TLPH Ensidnib Enasidenib 100mg

Product Information

• Product name: Ensidnib ENASIDENIB 100MG
• Manufacturer / brand: Laos TLPH Pharma
• Active ingredient: Enasidenib
• Current strength: 100MG
• SKU: AM-ITEM-30
• Site category: general medicines, IDH2 target

Product Summary

Ensidnib ENASIDENIB 100MG is an AISTIKA-listed product supplied by Laos TLPH 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

Enasidenib is the active ingredient used for this product page. Public prescribing information for Enasidenib 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

Enasidenib is a small molecule inhibitor of the isocitrate dehydrogenase 2 (IDH2) enzyme. Enasidenib targets the mutant IDH2 variants R140Q, R172S, and R172K at approximately 40-fold lower concentrations than the wild-type enzyme in vitro. Inhibition of the mutant IDH2 enzyme by enasidenib led to decreased 2-hydroxyglutarate (2-HG) levels and induced myeloid differentiation in vitro and in vivo in mouse xenograft models of IDH2 mutated AML.

Reference Indications

Enasidenib is an isocitrate dehydrogenase-2 inhibitor indicated for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) with an isocitrate dehydrogenase-2 (IDH2) mutation as detected by an FDA-approved test .

Reference Dosage and Administration

Recommended dosage of Enasidenib is 100 mg taken orally once daily with or without food until disease progression or unacceptable toxicity.

With this 100MG product, that corresponds to 1 x 100MG tablet 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 Patients treated with Enasidenib have experienced symptoms of differentiation syndrome, which can be fatal if not treated. Symptoms may include fever, dyspnea, acute respiratory distress, pulmonary infiltrates, pleural or pericardial effusions, rapid weight gain or peripheral edema, lymphadenopathy, bone pain, and hepatic, renal, or multi-organ dysfunction. If differentiation syndrome is suspected, initiate corticosteroid therapy and hemodynamic monitoring until symptom resolution . WARNING: DIFFERENTIATION SYNDROME See for complete boxed warning. Patients treated with Enasidenib have experienced symptoms of differentiation syndrome, which can be fatal if not treated.

Common Adverse Reactions and Monitoring

The safety evaluation of single-agent Enasidenib is based on 214 patients with relapsed or refractory AML who were assigned to receive 100 mg daily . The median duration of exposure to Enasidenib was 4.3 months (range 0.3 to 23.6). The 30-day and 60-day mortality rates observed with Enasidenib were 4.2% (9/214) and 11.7% (25/214), respectively. Differentiation syndrome events characterized as serious included pyrexia, renal failure acute, hypoxia, respiratory failure, and multi-organ failure. Ten of 214 patients (5%) required a dose reduction due to an adverse reaction; no adverse reaction required dose reduction in more than 2 patients.

Drug Interactions and Special Populations

Certain CYP1A2 and CYP2C19 Substrates: Avoid concomitant use unless otherwise recommended in the Prescribing Information . Certain CYP3A Substrates: Avoid concomitant use unless otherwise recommended in the Prescribing Information . Certain OATP1B1, OATP1B3, and BCRP Substrates: Avoid concomitant use unless otherwise recommended in the Prescribing Information . Consider reducing the frequency of caffeine intake from various food and beverages in a 24 hour period while taking Enasidenib because Enasidenib may increase the effect of caffeine in patients who are sensitive to it. Enasidenib is a CYP1A2 inhibitor. Enasidenib is a CYP2C19 inhibitor.

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: Idhifa 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.