Bezlotoxumab

What is Bezlotoxumab?

Bezlotoxumab (ZINPLAVA) is a human monoclonal antibody that binds to Clostridium difficile toxin B used for the prevention of recurrence of Clostridium difficile infection (CDI).

What are the uses of this medicine?

• This medicine is 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.

How does this medicine work?

• Bezlotoxumab (bez" loe tox' ue mab) is a human monoclonal antibody to the C. difficile toxin B that has high affinity for the toxin, blocking its binding to host cells.
• In several large clinical trials, bezlotoxumab given at the time of antibacterial therapy was found to decrease the rate of recurrence of C. difficile infection.
• In these same studies, a companion molecule, actoxumab, a human monoclonal antibody to the C. difficile toxin A, was found to be ineffective.

Who Should Not Use this medicine ?

• 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.

What drug interactions can this medicine cause?

• Since ZINPLAVA is eliminated by catabolism, no metabolic drug-drug interactions are expected.

Is this medicine FDA approved?

• It was approved for use in the United States in 2016.

How should this medicine be used?

• Administer ZINPLAVA during antibacterial drug treatment for CDI.

Recommended Dosage:

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

Administration

• ZINPLAVA must be diluted prior to intravenous infusion.
• Prepare the diluted solution immediately after removal of the vial(s) from refrigerated storage, or the vial(s) may be stored at room temperature protected from light for up to 24 hours prior to preparation of the diluted solution.
• Inspect vial contents for discoloration and particulate matter prior to dilution. ZINPLAVA is a clear to moderately opalescent, colorless to pale yellow solution. Do not use the vial if the solution is discolored or contains visible particles.
• Do not shake the vial.
• Withdraw the required volume from the vial(s) based on the patient's weight (in kg) and transfer into an intravenous bag containing either 0.9% Sodium Chloride Injection, USP or 5% Dextrose Injection, USP to prepare a diluted solution with a final concentration ranging from 1 mg/mL to 10 mg/mL. Mix diluted solution by gentle inversion. Do not shake.
• Discard vial(s) and all unused contents.
• Administer the diluted solution as an intravenous infusion over 60 minutes using a sterile, non-pyrogenic, low-protein binding 0.2 micron to 5 micron in-line or add-on filter.
• The diluted solution can be infused via a central line or peripheral catheter. Do not administer ZINPLAVA as an intravenous push or bolus.
• Do not co-administer other drugs simultaneously through the same infusion line.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Injection: 1,000 mg/40 mL (25 mg/mL) clear to moderately opalescent, colorless to pale yellow solution in a single-dose vial.

This medicine is available in fallowing brand namesː

• ZINPLAVA

What side effects can this medication cause?

The most common side effects that may happen on the day of or the day after receiving ZINPLAVA:

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

The most common side effects that may happen up to four weeks after receiving ZINPLAVA:

• nausea
• fever
• headache

ZINPLAVA may cause serious side effects, including:

• Heart failure

What special precautions should I follow?

• Heart Failure was reported more commonly in ZINPLAVA-treated patients with a history of congestive heart failure (CHF) in the two Phase 3 clinical trials.
• In patients with a history of CHF, ZINPLAVA should be reserved for use when the benefit outweighs the risk.

What to do in case of emergency/overdose?

• There is no clinical experience with overdosage of ZINPLAVA.

Management for overdosage:

• In case of overdose, patients should be closely monitored for signs or symptoms of adverse reactions, and appropriate symptomatic treatment should be instituted.

Can this medicine be used in pregnancy?

• Adequate and well controlled studies with ZINPLAVA have not been conducted in pregnant women.

Can this medicine be used in children?

• Safety and efficacy of ZINPLAVA in patients below 18 years of age have not been established.

What are the active and inactive ingredients in this medicine?

• The active ingredient is: bezlotoxumab
• The inactive ingredients are: citric acid monohydrate, diethylenetriaminepentaacetic acid, polysorbate 80, sodium chloride, sodium citrate dihydrate, and water for injection, USP. ZINPLAVA may also contain sodium hydroxide.

Who manufactures and distributes this medicine?

• Manufactured by: Merck Sharp & Dohme Corp., a subsidiary of

MERCK & CO., INC., Whitehouse Station.

What should I know about storage and disposal of this medication?

• Store in a refrigerator, 2ºC to 8ºC (36ºF to 46ºF) in original carton to protect from light.
• Do Not Freeze.
• Do Not Shake.

• Dailymed label info on Bezlotoxumab
• FDA Bezlotoxumab

Bezlotoxumab Resources
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