Cosela (Trilaciclib) – ES-SCLC | HongKong DengYue Medicine

Cosela Application Scope

Cosela is an intravenous CDK4/6 inhibitor used to reduce chemotherapy-induced myelosuppression in adults with extensive-stage small cell lung cancer (ES-SCLC).

Characteristics

• Ingredients: Trilaciclib (as trilaciclib dihydrochloride)

• Properties:

  • Reversible inhibitor of cyclin-dependent kinases CDK4 and CDK6

  • Temporarily arrests hematopoietic stem and progenitor cells in G1 phase (~16 hours)

  • Protecting bone marrow during chemotherapy

• Packaging Specification: Lyophilized powder in single-dose vials containing 300 mg trilaciclib

• Storage: Store at 20 °C–25 °C (68 °F–77 °F), protected from light and moisture

• Expiry Date: 24 months from the manufacture date

• Executive Standard: Meets FDA labeling requirements under NDA 214200

• Approval Number: FDA NDA 214200 (approved February 12, 2021)

• Date of Revision: Most recent label update: February 2021

• Manufacturer: G1 Therapeutics, Inc. (USA); marketed in China by Simcere Zaiming

Guidelines for the Use of Cosela

• Dosage and Administration:

  • Administer 240 mg/m² via 30-minute IV infusion within 4 hours before each chemo day

  • Max dose interval between days: 28 hours; skip chemo if dose missed

  • Hepatic impairment (moderate/severe): Reduce dose to 170 mg/m²

• Adverse Reactions:

  • Common (≥10%):

    • fatigue, hypocalcemia, hypokalemia, hypophosphatemia

    • elevated AST, headache, pneumonia

  • More serious:

    • injection-site reactions, hypersensitivity

    • interstitial lung disease/pneumonitis

• Contraindications: History of serious hypersensitivity to trilaciclib

• Precautions:

  • Monitor for infusion-site reactions, lung symptoms

  • hypersensitivity, fetal harm—advise contraception

Cosela Interactions

• Drug Interactions:

  • Avoid with substrates of OCT2, MATE1, MATE-2K

  • Where small changes could be serious

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.