Advanced or metastatic gastric or GEJ adenocarcinoma
Clinical trial safety: RAINBOW
RAINBOW: Adverse reaction profile for CYRAMZA + paclitaxel1,2
RAINBOW: Adverse reactions occurring at incidence rate ≥5% and a ≥2% difference between arms in patients receiving CYRAMZA + paclitaxel1
- The incidence of febrile neutropenia was 2.4% vs 1.2% in the CYRAMZA plus paclitaxel and placebo plus paclitaxel treatment arms, respectively1,2
- 19% of patients treated with CYRAMZA plus paclitaxel received granulocyte colony-stimulating factors vs 8.5% of patients treated with paclitaxel1,3
- In the RAINBOW trial, 28% of patients in the CYRAMZA plus paclitaxel treatment arm received CYRAMZA for at least 6 months1
- In the CYRAMZA plus paclitaxel treatment arm, the median duration of exposure to CYRAMZA was 18 weeks and to paclitaxel was 17.7 weeks. In the placebo plus paclitaxel treatment arm, the median duration of exposure was 12 weeks for each1,4
SELECT IMPORTANT SAFETY INFORMATION
- The most common serious adverse events with CYRAMZA plus paclitaxel in RAINBOW werre neutropenia (3.7%) and febriile neutropenia (2.4%); 19% of patients treated with CYRAMZA plus paclitaxel received granulocyte colony-stimulating factors.
- Adverse reactions resulting in discontinuation of any component of the CYRAMZA plus paclitaxel combination in 2% or more patients in RAINBOW were neutropenia (4%) and thrombocytopenia (3%).
- Clinically relevant adverse reactions reported in ≥1% and <5% of the CYRAMZA plus paclitaxel-treated patients in RAINBOW were sepsis (3.1%), including 5 fatal events, and gastrointestinal perforations (1.2%), including 1 fatal event.
RAINBOW: Additional adverse reactions to consider for CYRAMZA as an antiangiogenic therapy1
RAINBOW: Additional adverse reactions1,5,6
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.