Tibsovo Side Effects
Generic name: ivosidenib
Medically reviewed by Drugs.com. Last updated on Jul 12, 2023.
Note: This document contains side effect information about ivosidenib. Some dosage forms listed on this page may not apply to the brand name Tibsovo.
Applies to ivosidenib: oral tablet.
Oral route (Tablet)
Warning: Differentiation SyndromePatients treated with ivosidenib have experienced symptoms of differentiation syndrome, which can be fatal if not treated. 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.Early recognition and aggressive management of differentiation syndrome is required to lessen the likelihood of serious illness and death. Symptoms of differentiation syndrome should be described to patients when starting therapy and at follow-up visits. Differentiation syndrome has occurred as early as 10 days and up to 5 months after initiating therapy with another isocitrate dehydrogenase 2 inhibitor.
Serious side effects of Tibsovo
Along with its needed effects, ivosidenib (the active ingredient contained in Tibsovo) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur while taking ivosidenib:
- Black, tarry stools
- bleeding gums
- blood in the urine or stools
- blurred vision
- burning, tingling, numbness or pain in the hands, arms, feet, or legs
- chest pain or tightness
- decreased urination
- difficult or labored breathing
- difficulty in moving
- dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
- eye pain
- general feeling of illness
- irregular heartbeat, recurrent
- joint pain, stiffness, or swelling
- lower back, side, or stomach pain
- muscle ache, cramps, pain, or stiffness
- painful or difficult urination
- pale skin
- pinpoint red spots on the skin
- rapid weight gain
- sensation of pins and needles
- sore throat
- sores, ulcers, or white spots on the lips, tongue, or inside the mouth
- stabbing pain
- swelling of your arms, feet, or lower legs
- unusual bleeding or bruising
- unusual tiredness or weakness
- Inability to move the arms and legs
- sudden numbness and weakness in the arms and legs
Other side effects of Tibsovo
Some side effects of ivosidenib may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.
Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
- Cracked lips
- decreased appetite
- difficulty in swallowing
For Healthcare Professionals
Applies to ivosidenib: oral tablet.
The most common adverse reactions reported in patients with acute myeloid leukemia were decreased leukocytes, diarrhea, decreased hemoglobin, decreased platelets, increased glucose, fatigue, increased alkaline phosphatase, edema, decreased potassium, nausea, vomiting, decreased phosphate, decreased appetite, decreased sodium, leukocytosis, decreased magnesium, increased AST, arthralgia, dyspnea, increased uric acid, abdominal pain, increased creatinine, mucositis, rash, ECG QT prolonged, differentiation syndrome, decreased calcium, decreased neutrophils, and myalgia.
The most common adverse reactions reported in patients with cholangiocarcinoma were fatigue, nausea, abdominal pain, diarrhea, cough, decreased appetite, ascites, vomiting, anemia, rash, decreased hemoglobin, increased AST, and increased bilirubin.[Ref]
Very common (10% or more): ECG QT prolonged (up to 26%), hematoma (includes hematoma, eye hematoma, catheter site hematoma, oral mucosa hematoma, spontaneous hematoma, application site hematoma, injection site hematoma, periorbital hematoma; up to 15%), hypertension (includes increased blood pressure, essential hypertension, hypertension; up to 13%), hypotension (includes hypotension, orthostatic hypotension; up to 12%)
Frequency not reported: Ventricular fibrillation, pericardial effusion[Ref]
Very common (10% or more): Rash (includes dermatitis acneiform, dermatitis, rash, maculopapular rash, urticaria, erythematous rash, macular rash, pruritic rash, generalized rash, papular rash, skin exfoliation, skin ulcer, erythema, generalized exfoliative dermatitis, drug eruption, drug hypersensitivity; up to 26%), pruritus (up to 14%)[Ref]
