TLPH Aentrek Entrectinib 100mg

Product Information

• Product name: Aentrek ENTRECTINIB 100MG
• Manufacturer / brand: Laos TLPH Pharma
• Active ingredient: Entrectinib
• Current strength: 100MG
• SKU: AM-ITEM-19
• Site category: general medicines, NTRK target, ROS1 target

Product Summary

Aentrek ENTRECTINIB 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

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

Entrectinib is an inhibitor of the tropomyosin receptor tyrosine kinases (TRK) TRKA, TRKB, and TRKC (encoded by the neurotrophic tyrosine receptor kinase [ NTRK ] genes NTRK1, NTRK2, and NTRK3 , respectively), proto-oncogene tyrosine-protein kinase ROS1 (ROS1), and anaplastic lymphoma kinase (ALK) with IC 50 values of 0.1 to 2 nM. Entrectinib also inhibits JAK2 and TNK2 with IC 50 values > 5 nM. The major active metabolite of entrectinib, M5, showed similar in vitro activity against TRK, ROS1, and ALK.

Reference Indications

Entrectinib is a kinase inhibitor indicated for the treatment of: Adult patients with ROS1- positive metastatic non-small cell lung cancer (NSCLC) as detected by an FDA-approved test. Adult and pediatric patients older than 1 month of age with solid tumors that: have a neurotrophic tyrosine receptor kinase ( NTRK) gene fusion, as detected by an FDA-approved test without a known acquired resistance mutation, are metastatic or where surgical resection is likely to result in severe morbidity, and have progressed following treatment or have no satisfactory alternative therapy. This indication is approved under accelerated approval based on tumor response rate and durability 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

The public label should be checked for the indication-specific recommended dosage. Available administration instructions note that the medicine may be taken Recommended dosage is based on age and body surface area (BSA) as shown below. Administer Entrectinib capsules, capsules prepared as a suspension, or pellets once 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

Congestive Heart Failure (CHF) : Assess left ventricular ejection fraction (LVEF) prior to initiation of Entrectinib. Monitor patients for clinical signs and symptoms of CHF. Reduce dose or permanently discontinue Entrectinib based on severity of CHF or worsening LVEF. Withhold and then resume at same or reduced dose upon improvement or permanently discontinue Entrectinib based on severity. ( 2.7 , 5.2 ) Skeletal Fractures: Entrectinib increases the risk of fractures. Promptly evaluate patients with signs or symptoms of fractures. Hepatotoxicity : Monitor liver tests, including ALT and AST, every 2 weeks during the first month of treatment, then monthly thereafter, and as clinically indicated. Withhold or permanently discontinue Entrectinib based on severity. If withheld, resume Entrectinib at same or reduced dose based on severity.

Common Adverse Reactions and Monitoring

Entrectinib was studied in one dose-finding trial in adults [ALKA (n = 57)], one dose-finding and activity-estimating trial in adults [STARTRK-1 (n = 76)], one dose-finding and activity-estimating trial in pediatric and adult patients [STARTRK-NG (n = 16)], and one single arm, activity-estimating trial in adults [STARTRK-2 (n = 206)]. The population characteristics were: median age 55 years (range: 4 to 86 years); 5% (n = 17) were less than 18 years of age; 55% were female; and 66% were White, 23% were Asian, and 5% were Black; 3% were Hispanic/Latino. The most common tumors (≥ 5%) were lung (56%), sarcoma (8%), and colon (5%).

Drug Interactions and Special Populations

Moderate and Strong CYP3A Inhibitors : For adult and pediatric patients 2 years and older, reduce the dose of Entrectinib if coadministration of moderate or strong CYP3A inhibitors cannot be avoided. ( 2.8 , 7.1 ) For pediatric patients less than 2 years, avoid coadministration with Entrectinib. Moderate and Strong CYP3A Inducers : Avoid coadministration with Entrectinib. Drugs That Prolong QTc Interval : Avoid concomitant use with Entrectinib. Avoid coadministration of strong or moderate CYP3A inhibitors with Entrectinib. If coadministration is unavoidable, reduce the Entrectinib dose . Pediatric Patients less than 2 Years Avoid coadministration of Entrectinib with moderate or strong CYP3A inhibitors . Avoid grapefruit products during treatment with Entrectinib, as they contain inhibitors of CYP3A.

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: Rozlytrek 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.