Zinplava 25 mg/mL intravenous solution

Generic name:
Bezlotoxumab - injection

Pronunciation
(BEZ-loe-TOX-ue-mab)

Brand name(s)
Zinplava

Bezlotoxumab is used to prevent the return of a severe intestinal infection due to a bacteria called C. difficile. Bezlotoxumab belongs to a class of drugs known as monoclonal antibodies. It works by blocking the effects of toxins made by C. difficile bacteria during an infection.

Bezlotoxumab is not an antibiotic and will not work to treat bacterial infections. Your doctor will prescribe a separate antibiotic to treat your C. difficile infection. Carefully follow your doctor's directions for all your medications.

Read the Patient Information Leaflet if available from your pharmacist before you start using bezlotoxumab. If you have any questions, ask your doctor or pharmacist.

This medication is given by a health care professional. It is injected slowly into a vein over 60 minutes, as directed by your doctor, usually as a single dose. The dosage is based on your medical condition, weight, and response to treatment.

Infusion reactions may happen during the infusion of this drug and for 24 hours afterward. Tell your doctor right away if you have any symptoms of infusion reactions such as nausea, tiredness, fever, dizziness, headache, or shortness of breath.

Tell your doctor if your condition lasts or gets worse.

See also How to Use section.

Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including:

• symptoms of heart failure (such as shortness of breath, swelling ankles/feet, unusual tiredness, unusual/sudden weight gain)

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including:

• rash
• itching/swelling (especially of the face/tongue/throat)
• severe dizziness
• trouble breathing

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Before receiving bezlotoxumab, tell your doctor or pharmacist if you have any allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of:

• heart failure

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is unknown if this medication passes into breast milk. Consult your doctor before breastfeeding.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call 1-800-222-1222. Canada residents can call 1-844-764-7669.

Do not share this medication with others.

Lab and/or medical tests (such as stool tests) may be done while you are using this medication. Keep all medical and lab appointments. Consult your doctor for more details.

Not applicable.

Not applicable. This medication is given in a hospital or clinic or doctor's office and will not be stored at home.

HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.