Lojuxta: detailed information

Package leaflet: Information for the user

Lojuxta 5 mg hard capsules, 10 mg hard capsules, 20 mg hard capsules

lomitapide
This medicinal product is subject to additional monitoring. This will allow for rapid identification of new safety information. You can help by reporting any side effects you experience while taking this medicine. See the end of section 4 for information on how to report side effects.
Please read all of this leaflet carefully before you start taking this medicine, as it contains important information for you.

Keep this leaflet. 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. Do not give it to others, even if their symptoms are the same as yours, as it may be harmful.
If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

What Lojuxta is and what it is used for
What you need to know before taking Lojuxta
How to take Lojuxta
Possible side effects
How to store Lojuxta
Contents of the pack and other information

1. What Lojuxta is and what it is used for

Lojuxta is used to treat adult patients with very high cholesterol levels due to an inherited condition in their families (homozygous familial hypercholesterolemia or HoFH). This condition is usually inherited from both the father and the mother, who also 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 events at a young age. Lojuxta is used to reduce cholesterol levels in combination with a low-fat diet and other lipid-lowering treatments.

Lojuxta can lower blood levels of:

LDL cholesterol (low-density lipoprotein, or "bad" cholesterol)
total cholesterol
apolipoprotein B, a protein that carries "bad cholesterol" in the blood
triglycerides (fats transported in the blood)

2. What you should 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 liver function tests
if you have intestinal problems or are unable to absorb food from the 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) or telithromycin, clarithromycin, erythromycin (for bacterial infections) or indinavir, nelfinavir, saquinavir, ritonavir (for HIV infection) or diltiazem, verapamil (for high blood pressure or angina) or dronedarone (to regulate heart rhythm)
if you are pregnant, suspect you may be pregnant, or are planning a pregnancy (see section 2, “Pregnancy and breastfeeding”).

Warnings and precautions
Talk to your doctor or pharmacist before taking Lojuxta if:

you have had liver problems, even while taking other medicines. These capsules 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 prescribe blood tests to check your liver function before starting treatment, when your dose is increased, and regularly throughout treatment. These blood tests will help your doctor adjust your dose. If the tests show liver problems, your doctor may decide to reduce the dose or stop treatment.

In certain circumstances, you may experience fluid loss/dehydration, for example due to vomiting, nausea, or diarrhoea. It is important to avoid dehydration by drinking sufficient fluids (see section 4).
Children and adolescents
Studies have not been conducted in children and adolescents under 18 years of age. The use of this medicine in children and adolescents is therefore not recommended.
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 together 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 they may need to adjust the dose of Lojuxta:

cholesterol-lowering medicines (such as atorvastatin)
combined oral contraceptives (such as ethinylestradiol, norgestimate)
glucocorticoids (such as beclometasone, prednisolone), steroid medicines used to treat inflammation in conditions such as severe asthma or arthritis
medicines to treat cancer (such as bicalutamide, lapatinib, methotrexate, nilotinib, pazopanib, tamoxifen) or to treat nausea/vomiting during cancer therapy (such as fosaprepitant)
medicines to reduce the activity of the immune system (such as cyclosporine, tacrolimus)
medicines to treat bacterial or fungal infections (such as nafcillin, azithromycin, roxithromycin, clotrimazole)
medicines to treat and prevent blood clots (such as cilostazol, ticagrelor)
medicines to treat angina, chest pain caused by the heart (such as ranolazine)
medicines to lower blood pressure (such as amlodipine, lacidipine)
medicines to regulate heart rhythm (such as amiodarone)
medicines to treat epilepsy (such as phenobarbital, carbamazepine, phenytoin)
medicines to treat diabetes (such as pioglitazone, linagliptin)
medicines to treat tuberculosis (such as isoniazid, rifampicin)
tetracycline antibiotics to treat infections such as urinary tract infections
medicines to treat anxiety and depression (such as alprazolam, fluoxetine, fluvoxamine)
antacids (such as ranitidine, cimetidine)
aminoglutethimide, a medicine used to treat Cushing's syndrome
medicines to treat severe acne (such as isotretinoin)
paracetamol, for pain relief
medicines to treat cystic fibrosis (such as ivacaftor)
medicines to treat urinary incontinence (such as propiverine)
medicines to treat low sodium levels in the blood (such as tolvaptan)
medicines to treat excessive daytime sleepiness (such as modafinil)
certain herbal remedies: St. John’s wort (for depression), ginkgo (to improve memory), or goldenseal (for inflammation and infections)

