Laos Pharma No.2 LORLAMAK Lorlatinib 25mg

Product Information

• Product name: LORLAMAK Lorlatinib 25mg
• Manufacturer / brand: Laos State Pharmaceutical No.2
• Active ingredient: Lorlatinib
• Current strength: 25mg
• SKU: L2-ITEM-7
• Site category: general medicines, third generation

Product Summary

LORLAMAK Lorlatinib 25mg is an AISTIKA-listed product supplied by Laos State Pharmaceutical No.2. 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

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

Lorlatinib is a kinase inhibitor with in vitro activity against ALK and ROS1 as well as TYK1, FER, FPS, TRKA, TRKB, TRKC, FAK, FAK2, and ACK. Lorlatinib demonstrated in vitro activity against multiple mutant forms of the ALK enzyme, including some mutations detected in tumors at the time of disease progression on crizotinib and other ALK inhibitors. Lorlatinib also demonstrated anti-tumor activity and prolonged survival in mice implanted intracranially with EML4-ALK-driven tumor cell lines.

Reference Indications

Lorlatinib ® is indicated for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors are anaplastic lymphoma kinase (ALK)-positive as detected by an FDA-approved test. Lorlatinib is a kinase inhibitor indicated for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors are anaplastic lymphoma kinase (ALK)-positive as detected by an FDA-approved test.

Reference Dosage and Administration

Recommended dosage : 100 mg orally once daily. with or without food, until disease progression or unacceptable toxicity .

With this 25mg product, that corresponds to 4 x 25mg 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

Risk of Serious Hepatotoxicity with Concomitant Use of Strong CYP3A Inducers : Discontinue strong CYP3A inducers for 3 plasma half-lives of the strong CYP3A inducer prior to initiating Lorlatinib. ( 2.4 , 5.1 ) Central Nervous System (CNS) Effects : CNS effects include seizures, psychotic effects and changes in cognitive function, mood (including suicidal ideation), speech, mental status, and sleep. Withhold and resume Lorlatinib at same or reduced dose or permanently discontinue Lorlatinib based on severity. ( 2.3 , 5.2 ) Hyperlipidemia : Initiate or increase the dose of lipid-lowering agents. Withhold and resume Lorlatinib at same or reduced dose based on severity. ( 2.3 , 5.3 ) Atrioventricular Block : Withhold and resume Lorlatinib at same or reduced dose based on severity.

Common Adverse Reactions and Monitoring

Among 476 patients who received Lorlatinib, 75% were exposed for 6 months or longer and 61% were exposed for greater than 1 year. The most frequent Grade 3–4 laboratory abnormalities in ≥ 20% of 476 patients who received Lorlatinib were hypercholesterolemia (21%) and hypertriglyceridemia (21%). Previously Untreated ALK-Positive Metastatic NSCLC (CROWN Study) The safety of Lorlatinib was evaluated in 149 patients with ALK-positive NSCLC in a randomized, open-label, active-controlled trial for the treatment of patients with ALK-positive, locally advanced or metastatic, NSCLC who had not received previous systemic treatment for advanced disease .

Drug Interactions and Special Populations

Strong CYP3A Inducers : Contraindicated. ( 2.4 , 7.1 ) Moderate CYP3A Inducers : Avoid concomitant use. If concomitant use cannot be avoided, increase the Lorlatinib dose. ( 2.4 , 7.1 ) Strong CYP3A Inhibitors : Avoid concomitant use; reduce Lorlatinib dose if concomitant use cannot be avoided. ( 2.4 , 7.1 ) Fluconazole : Avoid concomitant use; reduce Lorlatinib dose if concomitant use cannot be avoided. ( 2.4 , 7.1 ) Certain CYP3A Substrates : Avoid concomitant use with CYP3A substrates for which minimal concentration changes may lead to serious therapeutic failures. Certain P-gp Substrates : Avoid concomitant use with P-gp substrates for which minimal concentration changes may lead to serious therapeutic failures. Discontinue strong CYP3A inducers for 3 plasma half-lives of the strong CYP3A inducer prior to initiating Lorlatinib .

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: Lorbrena 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.