Tibsovo Side Effects Center

Last updated on RxList: 6/3/2022
Tibsovo Side Effects Center

What Is Tibsovo?

Tibsovo (ivosidenib tablets) is an isocitrate dehydrogenase-1 (IDH1) inhibitor indicated for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) with a susceptible IDH1 mutation as detected by an FDA-approved test.

What Are Side Effects of Tibsovo?

Common side effects of Tibsovo include:

Dosage for Tibsovo

The dose of Tibsovo is 500 mg orally once daily with or without food until disease progression or unacceptable toxicity. Avoid a high-fat meal.

What Drugs, Substances, or Supplements Interact with Tibsovo?

Tibsovo may interact with itraconazole, fluconazole, rifampin, anti-arrhythmic medicines, fluoroquinolone antibiotics, triazole antifungals, and 5-HT3 receptor antagonists. Tell your doctor all medications and supplements you use.

Tibsovo During Pregnancy and Breastfeeding

Tell your doctor if you are pregnant or plan to become pregnant before using Tibsovo; it may harm a fetus. It is unknown if Tibsovo passes into breast milk. Because of the potential for adverse reactions in breastfed children, breastfeeding is not recommended while using Tibsovo and for at least 1 month after the last dose.

Additional Information

Our Tibsovo (ivosidenib tablets), for Oral Use Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

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Tibsovo Consumer Information

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Ivosidenib can cause a condition called differentiation syndrome, which affects blood cells and can be fatal if not treated. This condition may occur within 1 days to 3 months after you start taking ivosidenib.

Seek medical help right away if you have symptoms of differentiation syndrome:

  • fever, cough, trouble breathing;
  • dizziness;
  • rash;
  • decreased urination;
  • rapid weight gain; or
  • swelling in your arms or legs.

Call your doctor at once if you have:

  • fast or pounding heartbeats, fluttering in your chest, shortness of breath, sudden dizziness (like you might pass out);
  • jaundice (yellowing of the skin or eyes);
  • fluid build-up around the stomach--rapid weight gain, stomach pain and bloating, trouble breathing while lying down;
  • low red blood cells (anemia)--pale skin, tiredness, feeling light-headed or short of breath, cold hands and feet;
  • high white blood cell counts--fever, weakness, not feeling well, bleeding or bruising, nausea, loss of appetite, weight loss; or
  • nervous system problems--numbness, pain, tingling, weakness, burning or prickly feeling, vision or hearing problems, trouble breathing.

Your cancer treatments may be delayed or permanently discontinued if you have certain side effects.

Common side effects may include:

  • irregular heartbeats;
  • stomach pain or swelling, nausea, vomiting, loss of appetite;
  • diarrhea, constipation;
  • fever, tiredness;
  • low red blood cell or high white blood cell counts;
  • cough, shortness of breath;
  • sores in your mouth or throat;
  • rash;
  • abnormal liver function tests;
  • muscle or joint pain; or
  • swelling in your arms or legs.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Tibsovo (Ivosidenib Tablets)

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Tibsovo Professional Information

SIDE EFFECTS

The following clinically significant adverse reactions are described elsewhere in the labeling:

  • Differentiation Syndrome in AML [see WARNINGS AND PRECAUTIONS]
  • QTc Interval Prolongation [see WARNINGS AND PRECAUTIONS]
  • Guillain-Barré Syndrome [see WARNINGS AND PRECAUTIONS]

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

Acute Myeloid Leukemia

In AML, the safety population reflects exposure to TIBSOVO at 500 mg daily in combination with azacitidine or as monotherapy in patients in Studies AG120-C-009 (N=71) and AG120-C- 001 (N=213), respectively [see Clinical Studies]. In this safety population, the most common adverse reactions including laboratory abnormalities (≥ 25% in either trial) were leukocytes decreased, diarrhea, hemoglobin decreased, platelets decreased, glucose increased, fatigue, alkaline phosphatase increased, edema, potassium decreased, nausea, vomiting, phosphatase decreased, decreased appetite, sodium decreased, leukocytosis, magnesium decreased, aspartate aminotransferase increased, arthralgia, dyspnea, uric acid increased, abdominal pain, creatinine increased, mucositis, rash, electrocardiogram QT prolonged, neutrophils decreased, differentiation syndrome, calcium decreased, and myalgia.

