Ivosidenib: Drug information

For additional information see "Ivosidenib: Patient drug information"

For abbreviations, symbols, and age group definitions show table

ALERT: US Boxed Warning

Differentiation syndrome in acute myeloid leukemia and myelodysplastic syndromes

Patients treated with ivosidenib 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.

Brand Names: US

Tibsovo

Brand Names: Canada

Tibsovo

Pharmacologic Category

Antineoplastic Agent, IDH1 Inhibitor

Dosing: Adult

Dosage guidance:

Clinical considerations: Select patients for treatment of acute myeloid leukemia (AML), cholangiocarcinoma, and myelodysplastic syndromes (MDS) based on the presence of IDH1 mutations.

Acute myeloid leukemia, newly diagnosed, IDH1 mutated

Acute myeloid leukemia, newly diagnosed, IDH1 mutated (in adults ≥75 years of age and/or with comorbidities precluding the use of intensive induction chemotherapy):

Single-agent therapy: Oral: 500 mg once daily (Ref); continue until disease progression or unacceptable toxicity. In patients without disease progression or unacceptable toxicity, continue for a minimum of 6 months to allow time for clinical response.

In combination with azacitidine: Oral: 500 mg once daily (in combination with azacitidine) beginning on day 1 of each 28-day cycle until relapse, disease progression, or unacceptable toxicity (Ref). In patients without disease progression or unacceptable toxicity, continue for a minimum of 6 months to allow time for clinical response. Refer to protocol for additional details.

Acute myeloid leukemia, relapsed/refractory, IDH1 mutated

Acute myeloid leukemia, relapsed/refractory, IDH1 mutated: Oral: 500 mg once daily (Ref); continue until disease progression or unacceptable toxicity occurs. In patients without disease progression or unacceptable toxicity, continue for a minimum of 6 months to allow time for clinical response.

Cholangiocarcinoma, locally advanced or metastatic, previously treated, IDH1 mutated

Cholangiocarcinoma, locally advanced or metastatic, previously treated, IDH1 mutated: Oral: 500 mg once daily; continue until disease progression or unacceptable toxicity (Ref).

Myelodysplastic syndromes, relapsed or refractory, IDH1 mutated

Myelodysplastic syndromes, relapsed or refractory, IDH1 mutated : Oral: 500 mg once daily; continue until disease progression or unacceptable toxicity. In patients without disease progression or unacceptable toxicity, continue for a minimum of 6 months to allow time for clinical response.

Missed dose: If a dose is missed or not administered at the usual time, administer the dose as soon as possible and at least 12 hours prior to the next scheduled dose and return to the normal administration schedule the following day; do not administer 2 doses within 12 hours. If a dose is vomited, do not administer a replacement dose (wait until the next scheduled dose is due).

Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.

Dosing: Kidney Impairment: Adult

Note: Kidney function may be estimated using the MDRD formula.

eGFR ≥30 mL/minute/1.73 m²: No dosage adjustment necessary.

eGFR <30 mL/minute/1.73 m²: There are no dosage adjustments provided in the manufacturer's labeling (pharmacokinetics are unknown); consider risks versus potential benefits in patients with preexisting severe kidney impairment.

End-stage kidney disease requiring dialysis: There are no dosage adjustments provided in the manufacturer's labeling (pharmacokinetics are unknown); consider risks versus potential benefits in patients with preexisting end-stage kidney disease requiring dialysis.

Dosing: Liver Impairment: Adult

Hepatic impairment prior to treatment initiation:

Mild or moderate impairment (Child-Turcotte-Pugh class A or B): No dosage adjustment necessary.

Severe impairment (Child-Turcotte-Pugh class C): There are no dosage adjustments provided in the manufacturer's labeling (pharmacokinetics are unknown); consider risks versus potential benefits in patients with preexisting severe hepatic impairment.

Dosing: Adjustment for Toxicity: Adult

**Ivosidenib Recommended Dosage Modifications for Adverse Reactions**
Adverse reaction	Severity	Ivosidenib dosage modification
^a AML = acute myeloid leukemia; MDS = myelodysplastic syndromes.
Hematologic toxicity
Noninfectious leukocytosis	WBC >25,000/mm³ or An absolute increase in total WBC of >15,000/mm³ from baseline	Initiate cytoreductive therapy with hydroxyurea and/or leukapheresis if clinically indicated. Taper hydroxyurea once leukocytosis improves or resolves. Leukocytosis not improved with hydroxyurea: Withhold ivosidenib; then resume ivosidenib at 500 mg once daily when leukocytosis has resolved.
Nonhematologic toxicity
Differentiation syndrome (AML^a and MDS^a)	Suspected	Administer systemic corticosteroids (dexamethasone 10 mg IV every 12 hours [or equivalent]) and monitor hemodynamic status until symptoms resolve. Administer corticosteroids for a minimum of 3 days (symptoms of differentiation syndrome may recur if corticosteroids are stopped prematurely).
Differentiation syndrome (AML^a and MDS^a)	Severe signs and/or symptoms persisting for >48 hours after initiation of systemic corticosteroids	Withhold ivosidenib; resume when signs/symptoms of differentiation syndrome resolve to ≤ grade 2.
Guillain-Barré syndrome	Any	Permanently discontinue ivosidenib.
QTc prolongation	QTc >480 msec to 500 msec	Monitor electrolytes and supplement as clinically indicated. Review and adjust concomitant medications with known QTc interval-prolonging effects. Withhold ivosidenib; resume at 500 mg once daily when QTc ≤480 msec. Monitor ECGs at least weekly for 2 weeks following resolution of QTc prolongation.
	QTc >500 msec	Monitor electrolytes and supplement as clinically indicated. Review and adjust concomitant medications with known QTc interval-prolonging effects. Withhold ivosidenib; resume at a reduced dose of 250 mg once daily when QTc is within 30 msec of baseline or ≤480 msec. Consider re-escalation of dose to 500 mg once daily if alternative etiology for QTc prolongation can be identified. Monitor ECGs at least weekly for 2 weeks following resolution of QTc prolongation.
	Signs/symptoms of life-threatening arrhythmia	Permanently discontinue ivosidenib.
Other clinically significant toxicities
AML and MDS – single-agent therapy	≥ Grade 3	Withhold ivosidenib; resume at 250 mg once daily when toxicity resolves to ≤ grade 2 (may increase to 500 mg if toxicity resolves to ≤ grade 1). Recurrent ≥ grade 3 toxicity: Discontinue ivosidenib.
AML in combination with azacitidine or cholangiocarcinoma	≥ Grade 3	Withhold ivosidenib; resume at 500 mg once daily (grade 3 toxicity) or 250 mg once daily (grade 4 toxicity) when toxicity resolves to ≤ grade 1 or baseline. Recurrent grade 3 toxicity (second occurrence): Reduce ivosidenib to 250 mg once daily until toxicity resolves, then escalate to 500 mg once daily. Recurrent grade 3 toxicity (third occurrence) or recurrent grade 4 toxicity: Discontinue ivosidenib.

