Fedratinib (fed-RA-ti-nib)

Treats myelofibrosis.

Brand Name(s):

Inrebic

When This Medicine Should Not Be Used:

How to Use This Medicine:

Capsule

• Take your medicine as directed. Your dose may need to be changed several times to find what works best for you.
• You may take this medicine with or without food. However, taking this medicine with a high fat meal may prevent nausea and vomiting.
• You may also receive medicines to help prevent diarrhea, nausea, and vomiting.
• This medicine should come with a Medication Guide. Ask your pharmacist for a copy if you do not have one.
• Missed dose: If you miss a dose of this medicine, skip the missed dose and go back to your regular dosing schedule.
• 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 fedratinib works. Tell your doctor if you are using diltiazem, efavirenz, erythromycin, fluconazole, ketoconazole, metoprolol, midazolam, omeprazole, pantoprazole, rifampin, or ruxolitinib.

Warnings While Using This Medicine:

• Tell your doctor if your are pregnant, or if you have kidney disease, liver disease, heart disease, blood problems (including anemia, thrombocytopenia), rheumatoid arthritis, Vitamin B1 deficiency, or a history of cancer, blood clots, heart attack, or stroke. Tell your doctor if you are a current or past smoker.
• Do not breastfeed during treatment and for at least 1 month after the last dose.
• This medicine may cause the following problems:
  • Encephalopathy (brain disease), including Wernicke's encephalopathy, which may be serious and life-threatening
  • Increased risk of serious heart or blood vessel disease (including heart attack, stroke)
  • Increased risk of blood clots (including arterial thrombosis, deep vein thrombosis, pulmonary embolism)
  • 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.
• Medicines used to treat cancer are very strong and can have many side effects. Before receiving this medicine, make sure you understand all the risks and benefits. It is important for you to work closely with your doctor during your treatment.
• Cancer medicines can cause diarrhea, nausea, or vomiting, sometimes even after you receive medicine to prevent these effects. Ask your doctor or nurse about other ways to control any diarrhea, nausea, or vomiting that might happen.
• 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
• Change in how much or how often you urinate, painful urination
• Chest pain that may spread, trouble breathing, coughing up blood, unusual sweating, fainting
• Confusion, drowsiness, blurred vision, shaking, trembling, trouble remembering, problems with balance or walking
• Dark urine or pale stools, nausea, vomiting, loss of appetite, stomach pain, yellow skin or eyes
• Fever, chills, cough, sore throat, body aches
• Numbness or weakness in your arm or leg, or on one side of your body, pain in your lower leg
• Sores, reddish patch or irritated area, shiny bump, or pink growth on the skin
• Sudden or severe headache, problems with vision or speech
• Tiny red dots on the skin, especially on the lower legs
• Unusual bleeding, bruising, or weakness

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

• Diarrhea, weight loss
• Headache, dizziness
• Muscle spasms

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