Applies to ivosidenib: oral tablet.

Serious side effects of Ivosidenib

Along with its needed effects, ivosidenib 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

• 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
• 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
• painful or difficult urination
• pale skin
• pinpoint red spots on the skin
• rapid weight gain
• rash
• 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

Rare

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

Other side effects of 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:

More common

• Cracked lips
• decreased appetite
• diarrhea
• difficulty in swallowing
• nausea
• vomiting

For Healthcare Professionals

Applies to ivosidenib: oral tablet.

General

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

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%)

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

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

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

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

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%)

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

Oncologic

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.

Very common (10% or more): Differentiation syndrome (up to 25%)

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

Psychiatric

Very common (10% or more): Insomnia (up to 18%)

Renal

Very common (10% or more): Increased creatinine (up to 29%)

Frequency not reported: Acute kidney injury

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