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Drug overview for TIBSOVO (ivosidenib):
Generic name: ivosidenib (EYE-voe-SID-e-nib)
Drug class: Antineoplastic - Isocitrate Dehydrogenase-1 Inhibitor (IDH1)
Therapeutic class: Antineoplastics
Ivosidenib, a potent and selective inhibitor of isocitrate dehydrogenase-1 (IDH1), is an antineoplastic agent.
No enhanced Uses information available for this drug.
Generic name: ivosidenib (EYE-voe-SID-e-nib)
Drug class: Antineoplastic - Isocitrate Dehydrogenase-1 Inhibitor (IDH1)
Therapeutic class: Antineoplastics
Ivosidenib, a potent and selective inhibitor of isocitrate dehydrogenase-1 (IDH1), is an antineoplastic agent.
No enhanced Uses information available for this drug.
DRUG IMAGES
TIBSOVO 250 MG TABLET
The following indications for TIBSOVO (ivosidenib) have been approved by the FDA:
Indications:
Acute myeloid leukemia with isocitrate dehydrogenase-1 (IDH1) mutation
Cholangiocarcinoma with isocitrate dehydrogenase-1 (IDH1) mutation
Myelodysplastic syndrome with isocitrate dehydrogenase-1 (IDH1) mutation
Professional Synonyms:
IDH1 mutated CCA
IDH1 mutation-positive acute myeloid leukemia
IDH1 mutation-positive cholangiocarcinoma
Indications:
Acute myeloid leukemia with isocitrate dehydrogenase-1 (IDH1) mutation
Cholangiocarcinoma with isocitrate dehydrogenase-1 (IDH1) mutation
Myelodysplastic syndrome with isocitrate dehydrogenase-1 (IDH1) mutation
Professional Synonyms:
IDH1 mutated CCA
IDH1 mutation-positive acute myeloid leukemia
IDH1 mutation-positive cholangiocarcinoma
The following dosing information is available for TIBSOVO (ivosidenib):
No enhanced Dosing information available for this drug.
Ivosidenib is administered orally at approximately the same time each day without regard to meals; however, administration with a high-fat meal should be avoided because of increased systemic exposure of the drug. The tablets should be swallowed whole; they should not be chewed, crushed, or split. If a dose of ivosidenib is vomited, do not administer a replacement dose; wait until the next scheduled dose is due.
If a dose of ivosidenib is missed or not taken at the usual time, administer the dose as soon as possible and at least 12 hours prior to the next scheduled dose. Return to the normal schedule the following day. Do not administer 2 doses within 12 hours. Store ivosidenib tablets at 20-25degreesC (excursions permitted between 15-30degreesC).
If a dose of ivosidenib is missed or not taken at the usual time, administer the dose as soon as possible and at least 12 hours prior to the next scheduled dose. Return to the normal schedule the following day. Do not administer 2 doses within 12 hours. Store ivosidenib tablets at 20-25degreesC (excursions permitted between 15-30degreesC).
| DRUG LABEL | DOSING TYPE | DOSING INSTRUCTIONS |
|---|---|---|
| TIBSOVO 250 MG TABLET | Maintenance | Adults take 2 tablets (500 mg) by oral route once daily |
No generic dosing information available.
The following drug interaction information is available for TIBSOVO (ivosidenib):
There are 0 contraindications.
There are 0 severe interactions.
There are 0 moderate interactions.
The following contraindication information is available for TIBSOVO (ivosidenib):
Drug contraindication overview.
*None.
*None.
There are 2 contraindications.
Absolute contraindication.
| Contraindication List |
|---|
| Lactation |
| Torsades de pointes |
There are 6 severe contraindications.
Adequate patient monitoring is recommended for safer drug use.
| Severe List |
|---|
| Congenital long QT syndrome |
| Guillain-barre syndrome |
| Hypocalcemia |
| Hypokalemia |
| Hypomagnesemia |
| Pregnancy |
There are 1 moderate contraindications.
Clinically significant contraindication, where the condition can be managed or treated before the drug may be given safely.
| Moderate List |
|---|
| Chronic heart failure |
The following adverse reaction information is available for TIBSOVO (ivosidenib):
Adverse reaction overview.
The most common adverse reactions including laboratory abnormalities (>=25%) with ivosidenib in patients with AML are decreased leukocytes, diarrhea, decreased hemoglobin, decreased platelets, increased glucose, fatigue, increased alkaline phosphatase, edema, decreased potassium, nausea, vomiting, decreased phosphate, decreased appetite, decreased sodium, leukocytosis, decreased magnesium, increased aspartate aminotransferase, arthralgia, dyspnea, increased uric acid, abdominal pain, increased creatinine, mucositis, rash, QT prolongation, differentiation syndrome, decreased calcium, decreased neutrophils, and myalgia. The most common adverse reactions including laboratory abnormalities (>=25%) with ivosidenib in patients with relapsed or refractory MDS are increased creatinine, decreased hemoglobin, arthralgia, decreased albumin, increased aspartate aminotransferase, fatigue, diarrhea, cough, decreased sodium, mucositis, decreased appetite, myalgia, decreased phosphate, pruritus, and rash. The most common adverse reactions (>=15%) in patients with cholangiocarcinoma are fatigue, nausea, abdominal pain, diarrhea, cough, decreased appetite, ascites, vomiting, anemia, and rash. The most common laboratory abnormalities (>=10%) in patients with cholangiocarcinoma are decreased hemoglobin, increased aspartate aminotransferase, and increased bilirubin.
