Ojjaara: Uses, Side Effects and Dosage

What is OJJAARA?

OJJAARA is a prescription medicine used to treat adults with certain types of myelofibrosis (MF) who have anemia.

It is not known if OJJAARA is safe and effective in children.

Before taking OJJAARA, tell your healthcare provider about all of your medical conditions, including if you:

• have an infection. See “What are the possible side effects of OJJAARA?”
• have or have had hepatitis B
• have or have had liver problems
• have had a heart attack, or have or have had other heart problems, or stroke
• have or have had a blood clot
• smoke or were a smoker in the past
• have or have had any other cancers

• are pregnant or plan to become pregnant. OJJAARA may harm your unborn baby.

  Females who are able to become pregnant:

  • Use highly effective birth control (contraception) during treatment and for at least 1 week after the last dose of OJJAARA.
  • Tell your healthcare provider right away if you think you are pregnant or become pregnant during treatment with OJJAARA.
• are breastfeeding or plan to breastfeed. It is not known if OJJAARA passes into your breast milk. You should not breastfeed during treatment and for at least 1 week after the last dose of OJJAARA. Talk to your healthcare provider about the best way to feed your baby during this time.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Taking OJJAARA with certain other medicines may affect the amount of OJJAARA or the other medicines in your blood and may increase your risk of side effects.

Know the medicines you take. Keep a list of the medicines you take to show your healthcare provider and pharmacist when you get a new medicine.

How should I take OJJAARA?

• Take OJJAARA exactly as your healthcare provider tells you to take it.
• Do not change your dose or stop taking OJJAARA without first talking to your healthcare provider. If you stop treatment with OJJAARA, symptoms of your condition may return. See “What are the possible side effects of OJJAARA?”
• Take OJJAARA by mouth 1 time each day.

• Take OJJAARA with or without food.

• Swallow OJJAARA tablets whole. Do not cut, crush, or chew tablets.
• If you miss a dose of OJJAARA, skip the missed dose and take your next dose the following day at your regularly scheduled time. Do not take 2 doses at the same time to make up for the missed dose.
• If you take too much OJJAARA, call your healthcare provider or Poison Help line at 1-800-222-1222, or go to the nearest emergency room right away and take your bottle of OJJAARA with you.

What are the possible side effects of OJJAARA?

OJJAARA may cause serious side effects, including:

• Risk of Infections. People who take OJJAARA may develop serious infections that can lead to death, such as bacterial and viral infections, including COVID‑19. If you have an active infection, your healthcare provider should not start treatment with OJJAARA until your infection is gone. If you have had hepatitis B for a long time (chronic), OJJAARA may cause your hepatitis B to become active again.

• Your healthcare provider will monitor you and treat you for any infections that you get during treatment with OJJAARA.

  Tell your healthcare provider right away if you develop any of the following symptoms of infection:

• fever
• chills
• cough
• breathing problems

• diarrhea
• vomiting
• pain or burning feeling when passing urine

• Low platelet and white blood cell counts. OJJAARA may cause new or worsening low platelet and white blood cell counts. Low platelet counts may increase your risk for bleeding and low white blood cell counts may increase your risk for infection.

  Tell your healthcare provider right away if you have any signs of bleeding during treatment with OJJAARA, including:

• unusual bleeding
• black or tarry stools

• bruising

• Liver problems. OJJAARA may cause new or worsening increased liver enzymes and bilirubin in your blood.

  Tell your healthcare provider if you develop any of the following signs or symptoms of liver problems:

• tiredness
• loss of appetite
• pain in your right upper stomach area (abdomen)

• dark urine
• yellowing of your skin or the white part of your eyes

• Severe skin reactions. Severe skin reactions that can be life‑threatening have happened with OJJAARA.

  Tell your healthcare provider or get medical help right away if you get any of the following signs or symptoms of severe skin reactions, with or without fever:

• rash that keeps getting worse
• severe rash
• reddened skin
• flu‑like symptoms

• skin pain or burning
• blistering of the lips, eyes, or mouth
• blisters on the skin
• skin peeling

• Major cardiovascular events such as heart attack, stroke, and death. Major cardiac events have happened, especially in people with cardiac risk factors and who are current or past smokers, while taking another Janus kinase (JAK) inhibitor to treat rheumatoid arthritis. OJJAARA is in the JAK family of medicines.

