Pyrotinib is a small-molecule tyrosine kinase inhibitor (TKI), primarily indicated for the treatment of patients with HER2-positive breast cancer. Currently, its approved indication in China is as follows: in combination with capecitabine, for the treatment of patients with relapsed or metastatic HER2-positive breast cancer who have previously received trastuzumab therapy. This medication must be administered strictly in accordance with the doctor's instructions.
Detailed Indications and Administration Instructions
1. Patient Population
For patients with advanced or metastatic HER2-positive breast cancer who have experienced disease progression after prior trastuzumab (e.g., Herceptin) treatment.
Indicated for second-line or later-line therapy. HER2 status must be confirmed by pathological testing (immunohistochemistry 3+ or FISH positive).
2. Mechanism of Action
Pyrotinib irreversibly inhibits the tyrosine kinase activity of HER2, EGFR and other targets, blocking tumor cell proliferation signaling pathways and thereby inhibiting tumor growth.
3. Precautions for Administration
Must be used in combination with capecitabine. The specific dosage and treatment course shall be determined by the physician based on the patient's condition.
Liver function, electrocardiogram (ECG) and cardiac function (e.g., left ventricular ejection fraction) shall be evaluated prior to treatment.
Adverse reactions such as diarrhea, hand-foot syndrome and nausea may occur; preventive measures or symptomatic management should be implemented in advance.
4. Contraindications
Contraindicated in patients allergic to any component of the drug.
Contraindicated in pregnant and lactating women.
Patients with severe hepatic or renal insufficiency require careful evaluation.
Adverse Reactions and Management
Common adverse reactions include diarrhea (with a relatively high incidence), rash and oral ulcers. Physicians may recommend prophylactic use of antidiarrheal drugs.
For severe adverse reactions such as interstitial lung disease and cardiotoxicity, immediate discontinuation of the drug and medical attention are required.
Medical Guidance
Pyrotinib is a prescription-only medicine and must be used under the supervision of an oncologist. During treatment, patients need to regularly undergo imaging examinations and blood tests to evaluate treatment efficacy and safety. In case of severe adverse reactions or disease progression, patients should promptly contact their attending physician for treatment plan adjustment.
