Drug Detail:Cosela (Trilaciclib [ try-la-sye-klib ])
Generic Name: trilaciclib dihydrochloride 300mg in 20mL
Dosage Form: injection, powder, lyophilized, for solution
Drug Class: Other immunostimulants
Recommended Dosage
The recommended dose of COSELA is 240 mg/m2 per dose. Administer as a 30-minute intravenous infusion completed within 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.
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)].
| Adverse Reaction | Severity Grade* | Recommended Action |
|---|---|---|
|
* National Cancer Institute – Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 4.03x |
||
| 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. |
| 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. |
| 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. |
| Grade 4: Life-threatening consequences; urgent intervention indicated. | Permanently discontinue COSELA. | |
Preparation and Administration
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.
- If needed, the unused 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.
|
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 within 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 polyethylene sulfone, polyvinylidene fluoride, and cellulose acetate.
- Do not administer diluted COSELA solution with a polytetrafluorethylene (PTFE) in-line filter. PTFE in-line filters are not compatible with diluted COSELA solution.
- 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.
