艾伏尼布(ivosidenib)的副作用和不良反应

In addition to its expected therapeutic effects, when receiving ivosidenib treatment, it may also cause some adverse side effects. Although not all side effects will occur, if they do, medical intervention may be needed.

Common side effects of ivosidenib

Include black tarry stools, bleeding gums, blood in urine or stool, blurred vision, burning/tingling/numbness or pain in hands/arms/feet or legs, chest pain or tightness, chills, confusion, cough, decreased urination, difficulty breathing or shortness of breath, and difficulty moving.

Feeling dizzy/dizziness or light-headed when suddenly rising from a lying or sitting position, eye pain, fainting, fever, general feeling of malaise, headache, recurring irregular heartbeat, joint pain/stiffness, or swelling.

Lower back/side or stomach pain, muscle aches/cramps/pain or stiffness, painful or difficult urination, pale skin, pinpoint red spots on the skin, rapid weight gain, rash, pins and needles, sore throat, sores/ulcers or white spots on the lips/tongue or inside the mouth, sudden tingling sensation, swelling of the arms/feet or lower legs, unusual bleeding or bruising, unusual tiredness or weakness.

Rare side effects of ivosidenib

Including inability to move arms and legs, sudden numbness and weakness in arms and legs.

The pictures are from public channels (such as the official website of the FDA, the official website of the original drug manufacturer, etc.) and are for reference only.

Other side effects of ivosidenib

Some side effects usually do not require medical attention. These side effects may disappear during treatment as your body adjusts to the medication. Additionally, a health care professional may be able to tell you how to prevent or reduce some side effects.

If any of the following side effects persist, bother you, or you have any questions, please consult a health care professional:

Including chapped lips, decreased appetite, diarrhea, difficulty swallowing, nausea, vomiting.

Management of ivosidenib side effects for medical professionals

1. General adverse events

(1) The most common adverse reactions reported in patients with acute myeloid leukemia include: leukopenia, diarrhea, decreased hemoglobin, thrombocytopenia, increased blood sugar, fatigue, increased alkaline phosphatase, edema, decreased serum potassium, nausea, vomiting, decreased serum phosphate, decreased appetite, and decreased serum sodium.

Leukocytosis, low serum magnesium, elevated aspartate aminotransferase (AST), joint pain, dyspnea, elevated uric acid, abdominal pain, elevated creatinine, mucositis, rash, prolongation of QT interval on electrocardiogram, differentiation syndrome, low serum calcium, neutropenia, and myalgia.

(2). The most common adverse reactions reported in patients with cholangiocarcinoma include fatigue, nausea, abdominal pain, diarrhea, cough, loss of appetite, ascites, vomiting, anemia, rash, decreased hemoglobin, increased AST and increased bilirubin.

2. Cardiovascular system

(1), very common (10% or more): prolongation of QT interval on electrocardiogram (up to 26%), hematoma (including hematoma, ocular hematoma, catheter site hematoma, oral mucosal hematoma, Spontaneous hematoma, administration site hematoma, injection site hematoma, periorbital hematoma; up to 15%), hypertension (including elevated blood pressure, essential hypertension, hypertension; up to 13%), hypotension (including hypotension, orthostatic hypotension; up to 12%).

(2). Unreported frequency: ventricular fibrillation, pericardial effusion.

3. Skin system

Very common (10% or more): Rash (including acneiform dermatitis, dermatitis, rash, maculopapular rash, urticaria, erythematous rash, macular rash, pruritic rash, generalized rash, papule, skin scaling, skin ulcer, erythema, systemic exfoliative dermatitis, drug eruption, drug allergy; up to 26%), pruritus (up to 14%).

4. Gastrointestinal system

(1), very common (10% or more): diarrhea (up to 61%), nausea (up to 42%), vomiting (including vomiting, retching; up to 41%), abdominal pain (including abdominal pain, upper abdominal pain, abdominal discomfort, abdominal tenderness, lower abdominal pain, upper abdominal discomfort, gastrointestinal pain; up to 35%).

