Description and Brand Names

Drug information provided by: Merative, Micromedex®

US Brand Name

  1. Ojjaara

Descriptions


Momelotinib is used to treat intermediate or high-risk myelofibrosis, including primary myelofibrosis or secondary myelofibrosis (post-polycythemia vera myelofibrosis and post-essential thrombocythemia) in patients with anemia. Myelofibrosis is a life-threatening bone marrow problem which is manifested by the following symptoms: enlarged spleen (splenomegaly), severe itching, fever, night sweats, weight loss, bone pain, or unusual tiredness or weakness.

This medicine is available only with your doctor's prescription.

This product is available in the following dosage forms:

  • Tablet

Before Using

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of momelotinib in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of momelotinib in the elderly.

Breastfeeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Drug Interactions

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Alpelisib
  • Ceftobiprole Medocaril
  • Cyclosporine
  • Darolutamide
  • Elexacaftor
  • Eltrombopag
  • Gemfibrozil
  • Irinotecan
  • Methotrexate
  • Ozanimod
  • Rifampin
  • Rosuvastatin
  • Simvastatin
  • Sofosbuvir
  • Sulfasalazine
  • Sunitinib
  • Talazoparib
  • Tenofovir Alafenamide
  • Teriflunomide
  • Topotecan
  • Ubrogepant
  • Voclosporin

Other Interactions

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

  • Blood clots (eg, deep vein thrombosis, pulmonary embolism, arterial thrombosis), or history of or
  • Cancer, or history of or
  • Heart or blood vessel disease (eg, heart attack), or history of or
  • Liver disease (eg, hepatitis B), or history of or
  • Neutropenia (low number of white blood cells) or
  • Stroke, history of or
  • Thrombocytopenia (low number of platelets)—Use with caution. May make these conditions worse.
  • Infection—May decrease your body's ability to fight infection.
  • Liver disease, severe—Use with caution. The effects may be increased because of slower removal of the medicine from the body.
  • Smoker, current or past—May increase risk for serious side effects.

Proper Use

Take this medicine only as directed by your doctor. Your dose depends on your platelet count and needs to be changed several times in order to find out what works best for you. Do not use more medicine, do not use it more often, and do not use it for a longer time than your doctor ordered.

This medicine comes with a patient information insert. Read and follow the instructions carefully. Ask your doctor if you have any questions.

Keep using this medicine for as long as your doctor has told you to. Do not change your dose or stop taking this medicine without first talking with your doctor.

Take this medicine with or without food.

Swallow the tablet whole. Do not cut, crush, or chew it.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

  • For oral dosage form (tablets):
    • For myelofibrosis:
      • Adults—200 milligrams (mg) once a day, depending on your blood test results. Your doctor will adjust your dose as needed and tolerated.
      • Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions

It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly. Blood tests will be needed to check for unwanted effects.

Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control during treatment and for 1 week after the last dose. If you think you have become pregnant, tell your doctor right away.

This medicine lowers the number of some types of blood cells in your body. Because of this, you may bleed or get infections (eg, hepatitis B). Avoid being near people who are sick or have infections while you are using this medicine. Wash your hands often. Stay away from rough sports or other situations where you could be bruised, cut, or injured. Brush and floss your teeth gently. Be careful when using sharp objects, including razors and fingernail clipper.

Check with your doctor right away if you have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, unusual tiredness or weakness, or yellow eyes or skin. These could be symptoms of a serious liver problem.

This medicine may increase your risk of serious heart or blood vessel problems, including heart attack or stroke. Call your doctor right away if you have chest pain or discomfort, confusion, difficulty in speaking, double vision, headache, inability to move arms, legs, or facial muscles, nausea, pain or discomfort in the arms, jaw, back, or neck, sweating, trouble breathing, or vomiting.

Check with your doctor right away if you have anxiety, chest pain, cough, dizziness, lightheadedness, or fainting, fast heartbeat, pain, redness, or swelling in the arm or leg, pains in the chest, groin, or legs, especially calves of the legs, severe headaches, sudden loss of coordination, sudden onset of slurred speech, sudden vision changes, or trouble breathing. These may be symptoms of serious blood clots (eg, deep vein thrombosis, pulmonary embolism, arterial thrombosis).

This medicine may increase your risk of cancer (eg, lymphoma, non-melanoma skin cancer). Tell your doctor right away if you have black, tarry stools, general feeling of illness, swollen glands, weight loss, yellow skin and eyes, persistent non-healing sore, reddish patch or irritated area, shiny bump, pink growth, or white, yellow or waxy scar-like area on the skin.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

  1. Black, tarry stools
  2. bladder pain
  3. bleeding gums
  4. bloating or swelling of the face, arms, hands, lower legs, or feet
  5. blood in the stools
  6. bloody or cloudy urine
  7. blurred vision
  8. chest pain or tightness
  9. confusion
  10. coughing up blood
  11. cough or hoarseness
  12. diarrhea
  13. difficult, burning, or painful urination
  14. difficulty in breathing or swallowing
  15. dizziness
  16. dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
  17. fainting
  18. fast, slow, or irregular heartbeat
  19. fever or chills
  20. frequent urge to urinate
  21. headache
  22. increased menstrual flow or vaginal bleeding
  23. loss of taste or smell
  24. lower back or side pain
  25. muscle or body aches
  26. nausea or vomiting
  27. nosebleeds
  28. pale skin
  29. paralysis
  30. pinpoint red spots on the skin
  31. prolonged bleeding from cuts
  32. rapid weight gain
  33. red or dark brown urine
  34. sore throat
  35. stuffy or runny nose
  36. sweating
  37. tingling of the hands or feet
  38. ulcers, sores, or white spots in the mouth
  39. unusual bleeding or bruising
  40. unusual tiredness or weakness
  41. unusual weight gain or loss

Less common

  1. Blue lips, fingernails, or skin
  2. burning, numbness, tingling, or painful sensations
  3. decreased urine output
  4. dilated neck veins
  5. nerve pain
  6. swelling of the face, fingers, feet, or lower legs
  7. unsteadiness or awkwardness
  8. weakness in the arms, hands, legs, or feet

Incidence not known

  1. Anxiety
  2. chest discomfort
  3. dark urine
  4. difficulty in speaking
  5. double vision
  6. general feeling of illness
  7. inability to move the arms, legs, or facial muscles
  8. inability to speak
  9. loss of appetite
  10. pain, redness, or swelling in the arm or leg
  11. pain or discomfort in the arms, jaw, back, or neck
  12. pains in the chest, groin, or legs, especially the calves of legs
  13. persistent non-healing sore
  14. pink growth
  15. reddish patch or irritated area
  16. severe headaches of sudden onset
  17. shiny bump
  18. slow speech
  19. stomach pain, severe
  20. sudden loss of coordination
  21. sudden onset of slurred speech
  22. sudden vision changes
  23. swollen glands
  24. white, yellow or waxy scar-like area
  25. yellow eyes or skin

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

  1. Back pain
  2. burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
  3. itching skin
  4. pain in the arms or legs

Less common

  1. Feeling of warmth
  2. redness of the face, neck, arms and occasionally, upper chest

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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

Portions of this document last updated: July 01, 2024

Original article: https://www.mayoclinic.org/drugs-supplements/momelotinib-oral-route/before-using/drg-20555953