Ivosidenib tablets

What is this medication?

IVOSIDENIB (EYE voe SID e nib) targets proteins in cancer cells and stops the cancer cells from growing. It treats acute myelogenous leukemia and cholangiocarcinoma.

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

COMMON BRAND NAME(S): TIBSOVO

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

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

• Guillain-Barre syndrome
• heart disease
• history of irregular heartbeat
• kidney disease
• liver disease
• low levels of sodium, potassium or magnesium in the blood
• nervous system problems
• an unusual or allergic reaction to ivosidenib, 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. Take it as directed on the prescription label at the same time every day. Do not cut, crush, or chew this medicine. Swallow the tablets whole. You can take it with or without food. If it upsets your stomach, take it with food. Do not take it with a high-fat meal. Keep taking it unless your health care provider tells you to stop.

Do not take this medicine with grapefruit juice.

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 health care provider 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 vomit after taking a dose, do not take an additional dose. Take your next dose at your usual time. If you miss a dose, take it as soon as you can as long as there are at least 12 hours before your next dose. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

What may interact with this medication?

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

• cisapride
• dronedarone
• pimozide
• thioridazine

This medicine may also interact with the following medications:

• certain antivirals for HIV or hepatitis
• certain medicines for fungal infections like fluconazole, itraconazole, and ketoconazole
• certain medicines for irregular heart beat like amiodarone, encainide, flecainide, propafenone, quinidine
• certain medicines for seizures like carbamazepine, phenobarbital, phenytoin
• female hormones, like estrogen or progestins and birth control pills
• grapefruit juice
• other medicines that prolong the QT interval (cause an abnormal heart rhythm)
• 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?

This medicine may make you feel generally unwell. This is not uncommon as chemotherapy can affect healthy cells as well as cancer cells. Report any side effects. Continue your course of treatment even though you feel ill unless your health care provider tells you to stop.

You may need blood work while you are taking this medicine.

Do not become pregnant while taking this medicine. Women should inform their health care provider if they wish to become pregnant or think they might be pregnant. Men should not father a child while taking this medicine. There is potential for serious harm to an unborn child. Talk to your health care provider for more information. Do not breast-feed an infant while taking this medicine or for 1 month after the last dose.

Birth control may not work properly while you are taking this medicine. Talk to your health care provider about using an extra method of birth control.

This medicine may make it more difficult to get pregnant or father a child. Talk to your health care provider if you are concerned about your fertility.

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 (skin rash, itching or hives; swelling of the face, lips, or tongue)
• changes in vision
• cough
• edema (sudden weight gain; swelling of the ankles, feet, hands or other unusual swelling; trouble breathing)
• fever
• heartbeat rhythm changes (trouble breathing; chest pain; dizziness; fast, irregular heartbeat; feeling faint or lightheaded, falls)
• high blood sugar (increased hunger, thirst or urination, unusually weak or tired, blurry vision)
• kidney injury (trouble passing urine or change in the amount of urine)
• low blood pressure (dizziness; feeling faint or lightheaded, falls; unusually weak or tired)
• low magnesium levels (fast, irregular heartbeat; muscle cramp or pain; muscle weakness; tremors; seizures)
• mouth sores
• pain, tingling, numbness in the hands or feet
• trouble breathing
• unusually weak or tired

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

• constipation
• diarrhea
• joint pain
• lack or loss of appetite
• muscle pain
• nausea
• stomach pain
• vomiting

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 at room temperature between 20 and 25 degrees C (68 and 77 degrees F). Get rid of any unused medicine after the expiration date.

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

• Take the medicine to a medicine take-back program. Check with your pharmacy or law enforcement to find a location.
• If you cannot return the medicine, check the label or package insert to see if the medicine should be thrown out in the garbage or flushed down the toilet. If you are not sure, ask your health care provider. If it is safe to put it in the trash, take the medicine out of the container. Mix the medicine 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.