5mg, 10mg, 20mg hard lomitapide capsules
What Lojuxta is and what it is used for
Lojuxta contains the active substance lomitapide. Lomitapide is a drug that affects lipid levels. It works by blocking the effect of “microsomal triglyceride transfer protein”. This protein is found inside the cells of the liver and intestines, where it participates in the composition of fatty substances into larger particles which are then released into the blood. By blocking this protein, the drug lowers the levels of fat and cholesterol ( lipids ) in the blood.
Lojuxta is used to treat adult patients with very high cholesterol due to a hereditary disease ( homozygous familial hypercholesterolemia or HoFH). It is usually passed on by both the father and the mother, who also inherited high cholesterol levels from their parents. Patients have a very high level of “bad” cholesterol from a very early age. Bad cholesterol can lead to heart attack, stroke, or other events at an early age. Lojuxta is used in conjunction with a low-fat diet and other lipid-lowering treatments to lower your cholesterol levels.
Loyalty can lower blood levels by:
- low density lipoprotein ( LDL ) cholesterol (“bad” cholesterol )
- total cholesterol
- apolipoprotein -B, a protein that carries “bad cholesterol” in the blood
- triglyceride is (fat that is transported in the blood).
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 liver values
- if you have intestinal problems or can not absorb the food from the intestine
- if you are taking 40 mg simvastatin a day (another medicine used to lower cholesterol)
- if you are taking any of these medicines that affect the breakdown of lomitapide in your body:
- itraconazole, ketoconazole , fluconazole , voriconazole, posaconazole (for fungal infections)
- telithromycin, clarithromycin, erythromycin (against bacterial infections)
- indinavir, nelfinavir, saquinavir (for HIV – infection )
- diltiazem , verapamil (for high blood pressure or angina), and dronedarone (for regulating heart rhythm)
- if you are pregnant, trying to conceive or think you may be pregnant (see section 2 under “Pregnancy and breast-feeding”).
Warnings and cautions
Talk to your doctor or pharmacist before taking Lojuxta if you:
- have had liver problems, including liver problems while taking other medicines. These capsules can cause side effects that can also be a symptom of liver problems. These side effects are listed in section 4 and you must tell your doctor immediately if you have any of these signs and symptoms, as they may be caused by liver damage. Your doctor will take a blood sample for you 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 the blood tests show liver problems, your doctor may decide to lower your dose or discontinue treatment.
You may in some cases suffer from fluid loss/dehydration e.g. in case of vomiting, nausea, and diarrhea. It is important to avoid dehydration by drinking enough fluids (see section 4).
Children and young people
No studies have been performed on children and adolescents under 18 years of age. The use of this drug in children and adolescents is therefore not recommended.
Other drugs and Lojuxta
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Other medicines may affect the way Lojuxta works. Do not take any of the following medicines with Lojuxta:
- certain anti- bacterial – fungal or HIV – infection (see section 2 under “Do not take Lojuxta”)
- certain medicines for high blood pressure , angina or for regulating heart rhythm (see section 2 under “Do not take Lojuxta”).
You must also tell your doctor or pharmacist if you are taking any of the following medicines, as they may need to change your dose of Lojuxta:
- Cholesterol-lowering drugs (eg atorvastatin)
- combined oral contraceptives (eg ethinyl estradiol, norgestimate)
- glucocorticoids (eg beclomethasone, prednisolone ), steroid medicines used to treat inflammation in diseases such as severe asthma and arthritis
- cancer drugs (eg bicalutamide, lapatinib, methotrexate, nilotinib, pazopanib, tamoxifen) or nausea / vomiting in cancer treatment (eg fosaprepitant)
- drugs that lower the activity of the immune system (eg cyclosporine, tacrolimus)
- drugs for the treatment of bacterial or fungal infections (eg nafcillin, azithromycin, roxithromycin, clotrimazole)
- medicines for the treatment and prevention of blood clots (eg cilostazol, tikagrelor)
- drugs for the treatment of angina – chest pain caused by the heart (eg ranolazine)
- medicines for lowering blood pressure (eg amlodipine, lacidipine)
- drugs for regulating heart rhythm (eg amiodarone )
- drugs for the treatment of epilepsy (eg phenobarbital, carbamazepine, phenytoin )
- medicines used to treat diabetes (eg pioglitazone, linagliptin)
- drugs for the treatment of tuberculosis (eg isoniazid , rifampicin)
- tetracycline antibiotics for the treatment of infections such as urinary tract infections
- medicines to treat anxiety and depression (eg alprazolam, fluoxetine , fluvoxamine)
- antacids – antacids (eg ranitidine, cimetidine)
- aminoglutethimide – a drug used to treat Cushing’s syndrome
- medicines to treat severe forms of acne (eg isotretinoin)
- paracetamol – for the treatment of pain
- drugs for the treatment of cystic fibrosis (eg ivacaftar)
- drugs for the treatment of urinary incontinence (eg propiverine)
- drugs for the treatment of low sodium levels in the blood (eg tolvaptan)
- medicines to treat excessive daytime sleepiness (eg modafinil)
- certain herbal remedies:
- St. John’s wort (for depression)
- ginkgo (for improving memory)
- stillness (against inflammation and infection ).
