bezlotoxumab (Rx)

>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%)

Dyspnea (1%)

Hypertension (1%)

Dizziness (1%)

Fatigue (1%)

Contraindications

None

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

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

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

Pregnancy Categories

A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA: Information not available.

Mechanism of Action

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

Absorption

Peak plasma concentration: 185 mcg/mL (adults); 139 mcg/mL (children)

AUC: 53,000 mcg·h/mL (adults); 47,900 mcg·h/mL (children)

Distribution

Vd: 7.33 L

Metabolism

Eliminated by catabolism; no metabolic drug-drug interactions are expected

Elimination

Half-life: ~19 days

Clearance: 0.317 L/day; increases with increasing body weight

IV Compatibilities

0.9% NaCl

D5W

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

Storage

Does not contain preservatives

Unopened vials

• Refrigerate at 2-8ºC (36-46ºF) in original carton to protect from light
• Do not freeze
• Do not shake

Diluted solution

• May be stored either at room temperature for up to 16 hr or under refrigeration at 2-8°C (36-46°F) for up to 24 hr
• If refrigerated, allow the IV bag to come to room temperature prior to use
• These time limits include storage of the infusion solution in the IV bag through the duration of infusion
• Do not freeze the diluted solution