EFFECTIVE OCTOBER 1, 2020, CMS APPROVES NUZYRA IV FOR NEW TECHNOLOGY ADD-ON PAYMENT (NTAP)1

• Medicare will now provide an add-on payment for NUZYRA IV of up to $1,552.50, per qualifying case, toInpatient Prospective Payment System (IPPS)-participating acute care hospitals

• Provides an incremental reimbursement amount, in addition to the applicable MS-DRG–based reimbursement, forMedicare inpatient cases paid under the IPPS that involve the use of an eligible new medical service or technology

INDICATIONS

NUZYRA® 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.

USAGETo 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.

Please see Important Safety Information on the following pages and accompanying Full Prescribing Information.

CMS=Centers for Medicare & Medicaid Services; MS-DRG=Medicare Severity Diagnosis Related Group.

ABOUT NTAP1

• Helps ensure adequate payment for new medical services and technologies used to treat Medicare beneficiariesin the inpatient hospital setting for eligible hospitals

• Offers a temporary stop-gap measure until MS-DRG can be recalibrated

NUZYRA HAS BEEN GRANTED NTAP STATUS

IMPORTANT SAFETY INFORMATION (cont.) 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 accompanying Full Prescribing Information.

NUZYRA is contraindicated in patients with known hypersensitivity to omadacycline or tetracycline-class antibacterial drugs, or to any of the excipients.

US-NUA-0385 09/20

References: 1. Data on file. Paratek Pharmaceuticals, Inc, Boston, MA. 2. Centers for Medicare & Medicaid Services. Increasing access to innovative antibiotics for hospital inpatients using New Technology Add-On Payments: frequently asked questions. MLN Matters Number: SE20004. Article Release Date: January 21, 2020. Accessed September 2, 2020. https://www.cms.gov/files/document/SE20004.pdf 3. Centers for Medicare & Medicaid Services. Medicare Claims Processing Manual: Chapter 3 – Inpatient Hospital Billing. Rev. 10210. Issued July 10, 2020. Accessed September 3, 2020. https://www.cms.gov/regulations-and-guidance/guidance/manuals/downloads/clm104c03.pdf 4. NUZYRA [Prescribing Information]. Boston, MA: Paratek Pharmaceuticals, Inc.

© 2020 Paratek Pharmaceuticals, Inc. All rights reserved.PARATEK® and the hexagon logo are registered trademarks of Paratek Pharmaceuticals, Inc.NUZYRA® and its design logo are registered trademarks of Paratek Pharmaceuticals, Inc.

AVAILABLE AS A MONOTHERAPY IN IV AND ORAL FORMULATIONS4

ACTIVITY AGAINST SELECT GRAM-POSITIVES, GRAM-NEGATIVES, AND ATYPICALS, INCLUDING DRUG-RESISTANT STRAINS4

NO DOSAGE ADJUSTMENT REQUIRED FOR PATIENTS WITH RENAL OR HEPATIC IMPAIRMENT4

MAY BE USED AS AN ALTERNATIVE FOR PATIENTS WITH FLUOROQUINOLONE, BETA-LACTAM, OR SULFA ALLERGIES4

START YOUR APPROPRIATE PATIENTS WITH CABP AND ABSSSION NUZYRA TODAY

FROM HOSPITAL TO HOMETM WITH NUZYRA® (omadacycline)

NTAP DETAILS FOR NUZYRA IV1,3

Eligible facilitiesHospitals that are reimbursed under the IPPS (Inpatient Prospective Payment System). Critical Access Hospitals (CAH), excluded cancer hospitals, long-term acute care hospitals, VA/DoD facilities, and hospitals in the state of Maryland are not eligible

Setting of careAcute care hospital inpatient setting

Qualified patientsTraditional (fee for service) Medicare beneficiaries where the cost of the case exceeds the MS-DRG payment for the case

Amount of the NTAP paymentThe maximum payment is $1,552.50 for a qualifying patient treated with NUZYRA IV

Effective periodOctober 1, 2020 through September 30, 2021

ICD-10-PCS CODES AND ELIGIBILITY GUIDELINES1

ELIGIBLE HOSPITALS CAN REPORT THE USE OF NUZYRA IV BY RECORDING AN ICD-10-PCS CODE ON THE CLAIM

You are solely responsible for determining the appropriate codes and for any action you take in billing. The information provided here is not intended to be definitive or exhaustive, and is not intended to replace the guidance of a qualified professional advisor. Paratek and its agents make no warranties or guarantees, express or implied, concerning the accuracy or appropriateness of this information for your particular use. The use of this information does not guarantee payment or that any payment received will cover your costs. The information provided here is compiled from the sources believed to be accurate, but Paratek makes no representation that it is accurate. This information is subject to change. Consult the relevant manual and other guidelines for a description of each code to determine the appropriateness of a particular code and for information on additional codes.

