Ivosidenib Oral Tablet (IVOSIDENIB - 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.

Do not take this medicine with a high fat meal.

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.

Keep the desiccant (drying) packet in the bottle and keep the bottle closed tightly.

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

Drink plenty of water 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, take it as soon as you remember. If it is less than 12 hours to the next dose, do not take the dose. Return to your normal dosing schedule. Do not take 2 doses at one time.

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.

This medicine may decrease the effectiveness of some birth controls which use hormones (such as birth control pills and patches). Use an extra form of birth control, such as condoms, while on this medicine.

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

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.

Do not use the medication any more than instructed.

This medicine may cause dizziness or fainting. Do not stand or sit up quickly.

If possible, avoid using with alcohol, 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.

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

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 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.

• decreased appetite
• constipation or diarrhea
• dizziness
• lack of energy and tiredness
• headaches
• mouth sores or irritation
• 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:

• back pain
• chest pain
• cough that does not go away
• swelling of the legs, feet, and hands
• fainting
• fever
• numbness or tingling in hands and feet
• fast or irregular heart beats
• signs of kidney damage (such as change in urine color or bubbly urine)
• muscle aches, spasms or abnormal movements
• muscle weakness
• joint or muscle pain
• red, burning, or itchy skin
• shortness of breath
• difficulty or discomfort urinating
• blood in urine
• vaginal bleeding or spotting between periods
• 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.