Savolitinib is a targeted therapy for specific types of lung cancer, primarily indicated for patients with advanced non-small cell lung cancer (NSCLC) harboring MET exon 14 skipping alterations who have not responded adequately to conventional chemotherapy.
Indications
Savolitinib, a targeted anticancer agent, is indicated for adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring MET exon 14 skipping alterations, specifically applicable to the following populations:
Patients whose disease has progressed following platinum-containing chemotherapy regimens;
Patients who are unable to tolerate the adverse effects of conventional platinum-containing chemotherapy (e.g., severe nausea, renal impairment, etc.).
Key Medication Requirement: Positive MET exon 14 skipping alteration must be confirmed via reliable diagnostic testing methods prior to administration.
Dosage Form and Strength
Tablets: 100 mg, 200 mg
Dosage and Administration
Medical Supervision: This medication must be prescribed and administered under the guidance of specialist physicians with experience in cancer treatment. Patients shall strictly adhere to the physician’s instructions and must not formulate their own dosing regimens based solely on this package insert.
Dosing Regimen
Patients with body weight ≥ 50 kg: 600 mg once daily;
Patients with body weight < 50 kg: 400 mg once daily.
Administration Method: It is recommended to take the medication immediately after meals at a fixed time each day to maintain stable plasma drug concentrations.
Duration of Treatment: Continue administration until disease progression or the onset of intolerable severe adverse reactions.
Dose Adjustment: During treatment, physicians will flexibly adjust the regimen based on the patient’s individual response (e.g., severity of adverse reactions, physical tolerance). Adjustment measures may include temporary treatment interruption, dose reduction, or permanent discontinuation.
Note: Package inserts for the same drug produced by different manufacturers may contain discrepancies. In case of conflicting dosing instructions, consult a physician or licensed pharmacist immediately.
Contraindications
Patients with a history of severe hypersensitivity reactions to savolitinib or any of its excipients;
Patients with allergic diathesis;
Pregnant women and lactating women.
Precautions for Use (Special Populations Requiring Caution)
Patients with allergic diathesis (e.g., frequent allergies to pollen, dust mites, or certain foods);
Patients receiving antidiabetic drugs such as metformin;
Patients concurrently taking other medications that may induce cardiac arrhythmias.
Precautions for Cautionary Use
Conduct a detailed review of the patient’s allergy history and medication history prior to administration;
Monitor heart rate at a fixed time daily during treatment;
Carry antiallergic medications at all times for emergency use;
Seek immediate medical attention if abnormal symptoms such as skin rash or chest tightness occur.
Use in Special Populations
Pregnant Women, Women Planning Pregnancy, and Lactating Women
Voluntarily inform the treating physician of pregnancy or childbearing plans at the initial consultation;
Strictly follow the physician’s instructions for prenatal check-ups and drug concentration monitoring;
Confirm the drug’s elimination half-life in the body before resuming breastfeeding;
Exercise high vigilance regarding the potential risks of the drug on fetal development.
Drug Interactions
Potent metabolic enzyme inducers (e.g., rifampicin, carbamazepine): May reduce the plasma concentration of savolitinib by 55%–61%. Administration intervals of more than 4 hours are recommended, and the frequency of plasma drug concentration monitoring should be increased.
Herbal extracts (e.g., St. John's Wort preparations): Discontinue use 3 weeks prior to savolitinib administration, as co-administration may interfere with drug metabolism and cause fluctuations in therapeutic efficacy.
Cardiovascular system drugs (e.g., famotidine): May decrease the maximum plasma concentration of savolitinib by 21%. Adjust the medication interval and monitor electrocardiographic changes.
Antidepressant drugs (e.g., midazolam): May potentiate sedative effects. Reduce the dosage of hypnotics and avoid engaging in activities requiring fine motor skills (e.g., driving) during treatment.
Other Drugs
Antihypertensive agents: May enhance antihypertensive effects;
Anticoagulants: Increase the risk of bleeding;
Immunosuppressants: May affect drug distribution in the body.
Special Warning: Avoid consuming grapefruit juice during treatment. Patients taking other medications (including traditional Chinese medicines and health supplements) must inform their attending physician in advance.
Precautions
Clinical treatment regimens shall be individualized. Physicians will determine whether to combine savolitinib with other anticancer drugs based on the patient’s condition. For integrated traditional Chinese and Western medicine treatment, close monitoring by a specialist physician is required throughout the course, with timely regimen adjustments.
Maintain detailed records of all concurrent medications, including drug names, dosages, and administration times.
Conduct a comprehensive assessment of the patient’s health status before administration. Perform regular follow-up examinations during treatment to monitor therapeutic efficacy and safety.
Store the medication in a light-proof and moisture-proof place to maintain its stability. Do not arbitrarily substitute formulations from different dosage forms.
Missed Dose Management
If a dose is missed: If the next scheduled dose is not imminent, take the missed dose as soon as possible. If the missed dose is discovered when the next dose is approaching, skip the missed dose and resume the regular dosing schedule. Do not take a double dose to make up for the missed one.
Adverse Reactions
Hepatotoxicity
Clinical Manifestations: May impair liver function. Approximately 0.3% of patients may develop life-threatening liver injury. Hepatic-related adverse events occur at a median of 31 days after the first dose (range: 1 day to more than 1 year).
Special Populations: Patients with pre-existing hepatobiliary diseases, liver metastases, or abnormal liver function require a detailed risk assessment by a physician before treatment initiation.
Monitoring and Management: It is recommended to monitor liver function (transaminase and bilirubin levels) weekly during the initial phase of treatment, with the monitoring interval adjusted to every 2–3 weeks after 3 months. Most patients’ liver function can return to normal with hepatoprotective therapy or dose adjustment.
Severe Hypersensitivity Reactions
Clinical Manifestations
① Flu-like symptoms: Some patients may develop fever, chills, and other cold-like symptoms approximately 3 weeks after administration;
② Hypersensitivity syndrome: Skin rash, joint pain, abnormal blood test results, etc., may occur within 1 month of administration.
Warning Signs: Re-challenging with savolitinib after discontinuation due to hypersensitivity may trigger more severe reactions. Seek prompt medical attention if unexplained skin rash or persistent fever develops during treatment.
Management Protocol
① Discontinue the drug immediately and initiate antiallergic treatment (e.g., antihistamines, corticosteroids);
② If resumption of treatment is necessary, co-administer antiallergic medications and observe the patient in a hospital setting for 24 hours;
③ Patients with a history of severe hypersensitivity reactions must permanently discontinue savolitinib.
Discontinuation Indications
Contact a physician immediately if any of the following conditions occur, and the medical staff will determine whether to discontinue the drug and formulate subsequent management plans:
Yellowing of the skin or sclera (signs of jaundice);
Unexplained fever lasting more than 3 days;
Sudden dyspnea or severe skin rash.
