1. Indications and Usage
\nRelapsed or Refractory Acute Myeloid Leukemia (AML):
\nIndicated for adult patients with relapsed or refractory AML with a susceptible IDH1 mutation, as detected by an FDA-approved test.
\nNewly Diagnosed Acute Myeloid Leukemia (AML):
\nIndicated for adult patients with newly diagnosed AML with a susceptible IDH1 mutation who are \u226575 years old or who have comorbidities that preclude intensive induction chemotherapy.
\nCholangiocarcinoma:
\nIndicated for adult patients with locally advanced or metastatic cholangiocarcinoma with an IDH1mutation, as detected by an FDA-approved test, who have previously received systemic chemotherapy.
\n2. Dosage and Administration
\nRoute of Administration:
\nFor Oral Use ONLY.
\nRecommended Dosage:
\nDose: 500 mg (two 250 mg tablets) once daily.
\nTreatment Duration: Continue until disease progression or unacceptable toxicity. For AML\/MDS, continue for at least 6 months to assess response.
\nAdministration Instructions:
\nSwallow tablets whole with water; do not crush, chew, or split.
\nAdminister with or without food, but avoid high-fat meals.
\nMissed Dose: If a dose is missed, take it as soon as possible on the same day. Do not take the missed dose if it is the day of the next scheduled dose. Do not double the dose.
\nVomiting: If the patient vomits after taking a dose, do not administer a replacement dose; wait until the next scheduled dose.
\n3. Mechanism of Action
\nIDH1 Inhibition:
\nIvosidenib is a potent, orally bioavailable, small-molecule inhibitor of mutant IDH1.
\nReduction of 2-HG:
\nMutant IDH1 proteins gain a neomorphic function that produces the oncometabolite D-2-hydroxyglutarate (2-HG). Ivosidenib binds to mutant IDH1, inhibiting the production of 2-HG.
\nInduction of Differentiation:
\nReduction of 2-HG levels leads to the reversal of epigenetic dysregulation, promoting the differentiation of leukemic blasts into mature myeloid cells, thereby inducing apoptosis and reducing tumor burden.
\n4. Safety and Warnings
\nDifferentiation Syndrome:
\nA potentially life-threatening complication caused by the rapid differentiation of leukemic cells. Symptoms include fever, dyspnea, weight gain, pulmonary infiltrates, and hypotension. Monitor closely and administer corticosteroids promptly if suspected.
\nQTc Interval Prolongation:
\nCan cause QTc interval prolongation, which may lead to Torsades de Pointes. Obtain electrocardiograms (ECGs) and monitor electrolytes prior to initiation and regularly during treatment.
\nEmbryo-Fetal Toxicity:
\nCan cause fetal harm. Females of reproductive potential must use effective contraception during treatment and for at least 3 months after the final dose.
\n5. Adverse Reactions
\nAML (Most Common):
\nDifferentiation syndrome, fatigue, arthralgia, diarrhea, edema, nausea, dyspnea, prolonged QT interval, pyrexia, and rash.
\nCholangiocarcinoma (Most Common):
\nFatigue, nausea, diarrhea, abdominal pain, decreased appetite, cough, dyspnea, and rash.
\n6. Drug Interactions
\nCYP3A4 Inducers:
\nIvosidenib is a CYP3A4 inducer. Concomitant use with sensitive CYP3A4 substrates (e.g., certain anticoagulants) may decrease their exposure and efficacy.
\nStrong CYP3A4 Inhibitors:
\nConcomitant use with strong CYP3A4 inhibitors (e.g., ketoconazole, clarithromycin) may significantly increase ivosidenib exposure. Dose reduction of ivosidenib may be required.
\n7. Pharmaceutical Information
\nChemical Composition:
\nActive Ingredient: Ivosidenib.
\nAvailable Strength: 250 mg tablets.
\nAppearance: White to off-white, oval-shaped, film-coated tablets.
\nStorage: Store at room temperature (20\u00b0C\u201325\u00b0C \/ 68\u00b0F\u201377\u00b0F). Protect from moisture.<\/p>\n","protected":false},"excerpt":{"rendered":"
Brand Name: \u62d3\u8212\u6c83 \u00ae\uff08Tibsovo\u00ae\uff09
\nGeneric Name: Ivosidenib
\nStrength: 0.25 g (250 mg) per tablet, 60 tablets per box
\nManufacturer: Patheon Inc.
\nMarketing Authorization Holder: Servier Pharmaceuticals LLC (USA); domestic filing entities: CStone Pharmaceuticals (Suzhou) Co., Ltd. \/ Servier (Tianjin) Pharmaceutical Co., Ltd.
\nApproval Date in China: January 30, 2022
\nRegistration Number: \u56fd\u836f\u51c6\u5b57 HJ20220002
\nStorage: Store at 20\u00b0C\u201325\u00b0C (68\u00b0F\u201377\u00b0F) in the original package, protected from light and moisture. Brief exposure to 15\u00b0C\u201330\u00b0C (59\u00b0F\u201386\u00b0F) is permitted. Do not store in the bathroom. Keep out of reach of children.<\/p>\n
Price&Cost:Contact Us now for the best price of Ivosidenib \uff08Tibsovo\uff09<\/p>\n","protected":false},"featured_media":3925,"comment_status":"open","ping_status":"closed","template":"","meta":[],"product_brand":[],"product_cat":[27],"product_tag":[],"class_list":["post-3924","product","type-product","status-publish","has-post-thumbnail","product_cat-tablets","first","instock","shipping-taxable","product-type-simple"],"yoast_head":"\n