Fedratinib Oral Capsule (FEDRATINIB - ORAL)

Instructions

Swallow the medicine without crushing or chewing it.

Swallow with a full glass (8 oz) of water unless your doctor gives you different instructions.

You may take with food to prevent stomach upset.

Taking with a high fat meal may reduce nausea and vomiting.

This medicine will work best if you take it at about the same time every day.

Store at room temperature away from heat, light, and moisture. Do not keep in the bathroom.

Please ask your doctor, nurse, or pharmacist how to discard unused medicines safely.

Avoid grapefruit and grapefruit juice while on this medicine.

If you forget a dose, just wait. Use the next dose at the usual time. Do not use 2 doses at once.

Drug interactions can change how medicines work or increase risk for side effects. Tell your health care providers about all medicines taken. Include prescription and over-the-counter medicines, vitamins, and herbal medicines. Speak with your doctor or pharmacist before starting or stopping any medicine.

Tell your doctor if symptoms do not get better or if they get worse.

Your doctor may prescribe other medications to reduce side effects. Follow instructions carefully.

Keep using this medicine for the full number of days that it is prescribed. Do not stop the medicine even if you start to feel better.

You may need vitamin and mineral supplements while on this medicine. Please speak with your doctor or pharmacist.

Keep all appointments for medical exams and tests while on this medicine.

Brand Name(s): Inrebic

Generic Name: Fedratinib

Cautions

Tell your doctor and pharmacist if you ever had an allergic reaction to a medicine.

Do not use the medication any more than instructed.

This medicine may cause dizziness or fainting, especially after exercising or in hot weather. Be very careful when standing or sitting up quickly.

If possible, avoid using with marijuana or other medicines that can cause dizziness or drowsiness. These include allergy/cold products, muscle relaxers, sleep aids, and pain relievers.

Your ability to stay alert or to react quickly may be impaired by this medicine. Do not drive or operate machinery until you know how this medicine will affect you.

Please check with your doctor before drinking alcohol while on this medicine.

Call the doctor if there are any signs of confusion or unusual changes in behavior.

This medicine may reduce your body's ability to fight infections. Avoid contact with people with colds, flu or other infections. Contact your doctor if you develop fever, cough, sore throat, or chills.

Speak with your health care provider before receiving any vaccinations.

Do not breastfeed while on this medicine. You may safely start breastfeeding 1 month after stopping treatment.

This medicine can hurt a new baby in the womb. If you become pregnant while on this medicine, tell your doctor immediately. Your doctor may switch you to a different medicine.

Women who are pregnant or in their childbearing years should not touch or handle this medicine. This medicine can be absorbed through the woman's skin and harm the unborn baby.

Do not share this medicine with anyone who has not been prescribed this medicine.

Some patients have serious side effects from this medicine. Ask your pharmacist to show you the information from the Food and Drug Administration (FDA) and discuss it with you.

Side Effects

The following is a list of some common side effects from this medicine. Please speak with your doctor about what you should do if you experience these or other side effects.

• diarrhea
• dizziness
• lack of energy and tiredness
• headaches
• muscle aches, spasms or abnormal movements
• nausea and vomiting
• stomach upset or abdominal pain

Call your doctor or get medical help right away if you notice any of these more serious side effects:

• loss of balance
• bleeding or bruising
• chest pain
• changes in memory, mood, or thinking
• confusion
• coughing
• swelling of the legs, feet, and hands
• fever or chills
• sudden leg pain, swelling, warmth or redness
• signs of liver damage (such as yellowing of eye or skin, dark urine, or unusual tiredness)
• involuntary, repetitive movement of the eye
• shortness of breath
• slurred speech
• unsteadiness while walking
• blurring or changes of vision
• weakness on one side of the body
• sudden or unexplained weight gain

A few people may have an allergic reaction to this medicine. Symptoms can include difficulty breathing, skin rash, itching, swelling, or severe dizziness. If you notice any of these symptoms, seek medical help quickly.