Mucositis (including oral ulcers, esophageal pain, esophagitis, gum pain, gingivitis, oral ulcers, mucosal inflammation, oral pain, oropharyngeal pain, rectal pain, stomatitis; up to 28%), ascites (up to 23%), constipation (up to 21%), indigestion (up to 11%).

(2). Unreported frequency: stomatitis, intestinal obstruction.

5. Blood system

(1), very common (10% or more): leukopenia (up to 65%), hemoglobin decrease (up to 60%), thrombocytopenia (up to 58%), leukocytosis ( Includes leukocytosis, increased WBC count, hyperleukemia; up to 38%), neutropenia (up to 25%), neutropenia (up to 25%), lymphocytosis (up to 24%), and anemia (up to 18%).

(2). Unreported frequency: thrombocytopenia.

6. Liver system

(1), very common (10% or more): elevated aspartate aminotransferase (AST) (up to 37%), elevated bilirubin (up to 30%), elevated alanine aminotransferase (ALT) (up to 15%).

(2). Unreported frequency: elevated transaminase, hyperbilirubinemia, cholestatic jaundice, hepatic encephalopathy.

7. Metabolic system

(1), very common (10% or more): elevated blood sugar (up to 56%), loss of appetite (up to 39%), elevated uric acid (up to 32%).

(2), common (1% to 10%): tumor lysis syndrome.

(3). Unreported frequency: excessive fluid load.

8. Musculoskeletal system

Very common (10% or more): Arthralgia (including limb pain, joint pain, back pain, musculoskeletal stiffness, cancer pain, neck pain; up to 36%), myalgia (including myalgia, muscle weakness, musculoskeletal pain, musculoskeletal chest pain, musculoskeletal discomfort, intercostal myalgia; up to 25%).

9. Nervous system

(1), very common (10% or more): dizziness (up to 21%), headache (up to 16%), neuropathy (including burning sensation, lumbosacral plexopathy, peripheral neuropathy, paresthesias) common, peripheral motor neuropathy, ataxia, gait disorder, Guillain-Barré syndrome, peripheral sensory neuropathy, sensory impairment; up to 14%), peripheral neuropathy (including peripheral neuropathy, peripheral sensory neuropathy, paresthesia; up to 11%).

(2) Uncommon (0.1% to 1%): Guillain-Barre syndrome.

(3). Unreported frequency: cerebral ischemia, posterior reversible encephalopathy syndrome, progressive multifocal leukoencephalopathy.

10. Tumor-related

(1), very common (10% or more): differentiation syndrome (up to 25%).

Differentiation syndrome is often associated with other events such as peripheral edema, leukocytosis, pyrexia, dyspnea, pleural effusion, hypotension, hypoxemia, pulmonary edema, pneumonia, pericardial effusion, rash, fluid overload, tumor lysis syndrome, and elevated creatinine.

(2), Other

Very common (10% or more): fatigue (including fatigue, fatigue; up to 50%), elevated alkaline phosphatase (up to 46%), edema (including edema, facial edema, fluid overload, fluid retention, hypervolemia, peripheral edema, facial swelling; up to 43%), decreased serum potassium (up to 43%).

Decreased serum phosphate (up to 41%), decreased serum sodium (up to 39%), decreased serum magnesium (up to 38%), decreased serum calcium (up to 25%), increased serum potassium (up to 24%), fever (up to 23%), chest pain (including angina, chest pain, chest discomfort, non-cardiac chest pain; up to 16%), weight loss (up to 11%).

(3). Unreported frequency: sepsis, peripheral edema.

11. Mental system

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

12. Renal system

(1), very common (10% or more): elevated creatinine (up to 29%).

(2). Unreported frequency: acute kidney injury.

13. Respiratory system

(1), very common (10% or more): dyspnea (including dyspnea, exertional dyspnea, hypoxemia, respiratory failure; up to 33%), cough (including cough, sputum, upper airway cough syndrome; up to 27%), pleural effusion (up to 13%).

(2). Unreported frequency: pneumonia, pulmonary embolism, hypoxemia, pulmonary edema.