Patient Medication Information: uses, side effects, how to take - Ojjaara
Serious warnings and precautions box
What OJJAARA is used for:
OJJAARA is used in adults with myelofibrosis (a rare form of blood cancer affecting the bone marrow) who have moderate to severe anemia (a reduced number of red blood cells) to treat:
- splenomegaly (enlarged spleen) and/or
- other disease related symptoms.
How OJJAARA works:
OJJAARA works by blocking the action of certain enzymes in the body. These enzymes are called Janus Kinases (JAK1, JAK2) and activin A receptor, type 1 (ACVR1). By blocking the Janus Kinases (JAK1, JAK2), the over production of cytokines is prevented and inflammation reduced. Blocking activin A receptor type 1 (ACVR1) results in helping with red blood cell production. By doing so, OJJAARA relieves the enlarged spleen, anemia, and symptoms such as fever, night sweats, bone pain and weigh loss caused by myelofibrosis.
The ingredients in OJJAARA are:
Medicinal ingredient: momelotinib, as momelotinib hydrochloride
Non-medicinal ingredients: lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, propyl gallate, red iron oxide, silicon dioxide, sodium starch glycolate, talc, titanium dioxide, and yellow iron oxide.
- Serious infections have been reported in patients treated with OJJAARA. Some cases were life-threatening or led to death.
- You should not be taking OJJAARA if you have an infection.
- Your doctor should carefully assess and monitor you for the risk of developing any serious infections while you are taking OJJAARA. Your doctor should provide the appropriate treatment if you develop an infection.
OJJAARA comes in the following dosage forms:
Tablets; 100 mg, 150 mg and 200 mg
Do not use OJJAARA if:
- you are allergic to momelotinib or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container.
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take OJJAARA. Talk about any health conditions or problems you may have, including if you:
- have unusual bleeding or bruising under the skin, longer than usual bleeding after your blood has been drawn, or bleeding from your gums — these may be signs of a low blood platelet count.
- have an infection or have frequent infections — signs of an infection may include fever, chills, cough, breathing problems, diarrhea, vomiting, pain or burning feeling when passing urine. It may be necessary to treat your infection before starting OJJAARA.
- Have, or ever had, any liver problems, including Hepatitis B. Your healthcare professional may need to prescribe a different dose of OJJAARA.
Other warnings you should know about:
The following conditions have been reported with a similar drug. This similar drug is used to treat a type of arthritis (joint pain, swelling and stiffness) which OJJAARA is not used for.
New Cancers: Lymphoma (cancer of the lymphatic system) and other cancers. You may be at an even greater risk of cancer if you:
- are a smoker or were a smoker in the past, or
- have other cancers or had other cancers before.
Heart Problems: Major heart problems, including heart attack, stroke, death. You may be at an even greater risk of heart problems if you:
- are 65 years of age or older
- are a smoker or were a smoker in the past, or
- have any heart problems.
- Blood vessel problems: Blood clots, including in the lungs, arteries, arms and legs. You may be at an even greater risk of blood clots if you have any heart problems.
Lactose sensitivity: OJJAARA contains lactose (milk sugar). If you have been told by your doctor that you have an intolerance to some sugars, contact your healthcare professional before taking this medicine.
Blood cell count: Low blood cell counts including low platelets and low white blood cells are possible while taking OJJAARA. If this happens, your dose of OJJAARA may need to be stopped temporarily or reduced.
Tests and check-ups:
Before and during treatment, your healthcare professional will carry out blood tests to check your liver and blood cell levels (red blood cells, white blood cells and platelets). Your healthcare professional may adjust the dose or stop treatment based on the results of the blood tests.
Female Patients:
If you are pregnant, think you may be pregnant or are planning to have a baby, tell your healthcare professional before you take this medicine. There are specific risks you must discuss with your healthcare professional.
- Avoid becoming pregnant while you take OJJAARA. It could harm your baby.
- If you are a woman who could become pregnant, you must use highly effective contraception while you are taking OJJAARA. You should use an additional form of contraceptive if you are using hormonal birth control. You must continue to use effective birth control for at least 1 week after taking your last dose. Your healthcare professional may ask you to take a pregnancy test before starting your treatment, to confirm that you are not pregnant.
- Contact your healthcare professional immediately if you become pregnant while taking OJJAARA.
- It is not known if OJJAARA passes into breast milk. You must stop breast-feeding before you start taking OJJAARA. Do not begin breast feeding again until at least 1 week after taking your last dose.
- Tell your healthcare professional if you are breast-feeding before taking OJJAARA.
Driving and using machines
When you are taking OJJAARA, it may make you feel dizzy or have blurred vision and therefore influence your ability to drive and use machines. Observe caution when driving or using machines.
Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.
The following may interact with OJJAARA:
- rosuvastatin (a statin used to lower cholesterol)
- sulfasalazine (used to treat rheumatoid arthritis)
- cyclosporin (an immunosuppressant)
- carbamazepine (used to treat epilepsy and control fits or convulsions)
- phenobarbital (used to treat epilepsy and control fits or convulsions)
- phenytoin (used to treat epilepsy and control fits or convulsions)
- St John’s wort (Hypericum perforatum), a herbal product
How to take OJJAARA:
- Always take this medicine exactly as your healthcare professional has told you. Check with your healthcare professional if you are not sure.
