ZINPLAVA™

(bezlotoxumab) injection

Patient Profiles

Older adult

Help reduce CDI recurrence in patients aged 65 and older

Male, 76 years old

Not an actual patient.

History

  • A 76-year-old male patient and resident of a local nursing home has a 4-year history of anxiety and a 10-year history of enlarged prostate. 
  • Three weeks following antibiotic therapy for a UTI, he presented to the ED with dehydration caused by watery diarrhea 8 times a day, for the previous 2 days. 
  • A stool test confirmed C. difficile toxin. 
  • After 2 days in the hospital to treat dehydration, he was discharged back to the nursing home to complete his course of antibiotics for CDI.

Presentation

  • Three weeks after discharge from the hospital for his initial episode of CDI, he presented to the ED once again with dehydration and watery diarrhea 9 times a day, for the past 2 days.
  • Stool test confirmed the presence of CDI toxin.
  • A CT of the abdomen showed colitis of the sigmoid colon.

Lab results

  • C. difficile toxin: Positive
  • Total CO2: 23 mmol/L
  • Sodium: 154 mEq/L
  • Creatinine: 1.9 mg/dL
  • BUN: 23 mg/dL
  • Glucose: 67 mg/dL
  • WBC count: 17,000 cells/μL
  • Albumin: 3.0 g/dL

Vital signs

  • Temperature: 37.2°C

Treatment

  • He was readmitted to the medical/surgical floor, started on fluids for hydration, and prescribed antibiotics for CDAD.

Current situation

  • Although current symptoms of CDI may resolve with CDI antibiotics, the fact that he has already had a recurrence puts him at a higher risk for additional CDI episodes.1

Definitions

BUN = blood urea nitrogen 

CDAD = Clostridium difficile–associated diarrhea 

CDI = Clostridium difficile infection 

CT = computed tomography 

ED = emergency department 

UTI = urinary tract infection 

WBC = white blood cell

Reference

1. McFarland LV, Elmer GW, Surawicz CM. Breaking the cycle: treatment strategies for 163 cases of recurrent Clostridium difficile disease. Am J Gastroenterol. 2002;97(7):1769–1775. doi:10.1111/j.1572-0241.2002.05839.x.

Indication

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.

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 the two Phase 3 clinical trials 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 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 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 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.
  • As with all therapeutic proteins, there is a potential for immunogenicity following administration of ZINPLAVA. The detection of antibody formation is highly dependent on the sensitivity and specificity of the assay. Comparison of the incidence of antibodies to bezlotoxumab in the two Phase 3 studies (MODIFY I and II) with the incidence of antibodies in other studies or to other products may be misleading. In MODIFY I and II, none of the 710 evaluable ZINPLAVA-treated patients tested positive for treatment-emergent anti-bezlotoxumab antibodies.

Before prescribing ZINPLAVATM (bezlotoxumab), please read the Prescribing Information. The Patient Information is also available.

AINF-1245982-000007/18