Meet Michael^a

Actor portrayal.
^aThis case is hypothetical.

Diagnosis: Newly diagnosed AML
Age: 76 years
Gender: Male

Patients with high BM blast counts like Michael may be candidates for treatment with TIBSOVO + AZA

PATIENT CASE STUDY

HIGH BONE MARROW BLAST COUNT

Presentation

Symptoms:

Worsening dyspnea on exertion and fatigue
Fever
Frequent infections
Weakness

Medical history:

Controlled type 2 diabetes
ECOG PS 2

Hematology

Complete blood count:

WBC: 2.5 × 10⁹/L
Hgb: 7.8 g/dL
Plt: 36 × 10⁹/L
ANC: 0.4 × 10⁹/L

Multilineage dysplasia:

Absent

BM aspirate:

72% BM blasts^b

Additional Assessments

NGS findings:

IDH1+ (R132H mutant)

Cytogenetic risk status:

Intermediate (trisomy 8 [+8])

Metabolic panel:

Uric acid: 10.2 mg/dL
Serum creatinine: 1.3 mg/dL

57% of patients (41/72) treated with TIBSOVO + AZA had high BM blast counts (>50%) at baseline in the AGILE clinical trial¹

^aThis case is hypothetical.

ANC, absolute neutrophil count; AML, acute myeloid leukemia; BM, bone marrow; ECOG, Eastern Cooperative Oncology Group; Hgb, hemoglobin; IDH1, isocitrate dehydrogenase-1; Plt, platelets; WBC, white blood cell count.

Meet Margaret^a

Actor portrayal.
^aThis case is hypothetical.

Diagnosis: Newly diagnosed AML
Age: 72 years
Gender: Female

Patients with IC-ineligible mIDH1 AML and cytopenias like Margaret may be candidates for treatment with TIBSOVO + AZA

PATIENT CASE STUDY

AML WITH MULTIPLE CYTOPENIAS

Presentation

Symptoms:

Easy bruising and recurrent nosebleeds
Palpitations and shortness of breath
New-onset productive cough with yellowish sputum and mild chills

Medical history:

History of mild cytopenias that
worsened over the past 4 months

COPD
One unit of PRBC and one platelet transfusion within the past 6 weeks
ECOG PS 1

Hematology

Complete blood count:

WBC: 3.0 × 10⁹/L
Hgb: 8.0 g/dL
Plt: 23 × 10⁹/L
ANC: 0.3 × 10⁹/L

Multilineage dysplasia:

Present

BM aspirate:

20% BM blasts

Additional Assessments

NGS findings:

IDH1+ (R132C mutant)
SRSF2+

Cytogenetic risk status:

Intermediate (46,XX, +8)

54% of patients (39/72) treated with TIBSOVO + AZA were transfusion-dependent at baseline in the AGILE clinical trial^1,b

^aThis case is hypothetical.

^b Patients were defined as transfusion-dependent at baseline if they received any red blood cell or platelet transfusion within 56 days prior to the first dose of TIBSOVO.¹

AML, acute myeloid leukemia; ANC, absolute neutrophil count; BM, bone marrow; CrCl, creatinine clearance; ECOG PS, Eastern Cooperative Oncology Group Performance Status; IC, induction chemotherapy; mIDH1, mutant Isocitrate Dehydrogenase-1; NGS, next-generation sequencing; NPM1, nucleophosmin 1; WBC, white blood cell.

Meet Eleanor^a

Actor portrayal.
^aThis case is hypothetical.

Diagnosis: Newly diagnosed AML
Age: 65 years
Gender: Female

Patients with IC-ineligible mIDH1 AML defined by genetic abnormalities like Eleanor may be candidates for treatment with TIBSOVO + AZA

PATIENT CASE STUDY

MOLECULARLY DEFINED AML

Presentation

Symptoms:

Fatigue and generalized weakness for the past 2 months
Exertional dyspnea
Easy bruising

Medical history:

History of moderate chronic kidney disease (CrCl <40 mL/min)
ECOG PS 1

Hematology

Complete blood count:

WBC: 2.5 × 10⁹/L
Hgb: 8.0 g/dL
Plt: 48 × 10⁹/L
ANC: 0.9 × 10⁹/L

Multilineage dysplasia:

Present

BM aspirate:

15% BM blasts^b

Additional Assessments

NGS findings:

IDH1+ (R132G mutant)

NPM1+

Cytogenetic risk status:

Favourable

54% of patients (39/72) treated with TIBSOVO + AZA were transfusion-dependent at baseline in the AGILE clinical trial^1,b

^aThis case is hypothetical.

