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.
ZINPLAVA™
(bezlotoxumab) injection 25 mg/mL
For answers to questions you may have, select any of the topics below. To see a complete list of Q&As, scroll down.
ZINPLAVA is a human monoclonal antibody that binds to Clostridium difficile toxin B indicated to reduce recurrence of Clostridium difficile infection (CDI) in patients 18 years of age or older who are receiving antibacterial drug treatment of 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.
The recommended dose of ZINPLAVA is a single 10-mg/kg dose administered as an IV infusion over 60 minutes.
ZINPLAVA must be administered during the course of antibiotic treatment for a 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.
Definitions:
CDI = Clostridium difficile infection
IV = intravenous
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 ZINPLAVAYou may also find additional information using the guide for ZINPLAVA.
Download guide for ZINPLAVANovel mechanism of action targets toxin B
In vitro, ZINPLAVA neutralized the pathogenic action of toxin B
ZINPLAVA Infusion Center Locator
Help your patients find an infusion center near them to schedule their infusion of ZINPLAVA
Find ZINPLAVA HereThe potentially relevant codes (effective October 1, 2017), are:
Diagnosis | |
---|---|
A04.71 | Enterocolitis due to Clostridium difficile, recurrent |
A04.72 | Enterocolitis due to Clostridium 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.
Yes. Efficacy and safety of ZINPLAVA were investigated in 2 randomized, double-blind, placebo-controlled, multicenter Phase 3 trials in 1,554 adult patients. Enrolled patients had a confirmed diagnosis of CDI, defined as diarrhea (≥3 loose bowel movements in ≤24 hours) and a positive stool test for toxigenic C. difficile from a stool sample collected ≤7 days before study entry. Patients received a 10- to 14-day course of oral CDI antibiotics (metronidazole, vancomycin, or fidaxomicin). 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.
View full clinical data about efficacy of ZINPLAVAPatient Education
Help your patients find answers to:
- What is C. diff?
- What is ZINPLAVA? How does ZINPLAVA work?
- Possible side effects of ZINPLAVA?
- And more
Download patient brochureSelected 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.
ZINPLAVA is a human monoclonal antibody that binds to Clostridium difficile toxin B indicated to reduce recurrence of Clostridium difficile infection (CDI) in patients 18 years of age or older who are receiving antibacterial drug treatment of 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.
Before prescribing ZINPLAVATM (bezlotoxumab), please read the Prescribing Information. The Patient Information also is available.