Detailed instructions for neratinib/neratinib

1. Indications and Usage

Neratinib/Neratinibis a kinase inhibitor:

As a single agent, for the long-term adjuvant treatment of adult patients with early-stageHER2positive breast cancer receiving trastuzumab-based adjuvant therapy.

In combination with capecitabine, for the treatment of adult patients with advanced or metastatic HER2-positive breast cancer who have received two or more prior anti-her 2-based regimens in the metastatic setting.

2. Dosage and usage

Premedication for Diarrhea:When dose escalation is not used, initiate loperamide with the first dose of neratiniband continue for the first 56 days of treatment. After the 56th day, loperamide was used to maintain 1-2 bowel movements per day.

Long-term adjuvant treatment of early breast cancer:240mg (6tablets) taken orally once a day with food for one year until the disease recurs.

Advanced or metastatic breast cancer:On day 21 of cycle 1-21 Oral administration with food every day240mg (6tablets), plus capecitabine (750mg/m22 orally twice daily), administered on days 1-14 of the 21 cycle until disease progression or unacceptable toxicity.

Dose escalation: A two-week dose escalation of neratinib may also be initiated.

Dose interruptions and/or dose reductions are recommended based on individual safety and tolerability.

Hepatic Impairment:Reduce the starting dose to 80 mg in patients with severe hepatic impairment.

Three. Dosage form and strength

Tablet: 40mg.

Four. Contraindications

No.

Five. Warnings and Precautions

Diarrhea:Control diarrhea with neratinib dose escalation or loperamide prophylaxis, If diarrhea occurs despite recommended prophylaxis, treat with additional antidiarrheal agents, fluids, and electrolytes as clinically indicated. Patients with severe and/or persistent diarrhea should discontinue taking neratinib. Patients who develop grade 4 diarrhea or grade ≥ 2 diarrhea after maximum dose reduction should permanently discontinue neratinib.

2.Hepatotoxicity:Monitor liver function tests monthly for the first 3 months of treatment and then every 3 months during treatment as clinically indicated. Discontinue neratinib in patients who develop grade 3 liver dysfunction, and permanently discontinue neratinib in patients who develop grade 4 liver dysfunction.

3.Embryo-Fetal Toxicity:Lynx can cause harm to the fetus. Inform patients of the potential risk to the fetus and use effective contraception.

6. Adverse reactions

The most common adverse reactions (reported in ≥5% of patients) were:

Neratinib As a single agent:Diarrhea, nausea, abdominal pain, fatigue, vomiting, rash, stomatitis, decreased appetite, muscle cramps, indigestion, elevated AST or ALT, nail abnormalities, dry skin, bloating, nose bleeding, weight loss, and urinary tract infection.

Neratinib in combination with capecitabine:Diarrhea, nausea, vomiting, decreased appetite, constipation, fatigue/Fatigue, weight loss, dizziness, back pain, joint pain, urinary tract infection, upper respiratory tract infection, abdominal bloating, kidney damage, and muscle cramps. (6)

7. Drug interactions

Gastric acid reducers:Avoid concurrent use with proton pump inhibitors. At least 2 hours before H or at least H after pan>10hours to separateNERLYNX2-receptor antagonist. Or wait at least 3 hours after taking an antacid before taking neratinib.

PowerfulCYP3A4Inhibitors:Avoid combined use.

P-gpand moderateCYP3A4dual inhibitors:Avoid combined use.

Strong or moderateCYP3A4Inducers:Avoid combined use.

CertainP-gpsubstrates:MonitorP-gpsubstrates for adverse reactions when used concomitantly with neratinib where minimal concentration changes may result in serious adverse reactions.

8. Use among specific groups of people

Lactation period:It is recommended that women not breastfeed.

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