Primary navigation

    Nuzyra™

    Drug - Nuzyra™ (omadacycline) [Paratek Pharmaceuticals, Inc.]

    July 2019

    Therapeutic area - Tetracycline Antibiotics

    Initial approval criteria

    • Patient must be ≥ 18 years of age AND
    • If of childbearing potential, patient is NOT pregnant AND
    • Patient has a diagnosis of community-acquired bacterial pneumonia (CABP) AND meets the following requirements:
      • Infection is hypothesized to be caused by susceptible pathogens (Streptococcus pneumoniae, Staphylococcus aureus [methicillin-susceptible isolates; MSSA], Haemophilus influenzae, Haemophilus parainfluenzae, Klebsiella pneumoniae, Legionella pneumophila, Mycoplasma pneumoniae, and Chlamydophila pneumoniae) AND
      • Patient is continuing treatment from an acute care admission AND
      • Provider determines it would be clinically inappropriate to deescalate therapy or use alternative therapy based on susceptibility results or lack of susceptibility results in conjunction with clinical picture AND
      • Total treatment duration is 7 to 14 days AND
      • Patient is not a candidate for oral therapy and patient is prescribed 100 mg by intravenous infusion once daily OR
      • Patient is prescribed 300 mg orally once daily OR
    • Patient has a diagnosis of acute bacterial skin and skin structure infections (ABSSSI) AND meets the following requirements:
      • Infection is hypothesized to be caused by susceptible pathogens (S. aureus [methicillin-susceptible and -resistant isolates], Staphylococcus lugdunensis, Streptococcus pyogenes, Streptococcus anginosus group [includes S. anginosus, S. intermedius, and S. constellatus], Enterococcus faecalis, Enterobacter cloacae, and K. pneumoniae) AND
      • Total treatment duration is 7 to 14 days AND
      • Dosing follows approved FDA-dosing instructions if initiating or continuing therapy AND
      • If patient is prescribed intravenous therapy, the patient is not a candidate for oral therapy AND
      • If continuing therapy initiated in an acute care setting, provider determines it would be clinically inappropriate to deescalate therapy or use alternative therapy based on susceptibility results or lack of susceptibility results OR
      • Patient is initiating therapy and is not a candidate or has failed treatment with ≥ 2 preferred antibiotics from 2 different classes AND
      • Patient has NOT failed any agent within a tetracycline class ((i.e. doxycycline, minocycline, tetracycline, etc.) unless susceptibility results demonstrate that pathogen is NOT susceptible to other tetracyclines but is susceptible to omadacycline

    Renewal criteria

    • Patient continues to meet above criteria AND
    • Patient’s symptoms are clinically improving, as documented by provider AND
    • Prescriber documents that patient is adherent to administration of oral therapy, if applicable AND
    • Prescriber is extending treatment duration to a total duration of ≤ 14 days AND
    • Patient has no treatment-limiting adverse effects (e.g., Clostridium difficile associated diarrhea, severe photosensitivity, etc)

    Quantity limits

    CABP (following loading dose administered in an acute care setting):

    • One 100 mg IV injection/day OR
    • Two 150 mg tablets/day

    ABSSSI

    • Loading dose (only if patient is newly initiating therapy with omadacycline; for patients NOT continuing therapy):
      • 200 mg IV injection/day on first day of treatment OR
      • Three 150 mg tablets/day for days 1 and 2 AND
    • One 100 mg IV injection/day on subsequent days OR
    • Two 150 mg tablets/day on subsequent days

    Treatment course not to exceed 14 total days (including any doses administered in an acute care setting); additional treatment courses may be approved for new diagnoses (additional treatment should not be approved for infections that have not responded adequately to treatment with omadacycline)

    Questions?

    MHCP Provider Call Center 651-431-2700 or 800-366-5411

    back to top