Bezlotoxumab Injection

Name: Bezlotoxumab Injection

Other uses for this medicine

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

What special precautions should I follow?

Before receiving bezlotoxumab injection,

  • tell your doctor and pharmacist if you are allergic to bezlotoxumab, any other medications, or any of the ingredients in bezlotoxumab infusion. Ask your pharmacist for a list of the ingredients.
  • tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
  • tell your doctor if you have or have ever had heart failure.
  • tell your doctor if you are pregnant, plan to become pregnant, or are breastfeeding.

Indications

ZINPLAVA™ is 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 a high risk for CDI recurrence.

Limitation Of Use

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. [See DOSAGE AND ADMINISTRATION]

Side effects

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

The safety of ZINPLAVA was evaluated in two placebo-controlled, Phase 3 trials (Trial 1 n= 390 and Trial 2 n= 396). Patients received a single 10 mg/kg intravenous infusion of ZINPLAVA and concomitant standard of care antibacterial drugs (metronidazole, vancomycin or fidaxomicin) for CDI (SoC). Adverse reactions reported within the first 4 weeks after ZINPLAVA was administered are described for the pooled Phase 3 trial population of 786 patients. The median age of patients receiving ZINPLAVA was 65 years (range 18 to 100), 50% were age 65 years or older, 56% were female, and 83% were white.

The most common adverse reactions following treatment with ZINPLAVA (reported in ≥ 4% of patients within the first 4 weeks of infusion and with a frequency greater than placebo) were nausea, pyrexia, and headache (see Table 1).

Table 1: Adverse Reactions Reported in ≥ 4% of ZINPLAVA-Treated Patients with CDI and at a Frequency Greater than Placebo in Trial 1 and Trial 2*,†

Adverse Reaction ZINPLAVA with SoC‡
N=786 %		 Placebo with SoC‡
N=781 %
Gastrointestinal disorders
  Nausea 7% 5%
General disorders and administration site conditions
  Pyrexia 5% 3%
Nervous system disorders
  Headache 4% 3%
* All patients as treated population, defined as all randomized patients who received a dose of study medication, by treatment received
† Adverse reactions reported within 4 weeks of administration of ZINPLAVA or placebo
‡ SoC = Standard of Care antibacterial drugs (metronidazole or vancomycin or fidaxomicin) for CDI

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 the placebo-treated patients [see WARNINGS AND PRECAUTIONS].

One patient discontinued the ZINPLAVA infusion due to ventricular tachyarrhythmia that occurred 30 minutes after the start of the infusion.

Mortality rates were 7.1% and 7.6% in ZINPLAVA-treated patients and placebo-treated patients, respectively, during the 12-week follow-up period.

Infusion Related Reactions

Overall, 10% of ZINPLAVA-treated patients experienced one or more infusion specific adverse reactions on the day of, or the day after, the infusion compared to 8% of placebo-treated patients. 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% and 20% of patients experienced mild and moderate adverse reactions, respectively. These reactions resolved within 24 hours following onset.

Immunogenicity

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. Additionally, the observed incidence of antibody (including neutralizing antibody) positivity in an assay may be influenced by several factors including assay methodology, sample handling, timing of sample collection, concomitant medications, and underlying disease. For these reasons, comparison of the incidence of antibodies to bezlotoxumab in the studies described below with the incidence of antibodies in other studies or to other products may be misleading.

Following treatment with ZINPLAVA in Trial 1 and Trial 2, none of the 710 evaluable patients tested positive for treatment-emergent anti-bezlotoxumab antibodies.

Warnings

Included as part of the PRECAUTIONS section.

  • Clostridium Difficile Colitis (Antibiotic-Associated Colitis, C. difficile colitis)
  • Is C. diff (Clostridium difficile) Contagious?
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