Authors

  1. Aschenbrenner, Diane S. MS, RN

Abstract

* Trilaciclib (Cosela) is approved to protect normal bone marrow cells from damage secondary to chemotherapy in adults receiving a platinum-etoposide chemotherapy regimen or a topotecan chemotherapy regimen for extensive-stage small cell lung cancer.

 

 

Article Content

Myelosuppression is an adverse effect of many chemotherapies and can result in anemia, leukopenia, neutropenia, and thrombocytopenia. The Food and Drug Administration (FDA) recently approved trilaciclib (Cosela) to protect normal bone marrow cells from damage secondary to chemotherapy. The drug is approved for use in adults receiving a platinum-etoposide chemotherapy regimen or a topotecan chemotherapy regimen for extensive-stage small cell lung cancer. (Extensive-stage small cell lung cancer is cancer that has spread far from the original tumor.)

 

Trilaciclib's effectiveness was determined in three randomized, double-blind, placebo-controlled trials with a total of 245 patients with extensive-stage small cell lung cancer. Patients received trilaciclib or placebo intravenously before chemotherapy. Compared with patients who received placebo, those who received trilaciclib had a lower chance of developing severe neutropenia. Those who did develop severe neutropenia experienced it for a shorter duration.

 

The most common adverse effects of trilaciclib treatment include fatigue, hypocalcemia, hypokalemia, hypophosphatemia, elevation of aspartate aminotransferase levels, headache, and pneumonia. Trilaciclib also carries warnings for acute hypersensitivity, injection site reactions (including phlebitis and thrombophlebitis), interstitial lung disease (which can be severe, life threatening, or fatal) and/or pneumonitis, and embryo-fetal toxicity. Other serious adverse effects noted in clinical trials include respiratory failure, hemorrhage, and thrombosis.

 

Trilaciclib is reconstituted prior to administration and then further diluted. Nurses should administer trilaciclib as an intravenous infusion over 30 minutes and no more than four hours before starting chemotherapy on each day chemotherapy is administered. The labeling provides advice on how long to store diluted trilaciclib and necessary steps for safe administration.

 

Nurses should monitor patients for adverse effects. Injection-site reactions can present as pain or erythema during infusion, phlebitis, or thrombophlebitis. For mild to moderate injection-site reactions, the line or cannula should be flushed with a minimum of 20 mL of normal saline or 5% dextrose. For severe or life-threatening reactions, the infusion should be stopped and trilaciclib therapy discontinued. Patients should be monitored for signs and symptoms of acute drug hypersensitivity reactions, including facial, eye, and tongue edema; urticaria; pruritus; and anaphylactic reactions. For moderate (grade 2) acute drug hypersensitivity reactions, the infusion should be paused until the adverse reaction subsides (to a grade of 1 or less). For severe (grade 3) or life-threatening (grade 4) hypersensitivity reactions, the infusion should be stopped, and the provider contacted regarding discontinuation of trilaciclib. Patients should be monitored for pulmonary symptoms indicative of interstitial lung disease and/or pneumonitis, such as cough, dyspnea, or hypoxia. For recurrent moderate reactions or episodes of severe to life-threatening reactions, the therapy should be discontinued. (For a review of the grading of adverse events, see https://ctep.cancer.gov/protocoldevelopment/electronic_applications/docs/CTCAE_v.) Women of reproductive age should be taught to use an effective method of birth control during treatment and for at least three weeks after the final trilaciclib dose.

 

For complete prescribing information for trilaciclib, go to http://www.accessdata.fda.gov/drugsatfda_docs/label/2021/214200s000lbl.pdf.