TLPH Pitobrunib Pirtobrutinib 100mg

Product Information

• Product name: Pitobrunib Pirtobrutinib 100mg
• Manufacturer / brand: Laos TLPH Pharma
• Active ingredient: Pirtobrutinib
• Current strength: 100mg
• SKU: AM-ITEM-7
• Site category: general medicines, lymphoma

Product Summary

Pitobrunib Pirtobrutinib 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

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

Pirtobrutinib is a small molecule, noncovalent inhibitor of BTK. BTK is a signaling protein of the B-cell antigen receptor (BCR) and cytokine receptor pathways. Pirtobrutinib binds to wild type BTK and BTK harboring C481 mutations, leading to inhibition of BTK kinase activity. Pirtobrutinib showed dose-dependent anti-tumor activities in BTK wild type and BTK C481S mutant mouse xenograft models.

Reference Indications

Pirtobrutinib ® is a kinase inhibitor indicated for the treatment of: Adult patients with relapsed or refractory mantle cell lymphoma (MCL) after at least two lines of systemic therapy, including a BTK inhibitor. This indication is approved under accelerated approval based on response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. Adult patients with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL) who have previously been treated with a covalent BTK inhibitor. This indication is approved under accelerated approval based on response rate . Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

Reference Dosage and Administration

Recommended dosage: 200 mg orally once daily; swallow whole with water, with or without food.

With this 100mg product, that corresponds to 2 x 100mg 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

Infections: Monitor for signs and symptoms of infection, evaluate promptly, and treat. Hemorrhage: Monitor for bleeding and manage appropriately. Cytopenias: Monitor complete blood counts during treatment. Cardiac Arrythmias: Monitor for symptoms of arrhythmias and manage appropriately. Second Primary Malignancies: Other malignancies have developed, including skin cancers and other carcinomas. Monitor and advise patients to use sun protection. Hepatotoxicity, Including Drug-Induced Liver Injury: Monitor hepatic function throughout treatment. Embryo-Fetal Toxicity: Can cause fetal harm. Advise females of reproductive potential of potential risk to a fetus and to use effective contraception.

Common Adverse Reactions and Monitoring

The data in the reflect exposure to Pirtobrutinib as a single-agent, administered at 200 mg once daily in 704 patients with hematologic malignancies in the BRUIN and the BRUIN-CLL-321 studies. Among these 704 patients, the median duration of exposure was 12 months; 65% were exposed for at least 6 months and 50% were exposed for at least one year. The trial required a platelet count ≥ 50 x 10 9 /L, absolute neutrophil count ≥ 0.75 x 10 9 /L, hepatic transaminases ≤ 2.5 times upper limit of normal (ULN), and an ECOG performance status of 0 to 2.

Drug Interactions and Special Populations

Strong CYP3A Inhibitors: Avoid concomitant use. If concomitant use is unavoidable, reduce the Pirtobrutinib dose. ( 2.4 , 7.1 ) Strong or Moderate CYP3A Inducers: Avoid concomitant use. If concomitant use of moderate CYP3A inducers is unavoidable, increase the Pirtobrutinib dose. Avoid concomitant use of strong CYP3A inhibitors during treatment with Pirtobrutinib. If concomitant use of strong CYP3A inhibitors is unavoidable, reduce the Pirtobrutinib dosage . Strong or Moderate CYP3A Inducers Concomitant use of Pirtobrutinib with a strong or moderate CYP3A inducer decreased pirtobrutinib systemic exposure , which may reduce Pirtobrutinib efficacy. Avoid concomitant use of Pirtobrutinib with strong or moderate CYP3A inducers. If concomitant use of moderate CYP3A inducers is unavoidable, increase the Pirtobrutinib dosage .

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: JAYPIRCA 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.