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Cosela

trilaciclib
CDK4/6 Inhibitor (Myeloprotective)FDA Approved 2021G1 Therapeutics
Route
Oral
Half-Life
~5 hrs
FDA Approved
2021
Manufacturer
G1 Therapeutics
1. Indications and Usage

To decrease chemotherapy-induced myelosuppression when given prior to platinum/etoposide or topotecan in ES-SCLC.

2. Dosage and Administration

240 mg/m2 IV over 30 minutes, within 4 hours prior to chemotherapy on each chemo day.

3. Dosage Forms and Strengths

Injection: 300 mg lyophilized powder in single-dose vial

4. Contraindications

None listed in the prescribing information.

5. Warnings and Precautions
  • Injection Site Reactions: Administer through dedicated IV line.
  • ILD/Pneumonitis: Fatal cases reported.
  • Embryo-Fetal Toxicity: Can cause fetal harm.
6. Adverse Reactions
Most Common Adverse Reactions

Fatigue (34%), Hypocalcemia (24%), Hypokalemia (22%), Hypophosphatemia (21%), Increased AST (18%), Headache (16%), Pneumonia (14%)

Fatigue
34%
Hypocalcemia
24%
Hypokalemia
22%
Hypophosphatemia
21%
Increased AST
18%
Headache
16%
Pneumonia
14%

Consult the complete prescribing information for a comprehensive list of adverse reactions and their frequencies.

7. Drug Interactions

OCT2 and MATE1 Substrates: Trilaciclib inhibits OCT2/MATE1; may increase exposure of substrates like metformin.

8. Use in Specific Populations
Pregnancy

Consult the full prescribing information for pregnancy-related considerations.

Lactation

Refer to prescribing information for lactation guidance.

Pediatric Use

Pediatric safety and efficacy information is detailed in the full label.

Hepatic/Renal Impairment

Dose modifications for organ impairment are specified in the complete prescribing information.

12. Clinical Pharmacology
Mechanism of Action

Trilaciclib is a CDK4/6 inhibitor given before chemotherapy to transiently arrest hematopoietic stem cells in G1 phase, protecting them from chemotherapy cytotoxicity without compromising antitumor efficacy.

Pharmacokinetics

Volume of distribution: ~242 L. Protein binding: ~88%. Half-life: ~14 hours. Elimination: feces 56%, urine 34%.

14. Clinical Studies

Clinical efficacy and safety data supporting the approval are available in the full prescribing information and from the clinical trials listed below.

Pivotal Clinical Trials
Additional Resources
📋 All Trilaciclib Trials on ClinicalTrials.gov ↗ 📚 PubMed: Trilaciclib Clinical Trials ↗
FDA-Approved Tumor Types

Cosela has FDA-approved indications across the following cancer types covered on CancerDrugEvidence:

Small Cell Lung Cancer
External Resources
📋 DailyMed Label ↗🏛️ FDA Drugs@FDA ↗🔬 ClinicalTrials.gov ↗📚 PubMed Pivotal Trials ↗
Important Notice: This page is intended as a navigational reference to the FDA-approved prescribing information for Cosela. It does not replace the full prescribing information. Healthcare professionals should consult the complete package insert available at DailyMed before making prescribing decisions. Patient-specific factors should always guide clinical decision-making.

Frequently Asked Questions

What is Cosela (trilaciclib) approved for?

Cosela (trilaciclib) is an FDA-approved oncology agent. Refer to the full prescribing information for complete indication details.

How is Cosela (trilaciclib) administered?

Refer to the full prescribing information for dosing schedules, administration instructions, and dose modifications.

How does Cosela (trilaciclib) work?

Trilaciclib is a CDK4/6 inhibitor given before chemotherapy to transiently arrest hematopoietic stem cells in G1 phase, protecting them from chemotherapy cytotoxicity without compromising antitumor efficacy.

What are the most common side effects?

Fatigue (34%), Hypocalcemia (24%), Hypokalemia (22%), Hypophosphatemia (21%), Increased AST (18%), Headache (16%), Pneumonia (14%) Fatigue 34% Hypocalcemia 24% Hypokalemia 22% Hypophosphatemia 21% Increased AST 18% Headache 16% Pneumonia 14%

← All TherapiesFull Prescribing Information ↗