^b Patients were defined as transfusion-dependent at baseline if they received any red blood cell or platelet transfusion within 56 days prior to the first dose of TIBSOVO.¹

Meet Phil^a

Actor portrayal.
^aThis case is hypothetical.

Diagnosis: Newly diagnosed AML
Age: 75 years
Gender: Male

Patients with IC-ineligible mIDH1 sAML like Phil may be candidates for treatment with TIBSOVO + AZA

PATIENT CASE STUDY

SECONDARY ACUTE MYELOID LEUKEMIA

Presentation

Symptoms:

Recently reported fatigue and weakness
Unexplained weight loss (~10 lbs)
Easy bruising over arms and legs

Medical history:

Primary myelofibrosis diagnosed 5 years ago, treated with ruxolitinib

ECOG PS 1

Hematology

Complete blood count:

WBC: 20.0 × 10⁹/L
Hgb: 9.5 g/dL
Plt: 50 × 10⁹/L
ANC: 2.3 × 10⁹/L

Multilineage dysplasia:

Present

BM aspirate:

28% BM blasts

Additional Assessments

NGS findings:

IDH1+ (R132H mutant)
JAK2+ (V617F mutant)
SRSF2+
ASXL1+

Cytogenetic risk status:

Poor (trisomy 8 [+8], del[20q], -7)

Metabolic panel:

Uric acid: 9.2 mg/dL
Creatinine: 1.8 mg/dL
Potassium: 5.0 mEq/dL
Phosphate: 4.5 mg/dL

Of the 25% of sAML patients (18/72) treated with TIBSOVO + AZA, 22% had a history of MPN (4/18) in the AGILE clinical trial¹

^aThis case is hypothetical.

Meet Michael^a

Actor portrayal.
^aThis case is hypothetical.

PATIENT CASE STUDY

HIGH BONE MARROW BLAST COUNT

Diagnosis: Newly diagnosed AML
Age: 76 years
Gender: Male

Patients with high BM blast counts like Michael may be candidates for treatment with TIBSOVO + AZA

Clinical history

Presentation

Symptoms:

Worsening dyspnea on exertion and fatigue
Fever
Frequent infections
Weakness

Medical history:

Controlled type 2 diabetes
ECOG PS 2

Hematology

Complete blood count:

WBC: 2.5 × 10⁹/L
Hgb: 7.8 g/dL
Plt: 36 × 10⁹/L
ANC: 0.4 × 10⁹/L

Multilineage dysplasia:

Absent

BM aspirate:

72% BM blasts^b

Additional Assessments

NGS findings:

IDH1+ (R132H mutant)

Cytogenetic risk status:

Intermediate (trisomy 8 [+8])

Metabolic panel:

Uric acid: 10.2 mg/dL
Serum creatinine: 1.3 mg/dL

57% of patients (41/72) treated with TIBSOVO + AZA had high BM blast counts (>50%) at baseline in the AGILE clinical trial¹

^aThis case is hypothetical.

Meet Margaret^a

Actor portrayal.
^aThis case is hypothetical.

PATIENT CASE STUDY

AML WITH MULTIPLE CYTOPENIAS

Diagnosis: Newly diagnosed AML
Age: 72 years
Gender: Female

Patients with IC-ineligible mIDH1 AML and cytopenias like Margaret may be candidates for treatment with TIBSOVO + AZA

Clinical history

Presentation

Symptoms:

Easy bruising and recurrent nosebleeds
Palpitations and shortness of breath
New-onset productive cough with yellowish sputum and mild chills

Medical history:

History of mild cytopenias worsened over 4 months

COPD
One unit of PRBC and one platelet transfusion within the past 6 weeks
ECOG PS 1

Hematology

Complete blood count:

WBC: 3.0 × 10⁹/L
Hgb: 8.0 g/dL
Plt: 23 × 10⁹/L
ANC: 0.3 × 10⁹/L

Multilineage dysplasia:

Present

BM aspirate:

20% BM blasts

Additional Assessments

NGS findings:

IDH1+ (R132C mutant)
SRSF2+

Cytogenetic risk status:

Intermediate (46,XX, +8)

54% of patients (39/72) treated with TIBSOVO + AZA were transfusion-dependent at baseline in the AGILE clinical trial^1,b

^aThis case is hypothetical.

