Omjjara

Patient Information Leaflet

Omjjara 100 mg film-coated tablets, 150 mg film-coated tablets, 200 mg film-coated tablets

momelotinib
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 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, pharmacist, or nurse.
• 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, tell your doctor. See section 4.

Contents of this leaflet

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

1. What Omjjara is and what it is used for

Omjjara contains the active substance momelotinib. Momelotinib is a type of medicine known as a
protein kinase inhibitor.
Omjjara is used to treat enlargement of the spleen or other disease-related symptoms in
adult patients with myelofibrosis, a rare type of blood cancer, and moderate to severe anaemia.
In myelofibrosis, the bone marrow is replaced by scar tissue and is classified as follows:

• primary myelofibrosis, which develops in people who have never had bone marrow problems before, or
• secondary myelofibrosis, which develops in people who have other blood cancers, causing the body to produce too many red blood cells (post-polycythaemia vera myelofibrosis) or too many platelets, which promote blood clotting (post-essential thrombocythaemia myelofibrosis).

How Omjjara works
Enlargement of the spleen is one of the characteristics of myelofibrosis. Myelofibrosis is a
bone marrow disorder in which the 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. Omjjara blocks the action of certain proteins called Janus
kinases (JAK1, JAK2) and the activin A receptor type 1 (ACVR1), thereby preventing the
overproduction of cytokines and reducing inflammation. In this way, Omjjara relieves an enlarged spleen, anaemia, and symptoms such as fever, night sweats, bone pain, and weight loss caused by myelofibrosis.

2. What you need to know before taking Omjjara

Do not take Omjjara

• If you are allergic to momelotinib or to any of the other ingredients of this medicine (listed in section 6). If you are unsure whether this applies to you, do not take Omjjara before consulting your doctor.
• If you are pregnant or breastfeeding.

Warnings and precautions
Talk to your doctor
Talk to your doctor, pharmacist, or nurse before taking Omjjara or during treatment with Omjjara:

• if you have an infection or frequent infections. Signs of an infection include fever, chills, cough, breathing problems, diarrhea, vomiting, pain or a burning sensation when urinating.
• if you have had long-term (chronic) hepatitis B, as hepatitis B may reactivate.
• if you experience unusual bleeding or bruising under the skin, bleeding longer than usual after blood draws, or bleeding gums – these may be signs of low platelet levels (components that help blood to clot), also called thrombocytopenia.
• if you have any type of liver problems. Your doctor may need to prescribe a lower dose of Omjjara.

With another medicine of a similar type used to treat rheumatoid arthritis, the following have been observed: heart problems, blood clots, and tumors. Talk to your doctor or pharmacist before or during treatment:

• if you are over 65 years old. Patients aged 65 years and older may have an increased risk of heart problems, such as heart attack, and certain types of tumor.
• if you have or have had heart problems.
• if you have or have had a tumor.
• if you are a smoker or have previously smoked.
• if you have previously had blood clots in the veins of your legs (deep vein thrombosis) or in your lungs (pulmonary embolism), or if you are at increased risk of developing them, for example if:
  • you have recently had major surgery.
  • you use hormonal contraceptives/hormone replacement therapy.
  • you or a close relative have been diagnosed with a blood clotting disorder. Contact your doctor immediately if you experience:
• sudden shortness of breath or difficulty breathing.
• chest pain or pain in the upper back.
• swollen arms or legs.
• pain or tenderness in your legs.
• redness or color changes in your arms or legs. These may be signs of blood clots in the veins.
• if you notice new skin growths or changes in existing growths. Your doctor may recommend regular skin examinations while you are taking Omjjara.

Your doctor will assess whether Omjjara is suitable for you.
Blood tests
Before and during treatment, your doctor will perform blood tests to monitor levels of blood cells (red blood cells, white blood cells, and platelets) and liver function. Based on the results of these tests, your doctor may adjust the dose or discontinue treatment.
Children and adolescents
Omjjara must not be taken by children under 18 years of age, as the medicine has not been studied in this age group.
Other medicines and Omjjara
Tell your doctor, pharmacist, or nurse if you are taking, have recently taken, or might take any other medicines, including herbal preparations and over-the-counter medicines. This is because Omjjara may affect how other medicines work, and other medicines may affect how Omjjara works.
It is particularly important that you inform your doctor about any medicines you are taking that contain any of the following active substances, as a dose adjustment of Omjjara or the other medicine may be necessary.
The following may increase the risk of side effects with Omjjara:

• cyclosporine (used to prevent transplant rejection)

The following may reduce the effectiveness of Omjjara:

• carbamazepine (used to treat epilepsy and to control epileptic seizures or convulsions)
• phenobarbital (used to treat epilepsy or to control epileptic seizures or convulsions)
• phenytoin (used to treat epilepsy or to control epileptic seizures or convulsions)
• St John’s wort (Hypericum perforatum), a herbal product

Omjjara may affect other medicines:

• rosuvastatin (a statin used to lower cholesterol)
• sulfasalazine (used to treat rheumatoid arthritis)
• metformin (used to lower blood sugar levels)
• theophylline (used to treat breathing problems)
• tizanidine (used to treat muscle spasms)
• cyclophosphamide (used to treat cancer)

Pregnancy, breastfeeding, and fertility
Omjjara must not be taken during pregnancy. If you are pregnant, suspect you may be pregnant, or are planning a pregnancy, do not take this medicine, as it may harm the unborn child. Talk to your doctor for advice.
If you are a woman of childbearing potential, you must use a highly effective method of contraception during treatment with Omjjara and continue using a highly effective method of contraception for at least 1 week after the last dose. It is currently unknown whether Omjjara may reduce the effectiveness of hormonal contraceptives; therefore, it is recommended to add a barrier method during treatment and for at least 1 week after the last dose of Omjjara. Your doctor may ask you to take a pregnancy test before starting treatment to confirm that you are not pregnant.
Contact your doctor immediately if you become pregnant while taking Omjjara.
Omjjara must not be used during breastfeeding. It is unknown whether Omjjara passes into breast milk. A risk to the breastfed child cannot be excluded.
Before starting this medicine, inform your doctor if you are breastfeeding.
It is unknown whether Omjjara affects male or female fertility in humans. Omjjara has shown effects on fertility in animals. If you or your partner are planning to have a child, consult your doctor before or during treatment with this medicine.
Driving and using machines
Omjjara may cause side effects that affect your ability to drive. If you experience dizziness or blurred vision, do not drive or operate machinery until these effects have passed.
Omjjara contains lactose and sodium
Omjjara contains lactose (milk sugar). 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 tablet, i.e., essentially “sodium-free”.

3. How to take Omjjara

Take this medicine exactly as your doctor or pharmacist has told you.
If you are unsure, consult your doctor or pharmacist.
How much to take
The recommended starting dose of Omjjara is 200 mg taken orally once daily.
Your doctor may recommend a lower dose if you have liver problems.
If you experience certain side effects (such as bleeding or unusual bruising, diarrhoea,
or nausea) while taking Omjjara, your doctor may recommend a lower dose, or
temporarily or permanently discontinue treatment (see section 4).
How to take it
Take Omjjara at the same time each day, with or without food.
How long to take it
Continue taking Omjjara for as long as your doctor prescribes. This is a long-term treatment.
Your doctor will regularly monitor your condition to ensure the treatment is having the desired effect.
If you have any questions about the duration of treatment with Omjjara, speak to your doctor.
If you take more Omjjara than you should
If you accidentally take more Omjjara than prescribed by your doctor, contact your doctor immediately.
If you forget to take Omjjara
Simply take the next dose at the scheduled time the following day. Do not take a double dose to make up for a missed tablet.
If you stop taking Omjjara
Do not stop taking Omjjara without first discussing it with your doctor.
If you have any questions about using 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.
Talk to your doctor, pharmacist, or nurse if you experience any side effect that concerns you.
Serious side effects
Some side effects can be serious. Seek immediate medical help before taking your next scheduled dose if you experience any of the following serious side effects.
Very common side effects
May affect more than 1 in 10 people:

• Infections – signs or symptoms may include fever, chills, cough, breathing problems, diarrhoea, vomiting, pain or burning sensation when urinating
• Low platelet count (thrombocytopenia), which may cause bruising or bleeding longer than usual when injured

Other side effects
Other possible side effects include the following:
Very common side effects
May affect more than 1 in 10 people:

• dizziness
• headache
• cough
• diarrhoea
• feeling unwell (nausea)
• stomach ache (abdominal pain)
• feeling weak (asthenia)
• tiredness (fatigue)

Common side effects
May affect up to 1 in 10 people:

• low levels of a type of white blood cells (neutropenia), which may increase the risk of infections
• vitamin B1 deficiency (thiamine), which may cause loss of appetite, lack of energy, irritability
• numbness, tingling or weakness in arms, hands, legs or feet (peripheral neuropathy)
• abnormal tingling sensation (paraesthesia)
• fainting (syncope)
• dizziness (vertigo)
• blurred vision
• sudden redness of face, neck or chest (flushing)
• localized bleeding under the skin (haematoma)
• low blood pressure, which may cause dizziness when standing up (hypotension)
• constipation
• vomiting
• skin rash (redness, swelling or pain of the skin)
• joint pain (arthralgia)
• pain in limbs, hands or feet
• fever (pyrexia)
• abnormal blood test results (increased alanine aminotransferase and aspartate aminotransferase). These may indicate liver problems
• bruising (contusions)

Tell your doctor, pharmacist, or nurse if any of the side effects listed becomes severe or particularly bothersome, or if you notice any side effect not listed in this leaflet.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor. You may 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 Omjjara

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 bottle and the outer carton after
"Exp.". The expiry date refers to the last day of that month.
Store in the original bottle to protect the medicine from moisture. Do not remove the desiccant.
Do not ingest the desiccant. This medicine does not require any special storage temperature.
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 Omjjara contains
The active substance is momelotinib.