Dosing: Older Adult

Refer to adult dosing.

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Reported adverse reactions are for monotherapy in adults.

>10%:

Cardiovascular: Chest pain (16%), edema (32%), hypotension (12%), prolonged QT interval on ECG (10% to 26%)

Dermatologic: Skin rash (15% to 26%)

Endocrine & metabolic: Decreased serum magnesium (38%), decreased serum phosphate (25%), decreased serum potassium (31%), decreased serum sodium (39%), increased uric acid (32%)

Gastrointestinal: Abdominal pain (16% to 35%), constipation (20%), decreased appetite (18% to 24%), diarrhea (34% to 35%; grades ≥3: 2%), nausea (31% to 41%; grades ≥3: 1% to 2%), stomatitis (28%; grades ≥3: 3%), vomiting (18% to 23%; grades ≥3: 1% to 2%)

Hematologic & oncologic: Anemia (18%; grades ≥3: 7%), differentiation syndrome (19%; grades ≥3: 13%), leukocytosis (38%; grades ≥3: 8%)

Hepatic: Ascites (23%), increased serum alanine aminotransferase (15%), increased serum alkaline phosphatase (27%), increased serum aspartate aminotransferase (27% to 34%), increased serum bilirubin (16% to 30%, including hyperbilirubinemia)

Nervous system: Fatigue (39% to 43%), headache (13% to 16%), neuropathy (12%), peripheral neuropathy (11%)

Neuromuscular & skeletal: Arthralgia (36%), myalgia (18%)

Renal: Increased serum creatinine (23%)

Respiratory: Cough (22% to 27%), dyspnea (33%), pleural effusion (13%)

Miscellaneous: Fever (23%)

1% to 10%:

Hematologic & oncologic: Tumor lysis syndrome (8%; grades ≥3: 6%)

Hepatic: Cholestatic jaundice (serious: ≥2%)

Respiratory: Pneumonia (serious: ≥2%)

<1%:

Cardiovascular: Ventricular fibrillation

Nervous system: Guillain-Barré syndrome, progressive multifocal leukoencephalopathy

Frequency not defined: Renal: Acute kidney injury

Contraindications

There are no contraindications listed in the manufacturer's US labeling.

Canadian labeling: Hypersensitivity to ivosidenib or any component of the formulation; concomitant use of strong CYP3A4 inducers or dabigatran; congenital long QT syndrome; QT/QTc interval >500 msec (regardless of correction method used); family history of sudden death or polymorphic ventricular arrythmia.

Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.

Warnings/Precautions

Concerns related to adverse effects:

• Differentiation syndrome: Patients with acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS) treated with ivosidenib have experienced symptoms of differentiation syndrome. Differentiation syndrome is associated with rapid proliferation and differentiation of myeloid cells; may be life-threatening or fatal. Symptoms include noninfectious leukocytosis, peripheral edema, fever, dyspnea, pleural effusion, hypotension, hypoxia, pulmonary infiltrates, pulmonary edema, pneumonitis, pericardial effusions, rash, fluid overload, rapid weight gain, tumor lysis syndrome, hepatic, renal, or multiorgan dysfunction, and/or increased serum creatinine. Of patients who experienced differentiation syndrome, most recovered after corticosteroid treatment or ivosidenib treatment interruption. The onset of differentiation syndrome occurred from 1 day up to 3 months after ivosidenib treatment initiation; may occur with or without concomitant leukocytosis.

• Guillain-Barré syndrome: Guillain-Barré syndrome occurred in a small number of patients treated with ivosidenib.

• QT prolongation: Patients treated with ivosidenib may develop QT (QTc) prolongation and ventricular arrhythmias; some patients were found to have a QTc interval >500 msec and/or an increase from baseline QTc of >60 msec. Ventricular fibrillation (attributed to ivosidenib) was observed (case report). Patients with a baseline QTc of ≥450 or ≥470 msec (refer to specific trial for exclusion criteria) or with a history of long QT syndrome, uncontrolled or significant cardiovascular disease, or arrhythmic events (eg, heart failure, hypokalemia, family history of long QT syndrome) were excluded from clinical studies. Concomitant use of ivosidenib with medications known to prolong the QTc interval (eg, anti-arrhythmics, fluoroquinolones, triazole anti-fungals, 5-HT₃ receptor antagonists) and CYP3A4 inhibitors may increase the risk of QTc interval prolongation.

Other warnings/precautions:

• Appropriate use: Select patients for treatment of AML, cholangiocarcinoma, and MDS based on the presence of IDH1 mutations. Information on tests approved to detect IDH1 mutation may be found at http://www.FDA.gov/CompanionDiagnostics.

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Tablet, Oral:

Tibsovo: 250 mg [contains fd&c blue #2 (indigotine,indigo carmine)]

Generic Equivalent Available: US

Pricing: US

Tablets (Tibsovo Oral)

250 mg (per each): $682.98

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Dosage Forms: Canada

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Tablet, Oral:

Tibsovo: 250 mg [contains fd&c blue #2 (indigo carm) aluminum lake]

Prescribing and Access Restrictions

Ivosidenib is available through specialty pharmacies and various specialty institutions or accounts; distribution information is available at http://www.myagios.com or call 844-409-1411.