Newly Diagnosed AML

TIBSOVO in Combination with Azacitidine

The safety of TIBSOVO was evaluated in AML patients treated in combination with azacitidine, in Study AG120-C-009 [see Clinical Studies]. Patients received at least one dose of either TIBSOVO 500 mg daily (N=71) or placebo (N=73). Among patients who received TIBSOVO in combination with azacitidine, the median duration of exposure to TIBSOVO was 6 months (range 0 to 33 months). 34 patients (48%) were exposed to TIBSOVO for at least 6 months and 22 patients (31%) were exposed for at least 1 year.

Common (≥ 5%) serious adverse reactions in patients who received TIBSOVO in combination with azacitidine included differentiation syndrome (8%).

Fatal adverse reactions occurred in 4% of patients who received TIBSOVO in combination with azacitidine, due to differentiation syndrome (3%) and one case of cerebral ischemia.

Adverse reactions leading to discontinuation of TIBSOVO in ≥2% of patients were differentiation syndrome (3%) and pulmonary embolism (3%).

The most common (>5%) adverse reactions leading to dose interruption of TIBSOVO were neutropenia (25%), electrocardiogram QT prolonged (7%), and thrombocytopenia (7%).

Adverse reactions leading to dose reduction of TIBSOVO included electrocardiogram QT prolonged (8%), neutropenia (8%), and thrombocytopenia (1%).

The most common adverse reactions and laboratory abnormalities observed in Study AG120-C-009 are shown in Tables 2 and 3.

Table 2: Adverse Reactions (≥10%) in Patients with AML Who Received TIBSOVO + azacitidine with a Difference Between Arms of ≥ 2% Compared with Placebo + azacitidine in AG120-C-009

Body System Adverse Reaction TIBSOVO + Azacitidine
N=71
Placebo + Azacitidine
N=73
All Grades
n (%)
Grade ≥3
n (%)
All Grades
n (%)
Grade ≥3
n (%)
Gastrointestinal disorders
Nausea 30 (42) 2 (3) 28 (38) 3 (4)
Vomiting1 29 (41) 0 20 (27) 1 (1)
Investigations
Electrocardiogram QT prolonged 14 (20) 7 (10) 5 (7) 2 (3)
Psychiatric Disorders
Insomnia 13 (18) 1 (1) 9 (12) 0
Blood system and lymphatic system disorders
Differentiation Syndrome2 11 (15) 7 (10) 6 (8) 6 (8)
Leukocytosis3 9 (13) 0 1 (1) 0
Vascular disorders
Hematoma4 11 (15) 0 3 (4) 0
Hypertension5 9 (13) 3 (4) 6 (8) 4 (5)
Musculoskeletal and connective tissue disorders
Arthralgia6 21 (30) 3 (4) 6 (8) 1 (1)
Respiratory, thoracic and mediastinal disorders
Dyspnea7 14 (20) 2 (3) 11 (15) 4 (5)
Nervous system disorders
Headache 8 (11) 0 2 (3) 0
1 Grouped term includes vomiting and retching.
2 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, and creatinine increased.
3 Grouped term includes leukocytosis, white blood cell count increased.
4 Grouped term includes hematoma, eye hematoma, catheter sire hematoma, oral mucosa hematoma, spontaneous hematoma, application site hematoma, injection site hematoma, periorbital hematoma.
5 Grouped term includes blood pressure increased, essential hypertension, and hypertension.
6 Grouped term includes pain in extremity, arthralgia, back pain, musculoskeletal stiffness, cancer pain, and neck pain.
7 Grouped term includes dyspnea, dyspnea exertional, hypoxia, respiration failure.

