NUZYRA (omadacycline tosylate)

NUZYRA (omadacycline tosylate)

SELF ADMINISTRATION or OFFICE ADMINISTRATION 

Indication for Prior Authorization:

• Indicated for the treatment of adult patients with the following infections caused by susceptible microorganisms:
  • Community-acquired bacterial pneumonia (CABP)
    • Streptococcus pneumoniae, Staphylococcus aureus (methicillin-susceptible isolates), Haemophilus influenzae, Haemophilus parainfluenzae, Klebsiella pneumoniae, Legionella pneumophila, Mycoplasma pneumoniae, and Chlamydophila pneumoniae.
  • Acute bacterial skin and skin structure infections (ABSSSI)
    • Staphylococcus aureus (methicillin-susceptible and -resistant isolates), Staphylococcus lugdunensis, Streptococcus pyogenes, Streptococcus anginosus grp. (includes S. anginosus, S. intermedius, and S. constellatus), Enterococcus faecalis, Enterobacter cloacae, and Klebsiella pneumoniae.
• To reduce the development of drug-resistant bacteria and maintain the effectiveness of Nuzyra™ and other antibacterial drugs, Nuzyra™ should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria.

Patients must meet the following criteria for the indications above:

• Patient is 18 years of age or older, AND 
• Diagnosis of CABP or ABSSSI confirmed by chart not documentation, AND
• Documentation of bacterial culture and susceptibility, AND
• Prescribed by or in consultation with an infectious disease specialist, AND
• The patient meets one of the following:
  • Request is for continuation of therapy, initiated in an acute care hospital from which the patient has been discharged
  • Patient has tried and failed 2 preferred antibiotics

Dosing:

• CABP
  • Loading Dose: IV: 200 mg single dose on day 1 or 100 mg twice on day 1
  • Maintenance Dose:        
    • IV: 100 mg once daily
    • Oral: 300 mg once daily
• ABSSSI
  • Loading Dose:
    • IV: 200 mg single dose on day 1 or 100 mg twice on day 1
    • Oral: 450 mg once daily on days 1 and 2
  • Maintenance Dose:
    • IV: 100 mg once daily
    • Oral: 300 mg once daily
• Duration of therapy: 7-14 days

Approval:

• 1 treatment course (maximum of 14 days)