ICD-10-PCS CODEDESCRIPTOR

XW033B6Introduction of omadacycline anti-infective into peripheral vein, percutaneous approach, new technology group 6

XW043B6Introduction of omadacycline anti-infective into central vein, percutaneous approach, new technology group 6

IMPORTANT SAFETY INFORMATION (cont.) WARNINGS AND PRECAUTIONS (cont.) 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 of 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.

173116.indd 1173116.indd 1 9/21/20 1:51 PM9/21/20 1:51 PM

https://www.nuzyra.com/nuzyra-pi.pdf

NTAP=New Technology Add-On Payment; QIDP=qualified infectious disease product; MS-DRG=Medicare Severity Diagnosis Related Group.

Please see Important Safety Information continued on back cover and accompanying Full Prescribing Information.

PAYMENT AND TIMING1,2

The NTAP will provide certain eligible hospitals with a payment, in addition to the MS-DRG reimbursement, of up to 75% of the cost of NUZYRA IV for a period of 2 to 3 years, effective in the 2021 fiscal year (FY) starting on October 1, 2020.

The maximum additional payment for FY 2021 (beginning October 1, 2020) is $1,552.50 per admission. If the total covered costs of the case do not exceed the MS-DRG payment, then no additional payment is made for the admission.

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.

NUZYRA® (omadacycline) IV RECEIVED NTAP STATUS BASED ON1,2:

QIDP DESIGNATION NUZYRA received FDA QIDP designation because it is an innovative antibiotic for hospital inpatients

COST CRITERIONExisting MS-DRG payment for services involving NUZYRA IV is inadequate to meet the cost of services

ADDITIONAL PATIENT SUPPORT AND REIMBURSEMENT SERVICES ARE ALSO AVAILABLE THROUGH NUZYRA CENTRALTM

FOR MORE INFORMATION AND SUPPORT FROM NUZYRA CENTRALTM, CALL 1-877-4-NUZYRA

GLUE

GLUE

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https://www.nuzyra.com/nuzyra-pi.pdf

EFFECTIVE OCTOBER 1, 2020, CMS APPROVES NUZYRA IV FOR NEW TECHNOLOGY ADD-ON PAYMENT (NTAP)1

• Medicare will now provide an add-on payment for NUZYRA IV of up to $1,552.50, per qualifying case, to Inpatient Prospective Payment System (IPPS)-participating acute care hospitals

• Provides an incremental reimbursement amount, in addition to the applicable MS-DRG–based reimbursement, for Medicare inpatient cases paid under the IPPS that involve the use of an eligible new medical service or technology

INDICATIONS

NUZYRA® 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.

USAGETo 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.

Please see Important Safety Information on the following pages and accompanying Full Prescribing Information.

CMS=Centers for Medicare & Medicaid Services; MS-DRG=Medicare Severity Diagnosis Related Group.

ABOUT NTAP1

• Helps ensure adequate payment for new medical services and technologies used to treat Medicare beneficiaries in the inpatient hospital setting for eligible hospitals

• Offers a temporary stop-gap measure until MS-DRG can be recalibrated

NUZYRA HAS BEEN GRANTED NTAP STATUS

IMPORTANT SAFETY INFORMATION (cont.) 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 accompanying Full Prescribing Information.

NUZYRA is contraindicated in patients with known hypersensitivity to omadacycline or tetracycline-class antibacterial drugs, or to any of the excipients.

US-NUA-0385 09/20

References: 1. Data on file. Paratek Pharmaceuticals, Inc, Boston, MA. 2. Centers for Medicare & Medicaid Services. Increasing access to innovative antibiotics for hospital inpatients using New Technology Add-On Payments: frequently asked questions. MLN Matters Number: SE20004. Article Release Date: January 21, 2020. Accessed September 2, 2020. https://www.cms.gov/files/document/SE20004.pdf 3. Centers for Medicare & Medicaid Services. Medicare Claims Processing Manual: Chapter 3 – Inpatient Hospital Billing. Rev. 10210. Issued July 10, 2020. Accessed September 3, 2020. https://www.cms.gov/regulations-and-guidance/guidance/manuals/downloads/clm104c03.pdf 4. NUZYRA [Prescribing Information]. Boston, MA: Paratek Pharmaceuticals, Inc.