The most common adverse reactions including laboratory abnormalities (>=25%) with ivosidenib in patients with AML are decreased leukocytes, diarrhea, decreased hemoglobin, decreased platelets, increased glucose, fatigue, increased alkaline phosphatase, edema, decreased potassium, nausea, vomiting, decreased phosphate, decreased appetite, decreased sodium, leukocytosis, decreased magnesium, increased aspartate aminotransferase, arthralgia, dyspnea, increased uric acid, abdominal pain, increased creatinine, mucositis, rash, QT prolongation, differentiation syndrome, decreased calcium, decreased neutrophils, and myalgia. The most common adverse reactions including laboratory abnormalities (>=25%) with ivosidenib in patients with relapsed or refractory MDS are increased creatinine, decreased hemoglobin, arthralgia, decreased albumin, increased aspartate aminotransferase, fatigue, diarrhea, cough, decreased sodium, mucositis, decreased appetite, myalgia, decreased phosphate, pruritus, and rash. The most common adverse reactions (>=15%) in patients with cholangiocarcinoma are fatigue, nausea, abdominal pain, diarrhea, cough, decreased appetite, ascites, vomiting, anemia, and rash. The most common laboratory abnormalities (>=10%) in patients with cholangiocarcinoma are decreased hemoglobin, increased aspartate aminotransferase, and increased bilirubin.
There are 21 severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
|
Abnormal hepatic function tests Anemia Differentiation syndrome Hypocalcemia Hypokalemia Hypomagnesemia Hyponatremia Hypotension Increased aspartate transaminase Leukocytosis Leukopenia Neutropenic disorder Orthostatic hypotension Pleural effusions Prolonged QT interval Thrombocytopenic disorder |
Hyperbilirubinemia Peripheral motor neuropathy |
| Rare/Very Rare |
|---|
|
Guillain-barre syndrome Tumor lysis syndrome Ventricular arrhythmias |
There are 25 less severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
|
Acute abdominal pain Anorexia Arthralgia Chest pain Constipation Cough Diarrhea Dyspnea Edema Fatigue Fever Headache disorder Hyperglycemia Hypophosphatemia Increased alkaline phosphatase Myalgia Nausea Pruritus of skin Skin rash Stomatitis Vomiting |
Dizziness Dyspepsia Paresthesia Peripheral sensory neuropathy |
| Rare/Very Rare |
|---|
| None. |
The following precautions are available for TIBSOVO (ivosidenib):
Safety and efficacy of ivosidenib have not been established in pediatric patients.
Contraindicated
Severe Precaution
Management or Monitoring Precaution
Contraindicated
| None |
Severe Precaution
| None |
Management or Monitoring Precaution
| None |
Ivosidenib may cause fetal harm in humans based on animal findings. There are no available data regarding use of ivosidenib in pregnant women to inform a drug-associated risk of adverse developmental outcomes. In animal reproduction studies, embryofetal toxicity (e.g., decreased fetal weight, abortion) and teratogenicity (e.g., skeletal and visceral anomalies) were observed in rats and rabbits receiving ivosidenib at exposures levels approximately 2 times the human exposure at the recommended dosage. Patients should be apprised of the potential hazard to the fetus if ivosidenib is used during pregnancy.
It is not known whether ivosidenib or its metabolites are distributed into human milk. Because of the potential for serious adverse reactions to ivosidenib in nursing infants, women should be advised to discontinue nursing during ivosidenib therapy and for at least 1 month after the last dose. The effects of the drug on nursing infants or on the production of milk are unknown.
In clinicalstudies of ivosidenibin the treatment ofAML and MDS, 75% of ivosidenib-treated patients were >=65 years of age and 35% were >=75 years of age. In the study of ivosidenib for the treatment of cholangiocarcinoma, 37% of patients were>=65 years of age and 11% were>=75 years of age. No overall differences in effectiveness or safety were observed between patients>=65 years of age and younger patients.
The following prioritized warning is available for TIBSOVO (ivosidenib):
WARNING: Ivosidenib has rarely caused a serious (possibly fatal) condition called differentiation syndrome in patients with acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS). Get medical help right away if you develop any signs of differentiation syndrome, such as fever, cough, shortness of breath, chest pain, rapid weight gain, or swelling of arms/legs.
WARNING: Ivosidenib has rarely caused a serious (possibly fatal) condition called differentiation syndrome in patients with acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS). Get medical help right away if you develop any signs of differentiation syndrome, such as fever, cough, shortness of breath, chest pain, rapid weight gain, or swelling of arms/legs.
The following icd codes are available for TIBSOVO (ivosidenib)'s list of indications:
| Acute myeloid leukemia with IDh1 mutation | |
| C92.0 | Acute myeloblastic leukemia |
| C92.00 | Acute myeloblastic leukemia, not having achieved remission |
| C92.02 | Acute myeloblastic leukemia, in relapse |
| Cholangiocarcinoma with IDh1 mutation | |
| C22.1 | Intrahepatic bile duct carcinoma |
| C24.0 | Malignant neoplasm of extrahepatic bile duct |
| MDS with isocitrate dehydrogenase-1 (IDh1) mutation | |
| D46.9 | Myelodysplastic syndrome, unspecified |
| D46.Z | Other myelodysplastic syndromes |
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