Administration: Adult

Oral: Administer at approximately the same time each day, with or without food (do not administer with a high fat meal). Canadian product labeling recommends avoiding food for at least 2 hours before and 1 hour after ivosidenib administration. Do not split, crush, or chew tablets.

Hazardous Drugs Handling Considerations

This medication is not on the NIOSH (2024) list; however, it may meet the criteria for a hazardous drug. Ivosidenib may cause reproductive toxicity and teratogenicity.

Use appropriate precautions for receiving, handling, storage, preparation, dispensing, transporting, administration, and disposal. Follow NIOSH and USP 800 recommendations and institution-specific policies/procedures for appropriate containment strategy (NIOSH 2023; NIOSH 2024; USP-NF 2020).

Note: Facilities may perform risk assessment of some hazardous drugs to determine if appropriate for alternative handling and containment strategies (USP-NF 2020). Refer to institution-specific handling policies/procedures.

Medication Guide and/or Vaccine Information Statement (VIS)

An FDA-approved patient medication guide, which is available with the product information and as follows, must be dispensed with this medication:

Tibsovo: https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/211192s011lbl.pdf#page=38

Use: Labeled Indications

Acute myeloid leukemia, newly diagnosed, IDH1 mutated: Treatment (either as a single agent or in combination with azacitidine) of newly diagnosed acute myeloid leukemia (AML), in adults ≥75 years of age or with comorbidities that preclude use of intensive induction chemotherapy, with a susceptible isocitrate dehydrogenase-1 (IDH1) mutation as detected by an approved test.

Acute myeloid leukemia, relapsed/refractory, IDH1 mutated: Treatment of relapsed or refractory AML in adults with a susceptible IDH1 mutation as detected by an approved test.

Cholangiocarcinoma, locally advanced or metastatic, previously treated, IDH1 mutated: Treatment of previously treated, locally advanced, or metastatic cholangiocarcinoma in adults with an IDH1 mutation as detected by an approved test.

Myelodysplastic syndromes, relapsed or refractory, IDH 1 mutated: Treatment of relapsed or refractory myelodysplastic syndromes in adults with a susceptible IDH1 mutation as detected by an approved test.

Medication Safety Issues

Sound-alike/look-alike issues:

Ivosidenib may be confused with enasidenib, ibrutinib, idelalisib, imatinib, inavolisib, ixazomib, olutasidenib, revumenib, vorasidenib.

High alert medication:

The Institute for Safe Medication Practices (ISMP) includes this medication among its list of drug classes (chemotherapeutic agent, parenteral and oral) which have a heightened risk of causing significant patient harm when used in error (High-Alert Medications in Acute Care, Community/Ambulatory Care, and Long-Term Care Settings).

Metabolism/Transport Effects

Substrate of CYP3A4 (Major with inhibitors), CYP3A4 (Minor with inducers), P-glycoprotein (Minor); Note: Assignment of Major/Minor substrate status based on clinically relevant drug interaction potential;

Drug Interactions

Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the drug interactions program by clicking on the “Launch drug interactions program” link above.

Amiodarone: QT-prolonging Kinase Inhibitors (Highest Risk) may increase QTc-prolonging effects of Amiodarone. Management: Consider alternatives to this drug combination. If combined, monitor for QTc interval prolongation and ventricular arrhythmias. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk D: Consider Therapy Modification

Amisulpride (Oral): QT-prolonging Agents (Highest Risk) may increase QTc-prolonging effects of Amisulpride (Oral). Management: Consider alternatives to this drug combination. If combined, monitor for QTc interval prolongation and ventricular arrhythmias. Patients with additional risk factors for QTc prolongation may be at even greater risk. Risk D: Consider Therapy Modification

Atazanavir: May increase serum concentration of Ivosidenib. Ivosidenib may decrease serum concentration of Atazanavir. Risk X: Avoid

Azithromycin (Systemic): QT-prolonging Agents (Highest Risk) may increase QTc-prolonging effects of Azithromycin (Systemic). Management: Consider alternatives to this combination. Patients with other risk factors (eg, older age, female sex, bradycardia, hypokalemia, hypomagnesemia, heart disease, and higher drug concentrations) are likely at greater risk for these toxicities. Risk D: Consider Therapy Modification

Carbetocin: May increase QTc-prolonging effects of QT-prolonging Agents (Highest Risk). Management: Consider alternatives to this drug combination. If combined, monitor for QTc interval prolongation and ventricular arrhythmias. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk D: Consider Therapy Modification

Chloroquine: QT-prolonging Agents (Highest Risk) may increase QTc-prolonging effects of Chloroquine. Management: Consider alternatives to this combination. If combined, monitor for QTc interval prolongation and ventricular arrhythmias. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk D: Consider Therapy Modification

Citalopram: QT-prolonging Agents (Highest Risk) may increase QTc-prolonging effects of Citalopram. Risk X: Avoid

Clarithromycin: QT-prolonging Agents (Highest Risk) may increase QTc-prolonging effects of Clarithromycin. Risk X: Avoid

Clofazimine: QT-prolonging Agents (Highest Risk) may increase QTc-prolonging effects of Clofazimine. Management: Consider alternatives to this combination. If combined, monitor for QTc interval prolongation and ventricular arrhythmias. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk D: Consider Therapy Modification

ClomiPRAMINE: May increase QTc-prolonging effects of QT-prolonging Agents (Highest Risk). Management: Consider alternatives to this drug combination. If combined, monitor for QTc interval prolongation and ventricular arrhythmias. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk D: Consider Therapy Modification

CloZAPine: QT-prolonging Agents (Highest Risk) may increase QTc-prolonging effects of CloZAPine. Management: Consider alternatives to this combination. Patients with other risk factors (eg, older age, female sex, bradycardia, hypokalemia, hypomagnesemia, heart disease, and higher drug concentrations) are likely at greater risk for these toxicities. Risk D: Consider Therapy Modification