• Each 100 mg film-coated tablet contains momelotinib dihydrochloride monohydrate, equivalent to 100 mg of momelotinib.
• Each 150 mg film-coated tablet contains momelotinib dihydrochloride monohydrate, equivalent to 150 mg of momelotinib.
• Each 200 mg film-coated tablet contains momelotinib dihydrochloride monohydrate, equivalent to 200 mg of momelotinib.
• The excipients are: Tablet core: microcrystalline cellulose, lactose monohydrate, sodium starch glycolate (type A), magnesium stearate, anhydrous colloidal silica, and propyl gallate. Tablet coating: Opadry II brown containing polyvinyl alcohol, macrogol, titanium dioxide (E171), talc, yellow iron oxide (E172), and red iron oxide (E172).

See section 2 for information that Omjjara contains lactose and sodium.
Description of the appearance of Omjjara and contents of the pack
Omjjara 100 mg film-coated tablets are round, brown tablets, with an underlined “M” imprinted on one side and “100” on the other side.
Omjjara 150 mg film-coated tablets are triangular, brown tablets, with an underlined “M” imprinted on one side and “150” on the other side.
Omjjara 200 mg film-coated tablets are capsule-shaped, brown tablets, with an underlined “M” imprinted on one side and “200” on the other side.
Omjjara film-coated tablets are supplied in white bottles with a seal and child-resistant closure. Each bottle contains 30 tablets, a silica gel desiccant, a polyester coil, and is packaged in a cardboard box.
Marketing Authorization Holder and Manufacturer
GlaxoSmithKline Trading Services Limited
12 Riverwalk
Citywest Business Campus
Dublin 24
Ireland
For further information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:
België/Belgique/Belgien Lietuva
GlaxoSmithKline Pharmaceuticals s.a./n.v. GlaxoSmithKline (Ireland) Limited
Tél/Tel: + 32 (0)10 85 52 00 Tel: + 370 80000334
България Luxembourg/Luxemburg
GlaxoSmithKline (Ireland) Limited GlaxoSmithKline Pharmaceuticals s.a./n.v.
Teл.: + 359 80018205 Belgique/Belgien
Tél/Tel: + 32 (0)10 85 52 00
Česká republika Magyarország
GlaxoSmithKline, s.r.o. GlaxoSmithKline (Ireland) Limited
Tel: + 420 222 001 111 Tel.: + 36 80088309
[email protected]
Danmark Malta
GlaxoSmithKline Pharma A/S GlaxoSmithKline Trading Services Limited
Tlf.: + 45 36 35 91 00 Tel: + 356 80065004
[email protected]
Deutschland Nederland
GlaxoSmithKline GmbH & Co. KG GlaxoSmithKline BV
Tel.: + 49 (0)89 36044 8701 Tel: + 31 (0)33 2081100
[email protected]
Eesti Norge
GlaxoSmithKline (Ireland) Limited GlaxoSmithKline AS
Tel: + 372 8002640 Tlf: + 47 22 70 20 00
[email protected]
Ελλάδα Österreich
GlaxoSmithKline Μονοπρόσωπη A.E.B.E. GlaxoSmithKline Pharma GmbH
Τηλ: + 30 210 68 82 100 Tel: + 43 (0)1 97075 0
[email protected]
España Polska
GlaxoSmithKline, S.A. GSK Services Sp. Z o.o.
Tel: + 34 900 202 700 Tel.: + 48 (0)22 576 9000
[email protected]
France Portugal
Laboratoire GlaxoSmithKline GlaxoSmithKline – Produtos Farmacêuticos, Lda.
Tél: + 33 (0)1 39 17 84 44 Tel: + 351 21 412 95 00
[email protected] [email protected]
Hrvatska România
GlaxoSmithKline (Ireland) Limited GlaxoSmithKline Trading Services Limited
Tel: + 385 800787089 Tel: + 40 800672524
Ireland Slovenija
GlaxoSmithKline (Ireland) Limited GlaxoSmithKline (Ireland) Limited
Tel: + 353 (0)1 4955000 Tel: + 386 80688869
Ísland Slovenská republika
Vistor hf. GlaxoSmithKline (Ireland) Limited
Sími: +354 535 7000 Tel: + 421 800500589
Italia Suomi/Finland
GlaxoSmithKline S.p.A. GlaxoSmithKline Oy
Tel: + 39 (0)45 7741 111 Puh/Tel: + 358 (0)10 30 30 30
Sverige
Κύπρος GlaxoSmithKline AB
GlaxoSmithKline Trading Services Limited Tel: + 46 (0)8 638 93 00
Tηλ: + 357 80070017 [email protected]
Latvija
GlaxoSmithKline (Ireland) Limited
Tel: + 371 80205045
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. Additionally, links to other websites on rare diseases and their therapeutic treatments are provided.