Fedratinib oral capsules

What is this medication?

FEDRATINIB (fe dra TIN ib) is a medicine that targets proteins in cells and stops them from growing. It is used to treat myelofibrosis.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

COMMON BRAND NAME(S): INREBIC

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

• blood clots
• cancer
• heart attack
• heart disease
• kidney disease
• liver disease
• low blood counts (white cells, platelets, or red blood cells)
• low levels of thiamine (vitamin B1) in the blood
• smoke tobacco cigarettes
• stroke
• an unusual or allergic reaction to fedratinib, other medicines, foods, dyes, or preservatives
• pregnant or trying to get pregnant
• breast-feeding

How should I use this medication?

Take this medicine by mouth with a glass of water. Follow the directions on the prescription label. You can take it with or without food. If it upsets your stomach take it with food. Take your medicine at regular intervals. Do not take it more often than directed. Do not stop taking except on your doctor's advice.

A special MedGuide will be given to you by the pharmacist with each prescription and refill. Be sure to read this information carefully each time.

Talk to your pediatrician about the use of this medicine in children. Special care may be needed.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, skip it. Take your next dose at the normal time. Do not take extra or 2 doses at the same time to make up for the missed dose.

What may interact with this medication?

Do not take this medicine with any of the following medications:

• dofetilide
• eliglustat
• flibanserin
• lomitapide
• thioridazine

This medicine may also interact with the following medications:

• certain antiviral medicines for hepatitis, HIV or AIDS
• certain medicines for fungal infections like ketoconazole, itraconazole, posaconazole, and voriconazole
• certain antibiotics like clarithromycin and telithromycin
• certain medicines for seizures like carbamazepine, phenobarbital, and phenytoin
• grapefruit or grapefruit juice
• metformin
• metoprolol
• midazolam
• omeprazole
• rifampin
• St. John's wort

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Visit your health care provider for regular checks on your progress. You may need blood work done while you are taking this medicine.

You should make sure you get enough thiamine (vitamin B1) while you are taking this medicine. Discuss the foods you eat and the vitamins you take with your health care provider.

Do not breast-feed an infant while taking this medicine or for at least 1 month after stopping it.

Talk to your health care provider about your risk of cancer. You may be more at risk for certain types of cancer if you take this medicine.

This medicine may increase your risk of having certain heart problems. Get medical help right away if you have any chest pain or tightness, pain that radiates to the jaw or down the arm, or shortness of breath. These may be signs of a heart attack or other serious condition.

What side effects may I notice from receiving this medication?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue
• blurred vision or changes in vision
• confusion
• drowsiness
• loss of balance or coordination
• loss of memory
• low blood counts - this medicine may decrease the number of white blood cells, red blood cells, and platelets. You may be at risk for infections and bleeding.
• severe diarrhea
• severe nausea, vomiting
• signs and symptoms of liver injury like dark yellow or brown urine; general ill feeling or flu-like symptoms; light-colored stools; loss of appetite; right upper belly pain; unusually weak or tired; yellowing of the eyes or skin
• signs and symptoms of low red blood cells or anemia such as unusually weak or tired; feeling faint or lightheaded; falls; breathing problems
• trouble walking
• unusual bleeding or bruising

Side effects that usually do not require medical attention (report these to your doctor or health care professional if they continue or are bothersome):

• diarrhea
• headache
• muscle cramps
• nausea
• tiredness
• weight gain

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medication?

Keep out of the reach of children.

Store at room temperature below 30 degrees C (86 degrees F). Throw away any unused medicine after the expiration date.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.