Is Trilaciclib approved by the FDA?

Trilaciclib, marketed under the brand name Cosela, is a groundbreaking medication used to prevent bone marrow suppression in patients undergoing chemotherapy for small cell lung cancer. Trilaciclib was approved by the U.S. Food and Drug Administration (FDA) on February 12, 2021. This approval marked an important milestone, providing a new supportive care option for patients with small cell lung cancer undergoing chemotherapy.

Uses and Administration

Uses:

• Trilaciclib is specifically used to decrease the incidence of chemotherapy-induced myelosuppression (reduced bone marrow activity) in adult patients when administered prior to a platinum/etoposide-containing regimen or topotecan-containing regimen for extensive-stage small cell lung cancer.

Administration:

• The medication is given as an infusion into a vein, usually within four hours before the start of a chemotherapy session.
• The infusion must be administered slowly, taking at least 30 minutes to complete.

Precautions and Considerations

Before Taking Trilaciclib:

• Patients should inform their healthcare provider if they have any known allergies to trilaciclib.
• Trilaciclib may harm an unborn baby, so effective birth control is recommended during treatment and for at least three weeks after the last dose. Patients should notify their doctor if they become pregnant.
• Breastfeeding is not advised while using trilaciclib and for at least three weeks after the last dose.
• Patients with liver problems should discuss their condition with their doctor before starting treatment.

Potential Side Effects:

• Serious Side Effects: Pain, redness, warmth, itching, swelling, bruising, or skin changes at the injection site; fever, chills, cough with mucus; sudden chest pain, wheezing, dry cough, shortness of breath; low calcium or potassium levels.
• Common Side Effects: Low levels of calcium or potassium, headache, breathing problems, fatigue, and abnormal liver function tests.

Patients are encouraged to report any side effects to their healthcare provider or directly to the FDA at 1-800-FDA-1088.

Detailed Dosage Information

Usual Adult Dose for Chemotherapy Toxicity:

• 240 mg/m² administered intravenously over 30 minutes, completed within four hours before the start of chemotherapy.
• The interval between doses should not exceed 28 hours.

If a dose is missed, chemotherapy should be discontinued for that day, and both trilaciclib and chemotherapy can be resumed on the next scheduled chemotherapy day.

Conclusion

By mitigating the risk of bone marrow suppression, trilaciclib helps patients better tolerate chemotherapy, potentially improving their overall treatment experience and outcomes. As with any medication, it is crucial to discuss personal medical history and potential risks with a healthcare provider to ensure safe and effective use.

How to obtain the latest development progress of all drugs?

In the Synapse database, you can stay updated on the latest research and development advances of all drugs. This service is accessible anytime and anywhere, with updates available daily or weekly. Use the "Set Alert" function to stay informed. Click on the image below to embark on a brand new journey of drug discovery!