Pronunciation: tib-SOH-voh
Generic name: ivosidenib
Dosage form: oral tablets
Drug class: Miscellaneous antineoplastics

Medically reviewed by Carmen Pope, BPharm. Last updated on Oct 27, 2023.

What is Tibsovo?

Tibsovo (ivosidenib) is a once-daily oral medication that targets a specific gene mutation called the isocitrate dehydrogenase-1 (IDH1) mutation, which can affect your bone marrow. An IDH1 mutation prevents young blood cells from developing into healthy adult blood cells, which can result in blood and bone marrow disorders such as acute myeloid leukemia (AML).

Tibsovo may be used to treat adults with a confirmed susceptible IDH1 mutation with:

• newly diagnosed acute myeloid leukemia (AML) either in combination with azacitidine or as monotherapy in patients 75 years or older who have comorbidities that preclude the use of intensive induction chemotherapy
• relapsed or refractory AML
• relapsed or refractory myelodysplastic syndromes
• bile duct cancer (cholangiocarcinoma) that has progressed or has spread to other parts of the body (metastatic) after treatment with other medicine.

Tibsovo targets the IDH1 mutation. In regular cells, the IDH1 gene produces the IDH1 protein, involved in normal cellular chemical processes. However, when the IDH1 gene is modified due to a genetic mutation, it leads to an abnormal version of the IDH1 protein and other substances such as the oncometabolite, D-2-hydroxyglutarate (2-HG). Tibsovo decreases levels of 2-HG, reducing blast counts and increasing levels of mature myeloid cells. Blasts are undeveloped bone marrow cells that will later mature into red blood cells, white blood cells, or blood-clotting platelets. They are typically absent in the bloodstream, and their presence signals a bone marrow issue, such as myelodysplastic syndrome.

Up to 20% of people with cholangiocarcinoma, and 6% to 10% of people with AML have the IDH1 mutation.

Tibsovo was first FDA-approved on July 20, 2018.

Warnings

Tibsovo can cause irregular heartbeats that can be life-threatening, such as QTc interval prolongation. The risk is higher in people who also take other medications that cause QTc prolongation. Your healthcare provider will check the electrical activity of your heart with a test called an electrocardiogram (ECG) before and during treatment.

Guillain-Barré Syndrome has occurred in 0.8% of patients treated with Tibsovo. Tell your doctor if you develop weakness on one or both sides of your body, sensory alterations, burning or prickling sensations, or difficulty breathing.

Tibsovo can cause a condition called differentiation syndrome, which affects blood cells and can be fatal if not treated. It can occur within 1 day to 3 months after you start taking the treatment. Seek medical help right away if you have symptoms of differentiation syndrome: fever, dizziness, cough, trouble breathing, swelling, rapid weight gain, rash, or decreased urination.

It is not known if Tibsovo is safe and effective in children.

Before taking this medicine

You should not use Tibsovo if you are allergic to ivosidenib or any of the other ingredients in the tablets.

To make sure you can safely take Tibsovo, tell your doctor if you have ever had:

• heart disease
• long QT syndrome (in you or a family member)
• nerve problems
• an electrolyte imbalance (such as low levels of potassium, sodium, or magnesium in your blood)
• cirrhosis or other liver disease or
• kidney disease (or if you are on dialysis).
• are pregnant, plan to become pregnant, or are breastfeeding.

Pregnancy

Tibsovo can harm your unborn baby. Your doctor may conduct a pregnancy test if you are a woman of childbearing potential before starting Tibsovo and you should avoid becoming pregnant during treatment. Tell your healthcare provider right away if you inadvertently become pregnant or think you might be pregnant during treatment.

Tibsovo can make hormonal birth control less effective, including birth control pills, injections, implants, skin patches, and vaginal rings. Use barrier birth control to prevent pregnancy: condom, diaphragm, cervical cap, or contraceptive sponge.

Pregnancy may be less likely to occur while the mother or the father is using this medicine. Women should still use birth control to prevent pregnancy because the medicine can harm an unborn baby.

Breastfeeding

It is not known if Tibsovo passes into your breast milk. Do not breastfeed during your treatment and for 1 month after your last dose.

