TRILACICLIB INJ
Clinical Criteria Summary
Indication
- Decrease the incidence of chemotherapy-induced myelosuppression when administered prior to a platinum/etoposide containing regimen or topotecan-containing regimen for extensive-stage small cell lung cancer (ES-SCLC)
Dosing & Administration
- 240 mg/m2 IV over 30 minutes completed within 4 hours prior to the start of chemotherapy
- Formulated as a 300 mg/mL single-dose vial for injection
Contraindications & Warnings/Precautions
- Contraindicated in patients with a history of serious hypersensitivity to trilaciclib
- No boxed warnings
- Monitor for injection site reactions, including phlebitis and thrombophlebitis
- Withhold for moderate acute drug hypersensitivity reactions; permanently discontinue for severe or life-threatening reactions
- Permanently discontinue for recurrent symptomatic or severe/life-threatening interstitial lung disease (ILD)/pneumonitis
- May cause embryo-fetal toxicity
Special Populations
- Pregnancy: May cause fetal harm; use effective contraception during therapy and for at least 3 weeks after the final dose
- Lactation: No human data; potential for serious adverse reactions in breast-fed children
- Geriatric use: No overall differences in efficacy or safety observed
- Hepatic impairment: Not recommended for moderate or severe hepatic impairment (not studied in patients with total bilirubin >1.5 X ULN irrespective of AST)
Clinical Selection Criteria
- Consider for select patients with a high risk for prolonged neutropenia receiving first-line chemotherapy or second-line topotecan therapy for SCLC to prevent long durations of severe neutropenia
- Net clinical benefit is minimal; reduces duration of severe neutropenia but does not eliminate the need for granulocyte colony stimulating factor (G-CSF) use in some patients
Supportive Care & Growth Factor Guidance
- Primary prophylaxis with granulocyte growth factors is generally not warranted unless the risk of febrile neutropenia with the first cycle of chemotherapy is ≥20%
- If the risk is <20%, primary prophylaxis may be used if the patient has other risk factors for febrile neutropenia
- Growth factors are generally not routinely used if the patient is neutropenic but not febrile