Frequently asked questions about COSELA

Listed below are answers to some commonly asked questions about COSELA.

You can also always contact us directly at www.COSELAhcp.com/request-information if you have additional questions or would like more information.

In the clinical trials, PFS and OS were evaluated as secondary and exploratory endpoints. No statistically significant differences in PFS or OS were observed between the trilaciclib and placebo groups; however, the studies were not powered to detect differences in these outcomes.1

Based on clinical studies and some real-world evidence, COSELA has lowered the incidence of neutropenia, anemia, and thrombocytopenia from chemotherapy, and also lowered the occurrence of chemotherapy dose delays/reductions and hospitalizations in patients with ES-SCLC.1,2

In the clinical trials, PFS and OS were evaluated as secondary and exploratory endpoints. No statistically significant differences in PFS or OS were observed between the trilaciclib and placebo groups; however, the studies were not powered to detect differences in these outcomes.1

The clinical studies for COSELA were not designed to assess a comparative benefit across subgroups of patients.

Patients were not stratified by risk of myelosuppression or other baseline risk factors. COSELA may be given to any appropriate patient with ES-SCLC at risk of chemotherapy-induced myelosuppression and is not solely indicated for high-risk patients or any particular subgroup.1

COSELA is a transient CDK 4/6 inhibitor studied in patients with ES-SCLC, a tumor type largely insensitive to CDK4/6 inhibition.1

According to the COSELA Prescribing Information, patients should be monitored for signs and symptoms of injection-site reactions, phlebitis, and thrombophlebitis, including infusion-site pain and erythema during infusion.1

In clinical studies, use of G-CSFs and ESAs was allowed from Cycle 2 onwards, as clinically indicated. Therapeutic G-CSF was allowed at any time during the studies as clinically indicated. Prophylactic use of G-CSFs and ESAs was prohibited during Cycle 1.1

COSELA should be administered and completed within 4 hours of the start of chemotherapy on each day chemotherapy is given.
COSELA is given as an infusion, and patients typically receive it right before their chemotherapy in the same infusion chair.1

COSELA was specifically studied in patients with ES-SCLC and is indicated to decrease the incidence of chemotherapy-induced myelosuppression in patients with ES-SCLC. 1

The clinical studies for COSELA did not include assessments of safety and efficacy across modified chemotherapy schedules.1

CDK=cyclin-dependent kinase; ES-SCLC=extensive-stage small cell lung cancer; ESA=erythropoiesis-stimulating agent; G-CSF=granulocyte colony-stimulating factor.
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IMPORTANT SAFETY INFORMATION

CONTRAINDICATION

  • COSELA is contraindicated in patients with a history of serious hypersensitivity reactions to trilaciclib.

To report suspected adverse reactions, contact Pharmacosmos Therapeutics at 1-888-828-0655 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

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).

IMPORTANT SAFETY INFORMATION

CONTRAINDICATION

  • COSELA is contraindicated in patients with a history of serious hypersensitivity reactions to trilaciclib.

WARNINGS AND PRECAUTIONS

Injection-Site Reactions, Including Phlebitis And Thrombophlebitis

  • COSELA administration can cause injection-site reactions, including phlebitis and thrombophlebitis, which occurred in 56 (21%) of 272 patients receiving COSELA in clinical trials, including Grade 2 (10%) and Grade 3 (0.4%) adverse reactions. Monitor patients for signs and symptoms of injection-site reactions, including infusion-site pain and erythema during infusion. For mild (Grade 1) to moderate (Grade 2) injection-site reactions, flush line/cannula with at least 20 mL of sterile 0.9% Sodium Chloride Injection, USP or 5% Dextrose Injection, USP after end of infusion. For severe (Grade 3) or life-threatening (Grade 4) injection-site reactions, stop infusion and permanently discontinue COSELA. Injection-site reactions led to discontinuation of treatment in 3 (1%) of the 272 patients.

Acute Drug Hypersensitivity Reactions

  • COSELA administration can cause acute drug hypersensitivity reactions, which occurred in 16 (6%) of 272 patients receiving COSELA in clinical trials, including Grade 2 reactions (2%). Monitor patients for signs and symptoms of acute drug hypersensitivity 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.

Interstitial Lung Disease/Pneumonitis

  • Severe, life-threatening, or fatal interstitial lung disease (ILD) and/or pneumonitis can occur in patients treated with cyclin-dependent kinases (CDK)4/6 inhibitors, including COSELA, with which it occurred in 1 (0.4%) of 272 patients receiving COSELA in clinical trials. Monitor patients for pulmonary symptoms of ILD/pneumonitis. For recurrent moderate (Grade 2) ILD/pneumonitis, and severe (Grade 3) or life-threatening (Grade 4) ILD/pneumonitis, permanently discontinue COSELA.

Embryo-Fetal Toxicity

  • Based on its mechanism of action, COSELA can cause fetal harm when administered to a pregnant woman. Females of reproductive potential should use an effective method of contraception during treatment with COSELA and for at least 3 weeks after the final dose.

ADVERSE REACTIONS

  • Serious adverse reactions occurred in 30% of patients receiving COSELA. Serious adverse reactions reported in >3% of patients who received COSELA included respiratory failure, hemorrhage, and thrombosis.
  • Fatal adverse reactions were observed in 5% of patients receiving COSELA. Fatal adverse reactions for patients receiving COSELA included pneumonia (2%), respiratory failure (2%), acute respiratory failure (<1%), hemoptysis (<1%), and cerebrovascular accident (<1%).
  • Permanent discontinuation due to an adverse reaction occurred in 9% of patients who received COSELA. Adverse reactions leading to permanent discontinuation of any study treatment for patients receiving COSELA included pneumonia (2%), asthenia (2%), injection-site reaction, thrombocytopenia, cerebrovascular accident, ischemic stroke, infusion-related reaction, respiratory failure, and myositis (<1% each).
  • Infusion interruptions due to an adverse reaction occurred in 4.1% of patients who received COSELA.
  • The most common adverse reactions (≥10%) were fatigue, hypocalcemia, hypokalemia, hypophosphatemia, aspartate aminotransferase increased, headache, and pneumonia.

DRUG INTERACTIONS

  • COSELA is an inhibitor of OCT2, MATE1, and MATE-2K. Co-administration of COSELA may increase the concentration or net accumulation of OCT2, MATE1, and MATE-2K substrates in the kidney (e.g., dofetilide, dalfampridine, and cisplatin).

To report suspected adverse reactions, contact Pharmacosmos Therapeutics at 1-888-828-0655 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

This information is not comprehensive. Please see the Full Prescribing Information.