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 when this medicine is used together with statins. Muscle pain or muscle weakness may also occur. Contact your doctor immediately if you experience unexplained muscle pain, tenderness, or weakness. When using Lojuxta, you must not take more than 40 mg of simvastatin per day (see section 2, “Do not take Lojuxta”)
coumarin anticoagulants to thin the blood (such as warfarin)
medicines to treat cancer (such as everolimus, imatinib, lapatinib, nilotinib, topotecan)
medicines to reduce the activity of the immune system (such as sirolimus)
medicines to treat HIV (such as maraviroc)
medicines to treat and prevent blood clots (such as dabigatran etexilate)
medicines to treat angina, chest pain caused by the heart (such as ranolazine)
medicines to lower blood pressure (such as talinolol, aliskiren, ambrisentan)
medicines to regulate heart rhythm (such as digoxin)
medicines to treat diabetes (such as saxagliptin, sitagliptin)
medicines to treat gout (such as colchicine)
medicines to treat low sodium levels in the blood (such as tolvaptan)
antihistamine medicines to treat hay fever (such as fexofenadine)

Lojuxta with food, drinks, and alcohol

Do not drink grapefruit juice of any kind.
Alcohol consumption during treatment with Lojuxta is not recommended.
The 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 must follow a low-fat diet while taking this medicine. Consult a dietitian to find out what you can eat while taking Lojuxta.

Pregnancy and breastfeeding
Do not take this medicine if you are pregnant, suspect you may be pregnant, or are planning a pregnancy, as it may be harmful to the unborn baby. If you become pregnant while taking this medicine, contact your doctor immediately and stop taking the capsules.
Pregnancy

Before starting treatment, you must confirm that you are not pregnant and that you will use effective contraception as advised by your doctor. If you are taking oral contraceptives and experience an episode of diarrhoea or vomiting lasting more than 2 days, you must use an alternative contraceptive method (condoms, diaphragm) for 7 days after symptoms resolve.
If, after starting treatment with Lojuxta, you decide you wish to become pregnant, inform your doctor, as your treatment will need to be changed.

Breastfeeding

It is not known whether Lojuxta is excreted in breast milk. Inform your doctor if you are breastfeeding or plan to breastfeed. Your doctor may advise you to stop taking Lojuxta or to stop breastfeeding.

Driving and using machines
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 diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per capsule, i.e. essentially “sodium-free”.

3. How to take Lojuxta

Take this medicine exactly as your doctor or pharmacist has told you. If you have any doubts, consult your doctor or pharmacist.
These capsules must be prescribed by a doctor experienced in the treatment of lipid metabolism disorders, who will regularly monitor you.

The recommended starting dose is one 5 mg capsule per day. Your doctor may slowly increase the 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 reduce the dose. Do not change the dose yourself.

Take this medicine once daily with a glass of water before going to bed, at least 2 hours after your evening meal (see section 2, “Lojuxta with food, drinks and alcohol”).
Do not take this medicine with food, as this 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 colestyramine, take it at least 4 hours before or 4 hours after taking Lojuxta.

Due to the possibility of interactions with other medicines, your doctor may adjust the timing of your medication schedule. Alternatively, your doctor may reduce the dose of Lojuxta. Inform your doctor of any changes in the medicines you are taking.

While taking this medicine, you must also take daily supplements of vitamin E and essential fatty acids (omega-3 and omega-6). The usual daily amounts you will need are listed below. Ask your doctor or dietitian how to obtain these supplements. See section 2, “Lojuxta with food, drinks and alcohol”.

