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Tibsovo
Ivosidenib
$119460.00
250mg · 3 × 1 tablets · 6 months supply
BrandBranded medicine
$19910.00 per month
How long a supply?
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Annual cost
$238920a year at this pack size
Prescription required
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FDA boxed warningDifferentiation syndrome in aml and mds
Patients treated with TIBSOVO have experienced symptoms of differentiation syndrome, which can be fatal. Symptoms may include fever, dyspnea, hypoxia, pulmonary infiltrates, pleural or pericardial effusions, rapid weight gain or peripheral edema, hypotension, and hepatic, renal, or multi-organ dysfunction. If differentiation syndrome is suspected, initiate corticosteroid therapy and hemodynamic monitoring until symptom resolution.
Patients treated with TIBSOVO have experienced symptoms of differentiation syndrome, which can be fatal. If differentiation syndrome is suspected, initiate corticosteroid therapy and hemodynamic monitoring until symptom resolution.
About Tibsovo
Overview
Tibsovo (ivosidenib) is a medicine for adults with certain cancers that have a susceptible IDH1 mutation, confirmed by an FDA-approved test. It treats newly diagnosed acute myeloid leukemia (AML), alone or with azacitidine, in adults aged 75 or older or whose other medical conditions prevent intensive induction chemotherapy; it also treats AML that has returned or not responded to treatment. Other uses include myelodysplastic syndromes (MDS) that have returned or not responded to treatment, and previously treated bile duct cancer (cholangiocarcinoma) that is locally advanced or has spread elsewhere in the body. It works by blocking the altered IDH1 enzyme, reducing production of a substance called 2-HG.
What it treats
For adults with a susceptible IDH1 mutation detected by an FDA-approved test: - Newly diagnosed acute myeloid leukemia (AML), alone or with azacitidine, in adults aged 75 or older or with other medical conditions that prevent intensive induction chemotherapy. - Acute myeloid leukemia (AML) that has returned or has not responded to treatment. - Myelodysplastic syndromes (MDS) that have returned or have not responded to treatment. - Previously treated cholangiocarcinoma (bile duct cancer) that is locally advanced or has spread to other parts of the body.
Safety information
Side effects
Common side effects vary by the condition being treated. They include tiredness, diarrhea, nausea, vomiting, reduced appetite, abdominal pain and rash. In people with AML or MDS, common effects also include joint or muscle pain and inflammation of the mouth or other mucous membranes. Swelling and shortness of breath are common in AML; cough and itching are common in MDS. In cholangiocarcinoma, cough, anemia and fluid buildup in the abdomen are also common. Blood tests may show changes in blood cell counts, liver-related tests, creatinine and mineral levels. Increased blood sugar can occur in AML. Serious side effects include differentiation syndrome in people with AML or MDS, QT prolongation (a change in the heart’s electrical activity), and Guillain-Barré syndrome. Contact your doctor promptly if you develop new changes in movement or sensation, or if you are told you have any of these serious reactions. Your doctor will monitor your heart’s electrical activity with ECGs and check electrolyte levels. QT prolongation may require treatment changes or stopping Tibsovo. Tibsovo must be permanently stopped if Guillain-Barré syndrome is diagnosed.
FDA boxed warning
Differentiation syndrome in aml and mds
Patients treated with TIBSOVO have experienced symptoms of differentiation syndrome, which can be fatal. Symptoms may include fever, dyspnea, hypoxia, pulmonary infiltrates, pleural or pericardial effusions, rapid weight gain or peripheral edema, hypotension, and hepatic, renal, or multi-organ dysfunction. If differentiation syndrome is suspected, initiate corticosteroid therapy and hemodynamic monitoring until symptom resolution.
Patients treated with TIBSOVO have experienced symptoms of differentiation syndrome, which can be fatal. If differentiation syndrome is suspected, initiate corticosteroid therapy and hemodynamic monitoring until symptom resolution.
A boxed warning is the strongest warning the US Food and Drug Administration requires on a medicine label. Text is taken from the official label, with internal section references removed.
When to call your doctor
If symptoms are severe or getting worse quickly, seek emergency care rather than waiting.
Interactions
Some medicines can interact with Tibsovo: • Strong or moderate CYP3A4 inhibitors can increase the risk of QTc prolongation, a change in the heart’s electrical activity. Monitoring is needed, and your prescriber will need to adjust Tibsovo treatment if a strong inhibitor is used. • Strong CYP3A4 inducers and sensitive CYP3A4 substrates should not be used with Tibsovo. • Other medicines that prolong the QTc interval should be avoided. If use together is unavoidable, monitoring is needed. Ask your doctor to check whether any of your medicines fall into these groups.
Using Tibsovo
Dosing
Dosing is set by your prescriber. Each health care professional may prescribe medication differently according to a patient's medical history and condition, so follow the directions on your prescription label and speak to your doctor or pharmacist before changing anything.
Storage
Store below 25°C in a dry place, in the original pack, away from direct light and moisture. Do not keep it in a bathroom. Keep all medicines out of the sight and reach of children.
Clinical information on this page is summarised from the US FDA label TIBSOVO (IVOSIDENIB) TABLET, FILM COATED [SERVIER PHARMACEUTICAL LLC] (DailyMed, retrieved 19 September 2026).
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