Advanced gastric or GEJ adenocarcinoma
Clinical trial safety: REGARD
REGARD: Adverse reaction profile for CYRAMZA monotherapy1
REGARD: Adverse reactions occurring with CYRAMZA at incidence rate ≥5% and ≥2% higher than placebo1
- 14% of patients in the REGARD trial received CYRAMZA for at least 6 months1
- The median duration of exposure was 8 weeks
SELECT IMPORTANT SAFETY INFORMATION
- The most common serious adverse events with CYRAMZA were anemia (3.8%) and intestinal obstruction (2.1%). Red blood cell transfusions were given to 11% of CYRAMZA-treated patients vs 8.7% of patients who received placebo.
- Clinically relevant adverse reactions reported in ≥1% and <5% of CYRAMZA-treated patients in the REGARD trial were: neutropenia (4.7% CYRAMZA vs 0.9% placebo), epistaxis (4.7% CYRAMZA vs 0.9% placebo), rash (4.2% CYRAMZA vs 1.7% placebo), intestinal obstruction (2.1% CYRAMZA vs 0% placebo), and ATEs (1.7% CYRAMZA vs 0% placebo).
- Across clinical trials of CYRAMZA administered as a single agent, clinically relevant adverse reactions (including grade≥3) reported in CYRAMZA-treated patients included proteinuria, gastrointestinal perforation, and infusion-related reactions (IRRs).
- In the REGARD trial, according to laboratory assessment, 8% of CYRAMZA-treated patients developed proteinuria vs 3% of placebo-treated patients. Two patients discontinued CYRAMZA due to proteinuria. The rate of gastrointestinal perforation in the REGARD trial was 0.8% and the rate of IRRs was 0.4%.
REGARD: Additional adverse reactions to consider for CYRAMZA as an antiangiogenic therapy1,2
REGARD: Additional adverse reactions
IMPAIRED WOUND HEALING
- Impaired wound healing can occur with antibodies inhibiting the VEGF pathway. CYRAMZA has not been studied in patients with serious or nonhealing wounds. CYRAMZA, an antiangiogenic therapy, has the potential to adversely affect wound healing. Discontinue CYRAMZA therapy in patients with impaired wound healing. Withhold CYRAMZA prior to surgery. Resume CYRAMZA following the surgical intervention based on clinical judgment of adequate wound healing. If a patient develops wound healing complications during therapy, discontinue CYRAMZA until the wound is fully healed