Orpathys Savolitinib Tablets

1. Indications and Usage
Non-Small Cell Lung Cancer (NSCLC):
Indicated for the treatment of adult patients with locally advanced or metastatic NSCLC harboring MET exon 14 skipping alterations, who have progressed following platinum-based chemotherapy or who are intolerant to standard platinum-based chemotherapy.
Note: Treatment must be based on a validated test detecting MET exon 14 skipping positivity.
2. Dosage and Administration
Recommended Dosage (Weight-Based):
Patients ≥ 50 kg: 600 mg orally once daily.
Patients < 50 kg: 400 mg orally once daily.
Administration:
Swallow tablets whole with water. Take immediately after a meal at approximately the same time every day.
Dose Modifications:
Hepatotoxicity: Interrupt or discontinue based on severity of ALT/AST elevation.
Other Toxicities: Interrupt treatment for Grade ≥ 3 toxicities; resume at reduced dose upon recovery.
3. Mechanism of Action
MET Inhibition:
Savolitinib is a potent and highly selective Type Ib MET inhibitor.
Physiological Effect:
It binds to the active conformation of the MET kinase, inhibiting phosphorylation and downstream signaling pathways (such as PI3K/AKT and MAPK), thereby suppressing tumor cell proliferation, survival, and invasion.
4. Safety and Warnings
Hepatotoxicity:
Elevated transaminases (ALT/AST) and bilirubin have been reported. Monitor liver function tests (LFTs) before initiation and regularly during treatment.
Embryo-Fetal Toxicity:
May cause fetal harm. Females of reproductive potential must use effective contraception during treatment and for at least 1 month after the final dose. Males must use contraception during treatment and for 6 months after.
Phototoxicity:
Photosensitivity reactions may occur. Advise patients to use sunscreen and protective clothing.
5. Adverse Reactions
Most Common:
Nausea, edema (peripheral edema), fatigue, vomiting, decreased appetite, anemia, fever, diarrhea, and liver function abnormalities.
6. Drug Interactions
CYP3A4 Interaction:
Savolitinib is metabolized primarily by CYP3A4. Avoid concomitant use with strong CYP3A inhibitors or inducers.
Transporter Substrates:
Caution is advised when used with substrates of transporters (e.g., P-gp, BCRP).
7. Pharmaceutical Information
Chemical Composition:
Active Ingredient: Savolitinib.
Storage:
Store at room temperature. Keep in original package to protect from light and moisture.