Lucius LuciNera Neratinib 40mg

Product Information

• Product name: LuciNera Neratinib 40mg
• Manufacturer / brand: Laos Lucius Pharma
• Active ingredient: Neratinib
• Current strength: 40mg
• SKU: LU-ITEM-79
• Site category: HER2 target, other cancer

Product Summary

LuciNera Neratinib 40mg 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

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

Neratinib is an intracellular kinase inhibitor that irreversibly binds to epidermal growth factor receptor (EGFR), HER2, and HER4. Neratinib human metabolites M3, M6, M7 and M11 inhibited the activity of EGFR, HER2, and HER4 in vitro.

Reference Indications

Neratinib is a kinase inhibitor indicated: As a single agent, for the extended adjuvant treatment of adult patients with early-stage HER2-positive breast cancer, to follow adjuvant trastuzumab-based therapy.

Reference Dosage and Administration

Recommended Dose and Schedule Extended Adjuvant Treatment of Early-Stage Breast Cancer The recommended dose of Neratinib is 240 mg (six tablets) given orally once daily, with food, continuously until disease recurrence or for up to one year. administer antidiarrheal prophylaxis during the first 56 days of treatment and initiate with the first dose of Neratinib .

With this 40mg product, that corresponds to 6 x 40mg 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

Diarrhea: Manage diarrhea through either Neratinib dose escalation or loperamide prophylaxis ( 2.1 , 2.2 ). If diarrhea occurs despite recommended prophylaxis, treat with additional antidiarrheals, fluids, and electrolytes as clinically indicated. Withhold Neratinib in patients experiencing severe and/or persistent diarrhea. Permanently discontinue Neratinib in patients experiencing Grade 4 diarrhea or Grade ≥2 diarrhea that occurs after maximal dose reduction. ( 2.3 , 5.1 ) Hepatotoxicity: Monitor liver function tests monthly for the first 3 months of treatment, then every 3 months while on treatment and as clinically indicated. Withhold Neratinib in patients experiencing Grade 3 liver abnormalities and permanently discontinue Neratinib in patients experiencing Grade 4 liver abnormalities.

Common Adverse Reactions and Monitoring

Neratinib in combination with capecitabine: diarrhea, nausea, vomiting, decreased appetite, constipation, fatigue/asthenia, weight decreased, dizziness, back pain, arthralgia, urinary tract infection, upper respiratory tract infection, abdominal distention, renal impairment, and muscle spasms. Extended Adjuvant Treatment of Early-Stage Breast Cancer ExteNET The data described below reflect the safety data of Neratinib as a single agent in ExteNET, a multicenter, randomized, double-blind, placebo-controlled study of Neratinib within 2 years after completion of adjuvant treatment with trastuzumab-based therapy in women with HER2-positive early-stage breast cancer.

Drug Interactions and Special Populations

Gastric acid reducing agents: Avoid concomitant use with proton pump inhibitors. Separate Neratinib by at least 2 hours before or 10 hours after H 2 -receptor antagonists. ( 2.5 , 7.1 ) Strong CYP3A4 inhibitors: Avoid concomitant use. P-gp and moderate CYP3A4 dual inhibitors: Avoid concomitant use. Strong or moderate CYP3A4 inducers: Avoid concomitant use. Prevention or Management Avoid concomitant use of PPIs. Separate administration of Neratinib at least 2 hours before or 10 hours after the H 2 -receptor antagonist dose. Separate administration of Neratinib by at least 3 hours after antacids. Strong CYP3A4 Inhibitors Clinical Impact Concomitant use of Neratinib with a strong CYP3A4 inhibitor increased neratinib C max and AUC , which may increase the risk of Neratinib toxicity.

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: Nerlynx 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.