1. Indications and Usage
\nExtended Adjuvant Treatment of HER2-Positive Early Breast Cancer:
\nIndicated for the extended adjuvant treatment of adult patients with human epidermal growth factor receptor 2 (HER2)-positive early breast cancer, following adjuvant trastuzumab-based therapy.
\nTreatment of HER2-Positive Metastatic Breast Cancer:
\nIndicated for the treatment of adult patients with HER2-positive metastatic breast cancer who have received two or more prior anti-HER2 based regimens.
\n2. Dosage and Administration
\nRecommended Dosage:
\nStandard Dose: 240 mg (6 tablets of 40 mg) administered orally once daily, continuously for 1 year.
\nAdministration: Swallow tablets whole. Take with food.
\nProphylaxis for Diarrhea:
\nProphylaxis with loperamide must be initiated concomitantly with neratinib and continued for the first 56 days to manage diarrhea.
\nSchedule:
\nDays 1\u201314: Loperamide 4 mg, 3 times daily.
\nDays 15\u201356: Loperamide 4 mg, 2 times daily.
\nWeek 9 onwards: Loperamide 4 mg as needed to maintain 1\u20132 bowel movements per day.
\nDose Modifications:
\nIf diarrhea occurs, interrupt neratinib until resolved to \u2264 Grade 1, then resume at the same or reduced dose (200 mg, 160 mg, or 120 mg).
\n3. Mechanism of Action
\nIrreversible Kinase Inhibitor:
\nNeratinib is an irreversible tyrosine kinase inhibitor of HER2 (ErbB2), EGFR (ErbB1), and HER4 (ErbB4).
\nPhysiological Effect:
\nIt binds covalently to the cysteine residue in the ATP-binding pocket of the receptor, inhibiting autophosphorylation and downstream signaling pathways (such as PI3K\/Akt and MAPK), thereby inducing tumor cell apoptosis.
\n4. Safety and Warnings
\nDiarrhea:
\nSevere diarrhea is a common and potentially serious adverse reaction. Prophylactic loperamide is mandatory. Monitor for signs of dehydration and renal failure.
\nHepatotoxicity:
\nMonitor ALT and AST levels prior to initiation and periodically during treatment. Dose interruptions or reductions may be necessary for elevated transaminases.
\nEmbryo-Fetal Toxicity:
\nCan cause fetal harm. Advise females of reproductive potential to use effective contraception during treatment and for 1 month after the final dose.
\n5. Adverse Reactions
\nMost Common:
\nDiarrhea, nausea, fatigue, vomiting, abdominal pain, increased ALT\/AST, rash, decreased appetite, musculoskeletal pain, and dry skin.
\n6. Drug Interactions
\nAcid-Reducing Agents:
\nProton Pump Inhibitors (PPIs): Avoid co-administration.
\nH2-Receptor Antagonists: Administer neratinib at least 2 hours before or 10 hours after the H2-antagonist.
\nAntacids: Administer neratinib at least 3 hours after the antacid.
\nCYP3A Inhibitors:
\nAvoid co-administration with strong CYP3A inhibitors (e.g., ketoconazole) as they may increase neratinib exposure.
\n7. Pharmaceutical Information
\nStorage:
\nStore at 20\u00b0C to 25\u00b0C (68\u00b0F to 77\u00b0F); excursions permitted to 15\u00b0C to 30\u00b0C (59\u00b0F to 86\u00b0F). Keep in the original package to protect from moisture.<\/p>\n","protected":false},"excerpt":{"rendered":"
Brand Name: \u8d3a\u4fea\u5b89\u00ae(Nerlynx\u00ae)
\nGeneric Name: Neratinib Maleate
\nStrength: 40 mg per tablet, 180 tablets per bottle
\nManufacturer: Excella GmbH & Co. KG
\nMarketing Authorization Holder: Puma Biotechnology, Inc.\uff08\u7f8e\u56fd\uff09\uff1b\u4e2d\u56fd\u5883\u5185\u5546\u4e1a\u5316\u7531\u5317\u6d77\u5eb7\u6210\u5236\u836f\u6709\u9650\u516c\u53f8\u8d1f\u8d23
\nApproval Date in China: April 2020
\nRegistration Number: \u56fd\u836f\u51c6\u5b57 HJ20200009
\nStorage: Seal and store in a dry place below 25\u2103. Avoid moisture and high temperature. Keep out of reach of children<\/p>\n
Price&Cost:Contact Us now for the best price of Neratinib Maleate(Nerlynx)<\/p>\n","protected":false},"featured_media":3178,"comment_status":"open","ping_status":"closed","template":"","meta":[],"product_brand":[],"product_cat":[27],"product_tag":[],"class_list":["post-3177","product","type-product","status-publish","has-post-thumbnail","product_cat-tablets","first","instock","shipping-taxable","product-type-simple"],"yoast_head":"\n