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Overview: Tibsovo is used to treat certain types of cancers. Common side effects include diarrhea, nausea, vomiting, tiredness, and decreased appetite. Call your health care provider right away if you get a fever, cough, dizziness, unusual swelling, weakness, or numbness. Get emergency help if you have trouble breathing or reduced urine (pee).

Uses

What is Tibsovo used for?

Tibsovo (ivosidenib) is commonly used to treat certain types of acute myeloid leukemia (AML), myelodysplastic syndromes, and bile duct cancer (cholangiocarcinoma).

Tibsovo may also be used for other conditions as determined by your health care provider.

How does Tibsovo work (mechanism of action)?

Some cancers have an enzyme that is not normal. Tibsovo inhibits the abnormal enzyme, which leads to a lower amount of a natural substance. Lower amounts of this substance help certain cells called myeloid cells to develop normally. Your health care provider can run a test to see if your cancer may respond to Tibsovo. 

How is Tibsovo supplied (dosage forms)?

Brands and other names

  • Tibsovo

Dosage forms and strengths

  • 250 mg oral tablets

How should I store Tibsovo?

Tibsovo should be stored at room temperature, between 68 F and 77 F (20 C and 25 C). It can be exposed to temperatures between 59 F and 86 F (15 C and 30 C) for shorter periods of time, such as when transporting it. Store in a cool, dry place.

Do not remove the desiccant packet that comes in the bottle. This helps to keep the medicine dry.

Side Effects

What are the most common side effects of Tibsovo?

The most common side effects of Tibsovo are listed below. These side effects may vary depending on the condition that is being treated. Tell your health care provider if you have any of these side effects that bother you.

  • Diarrhea, nausea, vomiting, or stomach pain
  • Anemia
  • Tiredness
  • Swelling of your arms, legs, or stomach area
  • Decreased appetite
  • Cough
  • Muscle or joint pain
  • Mouth or lip sores

There may be other side effects of Tibsovo that are not listed here. Contact your health care provider if you think you are having a side effect of a medicine. In the U.S., you can report side effects to the FDA at www.fda.gov/medwatch or by calling 800-FDA-1088 (800-332-1088). In Canada, you can report side effects to Health Canada at www.health.gc.ca/medeffect or by calling 866-234-2345.

What are the serious side effects of Tibsovo?

While less common, the most serious side effects of Tibsovo are described below, along with what to do if they happen.

Severe Allergic Reactions. Tibsovo may cause allergic reactions, which can be serious. Stop taking Tibsovo and get help right away if you have any of the following symptoms of a serious allergic reaction.

  • Breathing problems or wheezing
  • Racing heart
  • Fever or general ill feeling
  • Swollen lymph nodes
  • Swelling of the face, lips, mouth, tongue, or throat
  • Trouble swallowing or throat tightness
  • Itching, skin rash, or pale red bumps on the skin called hives
  • Nausea or vomiting
  • Dizziness, feeling lightheaded, or fainting
  • Stomach cramps
  • Joint pain

Differentiation Syndrome. Tibsovo can cause a dangerous and sometimes life-threatening problem called differentiation syndrome. This syndrome happens when you have a large increase in myeloid cells and may happen a day after you start this medicine or up to three months later. Get emergency help if you have any of the following symptoms. 

  • Fever
  • Cough
  • Trouble breathing
  • Rash
  • Not urinating (peeing) as much as usual
  • Dizziness or lightheadedness
  • Quickly gaining weight
  • Swelling of your arms or legs

Heart Rhythm Changes. Tibsovo may cause a rare, dangerous heart rhythm problem called QT prolongation and torsade de pointes. Some people have a higher risk of this, including people who are older, have other people in their family who have had these conditions, have low potassium or magnesium levels, or who take medicines that can prolong the QT interval. Tell your health care provider right away if you faint or have changes in your heart rate or rhythm, such as a fast or skipping heartbeat.

Guillain-Barré Syndrome (GBS). Tibsovo can cause a condition called GBS, which is when your immune system suddenly attacks your nerves. Tell your health care provider right away if you get any of the following symptoms.

  • Weakness or tingling in your legs, arms, or upper body
  • Numbness and pain on one side or both sides of your body
  • Any changes in your ability to see, touch, hear, or taste
  • Burning or prickling feeling
  • Trouble breathing

Tumor Lysis Syndrome. Tibsovo can cause a fast breakdown of cancer cells. This can lead to a condition called tumor lysis syndrome, which can be serious. It is important to drink plenty of water while receiving Tibsovo and to keep all appointments for blood tests so your health care provider can see how your body is responding to Tibsovo. Tell your health care provider right away if you have any of the following signs of tumor lysis syndrome. 