Lojuxta can affect the way other medicines work. Tell your doctor or pharmacist if you are taking any of the following medicines:
- birth control pills (see section 2 under “Pregnancy and breast-feeding”).
- other drugs used to lower cholesterol, such as:
- statins, such as simvastatin . The risk of liver damage increases when this drug is used concomitantly with statins. Increased muscle aches and pains ( myalgia ) or weakness ( myopathy ) may also occur. Contact a doctor immediately if you experience any unexplained pain, soreness or weakness in the muscles. You should not take more than 40 mg simvastatin when using Lojuxta (see section 2 under “Do not take Lojuxta”)
- coumarin anticoagulants for blood thinning (eg warfarin )
- drugs for the treatment of cancer (eg everolimus, imatinib, lapatinib, nilotinib, topotecan)
- drugs that lower the activity of the immune system (eg sirolimus)
- drugs for HIV treatment (eg maravirok)
- medicines for the treatment and prevention of blood clots (eg dabigatran etexilate)
- drugs for the treatment of angina – chest pain caused by the heart (eg ranolazine)
- medicines to lower blood pressure (eg talinolol, aliskiren, ambrisentan)
- drugs for regulating heart rhythm (eg digoxin )
- medicines used to treat diabetes (eg saxagliptin, sitagliptin)
- drugs for the treatment of gout (eg colchicine)
- drugs for the treatment of low sodium levels in the blood (eg tolvaptan)
- antihistamines for the treatment of hay fever (eg fexofenadine).
Loyal with food, drink and alcohol
- Do not drink any type of grapefruit juice.
- Concomitant consumption of alcohol during Lojuxta treatment is not recommended.
- Your Lojux dose may need to be adjusted if you consume peppermint oil or oranges.
- To reduce the risk of stomach problems, you must stay on a low-fat diet while taking this medicine. Talk to a dietitian to find out what you can eat while taking Lojuxta.
Pregnancy and breastfeeding
Do not take this medicine if you are pregnant, trying to conceive, or think you may be pregnant, as there is a risk that it will harm the fetus. If you become pregnant while taking this medicine, contact your doctor immediately and stop taking the capsules.
Pregnancy
- Before starting treatment, certify that you are not pregnant and that you are using an effective method of contraception in accordance with your doctor’s instructions. If you are taking birth control pills and have diarrhea and / or vomiting that lasts for more than 2 days, you must use an alternative method of contraception (eg condoms, diapers ) for 7 days after the symptoms have disappeared.
- If you decide to become pregnant after starting treatment with Lojuxta, tell your doctor, as your treatment will need to be changed.
Breast-feeding
- It is not known if Lojuxta passes into breast milk. Tell your doctor if you are breast-feeding or planning to breast-feed. Your doctor may advise you to stop taking Lojuxta or to stop breast-feeding.
Driving and using machines
Your treatment may affect your ability to drive or use machines. If you get dizzy during the treatment, do not drive or use machines until you feel better.
Lojuxta contains lactose
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
How to take Lojuxta
Always take this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure. You should get these capsules from a doctor with specialized experience in the treatment of lipid disorders. Your doctor will also check you regularly.
The recommended starting dose is one 5 mg capsule daily. Your doctor may slowly increase your dose over time, up to a maximum of 60 mg each day. Your doctor will tell you:
- what dose to take and for how long,
- when to increase or decrease dose one
Do not change the dose yourself.
- Take this medicine with a glass of water once a day at bedtime, at least 2 hours after the evening meal (see section 2 under “Loyalty with food, drink and alcohol”).
- Do not take this medicine with food, as these capsules can cause stomach problems if taken with food.
- If you are taking another drug that lowers cholesterol levels by binding bile acids, such as cholesevelam or cholestyramine, you should take the drug that binds bile acids at least 4 hours before or 4 hours after taking Lojuxta.
As there is a possibility that other medicines affect or are affected by Lojuxta, your doctor may change the time of day when you take your medicines. Alternatively, your doctor may lower your Lojuxta dose. Inform your doctor about any changes that occur regarding 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 one you will need to take is listed below. Ask your doctor or dietitian how to get these supplements. See section 2 under “Loyalty with food, drink, and alcohol”.
| Daily amount | |
| E vitamin | 400 IU * |
| Omega-3 | Approximately |
| 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 a doctor or pharmacist immediately.
