For US Healthcare Professionals only
PRESCRIBINGINFORMATION REQUEST
SAMPLES
NUZYRA is indicated for the treatment of Community-Acquired Bacterial Pneumonia (CABP) and Acute Bacterial Skin and Skin Structure Infections (ABSSSI) in adults caused by select susceptible microorganisms.
JUST SELECT,
SEND, AND ASK
Follow these 3 steps when you
choose to prescribe NUZYRA
SELECT a NUZYRA network specialty pharmacy* or hospital outpatient specialty pharmacy in your Electronic Health Record (EHR) prescribing system.
Some practical benefits of our Specialty Pharmacy Network or your hospital outpatient specialty pharmacy
These specialty pharmacy partners can help patients get their NUZYRA—and support your office staff or care coordinator if a prior authorization (PA) is needed.
*Paratek Pharmaceuticals, Inc. does not recommend or prefer the use of one pharmacy over another. NUZYRA Specialty Pharmacy Network as of 06/26/24.
- Walgreens Specialty Pharmacy
- CVS Specialty
- Kroger Specialty
- Option Care
- Panther
- Perigon Pharmacy 360
- Hospital Outpatient Specialty Pharmacy
SEND the prescription to your selected NUZYRA network specialty pharmacy via e-Prescribe or fax.
Specialty pharmacy partners can assist with prior authorization when you INCLUDE THE FOLLOWING INFORMATION with a prescription:
ICD-10 codes1, for example:
ABSSSI:
- L08.9 Local infection of the skin and subcutaneous tissue
- L03.116 Cellulitis of left lower limb
- L03.115 Cellulitis of right lower limb
- L03.119 Cellulitis of unspecified part of limb
- L03.90 Cellulitis of unspecified
- A49.9 Bacterial infection, unspecified
CABP:
- J18.9 Pneumonia
- J18.0 Bronchopneumonia, unspecified organism
- J18.1 Lobar pneumonia, unspecified organism
- J18.8 Other pneumonia, unspecified organism
- J15 Bacterial pneumonia, not elsewhere classified
Dosing information: Oral-only treatment duration (7-14 days)2
For ABSSSI Oral:
|
Days 1-2 450 mg (3 tablets) once per day |
Maintenance Dose 300 mg once daily |
Total Tablet Count 16-30 |
For CABP Oral:
|
Day 1 300 mg (2 tablets) BID BID=twice a day |
Maintenance Dose 300 mg once daily |
Total Tablet Count 16-30 |
Tablets not shown at actual size.
When prescribing oral NUZYRA, instruct patient to:
- Fast for at least 4 hours and then take with water
- NUZYRA can be taken at bedtime or upon waking
- Not eat or drink (except water) for 2 hours after dosing
- Not consume dairy products, antacids, or multivitamins for 4 hours after dosing
Patients on anticoagulant therapy may require downward adjustment of their anticoagulant dosage while also taking NUZYRA.
See complete Dosing Guides
Include or attach most recent chart notes and face sheet to help limit exchanges between the pharmacy and your staff or care coordinators. CONSIDER:
- History of therapies or antibiotics tried/failed
- Allergies or sensitivities to other antibiotics (eg, sulfa, penicillin)
- At risk for C difficile (where fluoroquinolones are not appropriate)
- Contraindications
ASK the patient to accept a call from the pharmacy to review insurance coverage, bridge options, and eligibility for the patient assistance program.
Help ensure your patient speaks to the pharmacy
- Share the specialty pharmacy name and phone number with your patient
- Let your patient know that the specialty pharmacy will make multiple attempts to reach them
- If the patient has not heard from the specialty pharmacy within 24 hours, they should call the pharmacy directly
Specialty pharmacists will evaluate current medications to ensure no interactions, review dosing and administration, plus coordinate shipping and payment options.
Whether a prescription comes directly through a specialty pharmacy partner or NUZYRA CENTRAL®, medication will be delivered straight to your patient’s doorstep, via expedited shipping—at no extra charge.
