INREBIC 100 mg Hard Capsule

Содержание инструкции

1. Inrebic 100 mg hard capsules
   1. What is Inrebic and what it is used for
   2. What you need to know before you take Inrebic
   3. How to take Inrebic
   4. Possible side effects
   5. How to store Inrebic
   6. Package contents and other information

Inrebic 100 mg hard capsules

fedratinib

Medicinal product subject to additional monitoring. This will allow the rapid identification of
new safety information. You can contribute by reporting any adverse effects
experienced during the use of this medicine. See the end of section 4 for
information on how to report adverse effects.

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, 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, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

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

1. What is Inrebic and what it is used for

What is Inrebic
Inrebic contains the active substance fedratinib. It is a type of medicine known as a “protein kinase inhibitor”.

What is Inrebic used for
Inrebic is used for the treatment of adult patients with enlargement of the spleen or with symptoms related to myelofibrosis, a rare form of blood cancer.

How Inrebic works
An enlarged spleen is one of the characteristics of myelofibrosis. Myelofibrosis is a bone marrow disorder in which the bone marrow is replaced by scar tissue. The abnormal bone marrow is no longer able to produce enough normal blood cells and, as a result, the spleen becomes significantly enlarged. By blocking the action of certain enzymes (called Janus-associated kinases), Inrebic can reduce the size of the spleen in patients with myelofibrosis and relieve symptoms such as fever, night sweats, bone pain and weight loss in patients with myelofibrosis.

2. What you need to know before you take Inrebic

Do not take Inrebic

• if you are allergic to fedratinib or any of the other ingredients of this medicine (listed in section 6).
• if you are pregnant or suspect you may be pregnant.

Warnings and precautions
Talk to your doctor or pharmacist before taking these capsules and during treatment, if
you experience any of the following signs or symptoms:

A condition affecting the brain called encephalopathy, including Wernicke's encephalopathy

• Confusion, memory loss or difficulty thinking; loss of balance or problems walking.
• Eye problems, such as random eye movements, double vision, blurred vision and loss of vision. These could be signs of a brain condition called encephalopathy, including Wernicke's encephalopathy, which can lead to death. Contact your doctor immediately if you experience any of these signs or symptoms.

During treatment, talk to your doctor or pharmacist:

• If you experience a feeling of extreme fatigue, shortness of breath, paleness of the skin or a rapid heartbeat: these may be signs of a low red blood cell count.
• If you experience unusual bleeding or unusual bruising under the skin, bleeding that lasts longer than usual after a blood draw, or bleeding gums: these may be signs of a low platelet count in the blood.
• If you have frequent or recurring infections, which may be a sign of a low white blood cell count.
• If you have nausea, vomiting or diarrhoea.
• If you have or have ever had kidney problems.
• If you have or have ever had liver problems.
• If you have or have ever had pancreas problems.

The following effects have been observed with another type of medicine similar to this one used for the treatment
of rheumatoid arthritis: heart problems, blood clots and tumours. Talk to your doctor or
pharmacist before or during treatment if:

• you are over 65 years of age. Patients aged 65 years or older may have a higher risk of heart problems, including heart attack and some types of tumours.
• you have or have had heart problems.
• you have or have had a tumour.
• you are a smoker or have smoked in the past.
• you have had blood clots in the veins of your legs (deep vein thrombosis) or lungs (pulmonary embolism) in the past.
• you suddenly experience shortness of breath or difficulty breathing, chest pain or pain in the upper back, swelling of the leg or arm, pain or tenderness in the leg, or redness or colour change in the leg or arm because these may be signs of blood clots in the veins.
• you notice new growths on the skin or changes in existing growths. Your doctor may recommend periodic skin exams during treatment with Inrebic.

Your doctor will discuss with you whether Inrebic is appropriate for you.
Blood tests
Before and during treatment, you will need to have blood tests to check the levels of blood cells
(red blood cells, white blood cells and platelets) and the function of your liver and pancreas.
Before treatment, you will need to have a blood test to check your vitamin B1 level.
Your doctor will also tell you to take a daily dose of vitamin B1 supplement of 100 mg
during treatment. Your doctor may also request further blood tests to check the
level of vitamin B1 during treatment.
Your doctor may adjust the dose or stop treatment based on the results of the blood
tests.

Children and adolescents
Inrebic must not be used in children or young people under 18 years of age as this
medicine has not been studied in this age group.

Other medicines and Inrebic
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines. Inrebic can affect how some other medicines work. Also, some other medicines can affect how Inrebic works.
The following medicines may increase the risk of side effects with Inrebic:

• ketoconazole, fluconazole (used to treat fungal infections);
• fluvoxamine (used to treat depression);
• ritonavir (used to treat HIV/AIDS infections).

