Big Bear PRASEDX Pralsetinib 100mg

Product Information

• Product name: PRASEDX Pralsetinib 100mg
• Manufacturer / brand: Laos BigBear Pharma
• Active ingredient: Pralsetinib
• Current strength: 100mg
• SKU: BB-ITEM-60
• Site category: RET target, RET target in thyroid cancer, other cancer

Product Summary

PRASEDX Pralsetinib 100mg is an AISTIKA-listed product supplied by Laos BigBear 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

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

Pralsetinib is a kinase inhibitor of wild-type RET and oncogenic RET fusions (CCDC6- RET ) and mutations ( RET V804L, RET V804M and RET M918T) with half maximal inhibitory concentrations (IC 50s ) less than 0.5 nM. Certain RET fusion proteins and activating point mutations can drive tumorigenic potential through hyperactivation of downstream signaling pathways leading to uncontrolled cell proliferation.

Reference Indications

Pralsetinib is a kinase inhibitor indicated for treatment of: Adult patients with metastatic rearranged during transfection (RET ) fusion-positive non-small cell lung cancer as detected by an FDA approved test (NSCLC). Adult and pediatric patients 12 years of age and older with advanced or metastatic RET fusion-positive thyroid cancer who require systemic therapy and who are radioactive iodine-refractory (if radioactive iodine is appropriate). This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s). This indication is approved under accelerated approval based on overall response rate and duration of response .

Reference Dosage and Administration

Recommended dosage in adults and pediatric patients 12 years and older is 400 mg orally once daily on an empty stomach (no food intake for at least 2 hours before and at least 1 hour after taking Pralsetinib).

With this 100mg product, that corresponds to 4 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

WARNING: SERIOUS INFECTIONS, INCLUDING OPPORTUNISTIC INFECTIONS Pralsetinib may increase the risk for serious infections, including bacterial, fungal, viral and opportunistic infections, which can lead to hospitalization or death. Withhold, reduce the dose or permanently discontinue Pralsetinib based on severity . WARNING: SERIOUS INFECTIONS, INCLUDING OPPORTUNISTIC INFECTIONS See for complete boxed warning. Pralsetinib may increase the risk for serious infections, including bacterial, fungal, viral and opportunistic infections, which can lead to hospitalization or death. Withhold, reduce the dose or permanently discontinue Pralsetinib based on severity. ( 2.3 , 5.1 ) Serious Infections, Including Opportunistic Infections: Monitor for signs and symptoms of infection and treat appropriately.

Common Adverse Reactions and Monitoring

The most common Grade 3-4 laboratory abnormalities (≥ 2%) were decreased lymphocytes, decreased neutrophils, decreased hemoglobin, decreased phosphate, decreased leukocytes, decreased sodium, increased aspartate aminotransferase (AST), increased alanine aminotransferase (ALT), decreased calcium (corrected), decreased platelets, increased alkaline phosphatase, increased potassium, decreased potassium and increased bilirubin. The pooled safety population in the reflect exposure to Pralsetinib as a single agent at 400 mg orally once daily in 540 patients in ARROW .

Drug Interactions and Special Populations

Strong or moderate CYP3A inhibitors and/or P-gp inhibitors : Avoid coadministration. If coadministration cannot be avoided, reduce the dose of Pralsetinib. ( 2.4 , 7.1 , 12.3 ) Strong or moderate CYP3A inducers : Avoid coadministration. If coadministration cannot be avoided, increase the dose of Pralsetinib. Avoid coadministration of Pralsetinib with a strong or moderate CYP3A and/or P-gp inhibitor. If coadministration with any of the above inhibitors cannot be avoided, reduce the Pralsetinib dose . Strong or Moderate CYP3A Inducers Concomitant use with a strong CYP3A inducer decreases pralsetinib exposure , which may decrease efficacy of Pralsetinib. Avoid concomitant use of Pralsetinib with strong or moderate CYP3A 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: Gavreto 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.