Daily amount
Vitamin E 400 IU*
Omega-3
EPA 110 mg *
DHA 80 mg
ALA 210 mg
Omega-6
Linoleic acid 200 mg
*IU: International Units, mg: milligrams

If you take more Lojuxta than you should
Contact your doctor or pharmacist immediately.

If you forget to take Lojuxta
Take your usual dose at the regular time the next day. Do not take a double dose to make up for the missed dose.

If you stop taking Lojuxta
If you stop taking this medicine, your cholesterol levels may rise again. Talk to your doctor before stopping treatment with this medicine.

If you have any questions about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
Serious side effects:

abnormal blood tests regarding liver function have been commonly reported (may affect up to 1 in 10 people). Signs and symptoms of liver problems include:

o nausea
o vomiting
o stomach pain
o muscle aches
o fever
o yellowing of the skin or whites of the eyes
o unusual tiredness
o flu-like feeling

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

The following other side effects have also occurred:
Very common (may affect more than 1 in 10 people):

diarrhoea
nausea and vomiting
stomach pain or discomfort or stomach swelling
decreased appetite
indigestion
flatulence (gas)
constipation
weight loss

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

inflammation of the stomach and intestine leading to diarrhoea and vomiting
regurgitation (food coming back up)
hiccups
feeling of incomplete bowel movement, urgent need to pass stools
bleeding from the rectum or blood in the stools
dizziness, headache, migraine
tiredness, lack of energy or generalised weakness
enlarged, damaged or fatty liver
purplish skin discolouration, solid skin lumps, skin rash, yellowish skin bumps
changes in blood clotting tests
changes in blood cell counts
reduced 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, sinus inflammation, cough
low red blood cell count (anaemia)
dehydration, dry mouth
increased appetite
burning or tingling sensation of the skin
swelling of the eyes
ulcer or sore area 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 tests

Not known (frequency cannot be estimated from the available data):

hair loss (alopecia)
muscle pains (myalgia)
fluid loss which could cause headache, dry mouth, dizziness, tiredness or loss of consciousness (dehydration)

Reporting of side effects
If you get any side effects, including ones not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly through the national reporting system listed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store 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 or the carton after "Exp.". The expiry date refers to the last day of that month.
Store below 30 °C.
Keep the bottle tightly closed to protect the medicine from moisture.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Lojuxta contains

The active substance is lomitapide. Lojuxta 5 mg: each hard capsule contains lomitapide mesylate equivalent to 5 mg of lomitapide. Lojuxta 10 mg: each hard capsule contains lomitapide mesylate equivalent to 10 mg of lomitapide. Lojuxta 20 mg: each hard capsule contains lomitapide mesylate equivalent to 20 mg of lomitapide.
The other components are: pregelatinized starch, sodium starch glycolate (type A), microcrystalline cellulose, monohydrate lactose, anhydrous colloidal 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 red iron oxide (E172).
The shell of the 20 mg capsule contains gelatin and titanium dioxide (E171).
All capsules are printed with edible black ink.

Description of the appearance of Lojuxta and contents of the pack

Lojuxta 5 mg is a hard capsule with orange cap/white body, printed with “5 mg” on the body and “A733” on the cap in black ink.
Lojuxta 10 mg is a hard capsule with orange cap/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 white cap/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
Diapharm GmbH & Co. KG
Am Mittelhafen 56
48155 Münster
Germany

For further information on this medicinal product, please contact the local representative of the Marketing Authorization Holder:

België/Belgique/Belgien Lietuva
Chiesi sa/nv ExCEEd Orphan s.r.o.
Tél/Tel: + 32 (0)2 788 42 00 Bucharova 2657/12, Prague 5, 158 00
Czech Republic
Tel.: +370 661 663 99
[email protected]

България
ExCEEd Orphan s.r.o.
Bucharova 2657/12, Prague 5, 158 00
Czech Republic
Teл.: +359 888 918 090
[email protected]

Luxembourg/Luxemburg
Chiesi sa/nv
Tél/Tel: + 32 (0)2 788 42 00

Česká republika Magyarország
ExCEEd Orphan s.r.o. ExCEEd Orphan s.r.o.
Bucharova 2657/12, Prague 5, 158 00 Bucharova 2657/12, Prague 5, 158 00
Czech Republic Czech Republic
Tel: +420 724 321 774 Tel.: +36 20 399 4269
[email protected] [email protected]