  • Nausea and vomiting
  • Weakness
  • Swelling or fluid retention
  • Shortness of breath
  • Muscle cramps
  • Seizures

Warnings & Precautions

Who should not use Tibsovo?

Allergies to Ingredients. People who are allergic to any of the following should not take Tibsovo.

  • Ivosidenib
  • Tibsovo
  • Any of the ingredients in the specific product dispensed

Your pharmacist can tell you all of the ingredients in Tibsovo.

What should I know about Tibsovo before using it?

Do not take Tibsovo unless it has been prescribed to you by a health care provider. Take it as prescribed.

Do not share Tibsovo with other people, even if they have the same condition as you. It may harm them.

Keep Tibsovo out of the reach of children.

Take Tibsovo around the same time each day. 

Swallow Tibsovo whole. Do not split, crush, or chew the tablets.

What should I tell my health care provider before using Tibsovo?

Tell your health care provider about all of your health conditions and any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. This will help them know if Tibsovo is right for you.

In particular, make sure that you discuss any of the following.

Current and Past Health Conditions. Tell your health care provider if you have any of the following.

  • Heart problems, including a heart rhythm problem called long QT syndrome or QT prolongation
  • Electrolyte imbalance, such as sodium, potassium, calcium, or magnesium
  • Kidney problems
  • Liver problems
  • Nerve problems

Other Medicines and Supplements. Tibsovo may interact with other medicines and supplements. Before taking Tibsovo, tell your health care provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. See the Interactions section for more details.

Pregnancy. Tibsovo may cause harm to a fetus. You should not become pregnant during treatment with Tibsovo. Tell your health care provider right away if you are pregnant, think you have become pregnant, or plan to become pregnant.

Breastfeeding. It is not known if Tibsovo passes into breast milk. Do not breastfeed during treatment with Tibsovo and for one month after your last dose. Tell your health care provider if you are breastfeeding or plan to breastfeed.

How can I get more information about Tibsovo?

For more information about Tibsovo, you can visit the drugmaker’s website at www.tibsovo.com or call them at 800-807-6124.

Interactions

Does Tibsovo interact with foods or drinks?

Do not take Tibsovo with high-fat food or drink, such as whole milk. Food or drinks that are high in fat may increase your risk for certain side effects. Talk with your health care provider about what food and drinks to avoid when taking Tibsovo. 

It is unknown if drinking alcohol will affect Tibsovo, but heavy drinking can slow your immune response and make it harder for your body to fight cancer. Also, the risk of tiredness may increase if you drink alcohol while taking Tibsovo.

Does Tibsovo interact with other medicines (drug interactions)?

Always tell your health care provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using.

In particular, make sure that you discuss if you are using any of the following before taking Tibsovo.

  • Fluconazole (Diflucan), itraconazole (Sporanox, Tolsura), ketoconazole, posaconazole (Noxafil), or voriconazole (Vfend), which are medicines used for fungal infections
  • Rifampin (Rifadin), which is a medicine commonly used to treat an infection called tuberculosis
  • A birth control pill, patch, vaginal ring, implant, injection, or intrauterine device (IUD) that contains hormones
  • Any medicine that can cause QT prolongation, which is a potentially dangerous heart rhythm problem

Many other medicines may alter the blood levels of Tibsovo, and vice versa. Tell your health care provider about all medicines that you take or have recently taken.

This may not be a complete list of medicines that can interact with Tibsovo. Always check with your health care provider.

Does interact with other drugs you are taking?

Enter your medication into the WebMD interaction checker

Overdose/Missed Dose

What should I do if I accidentally use too much Tibsovo?

If you or someone else has used too much Tibsovo, get medical help right away, call 911, or contact a Poison Control center at 800-222-1222.

What should I do if I miss a dose of Tibsovo?

If you miss a dose of Tibsovo, take it as soon as possible, as long as your next scheduled dose is at least 12 hours away. Do not take two doses of Tibsovo within 12 hours. Return to your normal schedule the next day. Do not take double or extra doses.

If you vomit after taking Tibsovo, do not take another dose. Take your next dose at your usual time.