Bezlotoxumab

Clostridium difficile Infection

Clostridium difficile Infection Indicated to reduce recurrence of Clostridium difficile infection (CDI) in adults who are receiving antibacterial drug treatment for CDI and are at a high risk of recurrence The recommended dose is a single dose of 10 mg/kg administered as an intravenous infusion over 60 minutes.

Clostridioides difficile Infection Indicated to reduce recurrence of Clostridioides difficile infection (CDI) in patients aged >1 year who are receiving antibacterial drug treatment for CDI and are at a high risk for CDI recurrence <1 year: Safety and efficacy not established >1 year: 10 mg/kg IV infused over 1 hr as a single dose

Renal 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

No dose adjustment is necessary for patients >65 years of age

IV Preparation Must be diluted before IV 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 hr before preparation of the diluted solution Inspect vial contents for discoloration and particulate matter prior to dilution; should appear as 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 IV bag containing either 0.9% NaCl or D5W to prepare a diluted solution with a final concentration ranging from 1-10 mg/mL Mix diluted solution by gentle inversion; do not shake Discard vial(s) and all unused contents IV Administration Infuse diluted solution IV over 1 hr as a one-time single dose using a sterile, nonpyrogenic, low-protein binding 0.2-5 micron inline or add-on filter Can be infused via a central line or peripheral catheter Do not administer as an IV push or bolus Do not coadminister other drugs simultaneously through the same infusion line Administer during antibacterial drug treatment for CDI

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 In patients with a history of CHF, bezlotoxumab should be reserved for use when benefits outweigh risks

Not Classi Pregnancy Adequate and well-controlled studies of bezlotoxumab have not been conducted in pregnant women No animal reproductive and developmental studies have been conducted Lactation Unknown if distributed in human breast milk Consider the developmental and health benefits of breastfeeding along with the mother’s clinical need for the drug, and any potential adverse effects on the breastfed infant from the drug or from the underlying maternal condition

>10% Heart failure, history of CHF (12.7%) 1-10% Infusion-related reactions (10%) Nausea 7% Pyrexia 5% Headache 4% Heart failure, no history of CHF (2.3%)

Human monoclonal antibody that binds to C difficile toxin B and neutralizes its effects; does not bind to C difficile toxin A