Prospect: information for the patient

Omjjara 100mg film-coated tablets

Omjjara 150mg film-coated tablets

Omjjara 200mg film-coated tablets

momelotinib

This medicine is subject to additional monitoring, which will speed up the detection of new information about its safety. You can contribute by reporting any adverse effects you may experience. The final part of section4 includes information on how to report these adverse effects.

Read this prospect carefully before starting to take this medicine, as it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed only for you, and you must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience adverse effects, consult your doctor, pharmacist, or nurse, even if they do not appear in this prospect. See section4.

Omjjara contains the active ingredient called momelotinib. Momelotinib is a type of medication known as aprotein kinase inhibitor.

Omjjara is used to treat adult patients with an enlarged spleen or other symptoms related to myelofibrosis, a rare form of blood cancer, and moderate to severe anemia.

In myelofibrosis, the bone marrow is replaced by scar tissue and is classified as:

• primary myelofibrosis, which develops in people who have not previously had problems with their bone marrow, or;
• secondary myelofibrosis, which develops in people who have other blood cancers, which causes their body to produce too many red blood cells (secondary myelofibrosis to polycythemia vera) or platelets, which helps blood to clot (secondary myelofibrosis to essential thrombocytosis).

How Omjjara works

One of the characteristics of myelofibrosis is the enlargement of the spleen. Myelofibrosis is a bone marrow alteration, in which the bone marrow is replaced by scar tissue. The altered bone marrow cannot produce a sufficient amount of normal blood cells, and as a result, the spleen increases significantly in size. Omjjara blocks the action of certain proteins, called Janus Kinases (JAK1, JAK2) and the activin A receptor, type 1 (ACVR1) that prevent the overproduction of cytokines and reduce inflammation. In this way, Omjjara reduces the size of the enlarged spleen, improves anemia, and symptoms such as fever, night sweats, bone pain, and weight loss caused by myelofibrosis.

Do not take Omjjara

• if you are allergic to momelotinib or any of the other components of this medication (listed in section 6). If you are unsure if this applies to you,do not take Omjjarauntil you have consulted with your doctor
• if you are pregnant or breastfeeding.

Warnings and precautions

Inform your doctor

Consult your doctor, pharmacist, or nurse before starting to take Omjjara or during treatment with Omjjara:

• if you have aninfectionor have frequent infections—the signs of an infection may include fever, chills, cough, respiratory problems, diarrhea, vomiting, pain or burning sensation while urinating
• if you have had hepatitis B for a prolonged period (chronic), hepatitis B may become active again
• if you have unusual bleeding or bruising under the skin, prolonged bleeding after a blood draw or gum bleeding—these may be signs of low platelet count in the blood (component that helps blood clotting), also known as thrombocytopenia
• if you have anyliver problems. Your doctor may prescribe a lower dose of Omjjara.

Other types of medications similar to Omjjara used to treat rheumatoid arthritis have been observed: heart problems, blood clots, and cancer. Consult your doctor or pharmacist before or during treatment:

• if you are over 65years old. Patients 65years or older have a higher risk of developing heart problems, including heart attack and certain types of cancer
• if you have or have had heart problems
• if you have or have had cancer
• if you are a smoker or have been a smoker in the past
• if you have had previous blood clots in your leg veins (deep vein thrombosis) or lungs (pulmonary embolism) or if you have a higher risk of developing this, for example if:
• • you have had recent major surgery
  • you use hormonal contraceptives/hormone replacement therapy
  • you or a close relative have been diagnosed with a blood clotting disorder.

Inform your doctor immediatelyif you have:

• sudden shortness of breath or difficulty breathing
• chest pain or upper back pain
• swelling of the leg or arm
• pain or tenderness in the leg
• redness or discoloration in the leg or arm.

These may be signs of blood clots in the veins.

• if you notice any new skin growths or changes in existing growths. Your doctor may recommend regular skin checks while taking Omjjara.

Your doctor will discuss with you if Omjjara is suitable for you.