Table 3: Select Laboratory Abnormalities1, 2 (≥10%) That Worsened from Baseline in Patients with AML Who Received TIBSOVO + azacitidine in AG120-C-009

TIBSOVO + Azacitidine
N=71
Placebo + Azacitidine
N=73
Parameter All Grades
n (%)
Grade ≥ 3
n (%)
All Grades
n (%)
Grade ≥ 3
n (%)
Hematology Parameters
Leukocytes decreased 17 (24) 39 (55) 47 (64) 42 (58)
Platelets decreased 41 (58) 30 (42) 52 (71) 42 (58)
Hemoglobin decreased 40 (56) 33 (46) 48 (66) 42 (58)
Neutrophils decreased 18 (25) 16 (23) 25 (35) 23 (32)
Lymphocytes increased 17 (24) 1 (1) 7 (10) 1 (1)
Chemistry Parameters
Glucose increased 40 (56) 9 (13) 34 (47) 8 (11)
Phosphate decreased 29 (41) 7 (10) 25 (34) 9 (12)
Aspartate Aminotransferase increased 26 (37) 0 17 (23) 0
Magnesium decreased 25 (35) 0 19 (26) 0
Alkaline Phosphatase increased 23 (32) 0 21 (29) 0
Potassium increased 17 (24) 2 (3) 9 (12) 1 (1)
1 Laboratory abnormality is defined as new or worsened by at least one grade from baseline, or if baseline is unknown.
2 The denominator used to calculate percentages is the number of treated subjects who can be evaluated for CTCAE criteria for each parameter in each arm.

TIBSOVO Monotherapy

The safety profile of single-agent TIBSOVO was studied in 28 adults with newly diagnosed AML treated with 500 mg daily [see Clinical Studies]. The median duration of exposure to TIBSOVO was 4.3 months (range 0.3 to 40.9 months). Ten patients (36%) were exposed to TIBSOVO for at least 6 months and 6 patients (21%) were exposed for at least 1 year.

Common (≥ 5%) serious adverse reactions included differentiation syndrome (18%), electrocardiogram QT prolonged (7%), and fatigue (7%). There was one case of posterior reversible encephalopathy syndrome (PRES).

Common (≥ 10%) adverse reactions leading to dose interruption included electrocardiogram QT prolonged (14%) and differentiation syndrome (11%). Two (7%) patients required a dose reduction due to electrocardiogram QT prolonged. One patient each required permanent discontinuation due to diarrhea and PRES.

The most common adverse reactions reported in the trial are shown in Table 4.

Table 4: Adverse Reactions Reported in ≥ 10% (Any Grade) or ≥ 5% (Grade ≥ 3) of Patients with Newly Diagnosed AML in AG120-C-001

