Zinplava

What Is Zinplava?

Zinplava (bezlotoxumab) injection is a human monoclonal antibody that binds to Clostridium difficile (C. Diff.) 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 a high risk for CDI recurrence.

What Are Side Effects of Zinplava?

Common side effects of Zinplava include:

• nausea,
• fever, and
• headache.

Dosage for Zinplava

The recommended dose of Zinplava is a single dose of 10 mg/kg administered as an intravenous infusion over 60 minutes.

What Drugs, Substances, or Supplements Interact with Zinplava?

Zinplava may interact with other drugs. Tell your doctor all medications and supplements you use.

Zinplava During Pregnancy and Breastfeeding

Tell your doctor if you are pregnant or plan to become pregnant before using Zinplava. It is unknown how it would affect a fetus. It is unknown if Zinplava passes into breast milk. Consult your doctor before breastfeeding.

Additional Information

Our Zinplava (bezlotoxumab) injection Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

 

Zinplava Consumer Information

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• worsening symptoms of C. difficile infection, such as severe stomach pain or watery diarrhea;
• swelling in your hands, ankles, or feet;
• rapid weight gain; or
• shortness of breath (even with mild exertion).

Common side effects may include:

• nausea;
• fever; or
• headache.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Zinplava (Bezlotoxumab Injection)

 

Zinplava Professional Information

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.

Read the entire FDA prescribing information for Zinplava (Bezlotoxumab Injection)