Danmark Malta
Chiesi Pharma AB Amryt Pharmaceuticals DAC
Tlf.: + 46 8 753 35 20 Tel: +44 1604 549952
[email protected]

Deutschland Nederland
Chiesi GmbH Chiesi Pharmaceuticals B.V.
Tel: + 49 40 89724-0 Tel: + 31 88 501 64 00

Eesti Norge
ExCEEd Orphan s.r.o. Chiesi Pharma AB
Bucharova 2657/12, Prague 5, 158 00 Tlf: + 46 8 753 35 20
Czech Republic
Tel.: +370 661 663 99
[email protected]

Ελλάδα Österreich
Amryt Pharmaceuticals DAC Chiesi Pharmaceuticals GmbH
Tηλ: +800 44 474447 Tel: + 43 1 4073919
Tηλ: +44 1604 549952
[email protected]

España Polska
Chiesi España, S.A.U. ExCEEd Orphan s.r.o.
Tel: + 34 93 494 8000 Bucharova 2657/12, Prague 5, 158 00
Czech Republic
Tel.: +48 502 188 023
[email protected]

France Portugal
Chiesi S.A.S. Chiesi Farmaceutici S.p.A.
Tél: + 33 1 47688899 Tel: + 39 0521 2791

Hrvatska România
ExCEEd Orphan Distribution d.o.o. ExCEEd Orphan s.r.o.
Savska cesta 32, Zagreb, 100 00 Bucharova 2657/12, Prague 5, 158 00
Croatia Czech Republic
Tel: +385 99 320 0330 Tel: +40 744 366 015
[email protected] [email protected]

Ireland Slovenija
Chiesi Farmaceutici S.p.A. ExCEEd Orphan s.r.o.
Tel: + 39 0521 2791 Bucharova 2657/12, Prague 5, 158 00
Czech Republic
Tel: +386 30 210 050
[email protected]

Ísland Slovenská republika
Chiesi Pharma AB ExCEEd Orphan s.r.o.
Sími: +46 8 753 35 20 Bucharova 2657/12, Prague 5, 158 00
Czech Republic
Tel: +420 608 076 274
[email protected]

Italia Suomi/Finland
Chiesi Italia S.p.A. Chiesi Pharma AB
Tel: + 39 0521 2791 Puh/Tel: +46 8 753 35 20

Κύπρος Sverige
Amryt Pharmaceuticals DAC Chiesi Pharma AB
Tηλ: +800 44 474447 Tel: +46 8 753 35 20
Tηλ: +44 1604 549952
[email protected]

Latvija
ExCEEd Orphan s.r.o.
Bucharova 2657/12, Prague 5, 158 00
Czech Republic
Tel.: +370 661 663 99
[email protected]

This medicinal product has been authorised under “exceptional circumstances”. This means that, due to the rarity of the disease, it has not been possible to obtain complete information about this medicinal product. The European Medicines Agency will review any new information on this medicinal product annually, and this patient information leaflet will be updated if necessary.

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

Package leaflet: Information for the user

Lojuxta 30 mg hard capsules, 40 mg hard capsules, 60 mg hard capsules

lomitapide
This medicinal product is subject to additional monitoring. This will allow for rapid identification of new safety information. You can help by reporting any side effects you experience while taking this medicine. See the end of section 4 for information on how to report side effects.
Please read this leaflet carefully before taking this medicine, as it contains important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, consult your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to others, even if they have the same symptoms as you, because it could be harmful.
If you experience any side effect, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Contents of this leaflet:

What Lojuxta is and what it is used for
What you need to know before taking Lojuxta
How to take Lojuxta
Possible side effects
How to store Lojuxta
Contents of the pack and other information