TIBSOVO (500 mg daily)
N=28
Body System Adverse Reaction All Grades
n (%)
Grade ≥ 3
n (%)
Gastrointestinal disorders
Diarrhea 17 (61) 2 (7)
Nausea 10 (36) 2 (7)
Abdominal pain1 8 (29) 1 (4)
Constipation 6 (21) 1 (4)
Vomiting 6 (21) 1 (4)
Mucositis2 6 (21) 0
Dyspepsia 3 (11) 0
General disorders and administration site conditions
Fatigue3 14 (50) 4 (14)
Edema4 12 (43) 0
Metabolism and nutrition disorders
Decreased appetite 11 (39) 1 (4)
Blood system and lymphatic system disorders
Leukocytosis5 10 (36) 2 (7)
Differentiation Syndrome6 7 (25) 3 (11)
Musculoskeletal and connective tissue disorders
Arthralgia7 9 (32) 1 (4)
Myalgia8 7 (25) 1 (4)
Respiratory, thoracic, and mediastinal disorders
Dyspnea9 8 (29) 1 (4)
Cough10 4 (14) 0
Investigations
Electrocardiogram QT prolonged 6 (21) 3 (11)
Weight decreased 3 (11) 0
Nervous system disorders
Dizziness 6 (21) 0
Neuropathy11 4 (14) 0
Headache 3 (11) 0
Skin and subcutaneous tissue disorders
Pruritis 4 (14) 1 (4)
Rash12 4 (14) 1 (4)
1 Grouped term includes abdominal pain, upper abdominal pain, abdominal discomfort, and abdominal tenderness.
2 Grouped term includes aphthous ulcer, esophageal pain, esophagitis, gingival pain, gingivitis, mouth ulceration, mucosal inflammation, oral pain, oropharyngeal pain, proctalgia, and stomatitis.
3 Grouped term includes asthenia and fatigue.
4 Grouped term includes edema, face edema, fluid overload, fluid retention, hypervolemia, peripheral edema, and swelling face.
5 Grouped term includes leukocytosis, hyperleukocytosis, and increased white blood cell count.
6 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, and creatinine increased.
7 Grouped term includes arthralgia, back pain, musculoskeletal stiffness, neck pain, and pain in extremity.
8 Grouped term includes myalgia, muscular weakness, musculoskeletal pain, musculoskeletal chest pain, musculoskeletal discomfort, and myalgia intercostal.
9 Grouped term includes dyspnea, dyspnea exertional, hypoxia, and respiratory failure.
10 Grouped term includes cough, productive cough, and upper airway cough syndrome.
11 Grouped term includes burning sensation, lumbosacral plexopathy, neuropathy peripheral, paresthesia, and peripheral motor neuropathy.
12 Grouped term includes dermatitis acneiform, dermatitis, rash, rash maculo-papular, urticaria, rash erythematous, rash macular, rash pruritic, rash generalized, rash papular, skin exfoliation, and skin ulcer.

Changes in selected post-baseline laboratory values that were observed in patients with newly diagnosed AML are shown in Table 5.

Table 5: Most Common (≥ 10%) or ≥ 5% (Grade ≥ 3) New or Worsening Laboratory Abnormalities Reported in Patients with Newly Diagnosed AML1 in AG120-C-001

TIBSOVO (500 mg daily)
N=28
Parameter All Grades n (%) Grade ≥ 3 n (%)
Hemoglobin decreased 15 (54) 12 (43)
Alkaline phosphatase increased 13 (46) 0
Potassium decreased 12 (43) 3 (11)
Sodium decreased 11 (39) 1 (4)
Uric acid increased 8 (29) 1 (4)
Aspartate aminotransferase increased 8 (29) 1 (4)
Creatinine increased 8 (29) 0
Magnesium decreased 7 (25) 0
Calcium decreased 7 (25) 1 (4)
Phosphate decreased 6 (21) 2 (7)
Alanine aminotransferase increased 4 (14) 1 (4)
1 Laboratory abnormality is defined as new or worsened by at least one grade from baseline, or if baseline is unknown.

Relapsed Or Refractory AML

The safety profile of single-agent TIBSOVO was studied in 179 adults with relapsed or refractory AML treated with 500 mg daily [see Clinical Studies]. The median duration of exposure to TIBSOVO was 3.9 months (range 0.1 to 39.5 months). Sixty-five patients (36%) were exposed to TIBSOVO for at least 6 months and 16 patients (9%) were exposed for at least 1 year.

Serious adverse reactions (≥ 5%) were differentiation syndrome (10%), leukocytosis (10%), and electrocardiogram QT prolonged (7%). There was one case of progressive multifocal leukoencephalopathy (PML).

The most common adverse reactions leading to dose interruption were electrocardiogram QT prolonged (7%), differentiation syndrome (3%), leukocytosis (3%) and dyspnea (3%). Five out of 179 patients (3%) required a dose reduction due to an adverse reaction. Adverse reactions leading to a dose reduction included electrocardiogram QT prolonged (1%), diarrhea (1%), nausea (1%), decreased hemoglobin (1%), and increased transaminases (1%). Adverse reactions leading to permanent discontinuation included Guillain-Barré syndrome (1%), rash (1%), stomatitis (1%), and creatinine increased (1%).

The most common adverse reactions reported in the trial are shown in Table 6.

