TLPH Alynni Alectinib 150mg

Product Information

• Product name: Alynni Alectinib 150mg
• Manufacturer / brand: Laos TLPH Pharma
• Active ingredient: Alectinib
• Current strength: 150mg
• SKU: AM-ITEM-21
• Site category: general medicines, second generation

Product Summary

Alynni Alectinib 150mg 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

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

Alectinib is a tyrosine kinase inhibitor that targets ALK and RET. The major active metabolite of alectinib, M4, showed similar in vitro potency and activity. Alectinib and M4 demonstrated in vitro and in vivo activity against multiple mutant forms of the ALK enzyme, including some mutations identified in NSCLC tumors in patients who have progressed on crizotinib.

Reference Indications

Alectinib is a kinase inhibitor indicated for: adjuvant treatment in adult patients following tumor resection of anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC) (tumors ≥ 4 cm or node positive) as detected by an FDA-approved test. treatment of adult patients with ALK-positive metastatic NSCLC as detected by an FDA-approved test.

Reference Dosage and Administration

Recommended dosage information for Alectinib is provided in Table 1 . Administer Alectinib with 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

Hepatotoxicity: Monitor liver laboratory tests every 2 weeks during the first 3 months of treatment, then once a month and as clinically indicated, with more frequent testing in patients who develop transaminase and bilirubin elevations. ( 2.4 , 5.1 ) Interstitial Lung Disease (ILD)/Pneumonitis: Immediately withhold Alectinib in patients diagnosed with ILD/pneumonitis and permanently discontinue if no other potential causes of ILD/pneumonitis have been identified. ( 2.4 , 5.2 ) Renal Impairment: Withhold Alectinib for severe renal impairment, then resume Alectinib at reduced dose upon recovery or permanently discontinue ( 2.4 , 5.3 ). Bradycardia: Monitor heart rate and blood pressure regularly. If symptomatic, withhold Alectinib then reduce dose, or permanently discontinue.

Common Adverse Reactions and Monitoring

The pooled safety population described in the reflect exposure to Alectinib as a single agent at 600 mg orally twice daily in 533 patients in Studies NP28761, NP28673, ALEX and ALINA . Among 533 patients who received Alectinib, 75% were exposed for 6 months or longer and 64% were exposed for greater than one year. The most common (≥ 2%) Grade 3 or 4 laboratory abnormalities were increased CPK (6%), decreased hemoglobin (4.4%), increased ALT (4.2%), increased bilirubin (4.0%) and increased AST (3.4%).

Drug Interactions and Special Populations

Lactation: Do not breastfeed. There are no available data on Alectinib use in pregnant women. Administration of alectinib to pregnant rats and rabbits by oral gavage during the period of organogenesis resulted in embryo-fetal toxicity and abortion at maternally toxic doses with exposures approximately 2.7-fold those observed in humans treated with alectinib at 600 mg twice daily (see Data ) . Advise pregnant women of the potential risk to a fetus. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.

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: ALECENSA 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.