Safety Profile
Selected adverse reactions
- The most common adverse reactions occurring within 4 weeks of infusion with a frequency greater than placebo and reported in ≥4% of patients treated with ZINPLAVA and Standard of Care (SoC) CDI antibacterial drug therapy vs placebo and SoC antibacterial drug therapy were nausea (7% vs 5%), pyrexia (5% vs 3%), and headache (4% vs 3%).
- Serious adverse reactions occurring within 12 weeks following infusion were reported in 29% of ZINPLAVA-treated patients and 33% of placebo-treated patients. Heart failure was reported as a serious adverse reaction in 2.3% of the ZINPLAVA-treated patients and 1.0% of placebo-treated patients.
- One patient discontinued the ZINPLAVA infusion due to ventricular tachyarrhythmia that occurred 30 minutes after the start of the infusion.
- Mortality rates were similar across treatment arms (7.1% with ZINPLAVA and 7.6% with SoC CDI antibiotics alone) during the 12-week follow-up period.
- Infusion-related reactions: Following treatment with ZINPLAVA, 10% of patients experienced ≥1 infusion-specific adverse reactions the day of or the day after treatment, compared with 8% of those receiving placebo.
- Infusion-specific adverse reactions reported in ≥0.5% of patients receiving ZINPLAVA and at a frequency greater than placebo were nausea (3%), fatigue (1%), pyrexia (1%), dizziness (1%), headache (2%), dyspnea (1%), and hypertension (1%).
- For patients experiencing infusion-related adverse reactions, 78% were mild and 20% were moderate, and all resolved within 24 hours following onset.
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Warnings & Precautions / Drug Interactions