ZINPLAVA™

(bezlotoxumab) injection

Patient Profiles

Immunocompromised patient

Reduce CDI recurrence in immunocompromised patients

Female, teacher, 55 years old

Not an actual patient.

History

  • A 55-year-old female patient was diagnosed with multiple myeloma 4 months ago, and has been on a chemotherapy regimen for the past 2 months.
  • She presented to the hospital a week ago with chest pain, fever, productive cough, and dyspnea, and was admitted for pneumonia.

Presentation

  • She was initially hospitalized for pneumonia and was prescribed IV antibiotics. Subsequently, her chemotherapy regimen was put on hold.
  • A chest X-ray on Day 5 showed moderate improvement in pneumonia compared with Day 1, and her fever and cough improved.
  • After 6 days in the hospital, she experienced severe, watery diarrhea 6 times over 24 hours, with abdominal cramping and nausea.
  • A PCR and toxin test were both positive and confirmed presence of C. difficile toxin.

Lab results

  • C. difficile toxin: Positive
  • Total CO2: 22 mmol/L
  • Sodium: 148 mEq/L
  • Creatinine: 1.3 mg/dL
  • BUN: 22 mg/dL
  • Glucose: 75 mg/dL
  • Potassium: 3.4 mEq/L
  • Sputum culture: Positive for Streptococcus pneumoniae

Treatment

  • She was prescribed antibiotics for CDI.
  • She was also started on IV hydration.

Current situation

  • She now faces extended hospitalization as the result of a CDI acquired during her hospital stay.
  • She is isolated in a separate room due to CDI.
  • She has asked her family not to visit her because she is afraid of spreading her infection.
  • While CDI symptoms may resolve with SOC antibiotics, she is at higher risk for recurrence because of her immunocompromised status following chemotherapy treatment, and antibiotic therapy for her respiratory infection.

Definitions

BUN = blood urea nitrogen 

CDI = Clostridium difficile infection 

IV = intravenous 

PCR = polymerase chain reaction 

SOC = standard of care

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