Savolitinib(赛沃替尼片)

Introduction of Savolitinib

Savolitinib Tablets is China's first approved selective MET inhibitor, which was granted conditional approval in June 2021.

Indications

Savolitinib is a targeted therapy for specific types of lung cancer, which is mainly indicated for the treatment of patients with advanced non-small cell lung cancer (NSCLC) who harbor MET exon 14 skipping alterations and have an unsatisfactory response to conventional chemotherapy.

Overview

Dosage and Administration

Recommended Dosage

1.For patients with a body weight of 50 kg or above, the recommended dosage is 600mg once daily, administered continuously until disease progression or intolerable adverse reactions that preclude further treatment.

2.For patients with a body weight of less than 50 kg, the recommended dosage is 400mg once daily, also to be taken continuously until disease progression or unacceptable drug reactions.

Administration Management

It is recommended to take the medication immediately after a meal at a fixed time each day, such as consistently after breakfast, lunch, or dinner. This helps maintain a stable plasma drug concentration.

During treatment, physicians will continuously monitor the patient's condition and adjust the treatment plan flexibly based on the individual’s response to the drug (e.g., severity of adverse reactions, tolerability). Possible measures include temporary treatment suspension, dosage reduction, or permanent discontinuation of the medication.

Contraindications

This product is contraindicated in the following populations:

1.Individuals with a history of severe allergic reactions to this medication, or those with a hypersensitive constitution to any component of the medication;

2.Pregnant women and lactating females.

Adverse Reactions

Hepatotoxicity: This medication may impair liver function. According to clinical trial data:

Approximately 0.3% of patients (equivalent to 1 case per 300 patients) developed life-threatening liver injury;

The average time to onset of liver-related adverse events after the initial dose was 31 days (ranging from 1 day to more than 1 year);

Liver function returned to normal in most patients following hepatoprotective therapy or dosage adjustment.

Severe Hypersensitivity Reactions: Two specific types of reactions require close monitoring:

Influenza-like symptoms: Some patients may develop cold-like symptoms such as fever and chills around three weeks after medication administration;

Hypersensitivity syndrome: Manifestations may include skin rash, joint pain, and abnormal blood routine results, which usually occur within one month after the start of treatment.

Use in Special Populations

Pregnant women, women planning pregnancy, and lactating women must note the following: they should voluntarily inform the physician of their pregnancy or lactation status at the first medical consultation, strictly comply with the doctor’s instructions for prenatal examinations and drug concentration monitoring. Before breastfeeding, it is necessary to confirm the metabolic half-life of the drug in the body. Special vigilance should be paid to the potential impact of the drug on fetal development.

For more detailed drug information, please consult the official package leaflet.

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