  Get emergency help right away if you have any symptoms of a heart attack or stroke during treatment with OJJAARA, including:

  • discomfort in your chest that lasts for more than a few minutes, or that goes away and comes back
  • severe tightness, pain, pressure, or heaviness in your chest, throat, neck, or jaw
  • pain or discomfort in your arms, back, neck, jaw, or stomach
  • shortness of breath with or without chest discomfort
  • breaking out in a cold sweat
  • nausea or vomiting
  • feeling lightheaded
  • weakness in one part or on one side of your body
  • slurred speech

• Blood clots. Blood clots in the veins of the legs (deep vein thrombosis [DVT]) and lungs (pulmonary embolism [PE]) have happened in some people taking another JAK inhibitor to treat rheumatoid arthritis, and may be life‑threatening. Tell your healthcare provider if you have had blood clots in the veins of your legs or lungs in the past.

  Tell your healthcare provider right away if you have any signs and symptoms of blood clots during treatment with OJJAARA, including:

  • swelling, pain, or tenderness in one or both legs
  • sudden, unexplained chest pain
  • shortness of breath or difficulty breathing
• New cancers. New cancers, including lymphoma and other cancers, except non‑melanoma skin cancer, have happened in some people taking another JAK inhibitor to treat rheumatoid arthritis. The risk of new cancers is further increased in people who smoke or who smoked in the past.

• Worsening of symptoms after interruption or stopping treatment. Signs and symptoms of myelofibrosis may worsen after you stop treatment with OJJAARA. Do not interrupt or stop treatment with OJJAARA without talking to your healthcare provider. If you need to stop treatment with OJJAARA, your healthcare provider may give you instructions for slowly stopping treatment.

  Tell your healthcare provider right away if you get any of the following signs and symptoms after stopping treatment with OJJAARA:

• fever
• trouble breathing
• feeling dizzy or lightheaded

• weakness
• night sweats
• pain in your left upper stomach (abdomen) area or left shoulder

Your healthcare provider will do blood tests before you start treatment with OJJAARA and during treatment to check for side effects.

Your healthcare provider may change your dose, temporarily stop, or permanently stop treatment with OJJAARA if you get certain side effects.

The most common side effects of OJJAARA include:

• low platelet count
• bleeding
• bacterial infection
• tiredness

• dizziness
• diarrhea
• nausea

These are not all of the possible side effects of OJJAARA.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1‑800‑FDA‑1088.

How should I store OJJAARA?

• Store OJJAARA at room temperature between 68°F to 77°F (20°C to 25°C).
• Keep OJJAARA in its original bottle. The OJJAARA bottle contains a desiccant packet to help keep your tablets dry (protect from moisture). Keep the desiccant in the bottle.
• Tightly close the OJJAARA bottle after you take your dose.

Keep OJJAARA and all medicines out of the reach of children.

General information about the safe and effective use of OJJAARA.

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use OJJAARA for a condition for which it was not prescribed. Do not give OJJAARA to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare provider for information about OJJAARA that is written for health professionals.

What are the ingredients in OJJAARA?

Active ingredient: momelotinib dihydrochloride monohydrate

Inactive ingredients: lactose monohydrate, magnesium stearate, microcrystalline cellulose, propyl gallate, silicon dioxide, and sodium starch glycolate

Film coating: polyethylene glycol, polyvinyl alcohol, red iron oxide, talc, titanium dioxide, and yellow iron oxide

Trademarks are owned by or licensed to the GSK group of companies.

GlaxoSmithKline, Durham, NC 27701

For more information about OJJAARA, call 1‑888‑825‑5249 or visit our website at www.OJJAARA.com.

©2026 GSK group of companies or its licensor.

OJJ:4PIL

• This Patient Information has been approved by the U.S. Food and Drug Administration Revised: Mar 2026