Vientiane, Laos - January 3, 2024 - BigBearPharma, a leading biopharmaceutical company focused on developing and commercializing innovative cancer therapies, announced that Ivosidenib has been approved by the Lao Ministry of Health. It is sold under the brand name TEGLIDX.
Indications
1. Newly Diagnosed Acute Myeloid Leukemia
Ivosidenib is indicated in combination with azacitidine or as monotherapy for the treatment of newly diagnosed acute myeloid leukemia (AML) with a susceptible isocitrate dehydrogenase-1 (IDH1) mutation as detected by an FDA-approved test, in adults aged 75 years or older, or with comorbidities that preclude the use of intensive induction chemotherapy.
2. Relapsed or Refractory Acute Myeloid Leukemia
Ivosidenib is indicated for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) with a susceptible isocitrate dehydrogenase-1 (IDH1) mutation as detected by an FDA-approved test.
3. Relapsed or Refractory Myelodysplastic Syndrome
Ivosidenib is indicated for the treatment of adult patients with relapsed or refractory myelodysplastic syndrome (MDS) with a susceptible isocitrate dehydrogenase-1 (IDH1) mutation as detected by an FDA-approved test.
4. Locally Advanced or Metastatic Cholangiocarcinoma
Ivosidenib is indicated for the treatment of adult patients with previously treated, locally advanced or metastatic cholangiocarcinoma with an isocitrate dehydrogenase-1 (IDH1) mutation as detected by an FDA-approved test.
Dosage and Administration
1. Recommended Dosage
500 mg orally once daily with or without food, avoid high-fat meals.
2. Dosage Adjustment
Concomitant use with strong CYP3A4 inhibitors: reduce dose to 250 mg daily.
Common Adverse Reactions
1. Patients with AML
Leukopenia, diarrhea, decreased hemoglobin, thrombocytopenia, 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, prolonged QT interval on ECG, differentiation syndrome, decreased calcium, neutropenia, myalgia.
2. Patients with Relapsed or Refractory MDS
Increased creatinine, decreased hemoglobin, arthralgia, decreased albumin, increased aspartate aminotransferase, fatigue, diarrhea, cough, decreased sodium, mucositis, decreased appetite, myalgia, decreased phosphate, pruritus, and rash.
3. Patients with Cholangiocarcinoma
Fatigue, nausea, abdominal pain, diarrhea, cough, decreased appetite, ascites, vomiting, anemia, and rash. Common laboratory abnormalities are decreased hemoglobin, increased aspartate aminotransferase, and increased bilirubin.
Warnings and Precautions for Ivosidenib
The following are important precautions when using Ivosidenib:
1. Differentiation Syndrome in AML and MDS
Differentiation syndrome is associated with rapid proliferation and differentiation of bone marrow cells and may be life-threatening or fatal.
Symptoms of differentiation syndrome in patients treated with Ivosidenib include non-infectious leukocytosis, peripheral edema, fever, dyspnea, pleural effusion, hypotension, hypoxia, pulmonary edema, pneumonia, pericardial effusion, rash, fluid overload, tumor lysis syndrome, and increased creatinine.
2. QTc Interval Prolongation
Monitor ECG and electrolytes. If QTc interval prolongation occurs, reduce dose or interrupt, then resume dose or permanently discontinue Ivosidenib.
3. Guillain-Barré Syndrome
Monitor patients for new signs and symptoms of motor and/or sensory findings. Permanently discontinue Ivosidenib in patients diagnosed with Guillain-Barré syndrome.
