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Tibsovo Side Effects

Generic Name: ivosidenib

Medically reviewed by Drugs.com. Last updated on Aug 6, 2020.

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.

For the Consumer

Applies to ivosidenib: oral tablet

Warning

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.

Side effects requiring immediate medical attention

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:

More common

  • Blurred vision
  • burning, tingling, numbness or pain in the hands, arms, feet, or legs
  • chest pain
  • chills
  • confusion
  • cough
  • 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
  • fainting
  • fever
  • general feeling of illness
  • headache
  • irregular heartbeat, recurrent
  • joint pain, stiffness, or swelling
  • lower back, side, or stomach pain
  • muscle ache, cramps, pain, or stiffness
  • rapid weight gain
  • rash
  • sensation of pins and needles
  • sore throat
  • stabbing pain
  • swelling of your arms, feet, or lower legs
  • tightness in the chest
  • unusual tiredness or weakness

Rare

  • Inability to move the arms and legs
  • sudden numbness and weakness in the arms and legs

Side effects not requiring immediate medical attention

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:

More common

  • Cracked lips
  • decreased appetite
  • diarrhea
  • difficulty in swallowing
  • nausea
  • sores, ulcers, or white spots on the lips, tongue, or inside the mouth
  • vomiting

For Healthcare Professionals

Applies to ivosidenib: oral tablet

Hematologic

Common (1% to 10%): Hemoglobin decreased (60%), leukocytosis (e.g., leukocytosis, hyperleukocytosis, increased white blood cell count) (38%)[Ref]

Immunologic

Uncommon (0.1% to 1%): Guillain-Barre syndrome[Ref]

Musculoskeletal

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%)[Ref]

Metabolic

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[Ref]

Hepatic

Very common (10% or more): Alkaline phosphatase increased (27%), aspartate aminotransferase increased (27%), bilirubin increased (16%), alanine aminotransferase increased (15%)[Ref]

Respiratory

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%)[Ref]

Other

Very common (10% or more): Fatigue (39%), edema (e.g., peripheral edema, edema, fluid overload, fluid retention, face edema) (32%). pyrexia (23%)[Ref]

Nervous system

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%)[Ref]

Renal

Very common (10% or more): Creatinine increased (23%)[Ref]

Cardiovascular

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[Ref]

Dermatologic

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%)[Ref]

Gastrointestinal

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%)[Ref]

References

1. "Product Information. Tibsovo (ivosidenib)." Agios Pharmaceuticals, Cambridge, MA.

Frequently asked questions

Further information

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.