Bezlotoxumab

Generic name: bezlotoxumab
Brand name: Zinplava
Dosage form: intravenous solution (25 mg/mL)
Drug class: Immune globulins

Medically reviewed by  A Ras MD.

What is bezlotoxumab?

Bezlotoxumab is a prescription medicine that is used to lower the chance of a type of bacterial infection called C diff from coming back.

Description

Bezlotoxumab is a human monoclonal antibody that binds to C. difficile toxin B and neutralizes its effects. Bezlotoxumab is an IgG1 immunoglobulin with an approximate molecular weight of 148.2 kDa.

ZINPLAVA (bezlotoxumab) Injection is a sterile, preservative-free, clear to moderately opalescent, colorless to pale yellow solution that requires dilution for intravenous infusion. The product is provided in a 50 mL vial that contains 1000 mg of bezlotoxumab in 40 mL of solution. Each mL of solution contains bezlotoxumab (25 mg), citric acid monohydrate (0.8 mg), diethylenetriaminepentaacetic acid (0.0078 mg), polysorbate 80 (0.25 mg), sodium chloride (8.77 mg), sodium citrate dihydrate (4.75 mg), and Water for Injection, USP. The vial may contain sodium hydroxide to adjust the pH to 6.0.

Before taking bezlotoxumab, tell your doctor:

• If you are allergic to bezlotoxumab; any part of this medicine; or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.

This medicine may interact with other drugs or health problems.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take bezlotoxumab with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take bezlotoxumab?

• Tell all of your health care providers that you take bezlotoxumab. This includes your doctors, nurses, pharmacists, and dentists.
• This medicine will not treat a C diff infection. Keep taking your other antibiotic treatment for the C diff infection as you have been told by your doctor.
• Tell your doctor if you are pregnant, plan on getting pregnant, or are breast-feeding. You will need to talk about the benefits and risks to you and the baby.

How is bezlotoxumab best taken?

Use bezlotoxumab as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• It is given as an infusion into a vein over a period of time.

What do I do if I miss a dose?

• Call your doctor to find out what to do.

What are the side effects of bezlotoxumab that I need to call my doctor about immediately?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Signs of high blood pressure like very bad headache or dizziness, passing out, or change in eyesight.
• Serious heart failure has happened with bezlotoxumab. People with a history of heart failure who took bezlotoxumab had a higher chance of heart failure and death than those who did not take bezlotoxumab. Tell your doctor if you have ever had heart failure. Call your doctor right away if you have shortness of breath, a big weight gain, or swelling in the arms or legs that is new or worse.

What are some other side effects of bezlotoxumab?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Upset stomach.
• Fever.
• Headache.
• Feeling tired or weak.
• Dizziness.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.

If overdose is suspected:

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

How do I store and/or throw out bezlotoxumab?

• If you need to store bezlotoxumab at home, talk with your doctor, nurse, or pharmacist about how to store it.