^b Patients were defined as transfusion-dependent at baseline if they received any red blood cell or platelet transfusion within 56 days prior to the first dose of TIBSOVO.¹

Meet Eleanor^a

Actor portrayal.
^aThis case is hypothetical.

PATIENT CASE STUDY

MOLECULARLY DEFINED AML

Diagnosis: Newly diagnosed AML
Age: 65 years
Gender: Female

Patients with IC-ineligible mIDH1 AML defined by genetic abnormalities like Eleanor may be candidates for treatment with TIBSOVO + AZA

Clinical history

Presentation

Symptoms:

Fatigue and generalized weakness for the past 2 months
Exertional dyspnea
Easy bruising

Medical history:

History of moderate chronic kidney disease (CrCl <40 mL/min)
ECOG PS 1

Hematology

Complete blood count:

WBC: 2.5 × 10⁹/L
Hgb: 8.0 g/dL
Plt: 48 × 10⁹/L
ANC: 0.9 × 10⁹/L

Multilineage dysplasia:

Present

BM aspirate:

15% BM blasts^b

Additional Assessments

NGS findings:

IDH1+ (R132G mutant)

NPM1+

Cytogenetic risk status:

Favourable

54% of patients (39/72) treated with TIBSOVO + AZA were transfusion-dependent at baseline in the AGILE clinical trial^1,b

^aThis case is hypothetical.

^b Patients were defined as transfusion-dependent at baseline if they received any red blood cell or platelet transfusion within 56 days prior to the first dose of TIBSOVO.¹

Meet Phil^a

Actor portrayal.
^aThis case is hypothetical.

PATIENT CASE STUDY

SECONDARY ACUTE MYELOID LEUKEMIA

Diagnosis: Newly diagnosed AML
Age: 75 years
Gender: Male

Patients with IC-ineligible mIDH1 sAML like Phil may be candidates for treatment with TIBSOVO + AZA

Clinical history

Presentation

Symptoms:

Recently reported fatigue and weakness
Unexplained weight loss (~10 lbs)
Easy bruising over arms and legs

Medical history:

Primary myelofibrosis diagnosed 5 years ago, treated with ruxolitinib

ECOG PS 1

Hematology

Complete blood count:

WBC: 20.0 × 10⁹/L
Hgb: 9.5 g/dL
Plt: 50 × 10⁹/L
ANC: 2.3 × 10⁹/L

Multilineage dysplasia:

Present

BM aspirate:

28% BM blasts

Additional Assessments

NGS findings:

IDH1+ (R132H mutant)
JAK2+ (V617F mutant)
SRSF2+
ASXL1+

Cytogenetic risk status:

Poor (trisomy 8 [+8], del[20q], -7)

Metabolic panel:

Uric acid: 9.2 mg/dL
Creatinine: 1.8 mg/dL
Potassium: 5.0 mEq/dL
Phosphate: 4.5 mg/dL

Of the 25% of sAML patients (18/72) treated with TIBSOVO + AZA, 22% had a history of MPN (4/18) in the AGILE clinical trial¹

^aThis case is hypothetical.

See TIBSOVO access information

Reference: 1. Montesinos P, Recher C, Vives S, et al. Ivosidenib and azacitidine in IDH1-mutated acute myeloid leukemia. N Engl J Med. 2022;386(16):1519-1531. doi:10.1056/NEJMoa2117344

Indications

TIBSOVO is indicated for patients with a susceptible isocitrate dehydrogenase-1 (IDH1) mutation as detected by an FDA-approved test with:

Newly Diagnosed Acute Myeloid Leukemia (AML)

In combination with azacitidine or as monotherapy for the treatment of newly diagnosed AML in adults 75 years or older, or who have comorbidities that preclude use of intensive induction chemotherapy

Relapsed or Refractory AML

For the treatment of adult patients with relapsed or refractory AML

IMPORTANT SAFETY INFORMATION

WARNING: DIFFERENTIATION SYNDROME IN AML
Patients treated with TIBSOVO have experienced symptoms of differentiation syndrome, which can be fatal. 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.

WARNINGS AND PRECAUTIONS

Differentiation Syndrome in AML: Differentiation syndrome is associated with rapid proliferation and differentiation of myeloid cells and may be life-threatening or fatal. Symptoms of differentiation syndrome in patients treated with TIBSOVO included noninfectious leukocytosis, peripheral edema, pyrexia, dyspnea, pleural effusion, hypotension, hypoxia, pulmonary edema, pneumonitis, pericardial effusion, rash, fluid overload, tumor lysis syndrome, and creatinine increased.