If you forget to take Lojuxta
Just take your usual dose at the usual time the next day. Do not take a double dose to make up for a forgotten dose.
If you stop taking Lojuxta
If you stop taking this medicine, your cholesterol may start to rise again. You should contact your doctor before stopping this medicine.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Serious side effects:
- Abnormal blood tests regarding liver function have often been reported (may affect up to 1 in 10 people). Signs and symptoms of liver problems include following:
- nausea
- vomiting
- magont
- muscle aches and pains
- fever
- yellowing of the skin or whites of the eyes
- to feel more tired than usual
- to feel like you have the flu .
Tell your doctor immediately if you have any of these symptoms as your doctor may decide to stop your treatment.
In addition, the following other side effects have occurred:
Very common (may affect more than 1 in 10 people)
- diarrhea
- nausea and vomiting
- stomach pain, upset or bloated stomach
- reduced appetite
- indigestion
- flatulence (gas in the stomach)
- constipation
- weight loss
Common (may affect up to 1 in 10 people)
- inflammation of the stomach and intestines leading to diarrhea and vomiting
- regurgitation (food comes up again)
- belching
- feeling of not having emptied the bowel completely, urgent need to empty the bowel
- bleeding from the rectum or blood in the stool
- dizziness, headache, migraine
- fatigue, lack of energy or general feeling of weakness
- enlarged or damaged liver, fatty liver
- purple discoloration of the skin, hard bumps on the skin, rash, yellow bumps on the skin
- altered blood coagulation tests
- changed number blood s
- decreased levels of potassium , carotene, vitamin E and vitamin K in the blood
- muscle cramps.
Uncommon (may affect up to 1 in 100 people)
- flu or cold, fever, sinusitis, cough
- low red blood cell count ( anemia )
- dehydration (dryness), dry mouth
- increased appetite
- burning or stinging sensation in the skin
- swollen eyes
- sore or sore spot in the throat
- bloody vomiting
- 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 your way of walking
- abnormal lung function test.
No known frequency (can not be calculated from the available data)
- hair loss ( alopecia )
- muscle pain ( myalgia )
- fluid loss that may cause headache, dry mouth , dizziness, fatigue or unconsciousness (dehydration)
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 carton after “EXP”. The expiration date is the last day of the specified month.
Do not store above 30 ° C.
Close the bottle tightly. Moisture sensitive.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
Contents of the pack and other information
Content declaration
- The active substance is lomitapide.Lojuxta 5 mg: each hard capsule contains lomitapide mesilate equivalent to 5 mg lomitapide.Lojuxta 10 mg: each hard capsule contains lomitapide mesilate equivalent to 10 mg lomitapide. Lojuxta 20 mg: each hard capsule contains lomitapide mesilate equivalent to 20 mg lomitapide.
- The other ingredients are: pregelatinised starch , sodium starch glycolate (type A), microcrystalline cellulose, lactose monohydrate , colloidal anhydrous silica and magnesium stearate (for information on lactose monohydrate , see section 2 under “Lojuxta contains lactose”).
Capsule shell:
- The capsule shell of the 5 mg and 10 mg capsules contains gelatin, titanium dioxide (E171) and red iron oxide (E172).
- The capsule shell of the 20 mg capsules contains gelatin and titanium dioxide (E171).
- Printing in edible black is available on all capsules.
What the medicine looks like and contents of the pack
- Lojuxta 5 mg is a hard capsule with an orange-colored upper part / orange-colored lower part with “5 mg” printed on the lower part and “A733” on the upper part in black.
- Lojuxta 10 mg is a hard capsule with an orange-colored upper / white lower part with “10 mg” printed on the lower part and “A733” on the upper part in black.
- Lojuxta 20 mg is a hard capsule with a white top / white bottom with “20 mg” printed on the bottom and “A733” on the top in black.
Pack sizes:
28 capsules
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder
Amryt Pharmaceuticals DAC
45 Mespil Road
Dublin 4
Ireland
Manufacturer
HEALTH Pharma GmbH
Hafenweg 18-20
48155 Münster
Germany
Contact the representative of the marketing authorization holder to find out more about this medicine:
| Belgium / Belgique / BelgienAmryt Pharmaceuticals DACTel: +800 44 474447Tel: +44 1604 549952medinfo@amrytpharma.com | LithuaniaAmryt Pharmaceuticals DACTel: +800 44 474447Tel: +44 1604 549952medinfo@amrytpharma.com |
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