Lucius LuciDela Idelalisib 150mg

Product Information

• Product name: LuciDela Idelalisib 150mg
• Manufacturer / brand: Laos Lucius Pharma
• Active ingredient: Idelalisib
• Current strength: 150mg
• SKU: LU-ITEM-45
• Site category: chronic lymphocytic leukemia (CLL), other cancer

Product Summary

LuciDela Idelalisib 150mg 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

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

Idelalisib is an inhibitor of phosphatidylinositol 3-kinase, PI3Kδ, which is expressed in normal and malignant B-cells. Idelalisib induced apoptosis and inhibited proliferation in cell lines derived from malignant B-cells and in primary tumor cells. Idelalisib inhibits several cell signaling pathways, including B-cell receptor (BCR) signaling and the CXCR4 and CXCR5 signaling, which are involved in trafficking and homing of B-cells to the lymph nodes and bone marrow. Treatment of lymphoma cells with idelalisib resulted in inhibition of chemotaxis and adhesion, and reduced cell viability.

Reference Indications

Idelalisib is indicated, in combination with rituximab, for the treatment of patients with relapsed chronic lymphocytic leukemia (CLL) for whom rituximab alone would be considered appropriate therapy due to other co-morbidities. Idelalisib is a kinase inhibitor indicated for the treatment of patients with: Relapsed chronic lymphocytic leukemia (CLL), in combination with rituximab, in patients for whom rituximab alone would be considered appropriate therapy due to other co-morbidities. Limitations of use: Idelalisib is not indicated and is not recommended for first-line treatment of any patient, including patients with CLL, small lymphocytic lymphoma (SLL), follicular lymphoma (FL), and other indolent non-Hodgkin lymphomas.

Reference Dosage and Administration

Recommended dosage: 150 mg orally twice daily. administered orally twice daily with or without food until disease progression or unacceptable toxicity.

With this 150mg product, that corresponds to 1 x 150mg 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: FATAL AND SERIOUS TOXICITIES: HEPATIC, SEVERE DIARRHEA, COLITIS, PNEUMONITIS, INFECTIONS, and INTESTINAL PERFORATION Fatal and/or serious hepatotoxicity occurred in 16% of Idelalisib-treated patients. Monitor hepatic function prior to and during treatment. Interrupt and then reduce or discontinue Idelalisib as recommended . Fatal and/or serious and severe diarrhea or colitis occurred in 20% of Idelalisib-treated patients. Monitor for the development of severe diarrhea or colitis. Interrupt and then reduce or discontinue Idelalisib as recommended . Fatal and/or serious pneumonitis occurred in 4% of Idelalisib-treated patients. Monitor for pulmonary symptoms and bilateral interstitial infiltrates. Interrupt or discontinue Idelalisib as recommended . Fatal and/or serious infections occurred in 48% of Idelalisib-treated patients.

Common Adverse Reactions and Monitoring

Common laboratory abnormalities are neutropenia, ALT elevations and AST elevations. The pooled safety population described in the reflect exposure to Idelalisib at a dosage of 150 mg twice daily in 110 patients administered in combination with rituximab in Study 312-0116, and in combination with other drugs in 380 patients. Among 490 patients who received Idelalisib, 74% were exposed for 6 months or longer and 50% were exposed for one year or longer. Common laboratory abnormalities were neutropenia, ALT elevations and AST elevations.

Drug Interactions and Special Populations

Strong CYP3A Inhibitors : Additional monitoring required if alternative therapy is not available. Strong CYP3A Inducers : Avoid coadministration of strong CYP3A inducers. CYP3A Substrates : Avoid coadministration of sensitive CYP3A substrates. Table with Idelalisib that affect Idelalisib Concentrations Strong CYP3A Inhibitors Clinical Impact Coadministration with strong CYP3A inhibitors may increase idelalisib concentrations . Prevention or Management Use other drugs that are not strong CYP3A inhibitors. Strong CYP3A Inducers Clinical Impact Coadministration with strong CYP3A inducers may decrease idelalisib concentrations . Decreased idelalisib concentrations may reduce efficacy. Prevention or Management Avoid coadministration of Idelalisib with strong CYP3A4 inducers.

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: Zydelig 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.