ZINPLAVA™ (Bezlotoxumab)

ZINPLAVA™

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Important Safety Information

ZINPLAVA™ (bezlotoxumab) should only be used concurrently with antibacterial drug treatment. While it reduces the recurrence of Clostridium difficile infection (CDI), it does not treat the infection itself. CDI is a bacterial infection that may damage your colon and cause stomach pain and severe diarrhea. Heart failure was reported in some phases of the clinical trials. Therefore, if you have a history of congestive heart failure (CHF), talk to your doctor about your options.

The inactive ingredients of ZINPLAVA™ are citric acid monohydrate, diethylenetriaminepentaacetic acid, polysorbate 80, sodium chloride, sodium citrate dihydrate, and sodium hydroxide. Do not take ZINPLAVA™ if you are allergic to any of them.

What is the most important information I should know about ZINPLAVA™?

ZINPLAVA™ may cause your immune system to react. Talk to your doctor about your medical history, as well as every medication you’re currently taking — whether prescription, over-the-counter, herbal, or vitamin supplements.

If you are pregnant or trying to get pregnant, talk to your doctor about whether you should receive a ZINPLAVA™ infusion. It is unknown whether ZINPLAVA™ can be passed to your baby through breastfeeding.

ZINPLAVA™ Side Effects

As with any prescription medication, ZINPLAVA™ carries a risk of side effects — with adverse reactions sometimes occurring within four weeks of infusion. The most common side effects include:

  • Headache
  • Fever
  • Fatigue
  • Nausea
  • Shortness of breath
  • Dizziness
  • High blood pressure

Tell your doctor if you experience any negative side effects. You are also encouraged to report such side effects to the Food and Drug Administration (FDA) by visiting www.fda.gov/medwatch, or by calling 1-800-FDA-1088.

Indications

ZINPLAVA™ is an antibody that targets toxin B to reduce the recurrence of Clostridium difficile infection (CDI) in patients who are 18 years of age or older and are receiving antibacterial drug treatment — also those who are at high risk of CDI recurrence. The recommended dose is a single 10-mg/kg during a 60-minute treatment.

Please refer to the full prescribing information.