Table 6: Adverse Reactions Reported in ≥ 10% (Any Grade) or ≥ 5% (Grade ≥ 3) of Patients with Relapsed or Refractory AML

TIBSOVO (500 mg daily)
N=179
Body System Adverse Reaction All Grades
n (%)
Grade ≥ 3
n (%)
General disorders and administration site conditions
Fatigue1 69 (39) 6 (3)
Edema2 57 (32) 2 (1)
Pyrexia 41 (23) 2 (1)
Chest pain3 29 (16) 5 (3)
Blood system and lymphatic system disorders
Leukocytosis4 68 (38) 15 (8)
Differentiation Syndrome5 34 (19) 23 (13)
Musculoskeletal and connective tissue disorders
Arthralgia6 64 (36) 8 (4)
Myalgia7 33 (18) 1 (1)
Gastrointestinal disorders
Diarrhea 60 (34) 4 (2)
Nausea 56 (31) 1 (1)
Mucositis8 51 (28) 6 (3)
Constipation 35 (20) 1 (1)
Vomiting9 32 (18) 2 (1)
Abdominal pain10 29 (16) 2 (1)
Respiratory, thoracic, and mediastinal disorders
Dyspnea11 59 (33) 16 (9)
Cough12 40 (22) 1 (<1)
Pleural effusion 23 (13) 5 (3)
Investigations
Electrocardiogram QT prolonged 46 (26) 18 (10)
Skin and subcutaneous tissue disorders
Rash13 46 (26) 4 (2)
Metabolism and nutrition disorders
Decreased appetite 33 (18) 3 (2)
Tumor lysis syndrome 14 (8) 11 (6)
Nervous system disorders
Headache 28 (16) 0
Neuropathy14 21 (12) 2 (1)
Vascular disorders
Hypotension15 22 (12) 7 (4)
1 Grouped term includes asthenia and fatigue.
2 Grouped term includes peripheral edema, edema, fluid overload, fluid retention, and face edema.
3 Grouped term includes angina pectoris, chest pain, chest discomfort, and non-cardiac chest pain.
4 Grouped term includes leukocytosis, hyperleukocytosis, and increased white blood cell count.
5 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, and creatinine increased.
6 Grouped term includes arthralgia, back pain, musculoskeletal stiffness, neck pain, and pain in extremity.
7 Grouped term includes myalgia, muscular weakness, musculoskeletal pain, musculoskeletal chest pain, musculoskeletal discomfort, and myalgia intercostal.
8 Grouped term includes aphthous ulcer, esophageal pain, esophagitis, gingival pain, gingivitis, mouth ulceration, mucosal inflammation, oral pain, oropharyngeal pain, proctalgia, and stomatitis.
9 Grouped term includes vomiting and retching.
10 Grouped term includes abdominal pain, upper abdominal pain, abdominal discomfort, and abdominal tenderness.
11 Grouped term includes dyspnea, respiratory failure, hypoxia, and dyspnea exertional.
12 Grouped term includes cough, productive cough, and upper airway cough syndrome.
13 Grouped term includes dermatitis acneiform, dermatitis, rash, rash maculo-papular, urticaria, rash erythematous, rash macular, rash pruritic, rash generalized, rash papular, skin exfoliation, and skin ulcer.
14 Grouped term includes ataxia, burning sensation, gait disturbance, Guillain-Barré syndrome, neuropathy peripheral, paresthesia, peripheral sensory neuropathy, peripheral motor neuropathy, and sensory disturbance.
15 Grouped term includes hypotension and orthostatic hypotension.

Changes in selected post-baseline laboratory values that were observed in patients with relapsed or refractory AML are shown in Table 7.