Very common (10% or more): Diarrhea (up to 61%), nausea (up to 42%), vomiting (includes vomiting, retching; up to 41%), abdominal pain (includes abdominal pain, upper abdominal pain, abdominal discomfort, abdominal tenderness, lower abdominal pain, epigastric discomfort, gastrointestinal pain; up to 35%), mucositis (includes aphthous ulcer, esophageal pain, esophagitis, gingival pain, gingivitis, mouth ulceration, mucosal inflammation, oral pain, oropharyngeal pain, proctalgia, stomatitis; up to 28%), ascites (up to 23%), constipation (up to 21%), dyspepsia (up to 11%)
Very common (10% or more): Decreased leukocytes (up to 65%), decreased hemoglobin (up to 60%), decreased platelets (up to 58%), leukocytosis (includes leukocytosis, increased WBC count, hyperleukocytosis; up to 38%), decreased neutrophils (up to 25%), neutropenia (up to 25%), increased lymphocytes (up to 24%), anemia (up to 18%)
Very common (10% or more): Increased AST (up to 37%), increased bilirubin (up to 30%), increased ALT (up to 15%)
Very common (10% or more): Increased glucose (up to 56%), decreased appetite (up to 39%), increased uric acid (up to 32%)
Common (1% to 10%): Tumor lysis syndrome
Frequency not reported: Fluid overload[Ref]
Very common (10% or more): Arthralgia (includes pain in extremity, arthralgia, back pain, musculoskeletal stiffness, cancer pain, neck pain; up to 36%), myalgia (includes myalgia, muscular weakness, musculoskeletal pain, musculoskeletal chest pain, musculoskeletal discomfort, intercostal myalgia; up to 25%)[Ref]
Very common (10% or more): Dizziness (up to 21%), headache (up to 16%), neuropathy (includes burning sensation, lumbosacral plexopathy, peripheral neuropathy, paresthesia, peripheral motor neuropathy, ataxia, gait disturbance, Guillain-Barre syndrome, peripheral sensory neuropathy, sensory disturbance; up to 14%), peripheral neuropathy (includes peripheral neuropathy, peripheral sensory neuropathy, paresthesia; up to 11%)
Uncommon (0.1% to 1%): Guillain-Barre syndrome
Differentiation syndrome has been associated with other commonly reported events such as peripheral edema, leukocytosis, pyrexia, dyspnea, pleural effusion, hypotension, hypoxia, pulmonary edema, pneumonia, pericardial effusion, rash, fluid overload, tumor lysis syndrome, and increased creatinine.[Ref]
Very common (10% or more): Differentiation syndrome (up to 25%)[Ref]
Very common (10% or more): Fatigue (includes asthenia, fatigue; up to 50%), increased alkaline phosphatase (up to 46%), edema (includes edema, face edema, fluid overload, fluid retention, hypervolemia, peripheral edema, swelling face; up to 43%), decreased potassium (up to 43%), decreased phosphate (up to 41%), decreased sodium (up to 39%), decreased magnesium (up to 38%), decreased calcium (up to 25%), increased potassium (up to 24%), pyrexia (up to 23%), chest pain (includes angina pectoris, chest pain, chest discomfort, noncardiac chest pain; up to 16%), decreased weight (up to 11%)
Frequency not reported: Sepsis, peripheral edema[Ref]
Very common (10% or more): Insomnia (up to 18%)[Ref]
Very common (10% or more): Increased creatinine (up to 29%)
Frequency not reported: Acute kidney injury[Ref]
Very common (10% or more): Dyspnea (includes dyspnea, exertional dyspnea, hypoxia, respiration failure; up to 33%), cough (includes cough, productive cough, upper airway cough syndrome; up to 27%), pleural effusion (up to 13%)
Frequently asked questions
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Related treatment guides
1. Product Information. Tibsovo (ivosidenib). Servier Pharmaceuticals LLC. 2022.
2. Product Information. Tibsovo (ivosidenib). Servier Laboratories (Aust) Pty Ltd. 2023.
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
Some side effects may not be reported. You may report them to the FDA.