• Fever
• The skin or white of your eyes turn yellow
• You feel more tired than usual
• You feel like you have the flu

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

Other side effects have also been reported, including:

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

• Diarrhea
• Nausea and vomiting
• Stomach pain, discomfort, or bloating
• Loss of 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 returns to the mouth)
• Belching
• Sensation of incomplete defecation (deposit), urgent need to defecate
• Rectal bleeding (anus) or blood in stool
• Dizziness, headache, migraine
• Tiredness, lack of energy, or general weakness
• Enlarged, damaged, or fatty liver
• Discoloration of the skin, solid lumps on the skin, rash, yellowish lumps on the skin
• Changes in blood coagulation tests
• Changes in blood cell counts
• Decreased levels of potassium, carotene, vitamin E, and vitamin K in your blood
• Muscle spasms

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

• Flu or cold, fever, nasal congestion, cough
• Anemia (low red blood cell count)
• Dehydration, dry mouth
• Increased appetite
• Burning or itching of the skin
• Swelling of the eye
• Ulcer or painful spots in the throat
• Vomiting blood
• Dry skin
• Blisters
• Excessive sweating
• Pain or swelling in joints, hands, or feet
• Muscle pain
• Blood or proteins in urine
• Chest pain
• Changes in gait (walking)
• Abnormal liver function test results

Unknown (cannot be estimated from available data)

• Hair loss (alopecia)
• Muscle pain (myalgia)
• Loss of fluids that may cause headache, dry mouth, dizziness, fatigue, or loss of consciousness (dehydration)

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use:www.notificaRAM.es.By reporting side effects, you can contribute to providing more information about the safety of this medicine.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the label and on the carton box after "CAD". The expiration date is the last day of the month indicated.

Store below 30°C.

Keep the bottle perfectly closed to protect it from moisture.

Medicines should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the containers and medications that you no longer need. In this way, you will help protect the environment.

Composition of Lojuxta

• The active ingredient is lomitapida.

Lojuxta 5 mg: a hard capsule contains lomitapida mesilate equivalent to 5 mg of lomitapida.

Lojuxta 10 mg: a hard capsule contains lomitapida mesilate equivalent to 10 mg of lomitapida.

Lojuxta 20 mg: a hard capsule contains lomitapida mesilate equivalent to 20 mg of lomitapida.

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

Capsule coatings:

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

Appearance of Lojuxta and contents of the pack

• 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 Authorization Holder

Chiesi Farmaceutici S.p.A.

Via Palermo 26/A

43122 Parma

Italy

Manufacturer

Amryt Pharmaceuticals DAC

45 Mespil Road

Dublin 4

Ireland

For further information about this medicine, please contact the local representative of the marketing authorization holder:

Last update of this leaflet: January 2025

Other sources of information

This medicine has been authorised under «exceptional circumstances». This type of authorisation means that, due to the rarity of this disease, it has been impossible to obtain a complete information about this medicine. The European Medicines Agency will review all available information about this medicine every year and this leaflet will be updated accordingly.

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