Lucius LuciAsc Asciminib 40mg

Product Information

• Product name: LuciAsc Asciminib 40mg
• Manufacturer / brand: Laos Lucius Pharma
• Active ingredient: Asciminib
• Current strength: 40mg
• SKU: LU-ITEM-24
• Site category: chronic myeloid leukemia (CML), other cancer

Product Summary

LuciAsc Asciminib 40mg is an AISTIKA-listed product supplied by Laos Lucius 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

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

Asciminib is an ABL/BCR-ABL1 tyrosine kinase inhibitor. Asciminib inhibits the ABL1 kinase activity of the BCR::ABL1 fusion protein, by binding to the ABL myristoyl pocket.

Reference Indications

Asciminib is indicated for the treatment of adult patients with: Newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in chronic phase (CP). This indication is approved under accelerated approval based on major molecular response rate . Continued approval for this indication may be contingent upon verification of clinical benefit in a confirmatory trial(s). Previously treated Ph+ CML in CP. Ph+ CML in CP with the T315I mutation. Asciminib is a kinase inhibitor indicated for the treatment of adult patients with: Newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in chronic phase (CP). This indication is approved under accelerated approval based on major molecular response rate.

Reference Dosage and Administration

Recommended Dosage in Ph+ CML in CP: 80 mg orally once daily or 40 mg orally twice daily. Swallow tablets whole.

With this 40mg product, that corresponds to 2 x 40mg 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

Myelosuppression: Severe thrombocytopenia and neutropenia events may occur. Monitor complete blood counts regularly during therapy and manage by treatment interruption or dose reduction. ( 2.4 , 5.1 ) Pancreatic Toxicity: Monitor serum lipase and amylase. Interrupt, then resume at reduced dose or discontinue Asciminib based on severity. Evaluate for pancreatitis when lipase elevation is accompanied by abdominal symptoms. ( 2.4 , 5.2 ) Hypertension: Monitor blood pressure and manage hypertension as clinically indicated. Interrupt, dose reduce, or stop Asciminib if hypertension is not medically controlled. ( 2.4 , 5.3 ) Hypersensitivity: May cause hypersensitivity reactions. Monitor patients for signs and symptoms and initiate appropriate treatment as clinically indicated. Cardiovascular Toxicity: Cardiovascular toxicity may occur.

Common Adverse Reactions and Monitoring

Most common select laboratory abnormalities (≥ 20%) are lymphocyte count decreased, leukocyte count decreased, platelet count decreased, neutrophil count decreased, calcium corrected decreased, lipase increased, cholesterol increased, uric acid increased, alanine aminotransferase (ALT) increased, alkaline phosphatase (ALP) increased, hemoglobin decreased, triglycerides increased, creatine kinase increased, amylase increased, and aspartate aminotransferase (AST) increased.

Drug Interactions and Special Populations

Itraconazole Oral Solution Containing Hydroxypropyl-β-cyclodextrin: Avoid concomitant use of Asciminib at all recommended doses. Avoid use of Asciminib at 200 mg twice daily. Substrates of CYP2C9: Avoid concomitant use of Asciminib at all recommended doses. Substrates of BCRP: Avoid concomitant use with rosuvastatin at all recommended doses. Itraconazole Oral Solution Containing Hydroxypropyl-β-cyclodextrin Concomitant use of Asciminib with itraconazole oral solution containing hydroxypropyl-β-cyclodextrin decreases asciminib C max and AUC, which may reduce Asciminib efficacy . Avoid coadministration of Asciminib at all recommended doses with itraconazole oral solution containing hydroxypropyl-β-cyclodextrin. Strong CYP3A4 Inducers Concomitant use of Asciminib with strong CYP3A4 inducers decreases both the asciminib C max and AUC .

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: SCEMBLIX 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.