Nilatinib Maleate Dosage


Prevention of diarrhea: Antidiarrheal prophylaxis is recommended during the first 2 cycles (56 days) of treatment and should be started with the first dose of neratinib (see Dosage and Administration, Dose Adjustment, Precautions). Instruct the patient to take loperamide as shown in Table 1, and adjust the frequency of use to control the daily defecation to 1-2 times. Diarrhea can be controlled by temporarily discontinuing administration or reducing the dose of neratinib, depending on clinical need (see Dosage Adjustment). Recommended dose and regimen: The recommended dose of neratinib is 240mg(6 tablets) once daily with meals for one year. The patient was instructed to take neratinib at approximately the same time each day. Neratinib should be swallowed whole (tablets should not be chewed, crushed, or split before swallowing). If the patient missed the dose, the missed dose should not be supplemented, and the patient should be instructed to re-take neratinib the next day at the daily dose. Dose adjustment: Dose adjustment for adverse reactions: It is recommended to adjust the dose of neratinib according to individual safety and tolerance. Administration interruptions and/or dose reductions may be required to control certain adverse effects, see Tables 2-5. Patients who fail to recover from treatment-related toxicity to grade 0-1, have toxicity that results in a treatment delay of> 3 weeks, or cannot tolerate 120mg daily, stop using neratinib. Other clinical circumstances may lead to dose adjustment as indicated by clinical indications (e. g. intolerable toxicity, persistent grade 2 adverse reactions, etc.). Dose adjustment for diarrhea: Diarrhea management requires proper use of antidiarrheals, dietary changes, and appropriate adjustment of the dose of neratinib. Guidelines for dose adjustment of neratinib in the case of diarrhea are listed in Table 4. Dose adjustment for hepatic impairment: The starting dose of neratinib was reduced to 80mg in patients with severe hepatic impairment (ChildPughC). Dose adjustment is not recommended in patients with mild to moderate hepatic impairment (ChildPughA or B) (see Table: Adverse Reactions and Pharmacology and Toxicology). Dose adjustment for hepatotoxicity: Guidelines for dose adjustment of neratinib in case of hepatotoxicity are listed in Table 5. Changes in liver function should be assessed in patients who develop ≥ grade 3 diarrhea or any signs or symptoms of liver toxicity requiring intravenous infusion therapy, such as increased fatigue, nausea, vomiting, right upper quadrant pain or tenderness, fever, rash, or eosinophilia. Fragmented bilirubin and prothrombin time should also be collected during the evaluation of hepatotoxicity (see [Precautions]). Concomitant use of acid-lowering drugs: Proton pump inhibitors (PPIs): Avoid concomitant use with neratinib (see [Drug interactions]). H2 receptor antagonist: Take neratinib at least 2 hours before the next dose of H2 receptor antagonist or 10 hours after the administration of H2 receptor antagonist (see [Drug Interactions]). ANTACID: Niratinib can be administered after 3 hours of antacid administration (see [Drug Interactions]).