1. What Lojuxta is and what it is 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 found within liver and intestinal cells, where it is involved in assembling fatty substances into larger particles that are subsequently released into the bloodstream. By blocking this protein, the medicine reduces levels of fats and cholesterol (lipids) in the blood.
Lojuxta is used to treat adult patients with very high cholesterol due to a condition inherited within their families (homozygous familial hypercholesterolemia or HoFH). This condition is typically inherited from both the father and the mother, who also have high cholesterol passed on to them by their own parents. The patient's level of "bad" cholesterol is very high from an early age. High levels of "bad" cholesterol may lead to heart attacks, strokes, or other events at a young age. Lojuxta is used to reduce cholesterol levels in combination with a low-fat diet and other lipid-lowering treatments.
Lojuxta can lower blood levels of:

LDL cholesterol (low-density lipoproteins, or "bad" cholesterol)
total cholesterol
apolipoprotein B, a protein that carries "bad" cholesterol in the blood
triglycerides (fats transported in the blood)

2. What you should 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 liver function tests
if you have intestinal problems or are unable to absorb food from the 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) or telithromycin, clarithromycin, erythromycin (for bacterial infections) or indinavir, nelfinavir, saquinavir, ritonavir (for HIV infection) or diltiazem, verapamil (for high blood pressure or angina) and dronedarone (to regulate heart rhythm)
if you are pregnant, suspect you may be pregnant, or are planning a pregnancy (see section 2, “Pregnancy and breastfeeding”).

Warnings and precautions
Talk to your doctor or pharmacist before taking Lojuxta if:

you have had liver problems, even while taking other medicines. These capsules 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 order blood tests to check your liver function before you start taking these capsules, when your dose is increased, and regularly throughout treatment. These blood tests will help your doctor adjust your dose. If the tests show liver problems, your doctor may decide to reduce the dose or stop treatment.

In certain situations, you may experience fluid loss/dehydration, for example due to vomiting, nausea, or diarrhoea. It is important to avoid dehydration by drinking sufficient fluids (see section 4).
Children and adolescents
Studies have not been conducted in children and adolescents under 18 years of age. The use of this medicine in children and adolescents is therefore not recommended.
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 together 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 they may need to adjust the dose of Lojuxta:

cholesterol-lowering medicines (such as atorvastatin)
combined oral contraceptives (such as ethinylestradiol, norgestimate)
glucocorticoids (such as beclomethasone, prednisolone), steroid medicines used to treat inflammation in conditions such as severe asthma or arthritis
medicines to treat cancer (such as bicalutamide, lapatinib, methotrexate, nilotinib, pazopanib, tamoxifen) or to treat nausea/vomiting during cancer therapy (such as fosaprepitant)
medicines to reduce the activity of the immune system (such as cyclosporine, tacrolimus)
medicines to treat bacterial or fungal infections (such as nafcillin, azithromycin, roxithromycin, clotrimazole)
medicines to treat and prevent blood clots (such as cilostazol, ticagrelor)
medicines to treat angina, chest pain caused by the heart (such as ranolazine)
medicines to lower blood pressure (such as amlodipine, lacidipine)
medicines to regulate heart rhythm (such as amiodarone)
medicines to treat epilepsy (such as phenobarbital, carbamazepine, phenytoin)
medicines to treat diabetes (such as pioglitazone, linagliptin)
medicines to treat tuberculosis (such as isoniazid, rifampicin)
tetracycline antibiotics to treat infections such as urinary tract infections
medicines to treat anxiety and depression (such as alprazolam, fluoxetine, fluvoxetine)
antacids (such as ranitidine, cimetidine)
aminoglutethimide, a medicine used to treat Cushing's syndrome
medicines to treat severe acne (such as isotretinoin)
paracetamol, for pain relief
medicines to treat cystic fibrosis (such as ivacaftor)
medicines to treat urinary incontinence (such as propiverine)
medicines to treat low sodium levels in the blood (such as tolvaptan)
medicines to treat excessive daytime sleepiness (such as modafinil)
certain herbal remedies: St. John’s wort (for depression), ginkgo (to improve memory), or goldenseal (for inflammation and infections)

