Tibsovo Side Effects

Generic name: ivosidenib

Medically reviewed by Drugs.com. Last updated on Jun 11, 2024.

Note: This document provides detailed information about Tibsovo Side Effects associated with ivosidenib. Some dosage forms listed on this page may not apply specifically to the brand name Tibsovo.

Applies to ivosidenib: oral tablet.

Precautions

It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly. Blood and urine tests may be needed to check for unwanted effects.

Using this medicine may increase your risk of having a condition called differentiation syndrome, which may be life-threatening. It may occur within 1 day and up to 3 months after treatment with this medicine. Check with your doctor right away if you start to have a fever, cough, trouble breathing, swelling of the arms or legs or around the neck, groin, or underarms, rapid weight gain, or bone pain.

This medicine may also cause a serious reaction called tumor lysis syndrome (TLS). Call your doctor right away if you have a change in how much or how often you urinate, rapid weight gain, muscle or joint pain, swelling of the feet or lower legs, or unusual tiredness or weakness.

Contact your doctor right away if you have any changes to your heart rhythm. You might feel dizzy or faint, or you might have a fast, pounding, or uneven heartbeat. Make sure your doctor knows if you had a heart rhythm problem, including QT prolongation.

Contact your doctor immediately if fever, rash, joint pain, sudden numbness and weakness in the arms and legs, or inability to move the arms and legs occurs. These could be symptoms of an autoimmune syndrome where the body attacks itself.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

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:

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:

For healthcare professionals

Applies to ivosidenib: oral tablet.

General adverse events

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]

Cardiovascular

• 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]

Dermatologic

• 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]

Gastrointestinal

• 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%)
• Frequency not reported: Stomatitis, intestinal obstruction^[Ref]

Hematologic

• 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%)
• Frequency not reported: Thrombocytopenia^[Ref]

Hepatic

• Very common (10% or more): Increased AST (up to 37%), increased bilirubin (up to 30%), increased ALT (up to 15%)
• Frequency not reported: Increased transaminases, hyperbilirubinemia, cholestatic jaundice, hepatic encephalopathy^[Ref]

Metabolic

• 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]

Musculoskeletal

• 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]

Nervous system

• 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
• Frequency not reported: Cerebral ischemia, posterior reversible encephalopathy syndrome, progressive multifocal leukoencephalopathy^[Ref]

Oncologic

• Very common (10% or more): Differentiation syndrome (up to 25%)^[Ref]

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]

Other

• 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]

Psychiatric

• Very common (10% or more): Insomnia (up to 18%)^[Ref]

Renal

• Very common (10% or more): Increased creatinine (up to 29%)
• Frequency not reported: Acute kidney injury^[Ref]

Respiratory

• 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%)
• Frequency not reported: Pneumonia, pulmonary embolism, hypoxia, pulmonary edema^[Ref]

See also:

Frequently asked questions

• What is Tibsovo used to treat?

Further information

Tibsovo side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.

Medical Disclaimer