Observed safety profile

Adverse reactions occurring in ≥10% of patients with B-cell malignancies receiving COPIKTRA 25 mg BID

Data reflect exposure to COPIKTRA across 4 clinical trials totaling 442 patients with previously treated hematologic malignancies, of which 22% (n=96) were patients with FL.

  • Serious adverse reactions were reported in 58% of FL patients and most often involved diarrhea or colitis, pneumonia, renal insufficiency, rash, and sepsis
  • The most common adverse reactions (≥20% of FL patients) were diarrhea or colitis, nausea, fatigue, musculoskeletal pain, rash, neutropenia, cough, anemia, pyrexia, headache, mucositis, abdominal pain, vomiting, transaminase elevation, and thrombocytopenia
  • *

    Grouped term for reactions with multiple preferred terms.

  • Diarrhea or colitis includes the preferred terms: colitis, enterocolitis, colitis microscopic, colitis ulcerative, diarrhea, diarrhea hemorrhagic.

  • Rash includes the preferred terms: dermatitis (including allergic, exfoliative, perivascular), erythema (including multiforme), rash (including exfoliative, erythematous, follicular, generalized, macular and papular, pruritic, pustular), TEN and toxic skin eruption, DRESS, drug eruption, SJS.

  • §

    Pneumonia includes the preferred terms: All preferred terms containing "pneumonia" except for "pneumonia aspiration"; bronchopneumonia, bronchopulmonary aspergillosis.

  • ||

    Transaminase elevation includes the preferred terms: alanine aminotransferase increased, aspartate aminotransferase increased, transaminases increased, hypertransaminasemia, hepatocellular injury, hepatotoxicity.
    DRESS, drug reaction with eosinophilia and systemic symptoms; SJS, Stevens-Johnson syndrome; TEN, toxic epidermal necrolysis.

New or worsening laboratory abnormalities in ≥20% of patients with B-cell malignancies receiving COPIKTRA 25 mg BID

Data reflect exposure to COPIKTRA across 4 clinical trials totaling 442 patients with previously treated
hematologic malignancies, of which 22% (n=96) were patients with FL.

  • Grade 4 laboratory abnormalities developing in ≥2% of patients included neutropenia (24%), thrombocytopenia (7%), lipase increased (4%), lymphocytopenia (3%), and leukopenia (2%)1
  • COPIKTRA was discontinued in 29% of patients with FL, most often due to diarrhea or colitis and rash
  • Includes laboratory abnormalities that are new or worsening in grade or with worsening from baseline unknown.

  • #

    Percentages are based on number of patients with at least 1 postbaseline assessment; not all patients were evaluable.

  • ALP, alkaline phosphatase; ALT, alanine aminotransferase; AST, aspartate aminotransferase.