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.