The following medicines may reduce the effectiveness of Inrebic:

• rifampicin (used to treat tuberculosis [TB] and some other infections);
• phenytoin (used to treat epilepsy and control epileptic seizures or convulsions);
• efavirenz (used to treat HIV/AIDS infections).

Inrebic can have effects on other medicines:

• midazolam (used to help with sleep or relieve anxiety);
• omeprazole (used to treat stomach problems);
• metoprolol (used to treat angina or high blood pressure);
• metformin (used to lower blood sugar levels);
• also simvastatin, S-mephenytoin and dextromethorphan.

Your doctor will determine whether the dose needs to be adjusted.
Also, tell your doctor if you have recently had surgery or are about to have
surgery as Inrebic may interact with some sedatives.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, are planning to become pregnant or are breastfeeding
ask your doctor or pharmacist for advice before taking this medicine.
Do not take Inrebic during pregnancy. If you are of childbearing potential, you must use effective
contraception while taking the capsules and avoid pregnancy for at least one month after the last dose.
Avoid breastfeeding while taking Inrebic and for at least one month after the last dose,
because it is not known whether this medicine passes into breast milk.

Driving and using machines
If you experience dizziness, avoid driving vehicles or using machines until these
side effects have resolved.

Inrebic contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per dose, that is to say essentially “sodium-free”.

3. How to take Inrebic

Take this medicine following exactly the instructions of your doctor or pharmacist. If you
have any doubts, ask your doctor or pharmacist.
The recommended dose is 400 mg (four 100 mg capsules) to be taken by mouth once a
day.
You will undergo blood tests before and during the period you take this medicine to
monitor your progress. The doctor will also tell you to take a daily dose of vitamin B1 supplement of 100 mg during treatment (see paragraph 2 “Blood tests”).
If you experience certain side effects while taking Inrebic (see paragraph 4), the
doctor may reduce the dose or suspend or discontinue treatment.

How to take the capsules

• Swallow the capsules whole, preferably with a glass of water.
• Do not break, open or chew the capsules.
• The capsules can be taken with or without food, but it is preferable to take them with food to avoid feeling nauseous or vomiting.

You must continue to take Inrebic for as long as indicated by your doctor. This is a long-term treatment.

If you take more Inrebic than you should
If you accidentally take too many Inrebic capsules or a higher dose than prescribed,
contact your doctor or pharmacist immediately.

If you forget to take Inrebic
If you forget a dose or vomit after taking a capsule, skip the missed dose and take the
next scheduled dose at the usual time the following day. Do not take a double dose to
make up for the missed or vomited capsule.

If you stop taking Inrebic
Do not stop taking Inrebic unless your doctor tells you to.
If you have any doubts about the use of this medicine, ask your doctor, pharmacist or
nurse.

4. Possible side effects

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

Tell your doctor immediately if you notice any of the following symptoms, which could be a sign of a serious condition affecting the brain called encephalopathy
(including Wernicke's encephalopathy):

• confusion, memory loss or difficulty thinking;
• loss of balance or problems walking;
• eye problems such as double vision, blurred vision and loss of vision or random eye movements.

If you get any other side effects, talk to your doctor. These can include:

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

• Low levels of red blood cells which can cause tiredness, shortness of breath, pale skin or a fast heartbeat ( anemia).
• Reduced platelets in the blood, which can cause a tendency to bleed or bruise easily ( thrombocytopenia).
• Reduced white blood cells ( neutropenia), sometimes with fever. Low levels of white blood cells can reduce your ability to fight infections.
• Feeling sick ( nausea) or being sick ( vomiting).
• Diarrhoea.
• Constipation.
• Bleeding.
• Urinary tract infection.
• Headache.
• Muscle spasms.
• Tiredness ( fatigue) or weakness ( asthenia).
• Changes in blood test results ( increased alanine aminotransferase, increased aspartate aminotransferase, increased blood creatinine, increased levels of amylaseand lipase) These could be signs of problems with your liver, kidneys or pancreas.

Common side effects(may affect up to 1 in 10 people)

• Dizziness.
• High blood pressure ( hypertension).
• Difficult digestion ( dyspepsia).
• Bone pain.
• Pain in the arms, hands or feet ( limb pain).
• Weight gain.
• Pain when urinating.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell 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 Inrebic

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 package and the bottle after
Exp. The expiry date refers to the last day of that month.
Keep the bottle tightly closed to protect the medicine from moisture.
This medicine does not require any particular storage conditions.
Do not dispose of any medicine in the 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 Inrebic contains

• The active ingredient is fedratinib. Each hard capsule contains fedratinib dihydrochloride monohydrate, equivalent to 100 mg of fedratinib.
• The other ingredients are: o The capsule contains microcrystalline cellulose (contains microcrystalline cellulose [E460] and anhydrous colloidal silica [E551]) and sodium stearyl fumarate (see section 2, “Inrebic contains sodium”). o The capsule coating contains gelatin (E441), titanium dioxide (E171) and red iron oxide (E172). o The white printing ink consists of shellac (E904), titanium dioxide (E171) and propylene glycol (E1520).