Table 7: Most Common (≥ 10%) or ≥ 5% (Grade ≥ 3) New or Worsening Laboratory Abnormalities Reported in Patients with Relapsed or Refractory AML1

TIBSOVO (500 mg daily)
N=179
Parameter All Grades
n (%)
Grade ≥ 3
n (%)
Hemoglobin decreased 108 (60) 83 (46)
Sodium decreased 69 (39) 8 (4)
Magnesium decreased 68 (38) 0
Uric acid increased 57 (32) 11 (6)
Potassium decreased 55 (31) 11 (6)
Alkaline phosphatase increased 49 (27) 1 (1)
Aspartate aminotransferase increased 49 (27) 1 (1)
Phosphate decreased 45 (25) 15 (8)
Creatinine increased 42 (23) 2 (1)
Alanine aminotransferase increased 26 (15) 2 (1)
Bilirubin increased 28 (16) 1 (1)
1 Laboratory abnormality is defined as new or worsened by at least one grade from baseline, or if baseline is unknown.

Locally Advanced Or Metastatic Cholangiocarcinoma

The safety of TIBSOVO was studied in patients with previously treated, locally advanced or metastatic cholangiocarcinoma in Study AG120-C-005 [see Clinical Studies]. Patients received at least one dose of either TIBSOVO 500 mg daily (N=123) or placebo (N=59). The median duration of treatment was 2.8 months (range 0.1 to 34.4 months) with TIBSOVO.

Serious adverse reactions occurred in 34% of patients receiving TIBSOVO. Serious adverse reactions in ≥2% of patients in the TIBSOVO arm were pneumonia, ascites, hyperbilirubinemia, and jaundice cholestatic. Fatal adverse reactions occurred in 4.9% of patients receiving TIBSOVO, including sepsis (1.6%) and pneumonia, intestinal obstruction, pulmonary embolism, and hepatic encephalopathy (each 0.8%)

TIBSOVO was permanently discontinued in 7% of patients. The most common adverse reactions leading to permanent discontinuation was acute kidney injury (1.6%).

Dose interruptions due to adverse reactions occurred in 29% of patients treated with TIBSOVO. The most common (>2%) adverse reactions leading to dose interruption were hyperbilirubinemia, alanine aminotransferase increased, aspartate aminotransferase increased, ascites, and fatigue.

Dose reductions of TIBSOVO due to an adverse reaction occurred in 4.1% of patients. Adverse reactions leading to dose reduction were electrocardiogram QT prolonged (3.3%) and neuropathy peripheral (0.8%).

The most common adverse reactions (≥15%) were fatigue, nausea, abdominal pain, diarrhea, cough, decreased appetite, ascites, vomiting, anemia, and rash.

Adverse reactions and laboratory abnormalities observed in Study AG120-C-005 are shown in Tables 8 and 9.

Table 8: Adverse Reactions Occurring in ≥ 10% of Patients Receiving TIBSOVO in Study AG120-C-005

TIBSOVO (500 mg daily)
N=123
Placebo
N=59
Body System
Adverse Reaction
All Grades
n (%)
Grade ≥ 3
n (%)
All Grades
n (%)
Grade ≥ 3
n (%)
General disorders and administration site conditions
Fatigue1 53 (43) 4 (3) 18 (31) 3 (5)
Gastrointestinal disorders
Nausea 51 (41) 3 (2) 17 (29) 1 (2)
Diarrhea 43 (35) 0 10 (17) 0
Abdominal pain2 43 (35) 3 (2) 13 (22) 2 (3)
Ascites 28 (23) 11 (9) 9 (15) 4 (7)
Vomiting3 28 (23) 3 (2) 12 (20) 0
Respiratory, thoracic, and mediastinal disorders
Cough4 33 (27) 0 5 (9) 0
Metabolism and nutrition disorders
Decreased appetite 30 (24) 2 (2) 11 (19) 0
Blood and lymphatic system disorders
Anemia 22 (18) 8 (7) 3 (5) 0
Skin and subcutaneous tissue disorders
Rash5 19 (15) 1 (1) 4 (7) 0
Nervous system disorders
Headache 16 (13) 0 4 (7) 0
Neuropathy peripheral6 13 (11) 0 0 0
Investigations
Electrocardiogram QT prolonged 12 (10) 2 (2) 2 (3) 0
1 Grouped term includes asthenia and fatigue.
2 Grouped term includes abdominal pain, abdominal pain upper, abdominal discomfort, abdominal pain lower, epigastric discomfort, abdominal tenderness, and gastrointestinal pain.
3 Grouped term includes vomiting and retching.
4 Grouped term includes cough and productive cough.
5 Grouped term includes rash, rash maculo-papular, erythema, rash macular, dermatitis exfoliative generalized, drug eruption, and drug hypersensitivity.
6 Grouped term includes neuropathy peripheral, peripheral sensory neuropathy, and paresthesia.