CYP2C9 Substrates (Narrow Therapeutic Index/Sensitive with Inducers): Ivosidenib may decrease serum concentration of CYP2C9 Substrates (Narrow Therapeutic Index/Sensitive with Inducers). Management: Consider alternatives to this combination when possible. If combined, monitor for decreased effectiveness of these CYP2C9 substrates if combined with ivosidenib. Risk D: Consider Therapy Modification

CYP3A4 Inducers (Strong): May decrease serum concentration of Ivosidenib. Risk X: Avoid

CYP3A4 Inhibitors (Moderate): May increase serum concentration of Ivosidenib. Management: Avoid use of moderate CYP3A4 inhibitors with ivosidenib whenever possible. If combined, monitor for increased ivosidenib toxicities, including QTc prolongation. Risk D: Consider Therapy Modification

CYP3A4 Inhibitors (Strong): May increase serum concentration of Ivosidenib. Management: Avoid use of a strong CYP3A4 inhibitor with ivosidenib whenever possible. When combined use is required, reduce the ivosidenib dose to 250 mg once daily and monitor for increased ivosidenib toxicities, including QTc interval prolongation. Risk D: Consider Therapy Modification

CYP3A4 Substrates (Narrow Therapeutic Index/Sensitive with Inducers): Ivosidenib may decrease serum concentration of CYP3A4 Substrates (Narrow Therapeutic Index/Sensitive with Inducers). Management: Consider alternatives to this combination when possible. If combined, monitor for decreased effectiveness of these CYP3A4 substrates if combined with ivosidenib. Risk D: Consider Therapy Modification

Dabigatran Etexilate: Ivosidenib may decrease serum concentration of Dabigatran Etexilate. Risk C: Monitor

Dabrafenib: May increase QTc-prolonging effects of QT-prolonging Agents (Highest Risk). Management: Consider alternatives to this drug combination. If combined, monitor for QTc interval prolongation and ventricular arrhythmias. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk D: Consider Therapy Modification

Dasatinib: QT-prolonging Agents (Highest Risk) may increase QTc-prolonging effects of Dasatinib. Management: Consider alternatives to this combination. Patients with other risk factors (eg, older age, female sex, bradycardia, hypokalemia, hypomagnesemia, heart disease, and higher drug concentrations) are likely at greater risk for these toxicities. Risk D: Consider Therapy Modification

Domperidone: QT-prolonging Agents (Highest Risk) may increase QTc-prolonging effects of Domperidone. Risk X: Avoid

Doxepin-Containing Products: QT-prolonging Agents (Highest Risk) may increase QTc-prolonging effects of Doxepin-Containing Products. Management: Consider alternatives to this combination. Patients with other risk factors (eg, older age, female sex, bradycardia, hypokalemia, hypomagnesemia, heart disease, and higher drug concentrations) are likely at greater risk for these toxicities. Risk D: Consider Therapy Modification

Dronedarone: Ivosidenib may increase QTc-prolonging effects of Dronedarone. Dronedarone may increase serum concentration of Ivosidenib. Management: Consider alternatives to this drug combination. If combined, monitor for QTc interval prolongation and ventricular arrhythmias. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk D: Consider Therapy Modification

DroPERidol: QT-prolonging Agents (Highest Risk) may increase QTc-prolonging effects of DroPERidol. Management: Consider alternatives to this combination. Patients with other risk factors (eg, older age, female sex, bradycardia, hypokalemia, hypomagnesemia, heart disease, and higher drug concentrations) are likely at greater risk for these toxicities. Risk D: Consider Therapy Modification

Encorafenib: May increase QTc-prolonging effects of Ivosidenib. Encorafenib may decrease serum concentration of Ivosidenib. Risk X: Avoid

Entrectinib: May increase QTc-prolonging effects of QT-prolonging Agents (Highest Risk). Risk X: Avoid

Escitalopram: QT-prolonging Agents (Highest Risk) may increase QTc-prolonging effects of Escitalopram. Management: Consider alternatives to this combination. Patients with other risk factors (eg, older age, female sex, bradycardia, hypokalemia, hypomagnesemia, heart disease, and higher drug concentrations) are likely at greater risk for these toxicities. Risk D: Consider Therapy Modification

Etelcalcetide: May increase QTc-prolonging effects of QT-prolonging Agents (Highest Risk). Management: Consider alternatives to this drug combination. If combined, monitor for QTc interval prolongation and ventricular arrhythmias. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk D: Consider Therapy Modification

Fexinidazole: May increase QTc-prolonging effects of QT-prolonging Agents (Highest Risk). Risk X: Avoid

Fingolimod: May increase QTc-prolonging effects of QT-prolonging Agents (Highest Risk). Management: Monitor for QTc interval prolongation and ventricular arrhythmias (including TdP) with a continuous overnight ECG when fingolimod is combined with QT prolonging drugs. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk C: Monitor

Flecainide: QT-prolonging Agents (Highest Risk) may increase QTc-prolonging effects of Flecainide. Management: Consider alternatives to this combination. Patients with other risk factors (eg, older age, female sex, bradycardia, hypokalemia, hypomagnesemia, heart disease, and higher drug concentrations) are likely at greater risk for these toxicities. Risk D: Consider Therapy Modification

Fluorouracil Products: QT-prolonging Agents (Highest Risk) may increase QTc-prolonging effects of Fluorouracil Products. Management: Consider alternatives to this drug combination. If combined, monitor for QTc interval prolongation and ventricular arrhythmias. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk D: Consider Therapy Modification

Flupentixol: QT-prolonging Agents (Highest Risk) may increase QTc-prolonging effects of Flupentixol. Risk X: Avoid

Fusidic Acid (Systemic): May increase serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Management: Consider avoiding this combination if possible. If required, monitor patients closely for increased adverse effects of the CYP3A4 substrate. Risk D: Consider Therapy Modification

Gadobenate Dimeglumine: QT-prolonging Agents (Highest Risk) may increase QTc-prolonging effects of Gadobenate Dimeglumine. Management: Consider alternatives to this combination. If combined, monitor for QTc interval prolongation and ventricular arrhythmias. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk D: Consider Therapy Modification

