Note: This document contains side effect information about ivosidenib. Some of the 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.
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:
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:
Applies to ivosidenib: oral tablet
Common (1% to 10%): Hemoglobin decreased (60%), leukocytosis (e.g., leukocytosis, hyperleukocytosis, increased white blood cell count) (38%)
Uncommon (0.1% to 1%): Guillain-Barre syndrome
Very common (10% or more): Arthralgia (e.g., arthralgia, back pain, musculoskeletal stiffness, neck pain, pain in extremity) (36%), myalgia (e.g., myalgia, muscular weakness, musculoskeletal pain, musculoskeletal chest pain, musculoskeletal discomfort, myalgia intercostal) (18%)
Very common (10% or more): Sodium decreased (39%), magnesium decreased (38%), uric acid increased (32%), potassium decreased (31%), phosphate decreased (25%), decreased appetite (18%)
Common (1% to 10%): Tumor lysis syndrome
Very common (10% or more): Alkaline phosphatase increased (27%), aspartate aminotransferase increased (27%), bilirubin increased (16%), alanine aminotransferase increased (15%)
Very common (10% or more): Dyspnea (33%), cough (e.g., cough, productive cough, upper airway cough syndrome) (22%), differentiation syndrome (can be 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, creatinine increased) (19%), pleural effusion (13%)
Very common (10% or more): Fatigue (39%), edema (e.g., peripheral edema, edema, fluid overload, fluid retention, face edema) (32%). pyrexia (23%)
Very common (10% or more): Headache (16%), neuropathy (e.g., ataxia, burning sensation, gait disturbance, Guillain-Barre syndrome, neuropathy peripheral, paresthesia, peripheral sensory neuropathy, peripheral motor neuropathy, sensory disturbance) (12%)
Very common (10% or more): Creatinine increased (23%)
Very common (10% or more): Chest pain (e.g., angina pectoris, chest pain, chest discomfort, non-cardiac chest pain) (16%), hypotension (e.g., hypotension, orthostatic hypotension) (12%)
Common (1% to 10%): Electrocardiogram QT prolonged
Very common (10% or more): Rash (e.g., dermatitis acneiform, dermatitis, rash, rash maculo-papular, urticaria, rash erythematous, rash macular, rash pruritic, rash generalized, rash papular, skin exfoliation, skin ulcer) (26%)
Very common (10% or more): Diarrhea (38%), nausea (31%), mucositis (e.g., aphthous ulcer, esophageal pain, esophagitis, gingival pain, gingivitis, mouth ulceration, mucosal inflammation, oral pain, oropharyngeal pain, proctalgia, stomatitis) (28%), constipation (20%), vomiting (18%), abdominal pain (16%)
Medically reviewed by BestRx Medical Team Last updated on 1/1/2020.
Source: Drugs.com Tibsovo