Midostaurin Oral Capsule 25 mg

Instructions

Swallow the medicine without crushing or chewing it.

Take the medicine with food.

Do not take on an empty stomach.

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

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.

Drink plenty of water while on this medicine.

Avoid grapefruit and grapefruit juice while on this medicine.

If you vomit after taking a dose, do not take an extra dose. Take your next dose at the usual time.

Tell your doctor if you have severe or persistent sweating, diarrhea or vomiting. These can increase your risk of a serious side effect.

If you forget to take a dose on time, return to your normal dosing schedule on the following day.

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.

Use effective birth control to avoid pregnancy.

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

Do not take the medicine more than twice during 24 hours.

Cautions

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

May cause mouth sores. Brush teeth gently. Avoid products containing alcohol. Rinse mouth with a mixture of water and baking soda or salt.

Some patients taking this medicine have experienced serious side effects. Please speak with your doctor to understand the risks and benefits associated with this 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.

Contact your doctor if you notice a change in the amount or darkening of your urine.

Tell the doctor or pharmacist if you are pregnant, planning to be pregnant, or breastfeeding.

Do not breastfeed while on this medicine. You may safely start breastfeeding 4 months after stopping treatment.

Do not use this medicine if you are pregnant. If you become pregnant, contact your doctor immediately.

This medicine can cause birth defects. Speak with your doctor about birth control methods that should be used while on this medicine.

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 of childbearing age should have a negative pregnancy test before starting this medicine.

Women must use reliable forms of birth control while using this medicine and for 4 months after stopping to prevent pregnancy.

Men with a female partner who is of childbearing age must use reliable birth control during sexual activity while taking this medicine and for 4 months after stopping to prevent pregnancy.

Do not take St. John's wort while on this 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.

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.

• agitated feeling or trouble sleeping
• constipation or diarrhea
• dizziness
• lack of energy and tiredness
• headaches
• mouth sores or irritation
• joint or muscle pain
• 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:

• bleeding or bruising
• chest pain
• cough that does not go away
• coughing up blood or vomit that looks like coffee grounds
• fainting
• fever or chills
• fast or irregular heart beats
• shortness of breath
• sore throat
• dark, tarry stool
• excessive thirst
• unusual or unexplained tiredness or weakness
• increased urinary frequency
• difficulty or discomfort urinating

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.