Advanced or metastatic 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
MOST COMMON ADVERSE REACTIONS – CYRAMZA ADMINISTERED AS A SINGE AGENT (REGARD)
- 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 REGARD were: neutropenia (4.7%), epistaxis (4.7%), rash (4.2%), intestinal obstruction (2.1%), and arterial thromboembolic events (1.7%).
- 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 IRRs. In REGARD, 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 REGARD 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 in patients who receive drugs that inhibit the VEGF or VEGFR pathway. CYRAMZA, a VEGFR2 antagonist, has the potential to adversely affect wound healing. CYRAMZA has not been studied in patients with serious or non-healing wounds.
- Withhold CYRAMZA for 28 days prior to elective surgery. Do not administer CYRAMZA for at least 28 days following a major surgical procedure and until the wound is fully healed. Discontinue CYRAMZA in patients who develop wound healing complications that require medical intervention.