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Recommended dose

TIBSOVO (ivosidenib tablets) offers convenient, once-daily oral dosing1

Ivosidenib Tablets

500 mg

(2 x 250-mg film-coated tablets) Tablets not shown at actual size.

Treatment with TIBSOVO has not been studied in patients with pre-existing severe renal or hepatic impairment. For patients with pre-existing severe renal or hepatic impairment, consider the risks and potential benefits before initiating treatment with TIBSOVO.

TIBSOVO should be taken at about the same time each day.

If a dose is missed or not taken at the usual time, patients should take the missed dose as soon as possible and at least 12 hours prior to the next scheduled dose. They should return to the normal schedule the following day. They should not take 2 doses within 12 hours. If a dose is vomited, patients should not take a replacement dose; they should wait until the next scheduled dose is due.

TIBSOVO tablets should not be split, crushed, or chewed.

TIBSOVO can be taken with or without food but should not be taken with a high-fat meal because of an increase in ivosidenib concentration.a

aAn example of a high-fat meal includes 2 eggs fried in butter, 2 strips of bacon, 2 slices of white bread with butter, 1 croissant with 1 slice of cheese, and 8 ounces of whole milk (approximately 1000 calories and 58 grams of fat).1

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Managing adverse reactions

Monitoring and dose modifications for toxicities1

  • Obtain an electrocardiogram (ECG) prior to treatment initiation
  • Monitor ECGs at least once weekly for the first 3 weeks of therapy and then at least once monthly for the duration of therapy
  • Manage any abnormalities promptly

QTc prolongation

QTc interval >480 to 500 msec
  • Monitor and supplement electrolyte levels as clinically indicated
  • Review and adjust concomitant medications with known QTc interval–prolonging effects
  • Interrupt TIBSOVO
  • Restart TIBSOVO at 500 mg once daily after the QTc interval returns to ≤480 msec
  • Monitor ECGs at least weekly for 2 weeks following resolution of QTc prolongation
QTc interval >500 msec
  • Monitor and supplement electrolyte levels as clinically indicated
  • Review and adjust concomitant medications with known QTc interval–prolonging effects
  • Interrupt TIBSOVO
  • Resume TIBSOVO at a reduced dose of 250 mg once daily when QTc interval returns to within 30 msec of baseline or ≤480 msec
  • Monitor ECGs at least weekly for 2 weeks following resolution of QTc prolongation
  • Consider re-escalating the dose of TIBSOVO to 500 mg daily if an alternative etiology for QTc prolongation can be identified
QTc interval prolongation with signs/symptoms of life-threatening arrhythmia
  • Discontinue TIBSOVO permanently

Guillain-Barré syndrome

  • Discontinue TIBSOVO permanently

Other Grade 3b adverse reactions

  • Interrupt TIBSOVO until toxicity resolves to Grade 1b or lower, or baseline, then resume at 500 mg daily (Grade 3 toxicity) or 250 mg daily (Grade 4 toxicity)
  • If Grade 3 toxicity recurs (a second time), reduce TIBSOVO dose to 250 mg daily until the toxicity resolves, then resume 500 mg daily
  • If Grade 3 toxicity recurs (a third time), or Grade 4 toxicity recurs, discontinue TIBSOVO

bGrade 1 is mild, Grade 2 is moderate, Grade 3 is severe, Grade 4 is life-threatening.

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Drug-Drug interactions

Drug-drug interactions with TIBSOVO1

Strong or moderate CYP3A4 inhibitors
  • Coadministration of them increased ivosidenib plasma concentrations, which may increase the risk of QTc interval prolongation
  • Consider alternative therapies that are not strong or moderate CYP3A4 inhibitors
  • If coadministration is unavoidable, reduce TIBSOVO to 250 mg once daily. If the strong inhibitor is discontinued, increase the TIBSOVO dose (after at least 5 half-lives of the strong CYP3A4 inhibitor) to the recommended dose of 500 mg once daily
  • Monitor patients for increased risk of QTc interval prolongation
Strong CYP3A4 inducers
  • Coadministration of them decreased ivosidenib plasma concentrations
  • Avoid coadministration
QTc interval–prolonging drugs
  • Coadministration of them may increase the risk of QTc interval prolongation
  • Avoid coadministration with TIBSOVO or replace with alternative therapies
  • If coadministration is unavoidable, monitor patients for increased risk of QTc interval prolongation
Effect of TIBSOVO on other drugs
  • Ivosidenib induces CYP3A4 and may induce CYP2C9
  • Coadministration will decrease concentrations of drugs that are sensitive CYP3A4 substrates and may decrease the concentrations of drugs that are sensitive CYP2C9 substrates
  • Use alternative therapies that are not sensitive substrates of CYP3A4 and CYP2C9
  • Do not administer with itraconazole or ketoconazole (CYP3A4 substrates) due to expected loss of antifungal efficacy
  • Coadministration may decrease the concentrations of hormonal contraceptives. Consider alternative methods of contraception
  • If coadministration with sensitive CYP3A4 substrates or CYP2C9 substrates is unavoidable, monitor patients for loss of therapeutic effect of these drugs
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Learn about IDH1 mutations ›

