Safety

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

Manage adverse reactions with dose reduction, treatment hold, or discontinuation of COPIKTRA, according to the Prescribing Information

  • *

    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

Median duration of exposure was 9 months (range, 0.1-53 months), with 36% of patients (n=160/442) having at least 1 year of exposure

  • 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.

Dive into Dual-Action Inhibition

COPIKTRA is the first and only dual PI3K-δ and PI3K-γ inhibitor that predominantly targets malignant B cells and the tumor microenvironment1,2

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