Cosela

About Trilaciclib

• Trilaciclib, also known as G1T28, received FDA approval on February 12, 2021. It acts as a CDK4 and CDK6 inhibitor, aiming to decrease the incidence of chemotherapy-induced myelosuppression in patients undergoing topotecan-containing regimens or CDK4 and CDK6 inhibitors. 
• By targeting these kinases, Trilaciclib injection works to protect bone marrow cells from the harmful effects of chemotherapy, thereby reducing myelosuppression. 
• While clinical trials have shown promising results in maintaining immune function and minimizing adverse events, further phase III trials are necessary to assess survival outcomes and quality of life improvements conclusively. 
• The success rate in patients treated with Trilaciclib has been encouraging, with potential benefits observed in reducing myelosuppression and enhancing patient outcomes during chemotherapy. 
• However, more extensive clinical trials are required to establish its efficacy conclusively and determine its impact on patient survival and quality of life.

Strength: 

• The strength of Trilaciclib is a single-dose vial containing a lyophilized cake with 300 mg of the medication.

Recommended Dosage:

Parenteral drug products such as COSELA must be visually inspected for particulate matter and discoloration prior to administration. Reconstitute each 300 mg vial with 19.5 mL of either 0.9% Sodium Chloride Injection, USP, or 5% Dextrose Injection, USP to achieve a concentration of 15 mg/mL. 

Swirl gently until dissolved, then inspect for clarity and color. The unused reconstituted solution can be stored at room temperature for up to 4 hours before dilution into an intravenous infusion bag. Dilute to a final concentration between 0.5 mg/mL and 3 mg/mL, mix gently, and store the diluted solution according to specified limits. Refrigeration or freezing is not recommended.

• The recommended dosage of COSELA injection is 240 mg/m2 per dose, administered as a 30-minute intravenous infusion completed within 4 hours prior to the start of chemotherapy on each chemotherapy day. 
• The interval between doses should not exceed 28 hours on consecutive days. In the event of a missed dose, chemotherapy should be discontinued for the day. 
• Both COSELA and chemotherapy can be resumed on the next scheduled chemotherapy day. If the treatment is discontinued, chemotherapy should be paused for 96 hours before resuming treatment.

Important:

Before starting Cosela, discuss your current medications, medical conditions, pregnancy status, or breastfeeding intentions with your healthcare provider to assess potential interactions and customize a safe treatment plan. Report any side effects promptly and seek personalized guidance from your doctor for any concerns or questions about Cosela or your treatment regimen.

Warnings & Precautions

• COSELA is contraindicated in patients with a history of serious hypersensitivity reactions to trilaciclib, which may include anaphylaxis. 
• Injection-site reactions, including phlebitis and thrombophlebitis, should be monitored during infusion, with discontinuation of the drug recommended for severe or life-threatening reactions. 
• Acute drug hypersensitivity reactions, such as edema, urticaria, pruritus, and anaphylaxis, should be monitored, with the medicine withheld for moderate reactions and permanently discontinued for severe or life-threatening ones. 
• Use caution with certain OCT2, MATE1, and MATE-2K substrates to avoid potential serious or life-threatening toxicities due to minimal concentration changes. 
• Patients treated with CDK4/6 inhibitors like COSELA should be monitored for pulmonary symptoms indicative of interstitial lung disease (ILD)/pneumonitis, with interruption and evaluation of new or worsening symptoms and permanent discontinuation in cases of recurrent symptomatic or severe/life-threatening ILD/pneumonitis. 
• Additionally, COSELA can cause embryo-fetal toxicity, necessitating patient counseling regarding the potential risk to a fetus and the importance of effective contraception use.

Common Cosela Side Effects:

• Fatigue
• Hypocalcemia
• Hypokalemia
• Hypophosphatemia
• Increased aspartate aminotransferase
• Headache
• Pneumonia

Use in Specific Population

• COSELA carries a risk of fetal harm when given to pregnant women due to its mechanism of action. However, there is insufficient data to evaluate potential. 
• There is no data available on the presence of trilaciclib in human or animal milk, its effects on breastfeeding infants, or its impact on milk production. 
• Due to the potential for serious adverse reactions in breastfed infants, lactating women should be advised not to breastfeed while taking the medicine and for at least 3 weeks after the final dose. 
• Pregnancy testing is recommended for females of reproductive potential before starting the treatment, as it can cause fetal harm if administered during pregnancy. 
• Effective contraception should be used by female patients of reproductive age during the treatment and for at least 3 weeks after the last dose to prevent pregnancy. 
• While no human studies have evaluated the effects on fertility, animal studies suggest it may impair fertility in females. 
• The safety and effectiveness in pediatric patients have not been established, and it is not recommended for use in patients with moderate or severe hepatic impairment. 
• Dosage adjustment is not necessary for patients with mild hepatic impairment.

Storage and Handling

• Store Cosela at 2°C to 8°C (36°F to 46°F)
• Keep the medicine protected from moisture.
• Do not freeze the medicine. 
• Keep the medicine away from pets and children.