Demographic, clinical symptoms, and
infusion reaction data were recorded from the patients' charts.
2% of patients in the sipuleucel-T group developed an acute
infusion reaction.
These fatalities were associated with an
infusion reaction symptom complex that included hypoxia, pulmonary infiltrates, acute respiratory distress syndrome, myocardial infarction, ventricular fibrillation, or cardiogenic shock.
Also, if they don't have such a robust response, it probably means they have antibodies to pegylated uricase, which also increases their risk of an
infusion reaction.
During an
infusion reaction, early intervention may prevent serious side effects and death.
Safe use is possible if rising concentrations of serum urate - a sign of antibody development and impending
infusion reaction - are caught in time.
If an
infusion reaction occurs, the infusion should be interrupted and appropriate medical management instituted.
Antibody concentrations at or above the cutoff increased the relative risk of an
infusion reaction by a factor of 2.
ProStorm[TM] is designed specifically to indicate when a cytokine storm first
infusion reaction may be a risk for a drug.
In the event of an
infusion reaction, the infusion rate may be slowed or interrupted.
The most common Grade 3-5 side effects (occurring in at least 5 percent of patients) observed more frequently in the Gazyva arm were low white blood cell count,
infusion reactions, low white blood cell count with fever and low platelet count.
ZW25 continues to be well-tolerated at all doses and schedules, with the most common adverse events being Grade 1 or 2 diarrhea,
infusion reactions or nausea.