Lojuxta 5 mg hard capsules

Package leaflet: Information for the user

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 under additional monitoring, which will allow quicker detection of new safety information. You can help by reporting any side effects you may experience. Information on how to report side effects is included at the end of section 4.

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

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are side effects not listed in this leaflet. See section 4.

Contents of the leaflet

1. What Lojuxta is and what it is used for
2. What you need to know before taking Lojuxta
3. How to take Lojuxta
4. Possible side effects
5. How to store Lojuxta
6. Contents of the pack and other information

1. What Lojuxta is and what it is used for

Lojuxta contains the active substance called lomitapide. Lomitapide is a "lipid-lowering agent" that works by blocking the action of "microsomal triglyceride transfer protein". This protein is located within the cells of the liver and intestine, where it participates in assembling fatty substances into larger particles that are then released into the bloodstream. By blocking this protein, the medicine reduces the levels of fats and cholesterol (lipids) in the blood.

Lojuxta is used to treat adult patients with very high levels of cholesterol due to an inherited condition (homozygous familial hypercholesterolemia or HoFH). This condition is typically inherited from both the father and the mother, who themselves have high cholesterol passed down from their parents. The patient's level of "bad" cholesterol is very high from an early age. High levels of "bad" cholesterol can lead to heart attacks, strokes, or other cardiovascular events at a young age. Lojuxta is used in combination 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 in the blood
• triglycerides (fat carried in the blood)

2. What you need to know before taking 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 nutrients from your intestine

• if you are taking more than 40 mg of simvastatin per day (another medicine used to lower cholesterol, see section “Other medicines and Lojuxta”)

• if you are taking 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

Talk to your doctor or pharmacist before starting Lojuxta if:

• you have had liver problems, including those occurring during treatment with other medicines. This medicine may cause side effects that could also be symptoms of liver problems. These side effects are listed in section 4 and you must inform your doctor immediately if you experience 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, when your dose is increased, and regularly during treatment. These blood tests will help your doctor adjust your dose. If your tests show any liver problems, your doctor may decide to reduce your dose or stop treatment.

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

Children and adolescents

Studies have not been conducted in children and adolescents under 18 years of age. Therefore, use of this medicine is not recommended in children and adolescents.

Other medicines and Lojuxta

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to 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 inform your doctor or pharmacist if you are taking any of the following medicines, as your Lojuxta dose may need to be adjusted:

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

• combined oral contraceptives (e.g., ethinylestradiol, norgestimate)

• glucocorticoids (e.g., beclometasone, prednisolone), which are corticosteroid medicines used to treat inflammation in conditions such as severe asthma or arthritis

• medicines to treat cancer (e.g., bicalutamide, lapatinib, methotrexate, nilotinib, pazopanib, tamoxifen) or nausea/vomiting associated with cancer treatment (e.g., fosaprepitant)

• medicines to reduce the activity of the immune system (e.g., cyclosporine, tacrolimus)

• medicines to treat bacterial or fungal infections (e.g., nafcillin, azithromycin, roxithromycin, clotrimazole)

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

• medicines to treat angina, a chest pain caused by heart problems (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 urinary tract infections

• medicines to treat anxiety and depression (e.g., alprazolam, fluoxetine, fluvoxamine)

• antacids (e.g., ranitidine, cimetidine)

• aminoglutethimide, a medicine used to treat Cushing's syndrome

• medicines to treat severe acne (e.g., isotretinoin)

• paracetamol for pain relief

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

• medicines to treat urinary incontinence (e.g., propiverine)

• medicines to treat low blood sodium levels (e.g., tolvaptan)

• medicines to treat excessive daytime sleepiness (e.g., modafinil)

• certain herbal remedies:

• 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:

• oral contraceptives (see section 2 “Pregnancy and breastfeeding”)

• other medicines used to lower cholesterol such as:

• statins like 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 immediately if you experience any unexplained muscle pain, tenderness, or weakness. You must not take more than 40 mg of simvastatin if you are taking Lojuxta (see section 2 “Do not take Lojuxta”)

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

• medicines to treat angina, a chest pain caused by heart problems (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 blood sodium levels (e.g., tolvaptan)

