Cosela Dosage

Generic name: trilaciclib dihydrochloride 300mg in 20mL
Dosage form: injection, powder, lyophilized, for solution
Drug class: Other immunostimulants

Medically reviewed by Drugs.com. Last updated on Aug 3, 2023.

Recommended Dosage

The recommended dose of COSELA is 240 mg/m2 per dose. Administer as a 30-minute intravenous infusion completed no more than 4 hours prior to the start of chemotherapy on each day chemotherapy is administered.

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.

Dose Modification

Dose Modification for Adverse Reactions

Withhold, discontinue, or alter the administration of COSELA to manage adverse reactions as described in Table 1 [see Warnings and Precautions (5)].

Table 1: Recommended Actions for Adverse Reactions
Adverse Reaction	Severity Grade*	Recommended Action
* National Cancer Institute – Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 4.03
Injection-site reactions including phlebitis and thrombophlebitis	Grade 1: Tenderness with or without symptoms (e.g., warmth, erythema, itching)	Interrupt or slow infusion of COSELA. 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.
	Grade 2: Pain; lipodystrophy; edema; phlebitis	Interrupt infusion of COSELA. If pain not severe, follow instructions for Grade 1. Otherwise, stop infusion in extremity and rotate site of infusion to site in alternative extremity. 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. Central access may also be considered.
	Grade 3: Ulceration or necrosis; severe tissue damage; operative intervention indicated. OR Grade 4: Life-threatening consequences; urgent interventions indicated.	Stop infusion and permanently discontinue COSELA.
Acute drug hypersensitivity reactions	Grade 2: Moderate; minimal, local, or noninvasive intervention indicated; limiting Activities of Daily Living (ADL).	Stop infusion and hold COSELA until recovery to Grade ≤1 or baseline, then consider resuming COSELA. If Grade 2 recurs, permanently discontinue COSELA.
Acute drug hypersensitivity reactions	Grade 3: Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care ADL. OR Grade 4: Life-threatening consequences; urgent intervention indicated.	Permanently discontinue COSELA.
Interstitial lung disease/pneumonitis	Grade 2 (symptomatic)	Hold COSELA until recovery to Grade ≤1 or baseline, then consider resuming COSELA. If Grade 2 recurs, permanently discontinue COSELA.
Interstitial lung disease/pneumonitis	Grade 3: Severe symptoms; limiting self-care ADL; oxygen indicated. OR Grade 4: Life-threatening respiratory compromise; urgent intervention indicated (e.g., tracheotomy or intubation)	Permanently discontinue COSELA.
Other toxicities	Grade 3: Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care ADL.	Hold COSELA until recovery to Grade ≤1 or baseline, then consider resuming COSELA. If Grade 3 recurs, permanently discontinue COSELA.
Other toxicities	Grade 4: Life-threatening consequences; urgent intervention indicated.	Permanently discontinue COSELA.

Dose Modifications for Hepatic Impairment

Reduce the dose of COSELA to 170 mg/m2 in patients with moderate or severe hepatic impairment (Child-Pugh classes B and C). No dose adjustment is required for patients with mild hepatic impairment (Child-Pugh class A) [see Use in Specific Populations (8.6) and Clinical Pharmacology (12.3)].

Preparation and Administration Instructions

Reconstitute and further dilute COSELA prior to intravenous infusion as outlined below. Use aseptic technique for reconstitution and dilution.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

Reconstitution of COSELA

Calculate the COSELA dose based on the patient's body surface area (BSA), the total volume of reconstituted COSELA solution required, and the number of COSELA vials needed.
Reconstitute each 300 mg vial with 19.5 mL of 0.9% Sodium Chloride Injection, USP or 5% Dextrose Injection, USP using a sterile syringe to obtain a concentration of 15 mg/mL of trilaciclib.
Gently swirl the vial for up to 3 minutes until the sterile lyophilized cake is completely dissolved. Do not shake.
Inspect the reconstituted solution for discoloration and particulate matter. Reconstituted COSELA solution should be a clear, yellow solution. Do not use if the reconstituted solution is discolored, cloudy, or contains visible particulates.
Reconstituted solution in the vial can be stored at 20°C to 25°C (68°F to 77°F) for up to 4 hours prior to transfer to the infusion bag. Do not refrigerate or freeze.
Discard any unused portion after use.

Dilution of Reconstituted COSELA Solution

Withdraw the required volume from the vial(s) of reconstituted COSELA solution and dilute into an intravenous infusion bag containing 0.9% Sodium Chloride Injection, USP or 5% Dextrose Injection, USP. The final concentration of the diluted COSELA solution should be between 0.5 mg/mL and 3 mg/mL.
Mix diluted solution by gentle inversion. Do not shake.
The diluted COSELA solution for infusion is a clear, yellow solution.
If not used immediately, store the diluted COSELA solution in the intravenous infusion bag as specified in Table 2. Discard if storage time exceeds these limits. Do not refrigerate or freeze.

Table 2: Diluted COSELA Solution Storage Conditions
a To ensure product stability, do not exceed specified storage durations.
Intravenous Infusion Bag Material	Diluent	Diluted COSELA Storage Durationa
Polyvinyl chloride (PVC), Ethylene vinyl acetate (EVA), Polyolefin (PO), or Polyolefin/polyamide (PO/PA)	5% Dextrose for Injection, USP	Up to 12 hours at 20°C to 25°C (68°F to 77°F)
PVC, EVA, or PO	0.9% Sodium Chloride Injection, USP	Up to 8 hours at 20°C to 25°C (68°F to 77°F)
PO/PA	0.9% Sodium Chloride Injection, USP	Up to 4 hours at 20°C to 25°C (68°F to 77°F)

Administration

Administer diluted COSELA solution as a 30-minute intravenous infusion completed no more than 4 hours prior to the start of chemotherapy.
Diluted COSELA solution must be administered with an infusion set, including an in-line filter (0.2 or 0.22 micron). Compatible in-line filters include polyethersulfone (PES), polyvinylidene fluoride (PVDF), and cellulose acetate (CA).
Do not administer diluted COSELA solution with a polytetrafluorethylene (PTFE) in-line filter as it is not compatible. PTFE is acceptable for use in air vent filters.
Do not co-administer other drugs through the same infusion line.
Do not co-administer other drugs through a central access device unless the device supports co-administration of incompatible drugs.
Upon completion of infusion of diluted COSELA solution, the infusion line/cannula must be flushed with at least 20 mL sterile 0.9% Sodium Chloride Injection, USP or 5% Dextrose Injection, USP.