COSELA: Integrated safety analysis

Adverse reactions in ≥5% of patients with ES-SCLC receiving COSELA

(with ≥2% higher incidence with COSELA compared to the chemotherapy regimens group)

Adverse Reactions1

  • The adverse reaction summary here presents pooled safety results from Studies 1, 2, and 3. The patients included in the pooling are those randomized patients who received at least 1 dose of COSELA (122 patients) or placebo (118)
  • 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
  • Permanent discontinuation due to an adverse reaction occurred in 9% of patients who received COSELA

ES-SCLC=extensive-stage small cell lung cancer.

Laboratory-related adverse reactions reported in this table represent a combined analysis of laboratory parameters and any reported laboratory-related adverse reactions.

a Graded per NCI CTCAEv4.03x.
b Hypocalcemia=calcium decreased (lab) or treatment-emergent adverse event (TEAE) preferred term “hypocalcemia.”
c Hypokalemia=potassium decreased (lab) or TEAE-preferred terms “hypokalemia,” “blood potassium decreased.”
d Hypophosphatemia=phosphate decreased (lab) or TEAE-preferred terms “hypophosphatemia,” “blood phosphorus decreased.”
e Aspartate aminotransferase increased=aspartate aminotransferase increased (lab) or TEAE-preferred term “blood aspartate aminotransferase increased.”
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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.