Unecritinib Fumarate Capsules | Lung Cancer

  • Generic Name/Brand Name: Unecritinib Fumarate Capsules / Amberni
  • Indications: Non-small cell lung cancer (NSCLC)
  • Dosage Form: Capsules
  • Specification: Each capsule contains 100 mg or 125 mg of unecritinib fumarate.
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Unecritinib Fumarate Capsules Application Scope

Indicated for the treatment of adult patients with advanced or metastatic non-small cell lung cancer (NSCLC) that is ROS1-positive.

Unecritinib Fumarate Capsules
Unecritinib Fumarate Capsules

 

Unecritinib Fumarate Capsules Characteristics

  • Ingredients: Active ingredient: unecritinib fumarate. Inactive ingredients: microcrystalline cellulose, anhydrous dibasic calcium phosphate, croscarmellose sodium, silicon dioxide, hydrogenated castor oil, and hypromellose capsule shells.

  • Properties: It is a small molecule tyrosine kinase inhibitor targeting ROS1, ALK, and c-Met.

  • Specification: Each capsule contains 100 mg or 125 mg of unecritinib fumarate.

  • Packaging Specification: Bottles containing 30 capsules.

  • Storage: Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F). Store in the original container and keep the bottle tightly closed to protect from moisture.

  • Expiry Date: Refer to the packaging for the expiration date.

  • Executive Standard: Complies with the standards approved by the National Medical Products Administration of China.

  • Approval Number: Specific approval number not provided.

  • Date of Revision: Not specified.

  • Manufacturer: Not specified.

Guidelines For The Use Of Unecritinib Fumarate Capsules

 

  • Dosage and Administration: The recommended dosage is 100 mg or 125 mg orally once daily. Capsules may be administered whole or may be used to prepare an oral suspension.

  • Adverse Reactions: Common adverse reactions include hepatotoxicity and hematotoxicity. The incidence of grade 3 and higher adverse events is low, with no treatment-related deaths reported.

  • Contraindications: Known hypersensitivity to it or any of its excipients.

  • Precautions: Monitor liver function and blood counts regularly during treatment. Adjust dosage or discontinue use if severe adverse reactions occur.

Unecritinib Fumarate Capsules Interactions

Drug Interactions: Concomitant use with strong CYP3A inhibitors or inducers may affect its plasma concentrations. Adjustments in dosing or monitoring may be necessary.

 

Note:

  • If there is a new packaging for the drug, the new packaging shall prevail. The above information is sourced from HongKong 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.
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