How should I take Tibsovo?

Take Tibsovo exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets.

• Swallow the tablet whole and do not crush, chew, or break it.
• The usual dosage is 500mg once daily with or without food.
• Take the medicine at the same time each day, with or without food.
• Do not change your dose or stop taking it without your doctor's advice.
• Drink plenty of liquids while you are taking Tibsovo but do not take it at the same time as foods that are high in fat, examples include 2 eggs fried in butter, 2 strips of bacon, 2 slices of white bread with butter, 1 croissant with 1 slice of cheese, and 8 ounces of whole milk (approximately 1,000 calories and 58 grams of fat).

If you vomit shortly after taking Tibsovo, do not take another dose. Take your next dose as scheduled.

What happens if I miss a dose?

Take the medicine as soon as you can, but skip the missed dose if your next dose is due in less than 12 hours. Do not take two doses within 12 hours.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while taking Tibsovo?

Avoid high-fat food at the same time as taking your dose of Tibsovo. Follow your doctor's instructions about any restrictions on food, beverages, or activity.

What are the side effects of Tibsovo?

Get emergency medical help if you have signs of an allergic reaction to Tibsovo: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Tibsovo may cause serious side effects, including:

• Differentiation syndrome, which affects blood cells and can be fatal if not treated. This condition may occur within 1 day to 3 months after you start taking Tibsovo. Seek medical help right away if you have symptoms of differentiation syndrome, such as:
  • fever, cough, trouble breathing
  • dizziness
  • rash
  • decreased urination
  • rapid weight gain or
  • swelling in your arms or legs.
• Changes in the electrical activity of your heart called QTc prolongation
  • Tell your healthcare provider right away if you feel dizzy, lightheaded, or faint.
• Guillain-Barré syndrome. Tell your healthcare provider right away if you develop any signs or
  • symptoms of Guillain-Barré syndrome, including:
  • weakness or tingling feeling 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 sensation
  • difficulty breathing.

Common Tibsovo side effects affecting 25% or more of patients include:

• irregular heartbeats
• stomach pain or swelling, nausea, vomiting, loss of appetite
• diarrhea, constipation
• fever, tiredness
• laboratory abnormalities such as low red blood cell or high white blood cell counts
• cough, shortness of breath
• sores in your mouth or throat
• rash
• abnormal liver function tests
• muscle or joint pain or
• swelling in your arms or legs.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

What other drugs will affect Tibsovo?

Tibsovo can cause a serious heart problem. Your risk may be higher if you also use certain other medicines for infections, asthma, heart problems, high blood pressure, depression, mental illness, cancer, malaria, or HIV.

Other drugs may interact with ivosidenib, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all other medicines you use.

What other drugs will affect Tibsovo?

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements, including:

• Strong or moderate CYP3A4 inhibitors, such as clarithromycin, nefazodone, itraconazole, ketoconazole, atazanavir, darunavir, indinavir, lopinavir, nelfinavir, ritonavir, or saquinavir
• Strong or moderate CYP3A4 inducers, such as phenobarbital, phenytoin, rifampicin, St. John's Wort, or glucocorticoids. Avoid coadministration.
• Sensitive CYP3A4 substrates, such as lenacapavir or hormonal contraceptives. Coadministration may increase the toxicity or decrease the efficacy of these agents.
• QTc prolonging drugs such as amiodarone, haloperidol, quetiapine, or flecainide

Know the medicines you take. Keep a list of them to show to your healthcare provider and pharmacist when you get a new medicine. See the prescribing information for a full list of interactions.

Storage

Store at room temperature between 68°F to 77°F (20°C to 25°C).

Do not remove the desiccant canister from the bottle.

Keep out of the reach of children.

Ingredients

Active: ivosidenib 250mg

Inactive: colloidal silicon dioxide, croscarmellose sodium, hypromellose acetate succinate, magnesium stearate, microcrystalline cellulose, and sodium lauryl sulfate. The tablet coating includes FD&C blue #2, hypromellose, lactose monohydrate, titanium dioxide, and triacetin.

Manufacturer

Servier Pharmaceuticals LLC.

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