Reference: 1. Tibsovo. Package insert. Servier Pharmaceuticals LLC; 2023.

 

TIBSOVO® (ivosidenib tablets) was studied in a phase 3, randomized, double-blind, placebo-controlled, multicenter trial—one of the largest clinical trials to date of a targeted therapy in cholangiocarcinoma1-3

cca-efficacy-modal cca-efficacy-modal

CCA, cholangiocarcinoma; ECOG PS, Eastern Cooperative Oncology Group Performance Status; IDH1, isocitrate dehydrogenase-1; mIDH1, mutated IDH1; NGS, next-generation sequencing; QD, once a day; RECIST, Response Evaluation Criteria in Solid Tumors.

References: 1. Tibsovo. Package insert. Servier Pharmaceuticals LLC; 2022. 2. Data on file. Servier Pharmaceuticals LLC. 3. Zhu AX, Macarulla T, Javle MM, et al. Final results from the ClarIDHy Phase III study of ivosidenib versus placebo in patients with previously treated cholangiocarcinoma and an isocitrate dehydrogenase 1 (IDH1) mutation. EMJ Oncol. 2021;9(suppl 2):2-5. doi:10.1200/JCO.2021.39.3_suppl.266

TIBSOVO® was studied in a patient population reflective of that seen in a clinical practice1,2

Selected baseline demographics and disease characteristics (N=185)1

  TIBSOVO
(n=124)		 Placebo
(n=61)
Demographics
Median age, years (min, max) 61 (33,80) 63 (40,83)
Sex
Male 36% 40%
Female 65% 61%
Race
White 57% 57%
Asian 12% 13%
Black 0.8% 1.6%
Native Hawaiian/Other Pacific Islander 0.8% 0%
American Indian or Alaska Native 0.8% 0
Disease characteristics
Prior lines of therapy
1 prior line of therapy 53% 54%
2 prior lines of therapy 47% 46%
ECOG PS
0 40% 31%
1 60% 67%
IDH1 mutation
R132C 68% 74%
R132L 17% 12%
R132G 14% 10%
R132H 0% 3.3%
R132S 1.6% 1.6%
Cholangiocarcinoma type at initial diagnosis
Intrahepatic 90% 95%
Metastatic disease 93% 92%

ECOG PS: Eastern Cooperative Oncology Group Performance Status.

References: 1.  Tibsovo. Package insert. Servier Pharmaceuticals LLC; 2023. 2. Data on file. Servier Pharmaceuticals LLC.

 

Indication

TIBSOVO is indicated for patients with a susceptible isocitrate dehydrogenase-1 (IDH1) mutation as detected by an FDA-approved test for the treatment of adult patients with locally advanced or metastatic cholangiocarcinoma who have been previously treated.

IMPORTANT SAFETY INFORMATION

WARNINGS AND PRECAUTIONS

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 (eg, 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, or electrolyte abnormalities, or in 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

  • In patients with cholangiocarcinoma, the most common adverse reactions (≥15%) were fatigue, nausea, abdominal pain, diarrhea, cough, decreased appetite, ascites, vomiting, anemia, and rash. The most common laboratory abnormalities (≥10%) were hemoglobin decreased, aspartate aminotransferase increased, and bilirubin increased.

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.

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Indication & Important Safety Information

INDICATION

TIBSOVO is indicated for patients with a susceptible isocitrate dehydrogenase-1 (IDH1) mutation as detected by an FDA-approved test for the treatment of adult patients with locally advanced or metastatic cholangiocarcinoma who have been previously treated.

IMPORTANT SAFETY INFORMATION

WARNINGS AND PRECAUTIONS

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 (eg, 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, or electrolyte abnormalities, or in 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.