If differentiation syndrome is suspected, initiate dexamethasone 10 mg IV every 12 hours (or an equivalent dose of an alternative oral or IV corticosteroid) and hemodynamic monitoring until improvement. If concomitant noninfectious leukocytosis is observed, initiate treatment with hydroxyurea or leukapheresis, as clinically indicated. Taper corticosteroids and hydroxyurea after resolution of symptoms and administer corticosteroids for a minimum of 3 days. Symptoms of differentiation syndrome may recur with premature discontinuation of corticosteroid and/or hydroxyurea treatment. If severe signs and/or symptoms persist for more than 48 hours after initiation of corticosteroids, interrupt TIBSOVO until signs and symptoms are no longer severe.

QTc Interval Prolongation: Patients treated with TIBSOVO can develop QT (QTc) prolongation and ventricular arrhythmias. Concomitant use of TIBSOVO with drugs known to prolong the QTc interval (e.g., anti-arrhythmic medicines, fluoroquinolones, triazole anti-fungals, 5-HT₃ receptor antagonists) and CYP3A4 inhibitors may increase the risk of QTc interval prolongation. Conduct monitoring of electrocardiograms (ECGs) and electrolytes. In patients with congenital long QTc syndrome, congestive heart failure, electrolyte abnormalities, or those who are taking medications known to prolong the QTc interval, more frequent monitoring may be necessary.

Interrupt TIBSOVO if QTc increases to greater than 480 msec and less than 500 msec. Interrupt and reduce TIBSOVO if QTc increases to greater than 500 msec. Permanently discontinue TIBSOVO in patients who develop QTc interval prolongation with signs or symptoms of life-threatening arrhythmia.

Guillain-Barré Syndrome: Guillain-Barré syndrome can develop in patients treated with TIBSOVO. Monitor patients taking TIBSOVO for onset of new signs or symptoms of motor and/or sensory neuropathy such as unilateral or bilateral weakness, sensory alterations, paresthesias, or difficulty breathing. Permanently discontinue TIBSOVO in patients who are diagnosed with Guillain-Barré syndrome.

ADVERSE REACTIONS

The most common adverse reactions including laboratory abnormalities (≥25%) in patients with AML are leukocytes decreased, diarrhea, hemoglobin decreased, platelets decreased, glucose increased, fatigue, alkaline phosphatase increased, edema, potassium decreased, nausea, vomiting, phosphate 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, differentiation syndrome, calcium decreased, neutrophils decreased, and myalgia.

DRUG INTERACTIONS

Strong or Moderate CYP3A4 Inhibitors: Reduce TIBSOVO dose with strong CYP3A4 inhibitors. Monitor patients for increased risk of QTc interval prolongation.

Strong CYP3A4 Inducers: Avoid concomitant use with TIBSOVO.

Sensitive CYP3A4 Substrates: Avoid concomitant use with TIBSOVO.

QTc Prolonging Drugs: Avoid concomitant use with TIBSOVO. If co-administration is unavoidable, monitor patients for increased risk of QTc interval prolongation.

LACTATION

Advise women not to breastfeed.

Please see Full Prescribing Information, including BOXED WARNING for AML patients.

Last update: September 2026

Information on this website is reviewed through established medical, legal, and regulatory processes to support accurate, balanced, and label‑consistent communication about TIBSOVO.

Patient profiles

Meet Michael^a

Meet Margaret^a

Meet Eleanor^a

Meet Phil^a

Indications

IMPORTANT SAFETY INFORMATION

WARNINGS AND PRECAUTIONS

ADVERSE REACTIONS

DRUG INTERACTIONS

LACTATION

INDICATIONS

IMPORTANT SAFETY INFORMATION

WARNING: DIFFERENTIATION SYNDROME IN AML

Meet Michaela

Meet Margareta

Meet Eleanora

Meet Phila

Indications

IMPORTANT SAFETY INFORMATION

WARNINGS AND PRECAUTIONS

ADVERSE REACTIONS

DRUG INTERACTIONS

LACTATION

INDICATIONS

IMPORTANT SAFETY INFORMATION

WARNING: DIFFERENTIATION SYNDROME IN AML

Meet Michael^a

Meet Margaret^a

Meet Eleanor^a

Meet Phil^a