Intravenous Extensive-stage small cell lung cancer
Adult: To decrease the incidence of chemotherapy-induced myelosuppression when administered before a platinum/etoposide-containing regimen or topotecan-containing regimen: 240 mg/m2 via infusion over 30 minutes to be completed within 4 hours before starting chemotherapy on each day chemotherapy is given. Dosing interval on sequential days should not be >28 hours. Slower infusion, dosing interruption, or discontinuation may be required according to individual safety or tolerability (refer to detailed product guidelines).
Hepatic Impairment
Moderate to severe: Not recommended.
Reconstitution
Reconstitute vial with 19.5 mL of NaCl 0.9% or dextrose 5% in water to obtain a concentration of 15 mg/mL. Swirl the vial gently for up to 3 minutes until the sterile lyophilised cake is completely dissolved; do not shake. To prepare the solution for infusion, withdraw the required volume from the vial(s) of reconstituted solution and further dilute in an infusion bag containing NaCl 0.9% or dextrose 5% in water to a final concentration of 0.5-3 mg/mL. Gently invert the infusion bag to mix; do not shake.
Contraindications
Hypersensitivity. Pregnancy and lactation.
Special Precautions
Moderate to severe hepatic impairment.
Adverse Reactions
Significant: Infusion site reactions (e.g. phlebitis, thrombophlebitis), acute hypersensitivity reactions (e.g. urticaria, pruritus, anaphylaxis; facial, eye, and tongue oedema). Gastrointestinal disorders: Upper abdominal pain. General disorders and administration site conditions: Fatigue, peripheral oedema. Investigations: Increased AST. Metabolism and nutrition disorders: Hypocalcaemia, hypokalaemia, hypophosphataemia, hyperglycaemia. Nervous system disorders: Headache. Respiratory, thoracic and mediastinal disorders: Pneumonia. Skin and subcutaneous tissue disorders: Rash. Vascular disorders: Thrombosis. Potentially Fatal: ILD and/or pneumonitis.
Patient Counseling Information
Women of childbearing potential must use proven birth control methods during therapy and for ≥3 weeks after stopping the treatment. Do not breastfeed during and for ≥3 weeks after stopping treatment.
Monitoring Parameters
Evaluate pregnancy status prior to initiating treatment in patients who may become pregnant. Monitor for signs and symptoms of infusion site reactions (e.g. pain, erythema), acute hypersensitivity reactions (e.g. urticaria, pruritus, anaphylaxis; facial, eye, and tongue oedema), and pulmonary symptoms associated with ILD/pneumonitis (e.g. cough, dyspnoea, hypoxia).
Drug Interactions
May increase the concentration or net accumulation of certain organic cation transporter (OCT) 2, multidrug and toxin extrusion (MATE) transporter 1, and MATE-2K substrates in the kidney (e.g. dofetilide, dalfampridine, cisplatin).
Action
Description: Trilaciclib is a selective, highly potent, and reversible inhibitor of cyclin-dependent kinase 4 and 6 (CDK4/6). It transiently induces haematopoietic stem and progenitor cell (HSPC) G1 cell cycle arrest, thereby preventing cell proliferation and resulting in myelopreservation. Pharmacokinetics: Metabolism: Extensively metabolised. Excretion: Mainly via faeces (approx 79.1%; 7% as unchanged drug); urine (14%; 2% as unchanged drug). Elimination half-life: Approx 14 hours.
Chemical Structure
Trilaciclib Source: National Center for Biotechnology Information. PubChem Compound Summary for CID 68029831, Trilaciclib. https://pubchem.ncbi.nlm.nih.gov/compound/Trilaciclib. Accessed Feb. 23, 2023.
V03AF12 - trilaciclib ; Belongs to the class of detoxifying agents used in antineoplastic treatment.
References
Anon. Trilaciclib. AHFS Clinical Drug Information [online]. Bethesda, MD. American Society of Health-System Pharmacists, Inc. https://www.ahfscdi.com. Accessed 28/12/2022.Anon. Trilaciclib. Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 28/12/2022.Cosela for Injection, for Intravenous Use (G1 Therapeutics, Inc.). U.S. FDA. https://www.fda.gov. Accessed 28/12/2022.Cosela Injection, Powder, Lyophilized, for Solution (G1 Therapeutics, Inc.). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 28/12/2022.
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