Lucius LuciBru Ibrutinib 140mg

Product Information

• Product name: LuciBru Ibrutinib 140mg
• Manufacturer / brand: Laos Lucius Pharma
• Active ingredient: Ibrutinib
• Current strength: 140mg
• SKU: LU-ITEM-33
• Site category: chronic graft-versus-host disease, chronic lymphocytic leukemia (CLL), lymphoma, other cancer

Product Summary

LuciBru Ibrutinib 140mg 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

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

Ibrutinib is a small-molecule inhibitor of Bruton’s tyrosine kinase (BTK). Ibrutinib forms a covalent bond with a cysteine residue in the BTK active site, leading to inhibition of BTK enzymatic activity. BTK is a signaling molecule of the B-cell antigen receptor (BCR) and cytokine receptor pathways. BTK’s role in signaling through the B-cell surface receptors results in activation of pathways necessary for B-cell trafficking, chemotaxis, and adhesion.

Reference Indications

Ibrutinib is a kinase inhibitor indicated for the treatment of: Adult patients with chronic lymphocytic leukemia (CLL)/Small lymphocytic lymphoma (SLL) . Adult patients with chronic lymphocytic leukemia (CLL)/Small lymphocytic lymphoma (SLL) with 17p deletion . Adult patients with Waldenström’s macroglobulinemia (WM) . Adult and pediatric patients age 1 year and older with chronic graft versus host disease (cGVHD) after failure of one or more lines of systemic therapy .

Reference Dosage and Administration

Recommended dosage of Ibrutinib for CLL/SLL and WM is 420 mg orally once daily until disease progression or unacceptable toxicity. taken orally once daily .

With this 140mg product, that corresponds to 3 x 140mg 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

Hemorrhage : Monitor for bleeding and manage . Infections : Monitor patients for fever and infections, evaluate promptly, and treat . Cardiac Arrhythmias , Cardiac Failure , and Sudden Death : Monitor for symptoms of arrhythmias and cardiac failure and manage . Hypertension : Monitor blood pressure and treat . Cytopenias : Check complete blood counts monthly . Second Primary Malignancies : Other malignancies have occurred in patients, including skin cancers, and other carcinomas . Hepatotoxicity, Including Drug- Induced Liver Injury : Monitor hepatic function throughout treatment . Tumor Lysis Syndrome (TLS) : Assess baseline risk and take precautions. Monitor and treat for TLS . Embryo-Fetal Toxicity : Can cause fetal harm.

Common Adverse Reactions and Monitoring

Because clinical trials are conducted under widely variable conditions, adverse reaction rates observed in clinical trials of a drug cannot be directly compared with rates of clinical trials of another drug and may not reflect the rates observed in practice. Unless otherwise specified, the pooled safety population described in the reflects exposure to Ibrutinib in 6 trials. Ibrutinib was administered as a single agent at 420 mg orally once daily (475 patients), as a single agent at 560 mg orally once daily [1.3 times the recommended adult dosage (174 patients)], and in combination with other drugs at 420 mg orally once daily (827 patients) in patients with B-cell malignancies.

Drug Interactions and Special Populations

CYP3A Inhibitors: Modify Ibrutinib dose as described ( 2.3 , 7.1 ). CYP3A Inducers: Avoid coadministration with strong CYP3A inducers . Increased ibrutinib concentrations may increase the risk of drug-related toxicity. Dose modifications of Ibrutinib are recommended when used concomitantly with posaconazole, voriconazole and moderate CYP3A inhibitors . Avoid concomitant use of other strong CYP3A inhibitors. Interrupt Ibrutinib if these inhibitors will be used short-term (such as anti-infectives for seven days or less) . Avoid grapefruit and Seville oranges during Ibrutinib treatment, as these contain strong or moderate inhibitors of CYP3A. Avoid coadministration with strong CYP3A inducers . Lactation : Advise not to breastfeed . Hepatic Impairment : Avoid use of Ibrutinib in patients with severe hepatic impairment.

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: Imbruvica 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.