Remind patients that the pharmacy calling may not be the one they normally use.
You (or a patient) can connect live to NUZYRA Central® for help at
1-877-4NUZYRA
(1-877-468-9972)
M-F, 8 AM – 8 PM ET
Is NUZYRA covered by Commercial
and Medicare insurance plans?
Considering NUZYRA for your patients?
REQUEST SAMPLESNUZYRA® (omadacycline) is a tetracycline-class antibacterial indicated for the treatment of adult patients with the following infections caused by susceptible microorganisms:
Community-Acquired Bacterial Pneumonia (CABP) caused by the following:
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) caused by the following:
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.
USAGE
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.
IMPORTANT SAFETY INFORMATION
CONTRAINDICATIONS
NUZYRA is contraindicated in patients with known hypersensitivity to omadacycline or tetracycline-class antibacterial drugs, or to any of the excipients.
WARNINGS AND PRECAUTIONS
Mortality imbalance was observed in the CABP clinical trial with eight deaths (2%) occurring in patients treated with NUZYRA compared to four deaths (1%) in patients treated with moxifloxacin. The cause of the mortality imbalance has not been established. All deaths, in both treatment arms, occurred in patients > 65 years of age; most patients had multiple comorbidities. The causes of death varied and included worsening and/or complications of infection and underlying conditions. Closely monitor clinical response to therapy in CABP patients, particularly in those at higher risk for mortality.
The use of NUZYRA during tooth development (last half of pregnancy, infancy and childhood to the age of 8 years) may cause permanent discoloration of the teeth (yellow-gray-brown) and enamel hypoplasia.
The use of NUZYRA during the second and third trimester of pregnancy, infancy and childhood up to the age of 8 years may cause reversible inhibition of bone growth.
Hypersensitivity reactions have been reported with NUZYRA. Life-threatening hypersensitivity (anaphylactic) reactions have been reported with other tetracycline-class antibacterial drugs. NUZYRA is structurally similar to other tetracycline-class antibacterial drugs and is contraindicated in patients with known hypersensitivity to tetracycline-class antibacterial drugs. Discontinue NUZYRA if an allergic reaction occurs.
Clostridioides difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents and may range in severity from mild diarrhea to fatal colitis. Evaluate if diarrhea occurs.
NUZYRA is structurally similar to tetracycline-class antibacterial drugs and may have similar adverse reactions. Adverse reactions, including photosensitivity, pseudotumor cerebri, and anti-anabolic action (which has led to increased BUN, azotemia, acidosis, hyperphosphatemia, pancreatitis, and abnormal liver function tests), have been reported for other tetracycline-class antibacterial drugs, and may occur with NUZYRA. Discontinue NUZYRA if any of these adverse reactions are suspected.
Prescribing NUZYRA in the absence of a proven or strongly suspected bacterial infection is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria.
ADVERSE REACTIONS
The most common adverse reactions (incidence ≥2%) are nausea, vomiting, infusion site reactions, alanine aminotransferase increased, aspartate aminotransferase increased, gamma-glutamyl transferase increased, hypertension, headache, diarrhea, insomnia, and constipation.
DRUG INTERACTIONS
Patients who are on anticoagulant therapy may require downward adjustment of their anticoagulant dosage while taking NUZYRA.
Absorption of tetracyclines, including NUZYRA is impaired by antacids containing aluminum, calcium, or magnesium, bismuth subsalicylate and iron containing preparations.
USE IN SPECIFIC POPULATIONS
Lactation: Breastfeeding is not recommended during treatment with NUZYRA.
Please see Full Prescribing Information for NUZYRA.
References:
- Centers for Medicare & Medicaid Services. ICD-10-CM Official Guidelines for Coding and Reporting FY 2019.
- NUZYRA [Prescribing Information]. Boston, MA: Paratek Pharmaceuticals, Inc.