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 when this medicine is used together with statins. Muscle pain or muscle weakness may also occur. Contact your doctor immediately if you experience unexplained muscle pain, tenderness, or weakness. When using Lojuxta, you must not take more than 40 mg of simvastatin per day (see section 2, “Do not take Lojuxta”)
coumarin anticoagulants to thin the blood (such as warfarin)
medicines to treat cancer (such as everolimus, imatinib, lapatinib, nilotinib, topotecan)
medicines to reduce the activity of the immune system (such as sirolimus)
medicines to treat HIV (such as maraviroc)
medicines to treat and prevent blood clots (such as dabigatran etexilate)
medicines to treat angina, chest pain caused by the heart (such as ranolazine)
medicines to lower blood pressure (such as talinolol, aliskiren, ambrisentan)
medicines to regulate heart rhythm (such as digoxin)
medicines to treat diabetes (such as saxagliptin, sitagliptin)
medicines to treat gout (such as colchicine)
medicines to treat low sodium levels in the blood (such as tolvaptan)
antihistamine medicines to treat hay fever (such as fexofenadine)

Lojuxta with food, drinks, and alcohol

Do not drink grapefruit juice of any kind.
Alcohol consumption during treatment with Lojuxta is not recommended.
The 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 must follow a low-fat diet while taking this medicine. Consult a dietitian to find out what you can eat while taking Lojuxta.

Before starting treatment, you must confirm that you are not pregnant and that you will use effective contraception as advised by your doctor. If you are taking oral contraceptives and experience an episode of diarrhoea or vomiting lasting more than 2 days, you must use an alternative contraceptive method (condoms, diaphragm) for 7 days after symptoms resolve.
If, after starting treatment with Lojuxta, you decide you wish to become pregnant, inform your doctor, as your treatment will need to be changed.

Breastfeeding

It is not known whether Lojuxta is excreted in breast milk. Inform your doctor if you are breastfeeding or plan to breastfeed. Your doctor may advise you to stop taking Lojuxta or to stop breastfeeding.

Driving and using machines
Treatment may affect your ability to drive or operate machinery. If you feel dizzy during treatment, do not drive or use machinery until you feel better.
Lojuxta contains lactose and sodium
If your doctor has diagnosed you with an intolerance to certain sugars, consult him before taking this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per capsule, i.e. essentially “sodium-free”.

3. How to take Lojuxta

Take this medicine exactly as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
These capsules must be prescribed by a doctor experienced in the treatment of lipid metabolism disorders, who will monitor you regularly.
The recommended starting dose is one 5 mg capsule daily. Your doctor may gradually increase the 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 the dose. Do not change the dose on your own.
Take this medicine once daily with a glass of water before going to bed, at least 2 hours after the evening meal (see section 2, “Lojuxta with food, drinks and alcohol”).
Do not take this medicine with food, as this may otherwise 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 colestipol, take it at least 4 hours before or 4 hours after taking Lojuxta.

Due to the possibility of interactions with other medicines, your doctor may adjust the timing of when you take your medicines. Alternatively, your doctor may reduce the dose of Lojuxta. Inform your doctor of any changes to the medicines you are taking.
While taking this medicine, you must also take daily supplements of vitamin E and essential fatty acids (omega-3 and omega-6). The usual daily amounts you will need are listed below. Ask your doctor or dietitian how to obtain these supplements. See section 2, “Lojuxta with food, drinks and alcohol”.

Daily amount
400 IU*
Vitamin E
Approximately
Omega-3
EPA 110 mg*
DHA 80 mg
ALA 210 mg
Omega-6
Linoleic acid 200 mg
*IU: International Units, mg: milligrams

If you take more Lojuxta than you should
Contact your doctor or pharmacist immediately.

If you forget to take Lojuxta
Take your usual dose at the regular time the next day. Do not take a double dose to make up for the missed dose.

If you stop taking Lojuxta
If you stop taking this medicine, your cholesterol levels may rise again. Speak to your doctor before stopping treatment with this medicine.

If you have any questions about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
Serious side effects:

Abnormal blood test results regarding liver function have been commonly reported (may affect up to 1 in 10 people). Signs and symptoms of liver problems include:
o nausea
o vomiting
o stomach pain
o muscle aches
o fever
o yellowing of the skin or whites of the eyes
o unusual tiredness
o flu-like feeling

Contact your doctor immediately if you experience any of these symptoms, as he or she may decide to stop treatment.

