Servier Canada
TIBSOVO®
PrTIBSOVO® (ivosidenib)

Additional clinical considerations

QTc interval prolongation

Patients treated with TIBSOVO® can develop QT (QTc) prolongation and ventricular arrhythmias.

Monitor electrocardiograms and electrolytes.

Patients should be informed of the risk of QT prolongation, its signs and symptoms (palpitations, dizziness, syncope or even cardiac arrest) and be advised to contact their health professional immediately if these occur.

If QTc interval prolongation occurs, dose reduce or interrupt, then resume dose or permanently discontinue TIBSOVO®.

Neutropenia

In the AGILE clinical trial, neutropenia was observed in 19% of patients with AML treated with TIBSOVO® + azacitidine, versus 7% in the placebo + azacitidine group.

Patients are advised to contact their healthcare team if they experience symptoms of infection that may indicate neutropenia, such as fatigue, fever, aches, pains, and flu-like symptoms.

Special considerations

Renal or hepatic impairment

The safety and efficacy of TIBSOVO® have not been established in patients with moderate and severe hepatic impairment (Child Pugh classes B and C) or severe renal impairment (eGFR < 30 mL/min/1.73 m2). TIBSOVO® should be used with caution in these patient populations, and patients should be closely monitored.

Reproductive health

Women of childbearing potential should have a pregnancy test prior to starting treatment with TIBSOVO® and should avoid becoming pregnant during therapy.

Women of childbearing potential and males with female partners of childbearing potential should use effective contraception during treatment with TIBSOVO® and for at least 1 month after the last dose.

TIBSOVO® may decrease the systemic concentrations of hormonal contraceptives and, therefore, concomitant use of an alternative contraceptive method such as barrier contraceptives is recommended.

Consult the TIBSOVO® Product Monograph

2-HG: 2-hydroxyglutarate; α-KG: alpha-ketoglutarate; AML: acute myeloid leukemia; AZA: azacitidine; PBO: placebo; CCA: cholangiocarcinoma; CI: confidence interval; CR: complete response; CRh: complete response with partial hematologic recovery; CTCAE: Common Terminology Criteria for Adverse Events; DLCO: diffusing capacity for carbon monoxide; ECG: electrocardiogram; ECOG PS: Eastern Cooperative Oncology Group Performance Status; EFS: event-free survival; eGFR: estimated glomerular filtration rate; FEV1: forced expiratory volume in 1 second; HR: hazard ratio; IDH1: isocitrate dehydrogenase-1; IRC: Independent Radiology Centre; IV: intravenous; mIDH1: mutated isocitrate dehydrogenase-1; MOA: mechanism of action; NCCN: National Comprehensive Cancer Network; OR: odds ratio; OS: overall survival; PBO: placebo; PCR: polymerase chain reaction; PD: pharmacodynamics; PK: pharmacokinetics; QD: daily; RECIST: Response Evaluation Criteria In Solid Tumors; SC: subcutaneous.

References:

  1. TIBSOVO® Product Monograph. Servier Canada. July 19, 2024.
  2. Montesinos P, et al. N Engl J Med. 2022 Apr 21;386(16):1519–1531.
  3. National Comprehensive Cancer Network. NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) Acute Myeloid Leukemia Version 2.2025 — January 27, 2025.
  4. National Comprehensive Cancer Network. NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) Biliary Duct Cancers Version 6.2024 — January 10, 2025.
  5. Abou-Alfa GK, et al. Lancet Oncol. 2020 Jun;21(6):796-807.
  6. Zhu AX, et al. JAMA Oncol. 2021 Nov 1;7(11):1669-1677.
  7. Dammacco F, Silvestris F, eds. Oncogenomics: From Basic Research to Precision Medicine. Academic Press; 2019.
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