Unecritinib Fumarate – NSCLC | DengYue Medicine

Unecritinib Fumarate Application Scope

Unecritinib fumarate is a kinase inhibitor prodrug used in the treatment of ROS1-positive NSCLC, which rapidly hydrolyzes to crizotinib in vivo to exert therapeutic effects.

Characteristics

• Ingredients: Unecritinib Fumarate

• Properties:

  • Molecular formula: C₂₃H₂₄Cl₂FN₅O₂·C₄H₄O₄

  • Molecular weight: 608.45

  • Appearance: Capsule form

• Packaging Specification: Available in 0.1 g and 0.125 g per capsule

• Storage: Store below 30°C in a dry place, protected from light and moisture

• Expiry Date: Typically 24 months from manufacturing (check packaging for exact date).

• Executive Standard:

  • Complies with Chinese Pharmacopoeia (ChP)

  • NMPA (National Medical Products Administration) regulations

• Approval Number: Refer to the specific drug packaging for the NMPA approval number.

• Date of Revision: Last updated: May 10, 2024

• Manufacturer: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Guidelines for the Use of Unecritinib Fumarate

• Dosage and Administration:

  • Recommended dose: 300 mg twice daily (taken with or without food)

  • Must be prescribed by an oncologist experienced in NSCLC treatment

• Adverse Reactions:

  • Common: Nausea, vomiting, diarrhea, fatigue, elevated liver enzymes.

  • Serious: Severe hepatotoxicity, QT prolongation, interstitial lung disease (monitor closely)

• Contraindications:

  • Hypersensitivity to Unecritinib or any excipients.

  • Severe hepatic or renal impairment.

  • Pregnancy and breastfeeding (teratogenic risk)

• Precautions:

  • Regular liver function tests and ECG monitoring are required.

  • Avoid concomitant use with strong CYP3A inhibitors/inducers

Unecritinib Fumarate Interactions

• Drug Interactions:

  • CYP3A4 inhibitors (e.g., ketoconazole): May increase Unecritinib exposure.

  • CYP3A4 inducers (e.g., rifampin): May reduce efficacy

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.