Gemifloxacin: QT-prolonging Kinase Inhibitors (Highest Risk) may increase QTc-prolonging effects of Gemifloxacin. Management: Consider alternatives to this drug combination. If combined, monitor for QTc interval prolongation and ventricular arrhythmias. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk D: Consider Therapy Modification

Gilteritinib: May increase QTc-prolonging effects of QT-prolonging Agents (Highest Risk). Management: Consider alternatives to this combination. If use is necessary, monitor for QTc interval prolongation and arrhythmias. Risk D: Consider Therapy Modification

Grapefruit Juice: May increase serum concentration of Ivosidenib. Management: Avoid consumption of grapefruit juice with ivosidenib whenever possible. When combined, monitor patients for increased ivosidenib toxicities, including QTc interval prolongation. Risk D: Consider Therapy Modification

Halofantrine: QT-prolonging Agents (Highest Risk) may increase QTc-prolonging effects of Halofantrine. Management: Consider alternatives to this combination. If combined, monitor for QTc interval prolongation and ventricular arrhythmias. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk D: Consider Therapy Modification

Haloperidol: QT-prolonging Kinase Inhibitors (Highest Risk) may increase QTc-prolonging effects of Haloperidol. Management: Consider alternatives to this drug combination. If combined, monitor for QTc interval prolongation and ventricular arrhythmias. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk D: Consider Therapy Modification

Hormonal Contraceptives: Ivosidenib may decrease serum concentration of Hormonal Contraceptives. Management: Consider alternative methods of contraception (ie, non-hormonal) in patients receiving ivosidenib. Risk D: Consider Therapy Modification

HydrOXYzine: May increase QTc-prolonging effects of QT-prolonging Agents (Highest Risk). Risk C: Monitor

Imipramine: May increase QTc-prolonging effects of QT-prolonging Agents (Highest Risk). Management: Consider alternatives to this drug combination. If combined, monitor for QTc interval prolongation and ventricular arrhythmias. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk D: Consider Therapy Modification

Inotuzumab Ozogamicin: QT-prolonging Agents (Highest Risk) may increase QTc-prolonging effects of Inotuzumab Ozogamicin. Management: Consider alternatives to this combination. If combined, monitor for QTc interval prolongation and ventricular arrhythmias. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk D: Consider Therapy Modification

Itraconazole: May increase serum concentration of Ivosidenib. Ivosidenib may decrease serum concentration of Itraconazole. Risk X: Avoid

Ketoconazole (Systemic): May increase serum concentration of Ivosidenib. Ivosidenib may decrease serum concentration of Ketoconazole (Systemic). Risk X: Avoid

Lefamulin: May increase QTc-prolonging effects of QT-prolonging CYP3A4 Substrates. Management: Do not use lefamulin tablets with QT-prolonging CYP3A4 substrates. Lefamulin prescribing information lists this combination as contraindicated. Risk X: Avoid

Levofloxacin-Containing Products (Systemic): QT-prolonging Kinase Inhibitors (Highest Risk) may increase QTc-prolonging effects of Levofloxacin-Containing Products (Systemic). Management: Consider alternatives to this drug combination. If combined, monitor for QTc interval prolongation and ventricular arrhythmias. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk D: Consider Therapy Modification

Lofexidine: QT-prolonging Agents (Highest Risk) may increase QTc-prolonging effects of Lofexidine. Management: Consider alternatives to this combination. If combined, monitor for QTc interval prolongation and ventricular arrhythmias. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk D: Consider Therapy Modification

Meglumine Antimoniate: May increase QTc-prolonging effects of QT-prolonging Agents (Highest Risk). Management: Consider alternatives to this drug combination. If combined, monitor for QTc interval prolongation and ventricular arrhythmias. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk D: Consider Therapy Modification

Methadone: QT-prolonging Kinase Inhibitors (Highest Risk) may increase QTc-prolonging effects of Methadone. Management: Consider alternatives to this drug combination. If combined, monitor for QTc interval prolongation and ventricular arrhythmias. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk D: Consider Therapy Modification

Midostaurin: QT-prolonging Agents (Highest Risk) may increase QTc-prolonging effects of Midostaurin. Management: Consider alternatives to this combination. If combined, monitor for QTc interval prolongation and ventricular arrhythmias. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk D: Consider Therapy Modification

Moxifloxacin (Systemic): QT-prolonging Agents (Highest Risk) may increase QTc-prolonging effects of Moxifloxacin (Systemic). Risk X: Avoid

Nilotinib: May increase QTc-prolonging effects of Ivosidenib. Nilotinib may increase serum concentration of Ivosidenib. Risk X: Avoid

OLANZapine: QT-prolonging Agents (Highest Risk) may increase QTc-prolonging effects of OLANZapine. Management: Consider alternatives to this combination. Patients with other risk factors (eg, older age, female sex, bradycardia, hypokalemia, hypomagnesemia, heart disease, and higher drug concentrations) are likely at greater risk for these toxicities. Risk D: Consider Therapy Modification

Ondansetron: QT-prolonging Agents (Highest Risk) may increase QTc-prolonging effects of Ondansetron. Management: Consider alternatives to this combination. If combined, monitor for QTc interval prolongation and ventricular arrhythmias. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk D: Consider Therapy Modification

Osimertinib: QT-prolonging Agents (Highest Risk) may increase QTc-prolonging effects of Osimertinib. Management: Consider alternatives to this combination. Patients with other risk factors (eg, older age, female sex, bradycardia, hypokalemia, hypomagnesemia, heart disease, and higher drug concentrations) are likely at greater risk for these toxicities. Risk D: Consider Therapy Modification

Oxytocin: May increase QTc-prolonging effects of QT-prolonging Agents (Highest Risk). Management: Consider alternatives to this drug combination. If combined, monitor for QTc interval prolongation and ventricular arrhythmias. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk D: Consider Therapy Modification

Pacritinib: QT-prolonging Agents (Highest Risk) may increase QTc-prolonging effects of Pacritinib. Management: Monitor for QTc interval prolongation and ventricular arrhythmias when these agents are combined. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk C: Monitor