The following additional side effects have also occurred:
Very common (may affect more than 1 in 10 people):

diarrhoea
nausea and vomiting
stomach pain or discomfort or stomach swelling
decreased appetite
indigestion
flatulence (gas)
constipation
weight loss

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

inflammation of the stomach and intestine leading to diarrhoea and vomiting
regurgitation (food coming back up)
hiccups
feeling of incomplete bowel movement, urgent need to defecate
rectal bleeding or blood in stools
dizziness, headache, migraine
tiredness, lack of energy or generalized weakness
enlarged, damaged or fatty liver
purple skin discolouration, solid skin lumps, skin rash, yellowish skin nodules
changes in blood clotting tests
changes in blood cell counts
reduced 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, sinus inflammation, cough
low red blood cell count (anaemia)
dehydration, dry mouth
increased appetite
burning or tingling sensation of the skin
eye swelling
ulcer or sore area 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 urine
chest pain
changes in walking (gait)
altered liver function tests

Not known (frequency cannot be estimated from the available data):

hair loss (alopecia)
muscle pains (myalgia)
fluid loss which could cause headache, dry mouth, dizziness, tiredness or loss of consciousness (dehydration)

Reporting of side effects
If you get any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via the national reporting system listed in Annex V. Reporting side effects can help provide more information on the safety of this medicine.

5. How to store 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 or the carton after "Exp.". The expiry date refers to the last day of that month.
Store below 30 °C.
Keep the bottle tightly closed to protect the medicine from moisture.
Do not dispose of any medicine 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 other information

What Lojuxta contains

The active substance is lomitapide. Lojuxta 30 mg: each hard capsule contains lomitapide mesilate equivalent to 30 mg of lomitapide. Lojuxta 40 mg: each hard capsule contains lomitapide mesilate equivalent to 40 mg of lomitapide. Lojuxta 60 mg: each hard capsule contains lomitapide mesilate equivalent to 60 mg of lomitapide.
The other components are: pregelatinized starch, sodium starch glycolate (type A), microcrystalline cellulose, monohydrate lactose, anhydrous colloidal silica, and magnesium stearate (see section 2, “Lojuxta contains lactose and sodium”).

Capsule shell:

The shell of the 30 mg capsules contains gelatin, titanium dioxide (E171), red iron oxide (E172), and yellow iron oxide (E172).
The shell of the 40 mg capsules contains gelatin, titanium dioxide (E171), and yellow iron oxide (E172).
The shell of the 60 mg capsule contains gelatin, titanium dioxide (E171), and yellow iron oxide (E172).
All capsules are printed with edible black ink.

Description of the appearance of Lojuxta and pack contents

Lojuxta 30 mg is a hard capsule with an orange cap and yellow body, printed on the body with “30 mg” and on the cap with “A733” in black ink.
Lojuxta 40 mg is a hard capsule with a yellow cap and white body, printed on the body with “40 mg” and on the cap with “A733” in black ink.
Lojuxta 60 mg is a hard capsule with a yellow cap and yellow body, printed on the body with “60 mg” and on the cap with “A733” in black ink.

Pack size:
28 capsules

Marketing Authorization Holder
Chiesi Farmaceutici S.p.A.
Via Palermo 26/A
43122 Parma
Italy

Manufacturer
Diapharm GmbH & Co. KG
Am Mittelhafen 56
48155 Münster
Germany

For further information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:

België/Belgique/Belgien Lietuva
Chiesi sa/nv ExCEEd Orphan s.r.o.
Tél/Tel: + 32 (0)2 788 42 00 Bucharova 2657/12, Prague 5, 158 00
Czech Republic
Tel.: +370 661 663 99
[email protected]

България Luxembourg/Luxemburg
ExCEEd Orphan s.r.o. Chiesi sa/nv
Bucharova 2657/12, Prague 5, 158 00 Tél/Tel: + 32 (0)2 788 42 00
Czech Republic
Teл.: +359 888 918 090
[email protected]