• antihistamine medicines 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.
• Your dose of Lojuxta may need to be adjusted if you consume peppermint essential oil or bitter orange.
• To reduce the risk of stomach problems, you should follow a low-fat diet while taking this medicine. Consult your doctor about 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 newborn. 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 that you are using an effective method of contraception as advised by your doctor. If you are taking the oral contraceptive pill and experience an episode of diarrhea or vomiting lasting more than 2 days, you should use an alternative contraceptive method (e.g., condom, diaphragm) for the 7 days following symptom resolution.
• 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 not known whether Lojuxta is excreted in breast milk. Inform your doctor if you are breastfeeding or planning to breastfeed. Your doctor will advise you to stop taking Lojuxta or to discontinue breastfeeding.

Driving and using machines

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

Lojuxta contains lactose and sodium

If your doctor has informed you that you have an intolerance to certain sugars, consult them before taking this medicine.

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

3. How to take Lojuxta

Follow exactly the instructions for using this medicine as given by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again. These capsules should be prescribed by a specialist doctor experienced in the treatment of lipid disorders, who will also monitor you regularly.

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

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

Do not change it on your own.

• Take this medicine once daily 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 may cause stomach problems (see section 2, "Lojuxta with food, drinks and alcohol").
• If you are taking another cholesterol-lowering medicine that binds bile acids, such as colesevelam or cholestyramine, take the bile acid-binding medicine at least 4 hours before or 4 hours after taking Lojuxta.

Due to the risk of interactions with other medicines, your doctor may change the time of day when you take your medicines. Alternatively, your doctor may reduce your dose of Lojuxta. Inform your doctor of 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 needed is indicated below. Ask your doctor or dietitian how to obtain these supplements. See section 2, "Lojuxta with food, drinks and alcohol".

If you take more Lojuxta than you should

Contact your doctor or pharmacist immediately.

If you forget to take Lojuxta

Take your normal dose at the usual time on the following 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 levels may rise again. You should contact your doctor before stopping this medicine.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

Serious adverse effects:

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

• nausea

• vomiting

• stomach pain

• muscle pain

• fever

• yellowing of the skin or whites of the eyes

• feeling more tired than usual

• feeling as if you have the flu

Contact your doctor immediately if you experience any of these symptoms, as your doctor may decide to discontinue treatment.

Other adverse effects that have been reported include:

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 causing diarrhea and vomiting

• regurgitation (food returning to the mouth)

• eructation (belching)

• sensation of incomplete bowel movement (defecation), urgent need to defecate

• rectal bleeding (anus) or blood in the stool

• dizziness, headache, migraine

• fatigue, lack of energy or general weakness

• enlarged, damaged or fatty liver

• violet discoloration of the skin, solid lumps under the skin, rash, yellowish lumps on the skin

• changes in blood clotting tests

• changes in blood cell counts

• decreased levels of potassium, carotene, vitamin E and vitamin K in your blood

• muscle spasms

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

• flu or cold, fever, sinus inflammation, cough

• low red blood cell count (anemia)

• dehydration, dry mouth

• increased appetite

• burning or stinging sensation of the skin

• eye swelling

• ulcer or painful spots in the throat

• vomiting blood

• dry skin

• blisters

• excessive sweating

• joint pain or swelling, pain in hands or feet

• muscle pain

• blood or protein in the urine

• chest pain

• changes in walking (gait)

• abnormal liver function test result

Not known (cannot be estimated from available data)

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

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You may also report them directly through the national reporting system detailed in Appendix V. By reporting adverse 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 stated on the label and on the cardboard box after "EXP". The expiry date refers to the last day of the month indicated.

Store below 30 °C.

Keep the bottle tightly closed to protect it from moisture.

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

6. Contents of the pack and other 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 components 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 shell:

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

Appearance of Lojuxta and contents of the pack

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

Pack sizes:

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 medicinal product, contact the local representative of the Marketing Authorization Holder:

Date of the most recent review of this leaflet:

This medicinal product has been authorised under "exceptional circumstances". This means that, because the disease is rare, it has not been possible to obtain complete information about this medicinal product. The European Medicines Agency will evaluate all available information on this medicinal product every year, and this leaflet will be updated accordingly.

Other sources of information

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