© 2020 Paratek Pharmaceuticals, Inc. All rights reserved.PARATEK® and the hexagon logo are registered trademarks of Paratek Pharmaceuticals, Inc.NUZYRA® and its design logo are registered trademarks of Paratek Pharmaceuticals, Inc.

AVAILABLE AS A MONOTHERAPY IN IV AND ORAL FORMULATIONS4

ACTIVITY AGAINST SELECT GRAM-POSITIVES, GRAM-NEGATIVES, AND ATYPICALS, INCLUDING DRUG-RESISTANT STRAINS4

NO DOSAGE ADJUSTMENT REQUIRED FOR PATIENTS WITH RENAL OR HEPATIC IMPAIRMENT4

MAY BE USED AS AN ALTERNATIVE FOR PATIENTS WITH FLUOROQUINOLONE, BETA-LACTAM, OR SULFA ALLERGIES4

START YOUR APPROPRIATE PATIENTS WITH CABP AND ABSSSI ON NUZYRA TODAY

FROM HOSPITAL TO HOMETM WITH NUZYRA® (omadacycline)

NTAP DETAILS FOR NUZYRA IV1,3

Eligible facilitiesHospitals that are reimbursed under the IPPS (Inpatient Prospective Payment System). Critical Access Hospitals (CAH), excluded cancer hospitals, long-term acute care hospitals, VA/DoD facilities, and hospitals in the state of Maryland are not eligible

Setting of care Acute care hospital inpatient setting

Qualified patients Traditional (fee for service) Medicare beneficiaries where the cost of the case exceeds the MS-DRG payment for the case

Amount of the NTAP payment The maximum payment is $1,552.50 for a qualifying patient treated with NUZYRA IV

Effective period October 1, 2020 through September 30, 2021

ICD-10-PCS CODES AND ELIGIBILITY GUIDELINES1

ELIGIBLE HOSPITALS CAN REPORT THE USE OF NUZYRA IV BY RECORDING AN ICD-10-PCS CODE ON THE CLAIM

You are solely responsible for determining the appropriate codes and for any action you take in billing. The information provided here is not intended to be definitive or exhaustive, and is not intended to replace the guidance of a qualified professional advisor. Paratek and its agents make no warranties or guarantees, express or implied, concerning the accuracy or appropriateness of this information for your particular use. The use of this information does not guarantee payment or that any payment received will cover your costs. The information provided here is compiled from the sources believed to be accurate, but Paratek makes no representation that it is accurate. This information is subject to change. Consult the relevant manual and other guidelines for a description of each code to determine the appropriateness of a particular code and for information on additional codes.

ICD-10-PCS CODE DESCRIPTOR

XW033B6 Introduction of omadacycline anti-infective into peripheral vein, percutaneous approach, new technology group 6

XW043B6 Introduction of omadacycline anti-infective into central vein, percutaneous approach, new technology group 6

IMPORTANT SAFETY INFORMATION (cont.) WARNINGS AND PRECAUTIONS (cont.) 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 of 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.

173116.indd 1 173116.indd 19/21/20 1:51 PM 9/21/20 1:51 PM

EFFECTIVE OCTOBER 1, 2020, CMS APPROVES NUZYRA IV FOR NEW TECHNOLOGY ADD-ON PAYMENT (NTAP)1

• Medicare will now provide an add-on payment for NUZYRA IV of up to $1,552.50, per qualifying case, to Inpatient Prospective Payment System (IPPS)-participating acute care hospitals

• Provides an incremental reimbursement amount, in addition to the applicable MS-DRG–based reimbursement, for Medicare inpatient cases paid under the IPPS that involve the use of an eligible new medical service or technology

INDICATIONS

NUZYRA® 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.

USAGETo 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.

Please see Important Safety Information on the following pages and accompanying Full Prescribing Information.

CMS=Centers for Medicare & Medicaid Services; MS-DRG=Medicare Severity Diagnosis Related Group.

