Lucius LuciNinted Nintedanib 150mg

Product Information

• Product name: LuciNinted Nintedanib 150mg
• Manufacturer / brand: Laos Lucius Pharma
• Active ingredient: Nintedanib
• Current strength: 150mg
• SKU: LU-ITEM-147
• Site category: pulmonary fibrosis, other cancer

Product Summary

LuciNinted Nintedanib 150mg is an AISTIKA-listed product supplied by Laos Lucius 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

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

Nintedanib is a small molecule that inhibits multiple receptor tyrosine kinases (RTKs) and non-receptor tyrosine kinases (nRTKs). Nintedanib inhibits the following RTKs: platelet-derived growth factor receptor (PDGFR) α and β, fibroblast growth factor receptor (FGFR) 1-3, vascular endothelial growth factor receptor (VEGFR) 1-3, colony stimulating factor 1 receptor (CSF1R), and Fms-like tyrosine kinase-3 (FLT-3). These kinases except for FLT-3 have been implicated in pathogenesis of interstitial lung diseases (ILD).

Reference Indications

Nintedanib Capsules is a kinase inhibitor indicated in adults for: Treatment of idiopathic pulmonary fibrosis (IPF) Treatment of chronic fibrosing interstitial lung diseases (ILDs) with a progressive phenotype 1.1 Idiopathic Pulmonary Fibrosis Nintedanib Capsules is indicated for the treatment of adults with idiopathic pulmonary fibrosis (IPF).

Reference Dosage and Administration

Recommended dosage: 150 mg taken orally twice daily approximately 12 hours apart taken with food.

With this 150mg product, that corresponds to 1 x 150mg tablet 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

Hepatic impairment: Nintedanib Capsules is not recommended for use in patients with moderate or severe hepatic impairment. ( 2.3 , 2.4 , 5.1 , 8.6 , 12.3 ) Elevated liver enzymes and drug-induced liver injury: ALT, AST, and bilirubin elevations have occurred with Nintedanib capsules, including cases of drug- induced liver injury. The majority of hepatic events occur within the first three months of treatment. Liver enzyme and bilirubin increases were reversible with dose modification or interruption in the majority of cases. Monitor ALT, AST, and bilirubin prior to initiation of treatment, at regular intervals during the first three months of treatment, and periodically thereafter or as clinically indicated. Temporary dosage reductions or discontinuations may be required.

Common Adverse Reactions and Monitoring

The safety of Nintedanib capsules was evaluated in over 1000 IPF patients, and 332 patients with chronic fibrosing ILDs with a progressive phenotype. Over 200 IPF patients were exposed to Nintedanib capsules for more than 2 years in clinical trials. Idiopathic Pulmonary Fibrosis Nintedanib capsules were studied in three randomized, double-blind, placebo-controlled, 52-week trials. The median duration of exposure was 10 months for patients treated with Nintedanib capsules and 11 months for patients treated with placebo. Subjects ranged in age from 42 to 89 years (median age of 67 years). Most patients were male (79%) and Caucasian (60%).

Drug Interactions and Special Populations

Coadministration of P-gp and CYP3A4 inhibitors may increase Nintedanib exposure. Monitor patients closely for tolerability of Nintedanib Capsules. Coadministration with oral doses of a P-gp and CYP3A4 inhibitor, ketoconazole, increased exposure to Nintedanib by 60%. Concomitant use of P-gp and CYP3A4 inhibitors (e.g., erythromycin) with Nintedanib Capsules may increase exposure to Nintedanib . Coadministration with oral doses of a P-gp and CYP3A4 inducer, rifampicin, decreased exposure to Nintedanib by 50%. Concomitant use of P-gp and CYP3A4 inducers (e.g., carbamazepine, phenytoin, and St. John’s wort) with Nintedanib Capsules should be avoided as these drugs may decrease exposure to Nintedanib . Monitor patients on full anticoagulation therapy closely for bleeding and adjust anticoagulation treatment as necessary .

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: Nintedanib 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.