Lucius LuciPac Pacritinib 100mg

Product Information

• Product name: LuciPac Pacritinib 100mg
• Manufacturer / brand: Laos Lucius Pharma
• Active ingredient: Pacritinib
• Current strength: 100mg
• SKU: LU-ITEM-9
• Site category: myelofibrosis, other cancer

Product Summary

LuciPac Pacritinib 100mg 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

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

Pacritinib is an oral kinase inhibitor with activity against wild type Janus associated kinase 2 (JAK2), mutant JAK2V617F, FMS-like tyrosine kinase 3 (FLT3), and interleukin 1 receptor associated kinase-1 (IRAK1) which contribute to signaling of a number of cytokines and growth factors that are important for hematopoiesis and immune function. Pacritinib is also an inhibitor of activin A receptor, type 1/activin receptor like-kinase 2 (ACVR1/ALK2). MF is often associated with dysregulated JAK2 signaling. At clinically relevant concentrations, pacritinib does not inhibit JAK1.

Reference Indications

Pacritinib is indicated for the treatment of adults with intermediate or high-risk primary or secondary (post-polycythemia vera or post-essential thrombocythemia) myelofibrosis (MF) with a platelet count below 50 × 10 9 /L. This indication is approved under accelerated approval based on spleen volume reduction . Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). Pacritinib is a kinase inhibitor indicated for the treatment of adults with intermediate or high-risk primary or secondary (post-polycythemia vera or post-essential thrombocythemia) myelofibrosis with a platelet count below 50 × 10 9 /L . This indication is approved under accelerated approval based on spleen volume reduction.

Reference Dosage and Administration

Recommended dosage is 200 mg orally twice daily . taken 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

Hemorrhage: Avoid use in patients with active bleeding and hold Pacritinib prior to any planned surgical procedures. May require dose interruption, dose reduction or permanent discontinuation depending on severity . Diarrhea: Manage significant diarrhea with anti-diarrheals, dose reduction, or dose interruption . Thrombocytopenia: Manage by dose reduction or interruption . Prolonged QT Interval: Avoid use in patients with baseline QTc >480 msec. Interrupt and reduce Pacritinib dosage in patients who have a QTcF >500 msec. Correct hypokalemia prior to and during Pacritinib administration . Major Adverse Cardiac Events (MACE): Risk may be increased in current/past smokers and patients with other cardiovascular risk factors. Monitor for signs, evaluate and treat promptly .

Common Adverse Reactions and Monitoring

PERSIST-2 Trial The safety of Pacritinib was evaluated in the randomized, controlled PERSIST-2 trial . Prior Janus associated kinase (JAK) inhibitor therapy was permitted. Patients received Pacritinib at 200 mg twice daily (n=106), 400 mg once daily (n=104), or best available therapy (BAT) (n=98). Forty-seven (44%) of the 106 patients treated with Pacritinib 200 mg twice daily had a baseline platelet count of <50 × 10 9 /L. The 400 mg once daily dose could not be established to be safe, so further information on this arm is not provided. Fifty-four percent of patients were exposed for 6 months, and 18% were exposed for approximately 12 months.

Drug Interactions and Special Populations

Co-administration of Pacritinib with moderate CYP3A4 inhibitors can increase the exposure to pacritinib. Pacritinib is an inhibitor of P-gp, BCRP, and CYP1A2 and an inducer of CYP3A4 and CYP2C19. Monitor patients concomitantly receiving substrates of these transporters and enzymes, and adjust dose of the substrates as needed . Pacritinib may reduce the effectiveness of hormonal contraceptives 7.1 Effect of Other Drugs on Pacritinib Strong and Moderate CYP3A4 Inhibitors Pacritinib is predominantly metabolized by CYP3A4. Concomitant use of Pacritinib with doses of fluconazole greater than 200 mg once daily has not been studied. Strong CYP3A4 Inducers Pacritinib is predominantly metabolized by CYP3A4. Concomitant use of Pacritinib with strong CYP3A4 inducers decreases pacritinib exposure, which may reduce efficacy of Pacritinib .

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: Vonjo 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.