Adverse reaction profile for CYRAMZA monotherapy¹

REGARD: ADVERSE REACTIONS OCCURRING WITH CYRAMZA AT INCIDENCE RATE ≥ 5% AND ≥ 2% HIGHER THAN PLACEBO1

Monotherapy common ADR table
  • 14% of patients in the REGARD trial received CYRAMZA for at least 6 months1
    • The median duration of exposure was 8 weeks

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  • 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
Additional adverse reactions for CYRAMZA monotherapy

*Lab assessment.

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. 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.


References:
  1. CYRAMZA (ramucirumab) [package insert]. India, Eli Lilly & Company (India) Pvt. Ltd.
  2. Data on file, Eli Lilly and Company. ONC20140729a.
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