Prescribing Information

For US Healthcare Professionals only

How to prescribe

Streamlining the path from prescription to fill

Nuzyra SurePATH logo

NUZYRA® SurePath™ was built to help overcome some of the market access burdens and affordability barriers for patients.

How to prescribe NUZYRA: just select, send, and ask

Follow these 3 steps when you choose to prescribe NUZYRA.

Step 1

Select a NUZYRA network specialty pharmacy* or hospital outpatient specialty pharmacy in your Electronic Health Record (EHR) prescribing system.

These specialty pharmacies can help patients get their NUZYRA–and support your office staff or care coordinator if a prior authorization (PA) is needed.

  • Walgreens Specialty Pharmacy
  • CVS Specialty
  • Option Care
  • Panther
  • Perigon Pharmacy 360
  • Professional Arts Specialty Pharmacy
  • Hospital Outpatient Specialty Pharmacy

Find a local pharmacy

*Paratek Pharmaceuticals, Inc. does not recommend or prefer the use of one pharmacy over another. NUZYRA Specialty Pharmacy Network as of 06/24/2024.

Benefits of using our Specialty Pharmacy Network or your hospital outpatient specialty pharmacy

  • Pharmacists understand the needs of your acute patients
  • Pharmacies have NUZYRA in stock
  • They provide PA support, utilizing CoverMyMeds® electronic prior authorization tool
  • They can provide patient services like bridge, copay, and support for our patient assistance program
  • Specialty pharmacists will evaluate current medications for potential interactions, review dosing and administration, plus coordinate shipping and payment options

Download prior authorization checklist

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CoverMyMeds logo

Using CoverMyMeds® can assist in determination of PAs and tracking of submitted and pending PAs.

Step 2

Send the prescription to your selected NUZYRA network specialty pharmacy via CoverMyMeds®, ePrescribe, or fax.

Specialty pharmacies can help you complete the PA when you include the following with each prescription:

ICD-10 codes1

See examples

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 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

See full list of billing codes

ICD-10-CM codes are used by physicians to report a patient’s diagnosis. The following may apply to conditions covered within the approved Prescribing Information for NUZYRA. Paratek Pharmaceuticals, Inc. does not guarantee payment with respect to any particular code and we do not intend through this information to suggest a prescribing decision for any patient. Those decisions are within the prescriber’s individual judgment.

Dosing information2

See NUZYRA oral-only dosing

Treatment duration (7-14 days)2

ABSSSI Oral

Days 1-2
450 mg (3 tablets) once a day

Maintenance Dose
300 mg once daily

Image of Nuzyra pills enlarged
Tablets are not shown at actual size.

Total Tablet Count
16-30

CABP Oral

Day 1
300 mg (2 tablets) BID
BID=twice a day

Maintenance Dose
300 mg once daily

Image of Nuzyra pills enlarged
Tablets are not shown at actual size.

Total Tablet Count
16-30

Share instructions with patients

Chart notes + clinical data

What to consider

Include or attach most recent chart notes and clinical data to help limit exchanges between the pharmacy and your staff or care coordinators.

  • History of therapies or antibiotics tried/failed
  • Allergies or sensitivities to other antibiotics (eg, sulfonamide, penicillin)
  • At risk for C. difficile (where fluoroquinolones are not appropriate)
  • Contraindications

Prior authorization checklist

Review before PA submission

The information is general in nature and is not intended to be comprehensive nor replace the guidance of a qualified professional advisor.*

Important Information

Patient’s name, date of birth, insurance policy number (pharmacy benefit eg, RxBin and Rx Group Number), and other requested information

Physician and facility information: Name, provider NPI, address (city and state), phone, and fax numbers

Medical Details

Summary of patient’s diagnosis

  • ICD-10 code that applies to the need for NUZYRA
  • Antibiotic history

Summary of patient’s history, including chart notes and clinical data

  • Current severity of the patient’s condition, including any comorbidities or intolerance to other therapies
  • If available, provide diagnostic test results (ie, culture and susceptibility)

Submission

Submit all necessary information to the specialty pharmacy

  • The specialty pharmacy will then enter the information into CoverMyMeds®
  • When the entry is complete, the office will receive a key code
  • After the office reviews the completed form in CoverMyMeds®, the office must hit the “Send to Plan” button
  • NUZYRA is an acute care product, so please ensure the PA is submitted for expedited review

Not using CoverMyMeds®?

Submit the PA request form to the insurer†

  • PA forms can be obtained through the insurer’s website or by contacting their customer service

  • Always review the PA guidelines on the insurer’s website or contact their customer service for process information, including forms and contacts

    • Many insurers use a Pharmacy Benefits Manager (PBM) for patient prescription benefits, so you may be communicating with the PBM and not the insurer. This information can be found on the back of the patient’s insurance card

*Determination of coverage and reimbursement parameters, and appropriate coding for patient and/or procedure, is the responsibility of the provider. The information provided here is not a guarantee of coverage or reimbursement for Paratek Pharmaceuticals products. Paratek Pharmaceuticals makes no guarantees regarding the timeliness or appropriateness of this information for a particular use, given the frequent changes in public and private payer-specific requirements. †Insurers may have specific PA forms for different products or therapeutic areas. Always verify that the correct form for NUZYRA has been completed.

Get patients started on NUZYRA with ePrescribe

Step 3

Ask the patient to accept a call from the pharmacy to review insurance coverage, bridge options, and eligibility for the patient assistance program.

It’s crucial that the pharmacy connects with the patient to confirm these details.

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
  • Remind patients that the pharmacy calling may not be the one they normally use

Home delivery via expedited shipping

Whether a prescription comes directly through a specialty pharmacy or NUZYRA Central®, medication will be delivered straight to your patient’s doorstep, via expedited shipping–at no extra charge.

The majority of patients will receive their medication

within 24 hours

of the prescription being sent to the pharmacy.3

After submission of all necessary information.

NUZYRA Central® ePrescribe can help when planning the discharge of eligible patients

  • Verification of benefits, typically in 24 hours

    • For both oral (tablets) and IV formulations
    • For both commercially covered and Medicare Advantage patients
  • Insurance forms
  • Coordination of prior authorizations
  • Help evaluate all available patient services and medication dispensing

Processing can begin immediately upon submission—even before the patient is discharged.

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

NUZYRA Central® ePrescribe can help with your patient’s prescription

Get started
IMPORTANT SAFETY INFORMATION

INDICATIONS and USAGE

NUZYRA® (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, fixed drug eruption, 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: 1. Centers for Medicare & Medicaid Services. ICD-10-CM Official Guidelines for Coding and Reporting FY 2019. 2. NUZYRA [Prescribing Information]. Paratek Pharmaceuticals, Inc. 3. Data on file. Paratek Pharmaceuticals, Inc.