Cosela
(Trilaciclib)Dosage & Administration
COSELA is for intravenous use only.
The recommended dose of COSELA is 240 mg/m2 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 recommended dose of COSELA is 240 mg/m2per 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.
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.
If COSELA is discontinued, wait 96 hours from the last dose of COSELA before resumption of chemotherapy only.
Reduce dose in patients with moderate or severe hepatic impairment. (
Withhold, discontinue, or alter the administration of COSELA to manage adverse reactions as described in Table 1
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. |
| 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. | |
Reduce the dose of COSELA to 170 mg/m2in 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 Full Prescribing Information for instructions on 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.
aTo ensure product stability, do not exceed specified storage durations. | ||
Intravenous Infusion Bag Material | Diluent | Diluted COSELA Storage Duration a |
| 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) |
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Cosela Prescribing Information
Dosage and Administration (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 ].
Dose Modifications for Hepatic Impairment Reduce the dose of COSELA to 170 mg/m2in 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 and Clinical Pharmacology ]. | 8/2023 | ||||||||||||||||||||||||||||
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).
COSELA is for intravenous use only.
The recommended dose of COSELA is 240 mg/m2 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 recommended dose of COSELA is 240 mg/m2per 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.
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.
If COSELA is discontinued, wait 96 hours from the last dose of COSELA before resumption of chemotherapy only.
Reduce dose in patients with moderate or severe hepatic impairment. (
Withhold, discontinue, or alter the administration of COSELA to manage adverse reactions as described in Table 1
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. |
| 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. | |
Reduce the dose of COSELA to 170 mg/m2in 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 Full Prescribing Information for instructions on 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.
- 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.
- 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.
aTo ensure product stability, do not exceed specified storage durations. | ||
Intravenous Infusion Bag Material | Diluent | Diluted COSELA Storage Duration a |
| 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) |
- 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.
For injection: Contains the equivalent of 300 mg of trilaciclib (provided as 349 mg of trilaciclib dihydrochloride) as a sterile, preservative-free, yellow, lyophilized cake in a single-dose vial for reconstitution and further dilution.
Lactation: Advise not to breastfeed. (
There are no data on the presence of trilaciclib in either human or animal milk, the effects on the breastfed child or the effects on milk production. Because of the potential for serious adverse reactions in breastfed children, advise lactating women to not breastfeed while taking COSELA and for at least 3 weeks after the last dose.
COSELA is contraindicated in patients with a history of serious hypersensitivity reactions to trilaciclib. Reactions have included anaphylaxis
COSELA administration can cause acute drug hypersensitivity reactions, including facial edema and urticaria. Acute drug hypersensitivity reactions occurred in 16 (6%) of 272 patients receiving COSELA in clinical trials, including Grade 2 reactions (2%). One patient experienced a Grade 2 anaphylactic reaction 4 days after receiving COSELA, which resolved with epinephrine, and treatment with COSELA was continued. The median time to onset from start of COSELA was 77 days (range 2 to 256) and from the preceding dose of COSELA was 1 day (range 1 to 28). The median duration was 6 days (range 1 to 69 for the resolved cases). Acute drug hypersensitivity reactions resolved in 12 (75%) of the 16 patients.
Monitor patients for signs and symptoms of acute drug hypersensitivity reactions including facial, eye, and tongue edema, urticaria, pruritus, and anaphylactic reactions. For moderate (Grade 2) acute drug hypersensitivity reactions, stop infusion and hold COSELA until the adverse reaction recovers to Grade ≤1. For severe (Grade 3) or life-threatening (Grade 4) acute drug hypersensitivity reactions, stop infusion and permanently discontinue COSELA