Table 9: Selected Laboratory Abnormalities Occurring in ≥ 10% of Patients Receiving TIBSOVO in Study AG120-C-0051

TIBSOVO (500 mg daily)
N=123
Placebo
N=59
Parameter All Grades
n (%)
Grade ≥ 3
n (%)
All Grades
n (%)
Grade ≥ 3
n (%)
AST increased 41 (34) 5 (4) 14 (24) 1 (2)
Bilirubin increased 36 (30) 15 (13) 11 (19) 2 (3)
Hemoglobin decreased 48 (40) 8 (7) 14 (25) 0
1 Laboratory abnormality is defined as new or worsened by at least one grade from baseline, or baseline is unknown.

DRUG INTERACTIONS

Effect Of Other Drugs On Ivosidenib

Strong or Moderate CYP3A4 Inhibitors
Clinical Impact
  • Co-administration of TIBSOVO with strong or moderate CYP3A4 inhibitors increased ivosidenib plasma concentrations [see CLINICAL PHARMACOLOGY].
  • Increased ivosidenib plasma concentrations may increase the risk of QTc interval prolongation [see WARNINGS AND PRECAUTIONS].
Prevention or Management
  • Consider alternative therapies that are not strong or moderate CYP3A4 inhibitors during treatment with TIBSOVO.
  • If co-administration of a strong CYP3A4 inhibitor is unavoidable, reduce TIBSOVO to 250 mg once daily [see DOSAGE AND ADMINISTRATION].
  • Monitor patients for increased risk of QTc interval prolongation [see WARNINGS AND PRECAUTIONS].
Strong CYP3A4 Inducers
Clinical Impact
  • Co-administration of TIBSOVO with strong CYP3A4 inducers decreased ivosidenib plasma concentrations [see CLINICAL PHARMACOLOGY].
Prevention or Management
  • Avoid co-administration of strong CYP3A4 inducers with TIBSOVO.
Strong CYP3A4 Inducers
Clinical Impact
  • Co-administration of TIBSOVO with QTc prolonging drugs may increase the risk of QTc interval prolongation [see WARNINGS AND PRECAUTIONS].
Prevention or Management
  • Avoid co-administration of QTc prolonging drugs with TIBSOVO or replace with alternative therapies.
  • If co-administration of a QTc prolonging drug is unavoidable, monitor patients for increased risk of QTc interval prolongation [see WARNINGS AND PRECAUTIONS].

Effect Of Ivosidenib On Other Drugs

Ivosidenib induces CYP3A4 and may induce CYP2C9. Co-administration will decrease concentrations of drugs that are sensitive CYP3A4 substrates and may decrease concentrations of drugs that are sensitive CYP2C9 substrates [see CLINICAL PHARMACOLOGY]. Use alternative therapies that are not sensitive substrates of CYP3A4 and CYP2C9 during TIBSOVO treatment. If co-administration of TIBSOVO with sensitive CYP3A4 substrates or CYP2C9 substrates is unavoidable, monitor patients for loss of therapeutic effect of these drugs.

Do not administer TIBSOVO with anti-fungal agents that are substrates of CYP3A4 due to expected loss of antifungal efficacy.

Co-administration of TIBSOVO may decrease the concentrations of hormonal contraceptives, consider alternative methods of contraception in patients receiving TIBSOVO.

Read the entire FDA prescribing information for Tibsovo (Ivosidenib Tablets)

© Tibsovo Patient Information is supplied by Cerner Multum, Inc. and Tibsovo Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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