Description of the appearance of Inrebic and package contents

• Inrebic capsules are reddish-brown in color, 21.4-22.0 mm in size, with “FEDR” printed in white ink on the cap and “100 mg” on the body.
• The capsules are packaged in a high-density polyethylene (HDPE) bottle with a seal and a child-resistant polypropylene cap. Each bottle contains 120 capsules and is packaged in a cardboard box.

Marketing Authorisation Holder
Bristol-Myers Squibb Pharma EEIG
Plaza 254
Blanchardstown Corporate Park 2
Dublin 15, D15 T867
Ireland

Manufacturer
Celgene Distribution B.V.
Orteliuslaan 1000
3528 BD Utrecht
Netherlands
For further information on this medicinal product, contact the local representative of the marketing
authorisation holder:

Belgique/België/Belgien
N.V. Bristol-Myers Squibb Belgium S.A.
Tél/Tel: + 32 2 352 76 11
[email protected]

Lietuva
Swixx Biopharma UAB
Tel: + 370 52 369140
[email protected]

България
Swixx Biopharma EOOD
Teл.: + 359 2 4942 480
[email protected]

Luxembourg/Luxemburg
N.V. Bristol-Myers Squibb Belgium S.A.
Tél/Tel: + 32 2 352 76 11
[email protected]

Česká republika
Bristol-Myers Squibb spol. s r.o.
Tel: + 420 221 016 111
[email protected]

Magyarország
Bristol-Myers Squibb Kft.
Tel.: + 36 1 301 9797
[email protected]

Danmark
Bristol-Myers Squibb Denmark
Tlf: + 45 45 93 05 06
[email protected]

Malta
A.M. Mangion Ltd
Tel: + 356 23976333
[email protected]

Deutschland
Bristol-Myers Squibb GmbH & Co. KGaA
Tel: 0800 0752002 (+ 49 89 121 42 350)
[email protected]

Nederland
Bristol-Myers Squibb B.V.
Tel: + 31 (0)30 300 2222
[email protected]

Eesti
Swixx Biopharma OÜ
Tel: + 372 640 1030
[email protected]

Norge
Bristol-Myers Squibb Norway AS
Tlf: + 47 67 55 53 50
[email protected]

Ελλάδα
Bristol-Myers Squibb A.E.
Τηλ: + 30 210 6074300
[email protected]

Österreich
Bristol-Myers Squibb GesmbH
Tel: + 43 1 60 14 30
[email protected]

España
Bristol-Myers Squibb, S.A.
Tel: + 34 91 456 53 00
[email protected]

Polska
Bristol-Myers Squibb Polska Sp. z o.o.
Tel.: + 48 22 2606400
[email protected]

France
Bristol-Myers Squibb SAS
Tél: + 33 (0)1 58 83 84 96
[email protected]

Portugal
Bristol-Myers Squibb Farmacêutica Portuguesa,
S.A.
Tel: + 351 21 440 70 00
[email protected]

Hrvatska
Swixx Biopharma d.o.o.
Tel: + 385 1 2078 500
[email protected]

România
Bristol-Myers Squibb Marketing Services S.R.L.
Tel: + 40 (0)21 272 16 19
[email protected]

Ireland
Bristol-Myers Squibb Pharmaceuticals uc
Tel: 1 800 749 749 (+ 353 (0)1 483 3625)
[email protected]

Slovenija
Swixx Biopharma d.o.o.
Tel: + 386 1 2355 100
[email protected]

Ísland
Vistor hf.
Sími: + 354 535 7000
[email protected]
[email protected]

Slovenská republika
Swixx Biopharma s.r.o.
Tel: + 421 2 20833 600
[email protected]

Italia
Bristol-Myers Squibb S.r.l.
Tel: + 39 06 50 39 61
[email protected]

Suomi/Finland
Oy Bristol-Myers Squibb (Finland) Ab
Puh/Tel: + 358 9 251 21 230
[email protected]

Κύπρος
Bristol-Myers Squibb A.E.
Τηλ: 800 92666 (+ 30 210 6074300)
[email protected]

Sverige
Bristol-Myers Squibb Aktiebolag
Tel: + 46 8 704 71 00
[email protected]

Latvija
Swixx Biopharma SIA
Tel: + 371 66164750
[email protected]

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/ . In addition, links to other websites on rare diseases and related therapeutic treatments are provided.
For detailed information on this medicinal product, you can also scan the QR code on the secondary packaging with a smartphone. The same information is available at:
www.inrebic-eu-pil.com .