Blood tests

Before and during treatment, your doctor will perform blood tests to check the levels of blood cells (red blood cells, white blood cells, and platelets) as well as liver function. Your doctor may adjust the dose or stop treatment based on the results of these blood tests.

Children and adolescents

Omjjara is not indicated for use in children or adolescents under 18years old, as it has not been studied in this age group.

Other medications and Omjjara

Inform your doctor, pharmacist, or nurse if you are taking, have taken recently, or may need to take any other medication, including herbal products and over-the-counter medications. This is because Omjjara may affect the functioning of other medications. Additionally, some medications may affect the functioning of Omjjara.

It is particularly important to mention any medications that contain any of the following active ingredients, as your doctor may need to adjust the dose of Omjjara or the other medication.

The following medications may increase the risk of adverse effects with Omjjara:

• ciclosporina (usedto prevent transplant rejection).

The following medications may reduce the effectiveness of Omjjara:

• carbamazepine (used to treat epilepsy and prevent seizures and convulsions)
• phenobarbital (used to treat epilepsy and prevent seizures and convulsions)
• phenytoin(used to treat epilepsy and prevent seizures and convulsions)
• St. John's Wort (hypericum perforatum), a medicinal herb.

Omjjara may affect the following medications:

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

Pregnancy, breastfeeding, and fertility

Do not take Omjjara during pregnancy.If you are pregnant, think you may be pregnant, or plan to become pregnant, do not take this medication, as it may harm your baby. Consult your doctor before using this medication.

If you are a woman who may become pregnant, you should use highly effectivecontraceptiveswhile taking Omjjara and should continue to use these highly effective contraceptivesfor at least one weekafter taking the last dose. Currently, it is unknown if Omjjara may reduce the effectiveness of oral contraceptives, so it is recommended to add a barrier method during treatment andfor at least one weekafter taking the last dose of Omjjara. Your doctor may ask you to perform a pregnancy test before starting treatment to confirm that you are not pregnant.

If you become pregnant while taking Omjjara,inform your doctor immediately.

Do not take Omjjara during breastfeeding.It is unknown if the medication passes into breast milk. The risk in breastfed infants cannot be ruled out.

Inform your doctorif you are breastfeeding before taking this medication.

It is unknown if Omjjara affects male or female fertility in humans. Omjjara has effects on fertility in animals. If you or your partner plan to become pregnant, consult your doctor before or while taking this medication.

Driving and operating machinery

Omjjara may have adverse effects that affect your ability to drive. If you feel dizzy or have blurred vision, do not drive or operate machinery until these adverse effects have disappeared.

Omjjara contains lactose and sodium

Omjjara contains lactose (milk sugar). If your doctor has told you that you have a certain sugar intolerance, consult with them before taking this medication.

This medication contains less than 1mmol of sodium (23mg) per tablet; this is, essentially “sodium-free”.

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

How much medication to take

The recommended starting doseof Omjjara is 200mg taken once a day orally.

Your doctor may recommend a lower dose if you have liver problems.

If you experience certain adverse effects (such as bleeding or unusual bruising, diarrhea, or nausea) while taking Omjjara, your doctor may recommend a lower dose, or temporarily or permanently discontinue treatment (see section4).

How to take the medication

Take Omjjara every day at the same time, with or without food.

For how long to take the medication

Continue taking Omjjara for the time your doctor has indicated. This is a long-term treatment.

Your doctor will monitor your situation periodically to ensure that the treatment is having the desired effect.

If you have questions about how long to take Omjjara, talk to your doctor.

If you take more Omjjara than you should

If you accidentally take more Omjjara than your doctor has prescribed,contact your doctorimmediately.

If you forget to take Omjjara

Take the next dose at the scheduled time the following day. Do not take a double dose to make up for the missed dose.

If you interrupt treatment with Omjjara

Do not interrupt treatment with Omjjara unless you have agreed to do so with your doctor.

If you have any other questions about the use of this medication, ask your doctor, pharmacist, or nurse.

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

Consult your doctor, pharmacist or nurseif you experience any type of side effect that worries you.

