Iruplinalkib Application Scope

For adult patients (≥ 18 years) with ALK‑positive, locally advanced or metastatic NSCLC, including those who have progressed on or are intolerant to crizotinib. Currently approved in China (NMPA) for both second-line and first-line therapy.

Iruplinalkib Characteristics

Ingredients:
Active: Iruplinalkib (molecular formula C₂₉H₃₈ClN₆O₂P; CAS 1854943‑32‑0)
Properties:
Orally active, selective ALK/ROS1 TKI with potent anticancer activity in ALK‑positive NSCLC
Packaging Specification: Film-coated tablets. Dosage forms include initiation lead-in at 60 mg daily for 7 days, followed by 180 mg daily maintenance; marketed packaging likely mirrors this regimen .
Storage: Powder form: –20 °C (stable for ~3 years); in solution: –80 °C (stable for ~1 year)
Expiry Date: Printed on packaging; stability ~3 years at –20 °C (powder)
Executive Standard: Adheres to NMPA-approved standards; clinical data published in peer-reviewed literature
Approval Number: NMPA approval: June 28, 2023, for second-line use; first-line accepted Jan 2024 (NMPA review)
Date of Revision: Label/data updated through 2024 (e.g., WCLC 2024, BMC 2023)
Manufacturer: Qilu Pharmaceutical Co., Ltd. (Jinan, China)

Guidelines for the Use of Iruplinalkib

Dosage and Administration:
- Lead-in: 60 mg orally once daily for 7 days
- Maintenance: 180 mg orally once daily in 21‑day cycles.
Adverse Reactions:
- TRAEs in ~92–93% of patients.
- Common: elevated AST/ALT (43.2%/37.0%), increased CPK (34.9%), hypercholesterolemia (33.6%), hypertriglyceridemia (26.7%), hypertension (17.8%).
- Grade 3–4 TRAEs: ~30.8%; dose interruptions (14.4%), reductions (11%), discontinuations (2.7%).
Contraindications:
Not explicitly listed; use caution in history of interstitial lung disease, liver/pancreatic dysfunction, uncontrolled hypertension.
Precautions:
Monitor liver enzymes, lipid profiles, blood pressure, signs of pneumonitis. Dose reductions to 120 mg or 90 mg are allowed for toxicity. Use lead-in to reduce risk of early pulmonary events.

Iruplinalkib Interactions

Drug Interactions: (Not explicitly detailed in literature; typical TKI considerations apply.)
Avoid concomitant strong CYP3A inducers/inhibitors. Monitor effects with lipid‑modifying agents and antihypertensives.

Note:

If there is a new packaging for the drug, the new packaging shall prevail. The above information is sourced from DengYue Medicine.
It is only for internal discussion among medical staff and does not serve as a basis for medication. For specific medication guidelines, please consult the attending physician.