ZINPLAVA (bezlotoxumab)

ZINPLAVA (bezlotoxumab)

OFFICE ADMINISTRATION [medical benefit]

Indications for Prior Authorization:

• Indicated to reduce the recurrence of Clostridium difficile (c. difficile) infection (CDI) in patients at least 18 years of age who are receiving antibacterial drug treatment for CDI and are at a high-risk of CDI recurrence

Patients must met the following criteria for the indication(s) above:

• Patient is 18 years of age or older
• Prescribed by or in collaboration with a specialist
• Used in conjunction with antibacterial drug treatment of CDI
• Patient has at least one risk factor for higher likelihood of recurrent CDI (e.g. those over 65 years of age, those with compromised immune systems, previous antibiotic exposure, admission to a healthcare facility, prior CDI and hypervirulent strains)
• Patient has tried and failed first-line agents (e.g. Metronidazole, Dificid, and Vancomycin capsules)

Dosing:

• Administer Zinplava during antibacterial drug treatment for CDI
• Recommended dosing for Zinplava is a single dose of 10 mg/kg administered as an IV infusion over 60 minutes

Approval:

• 1 time treatment