Severe side effects

Some side effects can be severe. Seek medical attention immediately before taking the next scheduled dose if you experience the following severe side effects:

Very common side effects

May affect more than 1 in 10 people:

• infections— symptoms may include fever, chills, cough, respiratory problems, diarrhea, vomiting, pain or burning sensation while urinating
• low platelet count in the blood (thrombocytopenia) that may cause bruises or prolonged bleeding if injured.

Other side effects

Other possible side effects are listed below:

Very common side effects

May affect more than 1 in 10 people:

• dizziness
• headache
• cough
• diarrhea
• nausea
• abdominal pain
• feeling weak (asthenia)
• fatigue

Common side effects

May affect up to 1 in 10 people:

• low neutrophil count in the blood (neutropenia) that may increase the risk of infection
• vitamin B1 deficiency (thiamine) that may cause loss of appetite, lack of energy, irritability
• numbness, tingling or weakness in the arms, hands, legs or feet (peripheral neuropathy)
• abnormal tingling sensation (paresthesia)
• syncope (fainting)
• dizziness (vertigo)
• blurred vision
• sudden redness of the face, neck or upper chest (flushing)
• localized bleeding under the skin (hematoma)
• low blood pressure that may cause dizziness when standing up (hypotension)
• constipation
• vomiting
• joint pain (arthralgia)
• pain in the extremities, hands or feet
• fever (pyrexia)
• changes in blood test results (alanine aminotransferase elevatedand aspartate aminotransferase elevated). This may be a sign of liver problems
• bruising (contusion).

Inform your doctor, pharmacist or nurseif any of these side effects becomesevere or bothersome, or if you notice anyside effect that does not appear in this leaflet.

Reporting side effects

If you experience any type of side effect, consult your doctor,pharmacist or nurse, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through thenational reporting system included in theAppendix V. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the label of the bottle and on the packaging after CAD. The expiration date is the last day of the month indicated.

Store in the original packaging to protect it from moisture. Do not remove the desiccant. Do not ingest the desiccant. This medication does not require any special storage temperature.

Medications should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the packaging and medications that you no longer need. This will help protect the environment.

Composition of Omjjara

The active principle is momelotinib.

• Each film-coated tablet of 100 mg containsmomelotinib dihydrochloride monohydrate equivalent to 100mg of momelotinib.
• Each film-coated tablet of 150 mg containsmomelotinib dihydrochloride monohydrate equivalent to 150mg of momelotinib.
• Each film-coated tablet of 200 mg containsmomelotinib dihydrochloride monohydrate equivalent to 200mg of momelotinib.
• Theother excipients are:

Tablet core: microcrystalline cellulose, lactose monohydrate, carboxymethylstarch sodium (type A),magnesium stearate, colloidal anhydrous silica, and propyl gallate.

Tablet coating: Opadry II brown containing polyvinyl alcohol, macrogols, titanium dioxide (E171), talc, iron oxide yellow (E172), and iron oxide red (E172).

See section2 Omjjara contains lactose and sodium.

Appearance of the product and contents of the pack

Omjjara 100mg film-coated tablets are brown, round tablets, engraved with a“M”underline on one side and “100” on the other side.

Omjjara 150mg film-coated tablets are brown, triangular tablets, engraved with a“M”underline on one side and “150” on the other side.

Omjjara 200mg film-coated tablets are brown, capsule-shaped tablets, engraved with a“M”underline on one side and “200” on the other side.

Omjjara film-coated tablets are available in a white bottle with a child-resistant cap and a silica gel desiccant. Each bottle contains 30tablets, a polyester filler, and is packaged in a cardboard box.

Marketing authorization holder and responsible person for manufacturing

GlaxoSmithKline Trading Services Limited

12 Riverwalk

Citywest Business Campus

Dublín 24

Irlanda

For more information about this medicinal product, please contact the local representative of the marketing authorization holder:

Last update of the summary of product characteristics:

Other sources of information

The detailed information on this medicinal product is available on the website of the European Medicines Agency:http://www.ema.europa.eu. There are also links to otherwebsites on rare diseases and orphan medicines.