Qixinke Ilunocitinib Tablets

1. Indications and Usage
Non-Small Cell Lung Cancer: Treatment of patients with ALK-positive locally advanced or metastatic non-small cell lung cancer (NSCLC) who have progressed on or are intolerant to crizotinib.
2. Dosage and Administration
Route of Administration: Oral administration ONLY.
Recommended Dosage:
Days 1-7: 60 mg once daily.
Day 8 onwards: 180 mg once daily, if tolerated.
Duration: Continue until disease progression or unacceptable toxicity.
Critical Administration Instructions:
Swallowing: Tablets must be swallowed whole; do not crush, split, or chew.
Dietary Impact: Can be taken fasting or with food. The daily dosing time should be roughly fixed.
Missed Dose: If a missed dose occurs within 8 hours, take it as soon as possible. If >8 hours have passed, skip the dose and resume the regular schedule.
Vomiting: If vomiting occurs after taking a dose, do not take an extra dose; resume the next day at the regular time.
Dose Reduction: If unable to tolerate 180 mg, reduce to 120 mg, then 90 mg. If unable to tolerate 90 mg (or 60 mg in the initial phase), permanently discontinue the drug.
3. Mechanism of Action
ALK Inhibition: Iruplinalib is a selective and potent inhibitor of the anaplastic lymphoma kinase (ALK) tyrosine kinase.
Tumor Suppression: It inhibits the proliferation and metastasis of tumor cells by blocking ALK kinase activity.
Mutation Resistance: It exhibits significant inhibitory activity against common ALK resistance mutants, providing effective targeted therapy for NSCLC.
4. Safety and Warnings
Hypersensitivity: Contraindicated in patients with known hypersensitivity to iruplinalib or any excipients.
Hepatotoxicity: Abnormal liver function tests (elevated ALT, AST, and bilirubin) may occur. Liver function should be monitored regularly.
ILD/Pneumonitis: Interstitial lung disease (ILD) or pneumonitis may occur and requires vigilant monitoring.
Pregnancy and Lactation: Can cause fetal harm. Women of reproductive potential and male partners must use effective contraception during treatment and for at least 3 months after the last dose.
5. Adverse Reactions and Clinical Research
Most Common Adverse Reactions: Hypercholesterolemia, hypertriglyceridemia, hypertension, nausea, rash, diarrhea, vomiting, hyperuricemia, and liver function abnormalities.
Clinical Research Highlights: Clinical data indicate that most adverse reactions are Grade 1-2 (>3% Grade 3/4 events), and most can be managed through dose reduction or interruption.
6. Drug Interactions
CYP3A4 Modulators: CYP3A4 is the main enzyme mediating iruplinalib metabolism.
Strong Inducers (e.g., rifampicin): May decrease iruplinalib plasma concentrations.
Strong Inhibitors (e.g., fluconazole, clarithromycin, lopinavir): May increase iruplinalib plasma concentrations.
CYP and Transporter Substrates: Iruplinalib may alter plasma concentrations of co-administered CYP3A4, CYP2B6, CYP2C8 substrates and P-gp/BCRP/MATE1/MATE2-K substrates.
7. Pharmaceutical Information
Chemical Composition: Active Ingredient: Iruplinalib.
Appearance: Tablets (available in 30 mg and 60 mg strengths).
Packaging: Blister packaging.
Storage: Store at room temperature (specific storage conditions may vary by manufacturer); protect from moisture.