- Take your tablet about the same time once every day.
Take with or without food. Take by mouth. Swallow tablets whole. Do NOT cut, crush, break, dissolve or chew the tablet.
- You should not be taking OJJAARA with other JAK inhibitor medications.
- Do not stop taking OJJAARA unless your healthcare professional tells you to. If you have any further questions on the use of this medicine, ask your healthcare professional.
Your healthcare professional may change your dose depending on:
- the condition of your liver
- how you respond to OJJAARA
- whether you are taking other medications
Usual dose:
Take one 200 mg tablet once daily.
Overdose:
If you think you, or a person you are caring for, have taken too much OJJAARA, contact a healthcare professional, hospital emergency department, regional poison control centre or Health Canada’s toll-free number, 1-844 POISON-X (1-844-764-7669) immediately, even if there are no signs or symptoms.
Missed dose:
If you missed a dose of this medication, you do not need to make up the missed dose. Skip the missed dose and continue with your next scheduled dose. Do not take two doses at the same time.
Possible side effects from using OJJAARA:
These are not all the possible side effects you may have when taking OJJAARA. If you experience any side effects not listed here, tell your healthcare professional.
- Abnormal tingling sensation, numbness, weakness of the arms, hands, legs or feet
- back pain
- blurred vision
- cough
- diarrhea
- dizziness including vertigo (spinning sensation)
- feeling weak
- fever
- headache
- joint pain
- localized bleeding under the skin
- low blood pressure which can cause fainting or light-headedness when you stand up
- nausea
- pain in limbs, hands or feet
- redness, swelling or pain of the skin (rash)
- stomach ache
- sudden reddening of the face, neck or upper chest (flushing)
- tiredness
- vomiting
OJJAARA can cause abnormal blood test results. Your healthcare professional will decide when to perform blood tests and will interpret the results.
Serious side effects and what to do about them
| Frequency/Side Effect/Symptom | Talk to your healthcare professional | Stop taking this drug and get immediate medical help | |
|---|---|---|---|
| Frequency/Side Effect/Symptom | Talk to your healthcare professional | Stop taking this drug and get immediate medical help | |
| Only if severe | In all cases | ||
| Only if severe | In all cases | ||
| Very common | |||
| Infection: fever, chills, cough, cold sores, breathing problems, diarrhea, vomiting, pain or burning feeling when passing urine. | √ | ||
| Thrombocytopenia (low blood platelet count): bruising or bleeding longer than usual if you hurt yourself. | √ | ||
| Common | |||
| Arrhythmia (irregular heartbeat): a fluttering, pounding or racing feeling in the chest, fast or slow heartbeat, chest pain, shortness of breath | √ | ||
| Liver problems: loss of appetite, itching, pale coloured stools/ or unusually dark urine | √ | ||
| Neutropenia (decreased white blood cells): infections, fatigue, fever, aches, pains and flu-like symptoms | √ | ||
| Pneumonia (infection in the lungs): chest pain when you breath or cough, confusion, cough which may produce phlegm, fatigue, fever, sweating and shaking chills, nausea, vomiting or diarrhea, shortness of breath | √ | ||
| Urinary tract infection (infection in urinary system including kidneys, ureters, bladder and urethra): Pain or burning sensation while urinating, frequent urination, blood in urine, pain in the pelvis, strong smelling urine, cloudy urine | √ | ||
| Vitamin B1 deficiency: loss of appetite, lack of energy, irritability | √ | ||
| Unknown | |||
| Thrombosis (clot in a blood vessel): swelling and pain in one part of the body | √ | ||
| Hypersensitivity (allergic reactions): difficulty swallowing or breathing, wheezing, feeling sick to your stomach and throwing up, hives or rash, swelling of the face, lips, tongue or throat. | √ | ||
| Erythema multiforme (an allergic skin reaction): raised red or purple skin patches, and looks like small targets, possibly with blister or crust in the center; possibly swollen lips, mild itching or burning | √ | ||
| Toxic Epidermal Necrolysis (TEN) (severe skin reaction): redness, blistering and/or peeling of large areas of the skin | √ | ||
If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, tell your healthcare professional.
Reporting side effects
You can report any suspected side effects associated with the use of health products to Health Canada by:
- Visiting the Web page on Adverse Reaction Reporting (canada.ca/drug-device-reporting) for information on how to report online, by mail or by fax; or
- Calling toll-free at 1-866-234-2345.
NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.
Storage:
Do not use this medicine after the expiry date which is stated on the carton and bottle after “EXP”. The expiry date refers to the last day of that month.
Store between 15°C to 30°C in the original bottle to protect from moisture. Do not remove the desiccant.
Do not use this medicine if you notice any damage or signs of tampering to the pack.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
Keep out of reach and sight of children.
If you want more information about OJJAARA:
- Talk to your healthcare professional.
- Find the full product monograph that is prepared for healthcare professionals and includes the Patient Medication Information by visiting the Health Canada website: (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html; the manufacturer’s website [www.gsk.ca], or by calling 1-800-387-7374.
Date of Authorization: 2026-03-20
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