Ivosidenib (eye-voe-SID-e-nib)

Treats acute myeloid leukemia (AML), bile duct cancer, and myelodysplastic syndromes (MDS).

Brand Name(s):

Tibsovo

When This Medicine Should Not Be Used:

How to Use This Medicine:

Tablet

• Take your medicine as directed. Your dose may need to be changed several times to find what works best for you.
• Do not take this medicine with a high fat meal.
• Swallow the tablet whole. Do not crush, break, or chew it.
• Drink plenty of fluids to help prevent other unwanted effects.
• This medicine should come with a Medication Guide. Ask your pharmacist for a copy if you do not have one.
• Missed dose:
  • If you miss a dose and it is less than 12 hours until your next regular dose, skip the missed dose and take your next dose at the regular time. If you miss a dose and it is 12 hours or more until your next regular dose, take the missed dose as soon as possible, and then go back to your regular schedule. Do not administer 2 doses within 12 hours.
  • If you vomit after taking a dose of this medicine, do not take an additional dose. Take your next dose at your usual time.
• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Some medicines can affect how ivosidenib works. Tell your doctor if you are using any of the following:
  • Rifampin
  • Birth control pills
  • Medicine for heart rhythm problems
  • Medicine to treat and prevent nausea and vomiting caused by cancer medicines
  • Medicine to treat infection (including fluconazole, itraconazole, ketoconazole, fluoroquinolones)

Warnings While Using This Medicine:

• Do not breastfeed during treatment with this medicine and for at least 1 month after the last dose.
• Tell your doctor if you are pregnant, or if you have kidney disease, liver disease, heart failure, heart rhythm problems (including long QT syndrome), electrolyte imbalance, or an autoimmune disease (including Guillain-Barré syndrome).
• This medicine may cause the following problems:
  • Differentiation syndrome, including tumor lysis syndrome, which may be life-threatening
  • Heart rhythm problems
• Medicines used to treat cancer are very strong and can have many side effects. Before receiving this medicine, make sure you understand all the risks and benefits. It is important for you to work closely with your doctor during your treatment.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Changes in your hearing, vision, touch, or taste
• Fainting, dizziness, lightheadedness
• Fast, pounding, or uneven heartbeat
• Fever, chills, cough, sore throat. trouble breathing, change in how much or how often you urinate, body aches
• Joint pain, stiffness, or swelling, muscle pain, lower back, side, or stomach pain
• Numbness, tingling, or burning pain in your hands, arms, legs, or feet, numbness and pain on one side or both sides of your body
• Rapid weight gain, swelling of your arms or legs
• Unusual bleeding, bruising, or weakness

If you notice these less serious side effects, talk with your doctor:

• Diarrhea, constipation, nausea, vomiting, decreased appetite
• Sores or white patches on your lips, mouth, or throat

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088