FDA Approves Zinplava

The U.S. Food and Drug Administration (FDA) has approved Zinplava (bezlotoxumab), a monoclonal antibody indicated to reduce recurrence of Clostridium difficile infection (CDI) in adults who are receiving antibacterial drug treatment of CDI and are at high risk for CDI recurrence.

Zinplava is a prescription medicine used to help decrease the risk of C-diff from coming back in people 18 years of age or older who are taking an antibiotic for C-diff and who have a high risk of C-diff coming back.
C-diff is a bacterial infection
that can damage your colon and cause stomach pain and severe diarrhea. When people get C-diff, they often take an antibiotic to get rid of the infection. Even when treated by an antibiotic, C-diff can come back within weeks to months. Zinplava helps to decrease the risk of the infection from coming back. It works when given along with the antibiotic that you are taking to treat C-diff.
Zinplava is administered intravenously ,that is,via your vein.

Before you receive this medicine, be sure you understand what it is for.

• Zinplava helps decrease the risk of C-diff (Clostridium difficile infection) from coming back by working with the antibiotic that you are taking to treat your C-diff. It is not an antibiotic and does not replace the antibiotic.
• Keep taking your antibiotic for your C-diff as directed by your doctor.
• If you have questions about your treatment, ask your doctor or pharmacist.

Safety information

• It is not known if this medicine is safe and effective in children under 18 years old.
• If you are pregnant or trying to get pregnant, tell your doctor. It is not known if this medicine will harm your baby while you are pregnant. You and your doctor should decide together if you will receive Zinplava.
• If you are breastfeeding or plan to breastfeed, tell your doctor. It is not known if this medicine gets in your breast milk and will be passed to your baby. You and your doctor should decide together if you will receive Zinplava.
• Tell your doctor about any medical conditions you have now or have had before.
• Make sure to tell your doctor if you have or have had congestive heart failure (CHF).
• Tell your doctor about all of the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Zinplava side effects

Serious side effects include:

• Heart failure. Heart failure may happen in people who receive this medicine, and can be serious. People with a history of congestive heart failure (CHF) who received Zinplava had a higher rate of heart failure and death than those who did not.

Common side effects that may happen on the day of or the day after receiving Zinplava include:

• nausea
• headache
• fever
• feeling tired
• shortness of breath
• feeling dizzy
• high blood pressure

Common side effects that may happen up to four weeks after receiving Zinplava include:

• nausea
• fever
• headache

If you have any side effect that bothers you or does not go away, tell your doctor.

Active ingredient: bezlotoxumab

Inactive ingredients: citric acid monohydrate, diethylenetriaminepentaacetic acid, polysorbate 80, sodium chloride, sodium citrate dihydrate, and water for injection, USP. Zinplava may also contain sodium hydroxide.