PAZOPanib: QT-prolonging Agents (Highest Risk) may increase QTc-prolonging effects of PAZOPanib. Risk X: Avoid

Pentamidine (Systemic): QT-prolonging Agents (Highest Risk) may increase QTc-prolonging effects of Pentamidine (Systemic). Management: Consider alternatives to this combination. If combined, monitor for QTc interval prolongation and ventricular arrhythmias. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk D: Consider Therapy Modification

Pilsicainide: QT-prolonging Agents (Highest Risk) may increase QTc-prolonging effects of Pilsicainide. Management: Consider alternatives to this combination. If combined, monitor for QTc interval prolongation and ventricular arrhythmias. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk D: Consider Therapy Modification

Pimozide: QT-prolonging Agents (Highest Risk) may increase QTc-prolonging effects of Pimozide. Management: Consider alternatives to this combination. Patients with other risk factors (eg, older age, female sex, bradycardia, hypokalemia, hypomagnesemia, heart disease, and higher drug concentrations) are likely at greater risk for these toxicities. Risk X: Avoid

Piperaquine: QT-prolonging Agents (Highest Risk) may increase QTc-prolonging effects of Piperaquine. Risk X: Avoid

Posaconazole: May increase serum concentration of Ivosidenib. Ivosidenib may decrease serum concentration of Posaconazole. Risk X: Avoid

Probucol: QT-prolonging Agents (Highest Risk) may increase QTc-prolonging effects of Probucol. Risk X: Avoid

Propafenone: May increase QTc-prolonging effects of QT-prolonging Kinase Inhibitors (Highest Risk). Management: Consider alternatives to this drug combination. If combined, monitor for QTc interval prolongation and ventricular arrhythmias. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk D: Consider Therapy Modification

Propofol: May increase QTc-prolonging effects of QT-prolonging Agents (Highest Risk). Management: Consider alternatives to this drug combination. If combined, monitor for QTc interval prolongation and ventricular arrhythmias. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk D: Consider Therapy Modification

QT-prolonging Agents (Indeterminate Risk - Avoid): May increase QTc-prolonging effects of QT-prolonging Agents (Highest Risk). Management: Monitor for QTc interval prolongation and ventricular arrhythmias when these agents are combined. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk C: Monitor

QT-prolonging Agents (Indeterminate Risk - Caution): May increase QTc-prolonging effects of QT-prolonging Agents (Highest Risk). Management: Monitor for QTc interval prolongation and ventricular arrhythmias when these agents are combined. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk C: Monitor

QT-prolonging Class IA Antiarrhythmics (Highest Risk): QT-prolonging Kinase Inhibitors (Highest Risk) may increase QTc-prolonging effects of QT-prolonging Class IA Antiarrhythmics (Highest Risk). Management: Consider alternatives to this drug combination. If combined, monitor for QTc interval prolongation and ventricular arrhythmias. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk D: Consider Therapy Modification

QT-prolonging Class III Antiarrhythmics (Highest Risk): QT-prolonging Kinase Inhibitors (Highest Risk) may increase QTc-prolonging effects of QT-prolonging Class III Antiarrhythmics (Highest Risk). Management: Consider alternatives to this drug combination. If combined, monitor for QTc interval prolongation and ventricular arrhythmias. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk D: Consider Therapy Modification

QT-Prolonging Inhalational Anesthetics (Moderate Risk): May increase QTc-prolonging effects of QT-prolonging Agents (Highest Risk). Management: Consider alternatives to this drug combination. If combined, monitor for QTc interval prolongation and ventricular arrhythmias. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk D: Consider Therapy Modification

QT-prolonging Kinase Inhibitors (Highest Risk): May increase QTc-prolonging effects of QT-prolonging Kinase Inhibitors (Highest Risk). Risk X: Avoid

QT-prolonging Miscellaneous Agents (Highest Risk): QT-prolonging Kinase Inhibitors (Highest Risk) may increase QTc-prolonging effects of QT-prolonging Miscellaneous Agents (Highest Risk). Management: Consider alternatives to this drug combination. If combined, monitor for QTc interval prolongation and ventricular arrhythmias. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk D: Consider Therapy Modification

QT-prolonging Moderate CYP3A4 Inhibitors (Moderate Risk): Ivosidenib may increase QTc-prolonging effects of QT-prolonging Moderate CYP3A4 Inhibitors (Moderate Risk). QT-prolonging Moderate CYP3A4 Inhibitors (Moderate Risk) may increase serum concentration of Ivosidenib. Management: Consider alternatives to this drug combination. If combined, monitor for QTc interval prolongation and ventricular arrhythmias. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk D: Consider Therapy Modification

QT-prolonging Strong CYP3A4 Inhibitors (Highest Risk): May increase QTc-prolonging effects of Ivosidenib. QT-prolonging Strong CYP3A4 Inhibitors (Highest Risk) may increase serum concentration of Ivosidenib. Management: Avoid using strong CYP3A4 inhibitors together with ivosidenib if possible. If the combination must be used, reduce the ivosidenib dose to 250 mg once daily and monitor for increased ivosidenib toxicities, including QTc interval prolongation. Risk D: Consider Therapy Modification

QT-prolonging Strong CYP3A4 Inhibitors (Moderate Risk): Ivosidenib may increase QTc-prolonging effects of QT-prolonging Strong CYP3A4 Inhibitors (Moderate Risk). QT-prolonging Strong CYP3A4 Inhibitors (Moderate Risk) may increase serum concentration of Ivosidenib. Management: Avoid using strong CYP3A4 inhibitors together with ivosidenib if possible. If the combination must be used, reduce the ivosidenib dose to 250 mg once daily and monitor for increased ivosidenib toxicities, including QTc interval prolongation. Risk D: Consider Therapy Modification

QUEtiapine: QT-prolonging Agents (Highest Risk) may increase QTc-prolonging effects of QUEtiapine. Risk X: Avoid

