OMJJARA 100 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Omjjara 100mg film-coated tablets

Omjjara 150mg film-coated tablets

Omjjara 200mg film-coated tablets

momelotinib

This medicinal product is subject to additional monitoring, which will allow for quick identification of new safety information. You can help by reporting any side effects you may get. The last section of this leaflet includes information on how to report side effects.

Read all of this leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

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

1. What is Omjjara and what is it used for

Omjjara contains the active substance called momelotinib. Momelotinib is a type of medicine known as a protein 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 with 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 the body to produce too many red blood cells (secondary myelofibrosis to polycythemia vera) or platelets, which helps the blood to clot (secondary myelofibrosis to essential thrombocythemia).

How Omjjara works

One of the characteristics of myelofibrosis is the enlargement of the spleen. Myelofibrosis is a disorder of the bone marrow, in which the marrow is replaced by scar tissue. The altered marrow cannot produce enough normal blood cells, and as a result, the spleen increases significantly. Omjjara blocks the action of certain proteins, called Janus Kinases (JAK1, JAK2) and the activin receptor type 1 (ACVR1), which 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.

2. What you need to know before you take Omjjara

Do not take Omjjara

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

Warnings and precautions

Tell your doctor

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

• if you have an infectionor have frequent infections — signs of an infection may include fever, chills, cough, respiratory problems, diarrhea, vomiting, pain or burning sensation when urinating
• if you have had hepatitis Bfor a long time (chronic), hepatitis B may become active again
• if you have bleedingor bruisingunder the skin, prolonged bleeding after a blood test, or bleeding from the gums — these may be signs of low platelet count in the blood (thrombocytopenia)
• if you have any liver problems. Your doctor may prescribe a lower dose of Omjjara.

In other types of similar medicines used to treat rheumatoid arthritis, the following have been observed: heart problems, blood clots, and cancer. Consult your doctor or pharmacist before or during treatment:

• if you are over 65 years old. Patients over 65 years old have a higher risk of heart problems, including heart attack, and some 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 blood clots in the veins of your legs (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.

Tell your doctor immediatelyif you have:

• sudden 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
• redness or discoloration of 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 that you have regular skin checks while taking Omjjara.

Your doctor will discuss with you whether 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 interrupt treatment based on the results of these blood tests.

Children and adolescents

Omjjara is not indicated for use in children or adolescents under 18 years of age, as it 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 those obtained without a prescription. This is because Omjjara may affect the way other medicines work. Also, some medicines may affect the way Omjjara works.

It is particularly important that you mention any medicines that contain any of the following active substances, as your doctor may need to adjust the dose of Omjjara or the other medicine.

The following medicines may increase the risk of side effects with Omjjara:

• ciclosporin (used to prevent transplant rejection).

The following medicines 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 herbal medicine.

Omjjara may affect the following 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 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 medicine, as it may harm your baby. Consult your doctor before using this medicine.

If you are a woman who could become pregnant, you must use very effective contraceptionwhile taking Omjjara and must continue to use very effective contraception for at least one weekafter taking the last dose. It is currently unknown whether Omjjara may reduce the effectiveness of hormonal contraceptives, so it is recommended to add a barrier method during treatment and for 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, tell your doctor immediately.

Do not take Omjjara during breastfeeding.It is unknown whether the medicine passes into breast milk. The risk to the breastfed child cannot be excluded.

Tell your doctorif you are breastfeeding before taking this medicine.

It is unknown whether 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 medicine.

Driving and using machines

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

Omjjara contains lactose and sodium

Omjjara contains lactose (milk sugar). If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.

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

3. How to take Omjjara

Follow the instructions for administration of this medicine exactly as prescribed by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again.

How much medicine to take

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

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

If you have certain side effects (such as unusual bleeding or bruising, diarrhea, or nausea) while taking Omjjara, your doctor may recommend a lower dose or temporarily or permanently discontinue treatment (see section 4).

How to take the medicine

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

How long to take the medicine

Continue taking Omjjara for as long as your doctor has told you. This is a long-term treatment.

Your doctor will regularly check your condition 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 next day. Do not take a double dose to make up for forgotten doses.

If you stop taking Omjjara

Do not stop taking Omjjara unless you have agreed this with your doctor.

If you have any other questions 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, pharmacist, or nurseif you experience any side effects that worry you.

Serious side effects

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

Very common side effects

May affect more than 1 in 10people:

• infections — signs or symptoms may include fever, chills, cough, respiratory problems, diarrhea, vomiting, pain or burning sensation when urinating
• low platelet count in the blood (thrombocytopenia) that can cause bruising or bleeding more prolonged than usual if you are injured.

Other side effects

Other possible side effects are listed below:

Very common side effects

May affect more than 1 in 10people:

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

Common side effects

May affect up to 1 in 10people:

• low level of a type of white blood cell (neutropenia) that can increase the risk of infection
• deficiency of vitamin B1 (thiamine) that can cause loss of appetite, lack of energy, irritability
• numbness, tingling, or weakness in the arms, hands, legs, or feet (peripheral neuropathy)
• abnormal sensation of tingling (paresthesia)
• fainting (syncope)
• feeling of spinning (vertigo)
• blurred vision
• sudden redness of the face, neck, or upper chest (flush)
• localized bleeding under the skin (hematoma)
• low blood pressure that can cause dizziness when standing up (hypotension)
• constipation
• vomiting
• rash (redness, swelling, or pain in the skin)
• joint pain (arthralgia)
• pain in the limbs, hands, or feet
• fever (pyrexia)
• changes in blood test results (alanine aminotransferase elevatedand aspartate aminotransferase elevated). These may be signs of liver problems
• bruises (contusion).

Tell your doctor, pharmacist, or nurseif any of these side effects become serious or troublesome, or if you notice any side effects not listed in this leaflet.

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if they are not listed in this leaflet. You can also report side effects directly through the national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of 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 label and carton after EXP. The expiry date is the last day of the month stated.

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

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Container Content and Additional Information

Composition of Omjjara

The active ingredient 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 other excipients are:

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

Tablet coating: Opadry II brown containing polyvinyl alcohol, macroglols, titanium dioxide (E 171), talc, yellow iron oxide (E 172), and red iron oxide (E 172).

See section 2 Omjjara contains lactose and sodium.

Product Appearance and Container Content

Omjjara 100 mg film-coated tablets are brown, round tablets engraved with an underlined "M" on one side and "100" on the other side.

Omjjara 150 mg film-coated tablets are brown, triangular tablets engraved with an underlined "M" on one side and "150" on the other side.

Omjjara 200 mg film-coated tablets are brown, capsule-shaped tablets engraved with an underlined "M" on one side and "200" on the other side.

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

Marketing Authorization Holder and Manufacturer

GlaxoSmithKline Trading Services Limited

12 Riverwalk

Citywest Business Campus

Dublin 24

Ireland

You can request more information about this medicinal product by contacting the local representative of the marketing authorization holder:

Date of Last Revision of this Leaflet:MM/AAAA

Other Sources of Information

Detailed information on this medicinal product is available on the European Medicines Agency website: https://www.ema.europa.eu. There are also links to other websites on rare diseases and orphan medicines.