Trilacicilib
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Parth Vikram Singh, MBBS[2]
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Overview
Trilacicilib is a kinase inhibitor that is FDA approved for the treatment of chemotherapy-induced myelosuppression in adult patients when administered prior to a platinum/etoposide-containing regimen or topotecan-containing regimen for extensive-stage small cell lung cancer.. Common adverse reactions include fatigue, hypocalcemia,hypokalemia,hypophosphatemia, aspartate aminotransferase increased, headache, and pneumonia..
Adult Indications and Dosage
FDA-Labeled Indications and Dosage (Adult)
COSELA is a kinase inhibitor indicated to decrease the incidence of chemotherapy-induced myelosuppression in adult patients when administered prior to a platinum/etoposide-containing regimen or topotecan-containing regimen for extensive-stage small cell lung cancer.
- COSELA is for intravenous use only.
- The recommended dose of COSELA is 240 mg/m2 as a 30-minute intravenous infusion completed no more than 4 hours prior to the start of chemotherapy on each day chemotherapy is administered.
- Reduce dose in patients with moderate or severe hepatic impairment.
- See Full Prescribing Information for instructions on preparation and administration.
- DOSAGE FORMS AND STRENGTHS
For injection: 300 mg of trilaciclib as a lyophilized cake in a single-dose vial.
Off-Label Use and Dosage (Adult)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Trilacicilib in adult patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Trilacicilib in adult patients.
Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
There is limited information regarding Trilacicilib FDA-Labeled Indications and Dosage (Pediatric) in the drug label.
Off-Label Use and Dosage (Pediatric)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Trilacicilib in pediatric patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Trilacicilib in pediatric patients.
Contraindications
- COSELA is contraindicated in patients with a history of serious hypersensitivity reactions to trilaciclib. Reactions have included anaphylaxis
Warnings
Injection-Site Reactions, Including Phlebitis and Thrombophlebitis
- COSELA administration can cause injection-site reactions including phlebitis and thrombophlebitis. Injection-site reactions including phlebitis and thrombophlebitis occurred in 56 (21%) of 272 patients receiving COSELA in clinical trials, including Grade 2 (10%) and Grade 3 (0.4%) adverse reactions (ARs). The median time to onset from start of COSELA was 15 days (range 1 to 542) and from the preceding dose of COSELA was 1 day (1 to 15).The median duration was 1 day (range 1 to 151 for the resolved cases). Injection-site reactions including phlebitis and thrombophlebitis resolved in 49 (88%) of the 56 patients and led to discontinuation of treatment in 3 (1%) of the 272 patients.
- Monitor patients for signs and symptoms of injection-site reactions, phlebitis, and thrombophlebitis, including infusion-site pain and erythema during infusion. For mild (Grade 1) to moderate (Grade 2) injection-site reactions, flush line/cannula with at least 20 mL of sterile 0.9% Sodium Chloride Injection, USP or 5% Dextrose Injection, USP after end of infusion. For severe (Grade 3) or life-threatening (Grade 4) injection-site reactions, stop infusion and permanently discontinue COSELA.
Acute Drug Hypersensitivity Reactions
- COSELA administration can cause acute drug hypersensitivity reactions, including facial edema and urticaria. Acute drug hypersensitivity reactions occurred in 16 (6%) of 272 patients receiving COSELA in clinical trials, including Grade 2 reactions (2%). One patient experienced a Grade 2 anaphylactic reaction 4 days after receiving COSELA, which resolved with epinephrine, and treatment with COSELA was continued. The median time to onset from start of COSELA was 77 days (range 2 to 256) and from the preceding dose of COSELA was 1 day (range 1 to 28). The median duration was 6 days (range 1 to 69 for the resolved cases). Acute drug hypersensitivity reactions resolved in 12 (75%) of the 16 patients.
- Monitor patients 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, stop infusion and hold COSELA until the adverse reaction recovers to Grade ≤1. For severe (Grade 3) or life-threatening (Grade 4) acute drug hypersensitivity reactions, stop infusion and permanently discontinue COSELA [see Dosage and Administration (2.2)].
