Cosela

Cosela (Trilaciclib) is currently the only drug in the world that comprehensively prevents chemotherapy-induced myelosuppression (CIM). It was approved by the US FDA in February 2021 and has not yet been approved for marketing in China.

Cosela (Trilaciclib) is listed as the first standard therapy recommended for myelosuppression prevention before chemotherapy in patients with small cell lung cancer in the latest 2021 V3 version of the NCCN Guidelines.

Common name: trilaciclib

Trade name: Cosela

All names: Cosela, trilaciclib

Indications:

To reduce the incidence of myelosuppression induced by chemotherapy before platinum/etoposide-containing regimens or topotecan-containing regimens in adult patients with extensive-stage small cell lung cancer (ES-SCLC).

Usage and Dosage:

COSELA is for intravenous use only.

The recommended dose of COSELA is 240 mg/m2 as a 30-minute intravenous infusion within 4 hours before starting chemotherapy each day.

Strength:

300 mg/vial

Adverse Reactions:

The most common adverse reactions (incidence ≥10% of patients compared with placebo ≥2%) are fatigue, hypocalcemia, hypokalemia, hypophosphatemia, increased aspartate aminotransferase, headache and pneumonia.

Contraindications:

Patients with a history of severe allergic reaction to COSELA.

Precautions:

Injection site reactions, including phlebitis and thrombophlebitis:

Monitor for signs and symptoms of injection site reactions, including phlebitis and thrombophlebitis, during the infusion. Stop the infusion and permanently discontinue COSELA to avoid serious or life-threatening reactions.

Acute Drug Hypersensitivity: Monitor for signs and symptoms of acute drug hypersensitivity, including edema (face, eyes, and tongue), urticaria, pruritus, and anaphylaxis.

Do not use COSELA for moderate reactions, and permanently discontinue use for severe or life-threatening reactions.

Interstitial Lung Disease (ILD)/Pneumonitis: Patients receiving CDK4/6 inhibitors should be monitored for pulmonary symptoms of ILD/pneumonitis. Interrupt and evaluate new patients or worsening symptoms suspected to be due to ILD/pneumonitis.

COSELA should be permanently discontinued in patients with recurrent symptoms or severe/life-threatening ILD/pneumonitis.

Embryo-fetal toxicity: Can cause fetal harm. Advise patients with potential fetal risks and to use effective contraception.

Storage:

Store COSELA vials at 20°C to 25°C (68°F to 77°F); Allow to drift to 15°C to 30°C (59°F to 86°F)

Mechanism of Action:

Trilaciclib is a transient inhibitor of CDK 4 and 6. Hematopoietic stem and progenitor cells (HSPCs) in the bone marrow give rise to circulating neutrophils, RBCs, and platelets. HSPC proliferation depends on CDK4/6 activity.

Safety and Efficacy:

In clinical trials, Trilaciclib significantly reduced chemotherapy-induced bone marrow suppression. Patients who received this treatment also had fewer dose delays, reductions, infections, hospitalizations, and the need for rescue therapy than those who received chemotherapy alone.