Pyrotinib Maleate is an oral targeted therapy drug primarily indicated for the treatment of HER2-positive breast cancer. Administration must be strictly in accordance with medical advice. Attention should be paid to dosage adjustment, adverse effect monitoring, contraindications, and drug interactions. Do not adjust the dosage or discontinue the medication without authorization. The detailed usage instructions are as follows:
I. Indications and Medication Specifications
Target Population
Patients diagnosed with advanced or metastatic HER2-positive breast cancer, who usually require combination therapy with other agents (e.g., capecitabine).
Dosage and Administration
The standard dosage is 400 mg once daily, taken after meals.
If a dose is missed and the time elapsed is still within the same day’s dosing window, take the missed dose as soon as possible. Otherwise, skip the missed dose and resume the regular dosing schedule the next day.
Patients with abnormal liver or kidney function need dosage adjustment under the guidance of a physician.
II. Precautions
Common Adverse Effects
Diarrhea: May be severe; timely fluid replacement or administration of antidiarrheal medications is required.
Hand-Foot Syndrome: Manifested as erythema, swelling, and desquamation of the hands and feet; maintain clean and moist skin.
Other Effects: Skin rash, oral ulcers, fatigue, etc. Seek medical attention promptly if symptoms worsen.
Severe Adverse Effects
Interstitial Lung Disease: Discontinue the medication immediately and seek medical care if dyspnea or persistent cough occurs.
Hepatic Injury: Monitor liver function regularly. Prompt management is needed if jaundice or abdominal pain develops.
III. Contraindications and Populations Requiring Caution
Contraindicated Populations
Individuals hypersensitive to any component of the drug.
Pregnant or lactating women (may cause fetal malformation).
Populations Requiring Caution
Patients with moderate to severe hepatic or renal impairment.
Patients with underlying cardiac diseases or a history of pulmonary disorders.
IV. Drug Interactions
Avoid co-administration with potent CYP3A4 inhibitors (e.g., ketoconazole) or inducers (e.g., rifampicin), as these may affect drug efficacy or increase toxicity.
Close monitoring is required when co-administering with anticoagulants, antiarrhythmic drugs, and other medications of the kind.
V. Storage and Follow-up Visits
Storage Conditions
Store in a cool, dry place protected from light, with the temperature not exceeding 30℃.
Follow-up Requirements
Undergo imaging examinations and blood tests every 2–3 months during treatment to evaluate treatment efficacy and safety.
Compliance with the prescribed dosage regimen is critical to treatment success. Do not discontinue the medication or modify the treatment plan without authorization even if symptoms improve. In case of any abnormal reactions, contact the attending physician in a timely manner to adjust the treatment plan.
