Bezlotoxumab

Bezlotoxumab is used to reduce the recurrence of Clostridium difficile infection (CDI) in adults who are receiving antibacterial drug treatment for CDI and are at a high risk of recurrence.

Bezlotoxumab is available under the following different brand names: Zinplava.

Dosage Forms and Strengths

Solution for Injection

• 1000mg/40mL vial (25mg/mL)

Dosage Considerations – Should be Given as Follows:

Clostridium difficile Infection

• Indicated to reduce the recurrence of Clostridium difficile infection (CDI) in adults who are receiving antibacterial drug treatment for CDI and are at a high risk of recurrence
• 10 mg/kg intravenously (IV) infused over 1 hour as a single dose
• See Administration for information on preparing IV dilution and use of filter during IV infusion

Dosage Modifications

Renal or hepatic impairment

• No dosage adjustment required
• No clinically meaningful differences in the exposure of bezlotoxumab were found between patients with renal or hepatic impairment and patients with normal renal or normal hepatic function

Dosing Considerations

The safety and efficacy of repeat administration in patients with CDI have not been studied

Limitations of use

• Not indicated for the treatment of CDI
• Bezlotoxumab is not an antibacterial drug
• Should only be used in conjunction with antibacterial drug treatment of CDI
• Children under 18 years: Safety and efficacy not established

Common side effects of bezlotoxumab include:

• Heart failure
• Infusion-related reactions
• Nausea
• Fever
• Headache

This document does not contain all possible side effects and others may occur. Check with your physician for additional information about side effects.

If your doctor has directed you to use this medication, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider or pharmacist first.

• Bezlotoxumab has no listed severe interactions with other drugs.
• Bezlotoxumab has no listed serious interactions with other drugs.
• Bezlotoxumab has no listed moderate interactions with other drugs.
• Bezlotoxumab has no listed mild interactions with other drugs.

This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist. Check with your physician if you have health questions or concerns.

Warnings
 

This medication contains bezlotoxumab. Do not take Zinplava if you are allergic to bezlotoxumab or any ingredients contained in this drug.

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center immediately.

Contraindications

• None

Effects of Drug Abuse

• No information available

Short-Term Effects

• See "What Are Side Effects Associated with Using Bezlotoxumab?”

Long-Term Effects

• See "What Are Side Effects Associated with Using Bezlotoxumab?”

Cautions

• Heart failure was reported more commonly in clinical trials in bezlotoxumab-treated patients compared with placebo; these adverse reactions occurred primarily in patients with underlying congestive heart failure (CHF)
• In patients with a history of CHF, bezlotoxumab should be reserved for use when benefits outweigh risks

Pregnancy and Lactation

Adequate and well-controlled studies of bezlotoxumab have not been conducted in pregnant women. No animal reproductive and developmental studies have been conducted with bezlotoxumab. Consult your doctor.

It is unknown if bezlotoxumab is distributed in human breast milk. Consider the developmental and health benefits of breastfeeding along with the mother’s clinical need for bezlotoxumab, and any potential adverse effects on the breastfed infant from the drug or from the underlying maternal condition.