Frequently asked questions about ZINPLAVA
For answers to questions you may have, select any of the topics below. To see a complete list of Q&As, scroll down.
What is the indication and usage for ZINPLAVA™ (bezlotoxumab)?
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.
What is the recommended dosing for ZINPLAVA™ (bezlotoxumab)?
ZINPLAVA must be administered during the course of antibiotic treatment for a Clostridioides difficile infection (CDI) episode.
ZINPLAVA should be administered using a sterile, nonpyrogenic, low-protein–binding 0.2-micron to 5-micron in-line or add-on filter.
- ZINPLAVA can be infused via a central line or peripheral catheter.
- Do not administer as an IV push or bolus.
- Do not coadminister other drugs simultaneously
through the same infusion line.
The safety and efficacy of repeat administration of ZINPLAVA in patients with CDI have not been studied.
What is the Selected Safety Information for ZINPLAVA™ (bezlotoxumab)?
- 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.
Is there additional information to help my patients with the cost of ZINPLAVA™ (bezlotoxumab)?
Yes. The Merck Access Program for ZINPLAVA can help answer questions about: Insurance coverage for patients; Benefit investigations; Prior authorizations; Appeals; Coding and billing.
Merck Access Program for ZINPLAVA
You may also find additional information using the guide for ZINPLAVA.
What is the mechanism of action for ZINPLAVA™ (bezlotoxumab)?
- ZINPLAVA is a human monoclonal antibody that binds to C. difficile toxin B and neutralizes its effects. ZINPLAVA is not an antibiotic.
In vitro, ZINPLAVA neutralized the pathogenic action of toxin B
- The clinical significance of in vitro data is unknown.
What are the possible C. difficile ICD-10 codes for ZINPLAVA™ (bezlotoxumab)?
| Diagnosis | |
| A04.71 | Enterocolitis due to Clostridioides difficile, recurrent |
| A04.72 | Enterocolitis due to Clostridioides difficile, not specified as recurrent |
The above codes may be potentially relevant when billing for ZINPLAVA and its administration. Consult the relevant manual and/or other guidelines for a description of each code to determine the appropriateness of its use and for information on additional codes. Diagnosis codes should be selected only by a health care professional. Please consult with the applicable payer to understand the payer’s specific billing requirements. This information is subject to change.
You are solely responsible for determining the appropriate codes and for any action you take in billing. The information provided here is not intended to be definitive or exhaustive, and is not intended to replace the guidance of a qualified professional advisor. Merck and its agents make no warranties or guarantees, expressed or implied, concerning the accuracy or appropriateness of this information for your particular use given the frequent changes in public and private payer billing. The use of this information does not guarantee payment or that any payment received will cover your costs.
Are there clinical data on the efficacy of ZINPLAVA™ (bezlotoxumab) on the recurrence of C. diff?
Patients were randomized to receive either a single 10-mg/kg (body weight) IV infusion of ZINPLAVA (n=781) or placebo IV (n=773) during the course of the CDI antibiotic therapy. Patients were assessed for clinical cure of the presenting CDI episode, defined as no diarrhea for 2 consecutive days following the completion of a ≤14-day CDI regimen. Patients who achieved clinical cure were then assessed for recurrence of CDI through 12 weeks following administration of the infusion of ZINPLAVA or placebo. To view the study design and clinical end points, click the link below.
What are the side effects of ZINPLAVA™ (bezlotoxumab)?
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-specific adverse reactions, 78% were mild and 20% were moderate, and all resolved within 24 hours following onset.