Momelotinib (moe-me-LOE-ti-nib)

Treats myelofibrosis.

Brand Name(s):

Ojjaara

When This Medicine Should Not Be Used:

How to Use This Medicine:

Tablet

• Take your medicine as directed. Your dose may need to be changed several times to find what works best for you.
• Swallow the tablet whole. Do not cut, crush, or chew it.
• Read and follow the patient instructions that come with this medicine. Talk to your doctor or pharmacist if you have any questions.
• Missed dose: If you miss a dose of this medicine, skip the missed dose and go back to your regular dosing schedule. Do not take extra medicine to make up for a missed dose.
• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Some medicines can affect how momelotinib works. Tell your doctor if you are using rifampin or rosuvastatin.

Warnings While Using This Medicine:

• It is not safe to take this medicine during pregnancy. It could harm an unborn baby. Tell your doctor right away if you become pregnant. Use an effective form of birth control during treatment and for 1 week after the last dose.
• Do not breastfeed during treatment and for 1 week after the last dose.
• Tell your doctor if you have kidney disease, liver disease (including hepatitis B), heart or blood vessel disease, any type of infection, or a history of blood clots, heart attack, stroke, or skin cancer. Tell your doctor if you are a current or past smoker.
• This medicine may cause the following problems:
  • Increased risk of serious infections
  • Liver problems
  • Increased risk of serious heart or blood vessel disease, including heart attack or stroke
  • Increased risk of blood clots, including deep vein thrombosis, pulmonary embolism, arterial thrombosis
  • Increased risk of cancer, including lymphoma, skin cancer
• This medicine may make you bleed, bruise, or get infections more easily. Take precautions to prevent illness and injury. Wash your hands often.
• Do not stop using this medicine suddenly. Your doctor will need to slowly decrease your dose before you stop it completely.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Chest pain that may spread to your arms, jaw, back, or neck, trouble breathing, nausea, unusual sweating, fainting
• Coughing up blood, numbness or weakness in your arm or leg, or on one side of your body, pain in your lower leg
• Dark urine or pale stools, vomiting, loss of appetite, stomach pain, yellow skin or eyes
• Fever, chills, cough, sore throat, body aches
• Rapid weight gain, swelling in your hands, ankles, or feet
• Sores, reddish patch or irritated area, shiny bump, or pink growth on the skin
• Sudden or severe headache, problems with vision, speech, or walking
• Unusual bleeding, bruising, or weakness

If you notice these less serious side effects, talk with your doctor:

• Diarrhea
• Dizziness

If you notice other side effects that you think are caused by this medicine, tell your doctor

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