Big Bear REPODX Repotrectinib

Product Information

• Product name: REPODX Repotrectinib as shown on package
• Manufacturer / brand: Laos BigBear Pharma
• Active ingredient: Repotrectinib
• Current strength: as shown on package
• SKU: BB-ITEM-61
• Site category: ROS1 target, other cancer

Product Summary

REPODX Repotrectinib as shown on package 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

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

Repotrectinib is an inhibitor of proto-oncogene tyrosine-protein kinase ROS1 (ROS1) and of the tropomyosin receptor tyrosine kinases (TRKs) TRKA, TRKB, and TRKC. Fusion proteins that include ROS1 or TRK domains can drive tumorigenic potential through hyperactivation of downstream signaling pathways leading to unconstrained cell proliferation. Repotrectinib exhibited anti-tumor activity in cultured cells expressing ROS1 fusions and mutations including SDC4-ROS1, SDC4-ROS1 G2032R , CD74-ROS1, CD74-ROS1 G2032R , CD74-ROS1 D2033N , and CD74-ROS1 L2026M .

Reference Indications

Repotrectinib is a kinase inhibitor indicated for the treatment of adult patients with locally advanced or metastatic ROS1- positive non-small cell lung cancer (NSCLC). adult and pediatric patients 12 years of age and older with solid tumors that: have a neurotrophic tyrosine receptor kinase ( NTRK ) gene fusion and are locally advanced or metastatic or where surgical resection is likely to result in severe morbidity. have progressed following treatment or have no satisfactory alternative therapy. 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 the confirmatory trials.

Reference Dosage and Administration

Recommended Dosage : 160 mg orally once daily for 14 days, then increase to 160 mg twice daily, with or without food.

Dose conversion must be confirmed by a physician because the reference dose may vary by indication, organ function, toxicity, or interacting medicines.

This reference dosage is not an individualized prescription. Dose changes, treatment interruptions, or discontinuation must be directed by a physician.

Important Safety Information

Withhold and then resume at same or reduced dose upon improvement, or permanently discontinue Repotrectinib based on severity. Interstitial Lung Disease (ILD)/Pneumonitis: Monitor patients for new or worsening pulmonary symptoms indicative of ILD/pneumonitis. Immediately withhold in patients with suspected ILD/pneumonitis and permanently discontinue if ILD/pneumonitis is confirmed. Hepatotoxicity: Monitor liver function tests every 2 weeks during the first month of treatment, and as clinically indicated thereafter. Based on severity, withhold and then resume at same or reduced dose, or permanently discontinue. Myalgia with Creatine Phosphokinase (CPK) Elevation: Monitor serum CPK levels during treatment in patients reporting unexplained muscle pain, tenderness, or weakness.

Common Adverse Reactions and Monitoring

The pooled safety population described in and below reflects exposure to Repotrectinib in 426 patients with ROS1 -positive NSCLC (n=320), NTRK1/2/3 -positive solid tumors (n=104), or other solid tumors (n=2) in TRIDENT-1. Patients received Repotrectinib at a dose of 160 mg orally once daily for the first 14 days, then increased to 160 mg orally twice daily until disease progression or unacceptable toxicity . Eligible patients had an ECOG status of ≤1. Patients with a history of ILD, drug-related pneumonitis, significant, uncontrolled, active cardiovascular disease, or prolonged QTc interval were excluded from enrollment in this trial.

Drug Interactions and Special Populations

Strong and Moderate CYP3A Inhibitors : Avoid concomitant use. P-gp inhibitors : Avoid concomitant use. Strong and Moderate CYP3A Inducers : Avoid concomitant use. Certain CYP3A Substrates : Avoid concomitant use with CYP3A substrates, where minimal concentration changes can cause reduced efficacy. Hormonal contraceptives : Avoid concomitant use. Discontinue CYP3A inhibitors for 3 to 5 elimination half-lives of the CYP3A inhibitor prior to initiating Repotrectinib . P-gp Inhibitors Avoid concomitant use with P-gp inhibitors. Strong and Moderate CYP3A Inducers Avoid concomitant use with strong or moderate CYP3A inducers. Concomitant use of Repotrectinib with a strong or moderate CYP3A inducer may decrease repotrectinib plasma concentrations, which may decrease efficacy of Repotrectinib .

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: Augtyro 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.