Fedratinib Capsules

What is this medication?

FEDRATINIB (fe dra TIN ib) treats bone marrow cancer. It works by blocking a protein that causes cancer cells to grow and multiply. This helps to slow or stop the spread of cancer cells.

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
• Stroke
• Tobacco use
• An unusual or allergic reaction to fedratinib, other medications, foods, dyes, or preservatives
• Pregnant or trying to get pregnant
• Breastfeeding

How should I use this medication?

Take this medication by mouth with water. Take it as directed on the prescription label at the same time every day. You can take it with food or without food. If it upsets your stomach, take it with food. Keep taking it unless your care team tells you to stop.

Take a thiamine supplement every day while taking this medication. This medication can cause low levels of thiamine (vitamin B1) in your body. Serious adverse effects may occur if your levels are too low. Thiamine plays an important role in maintaining the health of your brain.

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 care team about the use of this medication 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 medication with any of the following:

• Dofetilide
• Eliglustat
• Flibanserin
• Lomitapide
• Thioridazine

This medication may also interact with the following:

• Certain antiviral medications for hepatitis, HIV, or AIDS
• Certain medications for fungal infections, such as ketoconazole, itraconazole, posaconazole, and voriconazole
• Certain antibiotics, such as clarithromycin and telithromycin
• Certain medications for seizures, such as 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 care team for regular checks on your progress. You may need blood work done while you are taking this medication.

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

Talk to your care team before breastfeeding. Changes to your treatment plan may be needed.

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

This medication 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 care team as soon as possible:

• Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
• Blood clot—pain, swelling, or warmth in the leg, shortness of breath, chest pain
• Dizziness, loss of balance or coordination, confusion or trouble speaking
• Eye pain, redness, irritation, or discharge with blurry or decreased vision
• Heart attack—pain or tightness in the chest, shoulders, arms, or jaw, nausea, shortness of breath, cold or clammy skin, feeling faint or lightheaded
• Liver injury—right upper belly pain, loss of appetite, nausea, light-colored stool, dark yellow or brown urine, yellowing skin or eyes, unusual weakness or fatigue
• Low red blood cell level—unusual weakness or fatigue, dizziness, headache, trouble breathing
• Severe or prolonged vomiting or diarrhea
• Stroke—sudden numbness or weakness of the face, arm, or leg, trouble speaking, confusion, trouble walking, loss of balance or coordination, dizziness, severe headache, change in vision
• Uncontrollable eye movements
• Unusual bruising or bleeding

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

• Diarrhea
• Fatigue
• Headache
• Muscle spasms
• Vomiting
• 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 and pets.

Store between 15 and 30 degrees C (59 and 86 degrees F). Get rid of any unused medication after the expiration date.

To get rid of medications that are no longer needed or have expired:

• Take the medication to a medication take-back program. Check with your pharmacy or law enforcement to find a location.
• If you cannot return the medication, check the label or package insert to see if the medication should be thrown out in the garbage or flushed down the toilet. If you are not sure, ask your care team. If it is safe to put it in the trash, empty the medication out of the container. Mix the medication with cat litter, dirt, coffee grounds, or other unwanted substance. Seal the mixture in a bag or container. Put it in the trash.

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.