Lucius LuciZonger Zongertinib 60mg

Product Information

• Product name: LuciZonger Zongertinib60 mg60 Zongertinib 60mg
• Manufacturer / brand: Laos Lucius Pharma
• Active ingredient: Zongertinib
• Current strength: 60mg
• SKU: LU-ITEM-137
• Site category: other cancer

Product Summary

LuciZonger Zongertinib60 mg60 Zongertinib 60mg 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

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

Zongertinib is a kinase inhibitor of human epidermal growth factor receptor 2 (HER2).

Reference Indications

Zongertinib is indicated for the treatment of adult patients with unresectable or metastatic non-squamous non-small cell lung cancer (NSCLC) whose tumors have HER2 (ERBB2) tyrosine kinase domain activating mutations, as detected by an FDA-authorized test . This indication is approved under accelerated approval based on objective response rate and duration of response . Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. Zongertinib is a kinase inhibitor indicated for the treatment of adult patients with unresectable or metastatic non-squamous non-small cell lung cancer (NSCLC) whose tumors have HER2 (ERBB2) tyrosine kinase domain activating mutations, as detected by an FDA-authorized test.

Reference Dosage and Administration

Recommended dosage of Zongertinib is based on body weight: Patients weighing less than 90 kg: 120 mg Patients weighing 90 kg or greater: 180 mg Take Zongertinib orally once daily with or without food until disease progression or unacceptable toxicity.

With this 60mg product, that corresponds to 2 x 60mg 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

Hepatotoxicity : Monitor liver function tests including ALT, AST, and total bilirubin at baseline prior to administration, every 2 weeks during the first 12 weeks, and then monthly thereafter as clinically indicated, with more frequent testing in patients who develop transaminase elevations. Interrupt, reduce the dose, or permanently discontinue Zongertinib based on severity. Left Ventricular Dysfunction : Monitor LVEF at baseline prior to administration and at regular intervals during treatment and as clinically indicated. Interrupt, reduce the dose, or permanently discontinue Zongertinib based on severity. Interstitial Lung Disease/Pneumonitis : Monitor for new or worsening symptoms indicative of ILD/pneumonitis (e.g., dyspnea, cough, fever). Interrupt, reduce the dose, or permanently discontinue Zongertinib based on severity.

Common Adverse Reactions and Monitoring

The most common (≥ 2%) Grade 3 or 4 laboratory abnormalities were decreased lymphocytes, increased alanine aminotransferase, increased aspartate aminotransferase, increased gamma glutamyl transferase, decreased potassium, and decreased neutrophils. The pooled safety population described in reflects exposure to Zongertinib in 292 patients with unresectable or metastatic non-squamous NSCLC with HER2 (ERBB2) mutations who received Zongertinib as a single agent at 120 mg orally once daily until disease progression or unacceptable toxicity in Beamion LUNG-1 .

Drug Interactions and Special Populations

Strong CYP3A Inducers : Avoid concomitant use with strong CYP3A inducers. If concomitant use cannot be avoided, increase Zongertinib dose. If concomitant use cannot be avoided, increase Zongertinib dose as recommended . Zongertinib is a CYP3A substrate. Strong CYP3A4 inducers decrease zongertinib exposure , which may reduce effectiveness of Zongertinib. Zongertinib is a BCRP inhibitor. Lactation : Advise not to breastfeed. There are no available data on the use of Zongertinib in pregnant women to inform a drug-associated risk. Oral administration of zongertinib to pregnant rats during the period of organogenesis caused structural abnormalities and alterations to growth at maternal exposures ≥ 19 times the human exposure based on AUC at the recommended dose .

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: HERNEXEOS 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.