Anpani Anlotinib Fumarate Capsules

1. Indications and Usage
Unecritinib fumarate capsules are indicated for the treatment of adult patients with ROS1-positive locally advanced or metastatic non-small cell lung cancer (NSCLC).
2. Dosage and Administration
Recommended Dosage: The recommended dosage is 300 mg taken orally twice daily until disease progression or intolerance.
Administration: Capsules should be swallowed whole and can be taken with or without food.
Missed Dose: If a dose is missed, take it as soon as possible unless it is within 6 hours of the next scheduled dose. Do not double the dose. If vomiting occurs after administration, take the next dose at the regular time.
Dose Reduction: For intolerable adverse reactions, the dose may be reduced to 250 mg twice daily, and further to 200 mg twice daily. If 200 mg twice daily remains intolerable, permanently discontinue the drug.
3. Mechanism of Action
Unecritinib is a tyrosine kinase inhibitor (TKI) and a derivative of crizotinib. It works by inhibiting ROS1 kinase and other related kinases (such as MET and ALK), thereby blocking downstream signaling pathways involved in tumor cell proliferation and survival.
4. Safety and Warnings
Hepatotoxicity: Monitor liver function tests before initiating treatment and at least once monthly during treatment.
Interstitial Lung Disease/Pneumonitis: Discontinue the drug permanently if drug-related interstitial lung disease or pneumonitis occurs.
QT Prolongation and Bradycardia: Monitor electrocardiogram (ECG) and electrolytes. Permanent discontinuation is required for severe QTc prolongation or life-threatening bradycardia.
Visual/Retinal Toxicity: Monitor for visual disturbances and discontinue if severe visual loss occurs.
5. Adverse Reactions and Clinical Research
Common Adverse Reactions: The most common adverse reactions include gastrointestinal disorders (nausea, vomiting, diarrhea, constipation, abdominal pain), metabolic disorders (hypertriglyceridemia, hypercholesterolemia, hypocalcemia), cardiac disorders (bradycardia, QT prolongation), and visual abnormalities.
Hematologic Toxicity: Neutropenia and leukopenia are common adverse events that may lead to treatment interruption.
6. Drug Interactions
CYP3A4 Inducers: Strong inducers (e.g., rifampin, phenytoin, carbamazepine) may decrease unecritinib plasma concentrations and reduce efficacy; avoid concomitant use.
CYP3A4 Inhibitors: Strong inhibitors (e.g., ketoconazole, clarithromycin, grapefruit juice) may increase unecritinib plasma concentrations and toxicity; avoid concomitant use.
CYP3A4 Substrates: Unecritinib is a weak inhibitor of CYP3A4; caution is advised when co-administering with narrow therapeutic index CYP3A4 substrates.
7. Pharmaceutical Information
Composition: The active ingredient is unecritinib fumarate.
Appearance: The capsules contain white or off-white powder.
Storage: Store at controlled room temperature and protect from moisture.