A cluster of hematopoietic stem and progenitor cells (HSPCs)

NEW to decrease the incidence of chemotherapy-induced myelosuppression in patients when administered prior to a platinum/etoposide-containing regimen or topotecan-containing regimen

For extensive-stage small cell lung cancer (ES-SCLC)

COSELA: DOSED FIRST TIME, EVERY TIME WITH CHEMOTHERAPY

  • The recommended dose of COSELA (trilaciclib) is 240 mg/m2 per dose. Administered as a 30-minute intravenous (IV) infusion completed within 4 hours of the start of chemotherapy on each day chemotherapy is administered
    • Dosage Forms and Strengths. For injection: contains the equivalent of 300 mg of trilaciclib as a sterile, preservative-free, yellow, lyophilized cake in a single-dose vial for reconstitution and further dilution.
Graph illustrating dosing for a Carboplatin/Etoposide containing and topotecan-containing regimenDAY 1COSELA Prior to Carboplatin& EtoposideDAY 2COSELAPrior toEtoposide21-DAYCYCLEDAY 3COSELAPrior toEtoposide21-DAYCYCLEDAY 1COSELAPrior toTopotecanDAY 2COSELAPrior toTopotecanCOSELAPrior toTopotecanDAY 3COSELAPrior toTopotecanDAY 4COSELAPrior toTopotecanDAY 5DOSING FOR A CARBOPLATIN/ETOPOSIDE CONTAINING REGIMEN (WITH OR WITHOUT ATEZOLIZUMAB)DOSING FOR TOPOTECAN-CONTAINING REGIMEN Graph illustrating dosing for a Carboplatin/Etoposide containing and topotecan-containing regimenDAY 1COSELA Prior to Carboplatin& EtoposideDAY 2COSELAPrior toEtoposide21-DAYCYCLEDAY 3COSELAPrior toEtoposide21-DAYCYCLEDAY 1COSELAPrior toTopotecanDAY 2COSELAPrior toTopotecanCOSELAPrior toTopotecanDAY 3COSELAPrior toTopotecanDAY 4COSELAPrior toTopotecanDAY 5DOSING FOR A ETOPOSIDE/CARBOPLATIN CONTAINING REGIMEN (WITH OR WITHOUT I/O)DOSING FOR TOPOTECAN-CONTAINING REGIMEN

Recommended actions for ADVERSE REACTIONS

  • Upon completion of infusion, flush line/cannula with at least 20 mL sterile 0.9% Sodium Chloride Injection, USP, or 5% Dextrose Injection, USP
  • If 0.9% Sodium Chloride Injection, USP is being used as a diluent/flush, consider changing to 5% Dextrose Injection, USP as appropriate for subsequent infusions

Note that COSELA is not a vesicant

Graph illustrating addressing injection site reactions, including phlebitis and thrombophlebitis Acute drug hypersensitivity reactions Grades 3 or 4, and if Grade 2 recurs ILD/pneumonitis Grades 3 or 4, and if Grade 2 recurs§ Other toxicities Grade 4, and if Grade 3 recursllSTOPINFUSIONGRADE 1GRADE 2Tenderness; with or withoutsymptoms such as warmth,erythema, and/or itchingPain; lipodystrophy;edema; phlebitisGRADE 3GRADE 4Ulceration ornecrosis; severetissue damage;operativeinterventionindicatedLife-threateningconsequences;urgentinterventionsindicatedSTOPINFUSIONSTOPINFUSION Interrupt, or slow infusion Change diluent* Rotate injection site OR Consider central access Change diluent*Reaction IsSEVEREPain IsNOT SEVEREINTERRUPTINFUSIONPERMANENTLYDISCONTINUEADDRESSING INJECTION SITE REACTIONS,INCLUDING PHLEBITIS AND THROMBOPHLEBITISPERMANENTLY DISCONTINUE COSELA FOR THE FOLLOWING ADDITIONAL ADVERSE REACTIONS: Graph illustrating addressing injection site reactions, including phlebitis and thrombophlebitisChange diluent*Interrupt, orslow infusionSTOPINFUSIONPERMANENTLYDISCONTINUEPain isNOTSEVERESEVERERotate injection siteORConsider central accessGRADE 1Tenderness;with or without symptoms such as warmth, erythema, and/or itchingGRADE 2Pain; lipodystrophy; edema; phlebitisGRADE 3Ulceration or necrosis; severe tissue damage; operative intervention indicatedLife-threatening consequences; urgent interventions indicatedGRADE 4ReactionisPERMANENTLY DISCONTINUE COSELA FOR THE FOLLOWING ADDITIONAL ADVERSE REACTIONS:Acute drug hypersensitivity reactions Grades 3 or 4, and if Grade 2 recursILD/pneumonitis Grades 3 or 4, and if Grade 2 recurs§Other toxicities Grade 4, and if Grade 3 recursllSTOPINFUSIONChange diluent*STOPINFUSIONINTERRUPTINFUSIONADDRESSING INJECTION SITE REACTIONS,INCLUDING PHLEBITIS AND THROMBOPHLEBITIS

Refer to the Prescribing Information for additional details.

Additional considerations: Ice/cold packs or warm compresses, depending on the patient’s symptoms, may be considered per institutional guidelines.1,2

Injection-Site Reaction Incidence

Injection-site reactions, including phlebitis and thrombophlebitis, occurred in 56 (21%) of the 272 patients receiving COSELA in clinical trials. Occurrence of Grade 2 adverse reactions was 10% and Grade 3 adverse reactions was 0.4%.

  • 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

ADDITIONAL WARNINGS AND PRECAUTIONS

Warnings and precautions for COSELA also include acute drug hypersensitivity, interstitial lung disease (ILD)/pneumonitis, and embryo-fetal toxicity.

Signs and Symptoms to Monitor

  • Acute drug hypersensitivity reactions: acute drug hypersensitivity reactions, including facial, eye, and tongue edema, urticaria, pruritus, and anaphylactic reactions
  • ILD/pneumonitis: pulmonary symptoms indicative of ILD/pneumonitis such as cough, dyspnea, and hypoxia

*If 0.9% Sodium Chloride Injection, USP is being used as a diluent/flush, consider changing to 5% Dextrose Injection, USP as appropriate for subsequent infusions.

Stop infusion in extremity and rotate site of infusion to site in alternative extremity.

Defined as: Grade 2=Moderate; minimal, local, or noninvasive intervention indicated; limiting Activities of Daily Living (ADL). Grade 3=Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care ADL. Grade 4=Life-threatening consequences; urgent intervention indicated.

§Defined as: Grade 2=Symptomatic. Grade 3=Severe symptoms; limiting self-care ADL; oxygen indicated. Grade 4=Life-threatening respiratory compromise; urgent intervention indicated (e.g., tracheotomy or intubation).

Defined as: Grade 3=Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care ADL. Grade 4=Life-threatening consequences; urgent intervention indicated.

Unexpected THERAPY INTERRUPTION

The interval between doses of COSELA on sequential days should not be greater than 28 hours.

Missed Treatment Session(s)

  • If the COSELA dose is missed, discontinue chemotherapy on the day the COSELA dose was missed. Consider resuming both COSELA and chemotherapy on the next scheduled day for chemotherapy

Discontinuation of Treatment

  • If COSELA is discontinued, wait 96 hours from the last dose of COSELA before resumption of chemotherapy only

INDICATION: COSELA is 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 (ES-SCLC).