ABOUT NTAP1

• Helps ensure adequate payment for new medical services and technologies used to treat Medicare beneficiaries in the inpatient hospital setting for eligible hospitals

• Offers a temporary stop-gap measure until MS-DRG can be recalibrated

NUZYRA HAS BEEN GRANTED NTAP STATUS

IMPORTANT SAFETY INFORMATION (cont.) 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 accompanying Full Prescribing Information.

NUZYRA is contraindicated in patients with known hypersensitivity to omadacycline or tetracycline-class antibacterial drugs, or to any of the excipients.

US-NUA-0385 09/20

References: 1. Data on file. Paratek Pharmaceuticals, Inc, Boston, MA. 2. Centers for Medicare & Medicaid Services. Increasing access to innovative antibiotics for hospital inpatients using New Technology Add-On Payments: frequently asked questions. MLN Matters Number: SE20004. Article Release Date: January 21, 2020. Accessed September 2, 2020. https://www.cms.gov/files/document/SE20004.pdf 3. Centers for Medicare & Medicaid Services. Medicare Claims Processing Manual: Chapter 3 – Inpatient Hospital Billing. Rev. 10210. Issued July 10, 2020. Accessed September 3, 2020. https://www.cms.gov/regulations-and-guidance/guidance/manuals/downloads/clm104c03.pdf 4. NUZYRA [Prescribing Information]. Boston, MA: Paratek Pharmaceuticals, Inc.

© 2020 Paratek Pharmaceuticals, Inc. All rights reserved.PARATEK® and the hexagon logo are registered trademarks of Paratek Pharmaceuticals, Inc.NUZYRA® and its design logo are registered trademarks of Paratek Pharmaceuticals, Inc.

AVAILABLE AS A MONOTHERAPY IN IV AND ORAL FORMULATIONS4

ACTIVITY AGAINST SELECT GRAM-POSITIVES, GRAM-NEGATIVES, AND ATYPICALS, INCLUDING DRUG-RESISTANT STRAINS4

NO DOSAGE ADJUSTMENT REQUIRED FOR PATIENTS WITH RENAL OR HEPATIC IMPAIRMENT4

MAY BE USED AS AN ALTERNATIVE FOR PATIENTS WITH FLUOROQUINOLONE, BETA-LACTAM, OR SULFA ALLERGIES4

START YOUR APPROPRIATE PATIENTS WITH CABP AND ABSSSI ON NUZYRA TODAY

FROM HOSPITAL TO HOMETM WITH NUZYRA® (omadacycline)

NTAP DETAILS FOR NUZYRA IV1,3

Eligible facilitiesHospitals that are reimbursed under the IPPS (Inpatient Prospective Payment System). Critical Access Hospitals (CAH), excluded cancer hospitals, long-term acute care hospitals, VA/DoD facilities, and hospitals in the state of Maryland are not eligible

Setting of careAcute care hospital inpatient setting

Qualified patientsTraditional (fee for service) Medicare beneficiaries where the cost of the case exceeds the MS-DRG payment for the case

Amount of the NTAP paymentThe maximum payment is $1,552.50 for a qualifying patient treated with NUZYRA IV

Effective periodOctober 1, 2020 through September 30, 2021

ICD-10-PCS CODES AND ELIGIBILITY GUIDELINES1

ELIGIBLE HOSPITALS CAN REPORT THE USE OF NUZYRA IV BY RECORDING AN ICD-10-PCS CODE ON THE CLAIM

You are solely responsible for determining the appropriate codes and for any action you take in billing. The information provided here is not intended to be definitive or exhaustive, and is not intended to replace the guidance of a qualified professional advisor. Paratek and its agents make no warranties or guarantees, express or implied, concerning the accuracy or appropriateness of this information for your particular use. The use of this information does not guarantee payment or that any payment received will cover your costs. The information provided here is compiled from the sources believed to be accurate, but Paratek makes no representation that it is accurate. This information is subject to change. Consult the relevant manual and other guidelines for a description of each code to determine the appropriateness of a particular code and for information on additional codes.

ICD-10-PCS CODEDESCRIPTOR

XW033B6Introduction of omadacycline anti-infective into peripheral vein, percutaneous approach, new technology group 6

XW043B6Introduction of omadacycline anti-infective into central vein, percutaneous approach, new technology group 6

IMPORTANT SAFETY INFORMATION (cont.) WARNINGS AND PRECAUTIONS (cont.) 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 of 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.

173116.indd 1173116.indd 1 9/21/20 1:51 PM9/21/20 1:51 PM

https://www.nuzyra.com/nuzyra-pi.pdf