Quizartinib: May increase QTc-prolonging effects of QT-prolonging Agents (Highest Risk). Management: Consider alternatives to this combination. Patients with other risk factors (eg, older age, female sex, bradycardia, hypokalemia, hypomagnesemia, heart disease, and higher drug concentrations) are likely at greater risk for these toxicities. Risk D: Consider Therapy Modification

Ribociclib: QT-prolonging Agents (Highest Risk) may increase QTc-prolonging effects of Ribociclib. Risk X: Avoid

RisperiDONE: QT-prolonging Agents (Highest Risk) may increase QTc-prolonging effects of RisperiDONE. QT-prolonging Agents (Highest Risk) may increase CNS depressant effects of RisperiDONE. Management: Consider alternatives to this drug combination. If combined, monitor for QTc interval prolongation and ventricular arrhythmias. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk D: Consider Therapy Modification

Sertindole: May increase QTc-prolonging effects of QT-prolonging Agents (Highest Risk). Risk X: Avoid

Sparfloxacin: QT-prolonging Agents (Highest Risk) may increase QTc-prolonging effects of Sparfloxacin. Risk X: Avoid

SUNItinib: QT-prolonging Agents (Highest Risk) may increase QTc-prolonging effects of SUNItinib. Management: Consider alternatives to this combination. Patients with other risk factors (eg, older age, female sex, bradycardia, hypokalemia, hypomagnesemia, heart disease, and higher drug concentrations) are likely at greater risk for these toxicities. Risk D: Consider Therapy Modification

Terbutaline: May increase QTc-prolonging effects of QT-prolonging Agents (Highest Risk). Management: Consider alternatives to this combination. Patients with other risk factors (eg, older age, female sex, bradycardia, hypokalemia, hypomagnesemia, heart disease, and higher drug concentrations) are likely at greater risk for these toxicities. Risk D: Consider Therapy Modification

Thioridazine: QT-prolonging Agents (Highest Risk) may increase QTc-prolonging effects of Thioridazine. Risk X: Avoid

Toremifene: QT-prolonging Agents (Highest Risk) may increase QTc-prolonging effects of Toremifene. Management: Consider alternatives to this combination. Patients with other risk factors (eg, older age, female sex, bradycardia, hypokalemia, hypomagnesemia, heart disease, and higher drug concentrations) are likely at greater risk for these toxicities. Risk D: Consider Therapy Modification

Vemurafenib: QT-prolonging Agents (Highest Risk) may increase QTc-prolonging effects of Vemurafenib. Management: Consider alternatives to this combination. Patients with other risk factors (eg, older age, female sex, bradycardia, hypokalemia, hypomagnesemia, heart disease, and higher drug concentrations) are likely at greater risk for these toxicities. Risk D: Consider Therapy Modification

Voriconazole: Ivosidenib may increase QTc-prolonging effects of Voriconazole. Voriconazole may increase serum concentration of Ivosidenib. Ivosidenib may decrease serum concentration of Voriconazole. Management: Avoid concurrent use of voriconazole with ivosidenib when possible. Decrease the ivosidenib dose to 250 mg once daily if combined. Monitor for QTc interval prolongation and decreased voriconazole concentrations and efficacy. Risk D: Consider Therapy Modification

Food Interactions

Administration of a single ivosidenib dose with a high-fat meal (~900 to 1,000 calories, 500 to 600 fat calories, 250 carbohydrate calories, and 150 protein calories) increased ivosidenib C_max 1.98-fold and AUC 1.24-fold. Management: Do not administer with a high-fat meal.

Pregnancy Considerations

Based on data from animal reproduction studies, in utero exposure to ivosidenib may cause fetal harm.

Breastfeeding Considerations

It is not known if ivosidenib is present in breast milk.

Due to the potential for serious adverse reactions in the breastfed infant, breastfeeding is not recommended by the manufacturer during therapy or for 1 month after the last ivosidenib dose.

Monitoring Parameters

Isocitrate dehydrogenase-1 (IDH1) mutation status prior to therapy initiation. For acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS), monitor blood counts and serum chemistries (prior to therapy initiation, at least weekly for the first month, then every other week for the second month, then monthly for the duration of therapy); creatine phosphokinase (weekly for the first month). For all patients, monitor ECG (prior to therapy initiation, at least weekly for the first 3 weeks and then monthly for the duration of therapy. More frequent ECG monitoring may be required if QTc interval prolongation occurs, in patients with congenital long QTc syndrome, heart failure, electrolyte abnormalities, or patients taking medications known to prolong the QTc interval. Monitor for signs/symptoms of differentiation syndrome (in patients with AML and MDS); monitor hemodynamic status if differentiation syndrome is suspected. Monitor for signs/symptoms of tumor lysis syndrome and onset of new signs or symptoms of motor and/or sensory neuropathy for Guillain-Barré syndrome (eg, unilateral or bilateral weakness, sensory alterations, paresthesias, or difficulty breathing). Monitor adherence.

The American Society of Clinical Oncology hepatitis B virus (HBV) screening and management provisional clinical opinion (ASCO [Hwang 2020]) recommends HBV screening with hepatitis B surface antigen, hepatitis B core antibody, total Ig or IgG, and antibody to hepatitis B surface antigen prior to beginning (or at the beginning of) systemic anticancer therapy; do not delay treatment for screening/results. Detection of chronic or past HBV infection requires a risk assessment to determine antiviral prophylaxis requirements, monitoring, and follow-up.

Mechanism of Action

Ivosidenib is an oral small-molecule inhibitor of the mutant isocitrate dehydrogenase 1 (IDH1) enzyme. Susceptible IDH1 mutations can lead to increased levels of 2-hydroxyglutarate (2-HG) in cells. 2-HG inhibits alpha-ketoglutarate-dependent enzymes, resulting in impaired hematopoietic differentiation (DiNardo 2018). In IDH1-mutated AML blood samples, ivosidenib decreased intracellular levels of 2-HG, reduced blast counts, and induced differentiation (resulting in increased percentages of mature myeloid cells). IDH1 mutations occur in ~6% to 10% of patients with acute myeloid leukemia (DiNardo 2018) and up to ~20% of patients with intrahepatic cholangiocarcinoma (Zhu 2021).

