Big Bear AIVODX Ivosidenib 250mg

Product Information

• Product name: AIVODX Ivosidenib 250mg
• Manufacturer / brand: Laos BigBear Pharma
• Active ingredient: Ivosidenib
• Current strength: 250mg
• SKU: BB-ITEM-25
• Site category: cholangiocarcinoma, IDH1 target, other cancer

Product Summary

AIVODX Ivosidenib 250mg is an AISTIKA-listed product supplied by Laos BigBear Pharma. This page summarizes the product identity, strength, SKU, site category, and public medical reference information. Product name, manufacturer, packaging, and strength follow this AISTIKA product page.

Active Ingredient and Reference Data

Ivosidenib is the active ingredient used for this product page. Public prescribing information for Ivosidenib was used for the medical reference sections. Medical details are provided for reference and must be interpreted by a qualified healthcare professional.

Mechanism of Action

Ivosidenib is a small molecule inhibitor that targets the mutant isocitrate dehydrogenase 1 (IDH1) enzyme. The most common of such mutations in patients with AML are R132H and R132C substitutions. Ivosidenib was shown to inhibit selected IDH1 R132 mutants at much lower concentrations than wild-type IDH1 in vitro. Inhibition of the mutant IDH1 enzyme by ivosidenib led to decreased 2-HG levels and induced myeloid differentiation in vitro and in vivo in mouse xenograft models of IDH1-mutated AML.

Reference Indications

Ivosidenib is an isocitrate dehydrogenase-1 (IDH1) inhibitor indicated for patients with a susceptible IDH1 mutation as detected by an FDA-approved test with: Newly Diagnosed Acute Myeloid Leukemia (AML) In combination with azacitidine or as monotherapy for the treatment of newly diagnosed AML in adults 75 years or older, or who have comorbidities that preclude use of intensive induction chemotherapy . Relapsed or refractory AML For the treatment of adult patients with relapsed or refractory AML . Relapsed or refractory Myelodysplastic Syndromes (MDS) For the treatment of adult patients with relapsed or refractory myelodysplastic syndromes . Locally Advanced or Metastatic Cholangiocarcinoma For the treatment of adult patients with locally advanced or metastatic cholangiocarcinoma who have been previously treated .

Reference Dosage and Administration

Recommended dosage of Ivosidenib is 500 mg taken orally once daily until disease progression or unacceptable toxicity . with or without food until disease progression or unacceptable toxicity .

With this 250mg product, that corresponds to 2 x 250mg tablets when that reference dose is clinically appropriate.

This reference dosage is not an individualized prescription. Dose changes, treatment interruptions, or discontinuation must be directed by a physician.

Important Safety Information

WARNING: DIFFERENTIATION SYNDROME IN AML AND MDS Patients treated with Ivosidenib have experienced symptoms of differentiation syndrome, which can be fatal. Symptoms may include fever, dyspnea, hypoxia, pulmonary infiltrates, pleural or pericardial effusions, rapid weight gain or peripheral edema, hypotension, and hepatic, renal, or multi-organ dysfunction. If differentiation syndrome is suspected, initiate corticosteroid therapy and hemodynamic monitoring until symptom resolution . WARNING: DIFFERENTIATION SYNDROME IN AML AND MDS See for complete boxed warning. Patients treated with Ivosidenib have experienced symptoms of differentiation syndrome, which can be fatal. If differentiation syndrome is suspected, initiate corticosteroid therapy and hemodynamic monitoring until symptom resolution ( 5.1 , 6.1 ).

Common Adverse Reactions and Monitoring

The most common laboratory abnormalities (≥10%) in patients with cholangiocarcinoma are hemoglobin decreased, aspartate aminotransferase increased, and bilirubin increased . Acute Myeloid Leukemia In AML, the safety population reflects exposure to Ivosidenib at 500 mg daily in combination with azacitidine or as monotherapy in patients in Studies AG120-C-009 (N=71) and AG120-C-001 (N=213), respectively . Newly Diagnosed AML Ivosidenib in Combination with Azacitidine The safety of Ivosidenib was evaluated in AML patients treated in combination with azacitidine, in Study AG120-C-009 . Patients received at least one dose of either Ivosidenib 500 mg daily (N=71) or placebo (N=73).

Drug Interactions and Special Populations

Strong or Moderate CYP3A4 Inhibitors: Reduce Ivosidenib dose with strong CYP3A4 inhibitors. Monitor patients for increased risk of QTc interval prolongation ( 2.4 , 5.2 , 7.1 , 12.3 ). Strong CYP3A4 Inducers: Avoid concomitant use with Ivosidenib ( 7.1 , 12.3 ). Sensitive CYP3A4 substrates: Avoid concomitant use with Ivosidenib ( 7.2 , 12.3 ). QTc Prolonging Drugs: Avoid concomitant use with Ivosidenib. If co-administration is unavoidable, monitor patients for increased risk of QTc interval prolongation ( 5.2 , 7.1 ). Increased ivosidenib plasma concentrations may increase the risk of QTc interval prolongation . Prevention or Management Consider alternative therapies that are not strong or moderate CYP3A4 inhibitors during treatment with Ivosidenib.

Storage and Purchase Notes

Store according to the package or pharmacist instructions and keep out of reach of children. Before ordering, confirm product name, strength, quantity, price, shipping details, and payment method. After receipt, check packaging, batch number, expiration date, and storage conditions.

Sources

Sources: TIBSOVO public prescribing information; openFDA/DailyMed public label data. These sources are used for public medical reference. Product information follows this AISTIKA product page.

DisclaimerThis page is for product information and public-label reference only. It does not provide diagnosis, prescription, or individualized medical advice. Consult a physician for treatment decisions.