Interstitial Lung Disease/Pneumonitis
- Severe, life-threatening, or fatal interstitial lung disease (ILD) and/or pneumonitis can occur in patients treated with cyclin-dependent kinases (CDK)4/6 inhibitors, the same drug class as COSELA. ILD/pneumonitis occurred in 1 (0.4%) of 272 patients receiving COSELA in clinical trials. The adverse reaction was Grade 3 and reported 2 months after discontinuing COSELA, in a patient receiving a confounding medication. The adverse reaction did not resolve.
- Monitor patients for pulmonary symptoms indicative of ILD/pneumonitis such as cough, dyspnea, and hypoxia. For recurrent moderate (Grade 2) ILD/pneumonitis, permanently discontinue COSELA. For severe (Grade 3) or life-threatening (Grade 4) ILD/pneumonitis, permanently discontinue COSELA.
Embryo-Fetal Toxicity
Based on its mechanism of action, COSELA can cause fetal harm when administered to a pregnant woman. Females of reproductive potential should use an effective method of contraception during treatment with COSELA and for at least 3 weeks after the final dose.
Adverse Reactions
Clinical Trials Experience
There is limited information regarding Trilacicilib Clinical Trials Experience in the drug label.
Postmarketing Experience
There is limited information regarding Trilacicilib Postmarketing Experience in the drug label.
Drug Interactions
There is limited information regarding Trilacicilib Drug Interactions in the drug label.
Use in Specific Populations
Pregnancy
Pregnancy Category (FDA):
There is no FDA guidance on usage of Trilacicilib in women who are pregnant.
Pregnancy Category (AUS):
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Trilacicilib in women who are pregnant.
Labor and Delivery
There is no FDA guidance on use of Trilacicilib during labor and delivery.
Nursing Mothers
There is no FDA guidance on the use of Trilacicilib in women who are nursing.
Pediatric Use
There is no FDA guidance on the use of Trilacicilib in pediatric settings.
Geriatic Use
There is no FDA guidance on the use of Trilacicilib in geriatric settings.
Gender
There is no FDA guidance on the use of Trilacicilib with respect to specific gender populations.
Race
There is no FDA guidance on the use of Trilacicilib with respect to specific racial populations.
Renal Impairment
There is no FDA guidance on the use of Trilacicilib in patients with renal impairment.
Hepatic Impairment
There is no FDA guidance on the use of Trilacicilib in patients with hepatic impairment.
Females of Reproductive Potential and Males
There is no FDA guidance on the use of Trilacicilib in women of reproductive potentials and males.
Immunocompromised Patients
There is no FDA guidance one the use of Trilacicilib in patients who are immunocompromised.
Administration and Monitoring
Administration
There is limited information regarding Trilacicilib Administration in the drug label.
Monitoring
There is limited information regarding Trilacicilib Monitoring in the drug label.
IV Compatibility
There is limited information regarding the compatibility of Trilacicilib and IV administrations.
Overdosage
There is limited information regarding Trilacicilib overdosage. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.
Pharmacology
There is limited information regarding Trilacicilib Pharmacology in the drug label.
Mechanism of Action
There is limited information regarding Trilacicilib Mechanism of Action in the drug label.
Structure
There is limited information regarding Trilacicilib Structure in the drug label.
Pharmacodynamics
There is limited information regarding Trilacicilib Pharmacodynamics in the drug label.
Pharmacokinetics
There is limited information regarding Trilacicilib Pharmacokinetics in the drug label.
Nonclinical Toxicology
There is limited information regarding Trilacicilib Nonclinical Toxicology in the drug label.
Clinical Studies
There is limited information regarding Trilacicilib Clinical Studies in the drug label.
How Supplied
There is limited information regarding Trilacicilib How Supplied in the drug label.
Storage
There is limited information regarding Trilacicilib Storage in the drug label.
Images
Drug Images
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Package and Label Display Panel
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Patient Counseling Information
There is limited information regarding Trilacicilib Patient Counseling Information in the drug label.
Precautions with Alcohol
Alcohol-Trilacicilib interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.
Brand Names
COSELA
Look-Alike Drug Names
There is limited information regarding Trilacicilib Look-Alike Drug Names in the drug label.
Drug Shortage Status
Price
References
The contents of this FDA label are provided by the National Library of Medicine.