Pharmacokinetics (Adult Data Unless Noted)

Onset:

Maximal inhibition of 2-hydroxyglutarate: Acute myeloid leukemia (AML): By day 14 (DiNardo 2018); cholangiocarcinoma: By day 28 (Lowery 2019).

Median time to response: AML: 1.9 months; range: 0.8 to 4.7 months (DiNardo 2018).

Median time to complete remission: AML: 2.8 months; range: 0.9 to 8.3 months (DiNardo 2018).

Duration:

Median duration of response: AML: 6.5 months (DiNardo 2018).

Median duration of complete remission: AML: 9.3 months (DiNardo 2018).

Absorption: Rapid (DiNardo 2018, Lowery 2019).

Distribution: V_dss: 403 L (relapsed or refractory AML); 504 L (newly diagnosed AML in combination with azacitidine); 706 L (cholangiocarcinoma); 552 L (relapsed or refractory myelodysplastic syndromes [MDS]).

Protein binding: 92% to 96%.

Metabolism: Hepatic; primarily metabolized via CYP3A4 with minor contributions via the N-dealkylation and hydrolytic pathways.

Bioavailability: A high-fat meal (~900 to 1,000 calories, 500 to 600 fat calories, 250 carbohydrate calories and 150 protein calories) increased ivosidenib C_max 1.98-fold and AUC 1.24-fold.

Half-life elimination: 58 hours (relapsed or refractory AML); 98 hours (newly diagnosed AML in combination with azacitidine); 129 hours (cholangiocarcinoma); 96 hours (relapsed or refractory MDS).

Time to peak: 3 hours (relapsed or refractory AML and relapsed or refractory MDS); 2 hours (cholangiocarcinoma and newly diagnosed AML in combination with azacitidine).

Excretion: Feces: 77% (67% as unchanged drug); urine: 17% (10% as unchanged drug).

Clearance: 5.6 L/hour (relapsed or refractory AML); 4.6 L/hour (newly diagnosed AML in combination with azacitidine); 6.1 L/hour (cholangiocarcinoma); 5.1 L/hour (relapsed or refractory MDS).

Brand Names: International

International Brand Names by Country

For country code abbreviations (show table)

(AE) United Arab Emirates: Tibsovo;
(AT) Austria: Tibsovo;
(BG) Bulgaria: Tibsovo;
(CZ) Czech Republic: Tibsovo;
(EE) Estonia: Tibsovo;
(FI) Finland: Tibsovo;
(FR) France: Tibsovo;
(GB) United Kingdom: Tibsovo;
(HU) Hungary: Tibsovo;
(IE) Ireland: Tibsovo;
(LT) Lithuania: Tibsovo;
(NL) Netherlands: Tibsovo;
(NO) Norway: Tibsovo;
(PL) Poland: Tibsovo;
(PR) Puerto Rico: Tibsovo;
(RU) Russian Federation: Tibsovo;
(SE) Sweden: Tibsovo;
(SI) Slovenia: Tibsovo;
(TW) Taiwan: Tibsovo

Abou-Alfa GK, Macarulla T, Javle MM, et al. Ivosidenib in IDH1-mutant, chemotherapy-refractory cholangiocarcinoma (ClarIDHy): a multicentre, randomised, double-blind, placebo-controlled, phase 3 study. Lancet Oncol. 2020;21(6):796-807. doi:10.1016/S1470-2045(20)30157-1 [PubMed 32416072]
DiNardo CD, Stein EM, de Botton S, et al. Durable remissions with ivosidenib in IDH1-mutated relapsed or refractory AML. N Engl J Med. 2018;378(25):2386-2398. [PubMed 29860938]
Hodson L, Ovesen J, Couch J, et al; US Centers for Disease Control and Prevention, National Institute for Occupational Safety and Health. Managing hazardous drug exposures: information for healthcare settings, 2023. https://doi.org/10.26616/NIOSHPUB2023130. Updated April 2023. Accessed December 27, 2024.
Hwang JP, Feld JJ, Hammond SP, et al. Hepatitis B virus screening and management for patients with cancer prior to therapy: ASCO provisional clinical opinion update. J Clin Oncol. 2020;38(31):3698-3715. doi:10.1200/JCO.20.01757 [PubMed 32716741]
Lowery MA, Burris HA 3rd, Janku F, et al. Safety and activity of ivosidenib in patients with IDH1-mutant advanced cholangiocarcinoma: a phase 1 study. Lancet Gastroenterol Hepatol. 2019;4(9):711-720. doi:10.1016/S2468-1253(19)30189-X [PubMed 31300360]
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 [PubMed 35443108]
Ovesen JL, Sammons D, Connor TH, et al; US Centers for Disease Control and Prevention, National Institute for Occupational Safety and Health. NIOSH list of hazardous drugs in healthcare settings, 2024. https://doi.org/10.26616/NIOSHPUB2025103. Updated December 18, 2024. Accessed December 20, 2024.
Roboz GJ, DiNardo CD, Stein EM, et al. Ivosidenib induces deep durable remissions in patients with newly diagnosed IDH1-mutant acute myeloid leukemia. Blood. 2020;135(7):463-471. doi:10.1182/blood.2019002140 [PubMed 31841594]
Tibsovo (ivosidenib) [prescribing information]. Boston, MA: Servier Pharmaceuticals; October 2023.
Tibsovo (ivosidenib) [product monograph]. Laval, Quebec, Canada: Servier Canada Inc; July 2024.
United States Pharmacopeia. <800> Hazardous Drugs—Handling in Healthcare Settings. In: USP-NF. United States Pharmacopeia; July 1, 2020. Accessed January 16, 2025. doi:10.31003/USPNF_M7808_07_01
Zhu AX, Macarulla T, Javle MM, et al. Final overall survival efficacy results of ivosidenib for patients with advanced cholangiocarcinoma with IDH1 mutation: the phase 3 randomized clinical ClarIDHy trial. JAMA Oncol. 2021;7(11):1669-1677. doi:10.1001/jamaoncol.2021.3836 [PubMed 34554208]

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Ivosidenib: Drug information