Incidence of infusion reactions in the GADOLIN trial 1,2

Infusion-related reactions (IRRs) with GAZYVA may be severe and life threatening and can occur at any time

  • Symptoms may include hypotension, tachycardia, dyspnea, and respiratory symptoms (eg, bronchospasm, larynx and throat irritation, wheezing, laryngeal edema)
  • Most frequently reported symptoms include nausea, fatigue, dizziness, vomiting, diarrhea, hypertension, flushing, headache, pyrexia, and chills
GAZYVA GADOLIN Takeaway Infusion Reaction Leading to Discontinuation Image
GAZYVA GADOLIN Incidence of IRRs Chart

IRRs for Cycle 1:

  • Grade 3-4 IRRs: 9%, All Grade IRRs: 55%
  • The incidence of infusion reactions was highest on Day 1 (38%) and gradually decreased on Days 2,* 8, and 15 (25%, 7%, and 4%, respectively)

IRRs for subsequent cycles:

  • Grade 3-4 IRRs: 1% in Cycle 2, 2% in Cycle 3, 1% in Cycle 4; absent in Cycles 5-6 and GAZYVA monotherapy
  • All Grade IRRs: 24% in Cycle 2, 22% in Cycle 3, 14% in Cycle 4, 15% in Cycle 5, 10% in Cycle 6, and 8% in GAZYVA monotherapy

Overall IRR incidence rates during treatment with GAZYVA + bendamustine followed by GAZYVA monotherapy:

  • Grade 3-4 IRRs: 11%
  • All Grade IRRs: 69%

*Day 2 consisted of bendamustine only.