ZINPLAVATM (bezlotoxumab) is a human monoclonal antibody that binds to Clostridioides difficile toxin B indicated to reduce recurrence of Clostridioides difficile infection (CDI) in patients 18 years of age or older who are receiving antibacterial drug treatment for CDI and are at high risk for CDI recurrence.
ZINPLAVA is not indicated for the treatment of CDI. ZINPLAVA is not an antibacterial drug. ZINPLAVA should only be used in conjunction with antibacterial drug treatment of CDI.
Selected Safety Information
- In patients with a history of congestive heart failure (CHF), ZINPLAVA should be used when the benefit outweighs the risk. Heart failure was reported more commonly in clinical trials in adults in ZINPLAVA-treated patients compared to placebo-treated patients. In patients with a history of CHF, 12.7% (n=15/118) of ZINPLAVA-treated patients and 4.8% (n=5/104) of placebo-treated patients had the serious adverse reaction of heart failure during the 12-week study period. During the same period, for patients with a history of CHF, there were more deaths in ZINPLAVA-treated patients 19.5% (n=23/118) than in placebo-treated patients 12.5% (n=13/104). The causes of death varied and included cardiac failure, infections, and respiratory failure.
- The most common adverse reactions occurring in adults 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) 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 in adults 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.
- In ZINPLAVA-treated adult patients, 10% experienced one or more infusion specific adverse reactions compared to 8% of placebo-treated patients, on the day of or the day after, the infusion. 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%). Of these patients, 78% experienced mild adverse reactions, and 20% experienced moderate adverse reactions. These reactions resolved within 24 hours following onset.