INDICATION appear to be uncommon. These events were reported primarily among pediatric patients. The contribution of Rapivab to these events has not been established. Patients with RAPIVAB is indicated for the treatment of acute uncomplicated influenza in patients 2 years influenza should be closely monitored for signs of abnormal behavior. and older who have been symptomatic for no more than 2 days. • Serious bacterial infections may begin with influenza-like symptoms or may coexist with IMPORTANT SAFETY INFORMATION or occur as complications during the course of influenza. Rapivab has not been shown to prevent such complications. LIMITATIONS OF USE ADVERSE REACTIONS • Efficacy of RAPIVAB is based on clinical trials of naturally occurring influenza in which The most common adverse reaction in adults (18 years of age and older) was diarrhea (8% the predominant influenza infections were influenza A virus; a limited number of subjects Rapivab vs 7% placebo). Lab abnormalities (incidence ≥2%) occurring more commonly with infected with influenza B virus were enrolled. Rapivab than placebo were elevated ALT 2.5 times the upper limit of normal (3% vs 2%), • Influenza viruses change over time. Emergence of resistance substitutions could decrease elevated serum glucose >160 mg/dL (5% vs 3%), elevated CPK at least 6 times the upper limit drug effectiveness. Other factors (for example, changes in viral virulence) might also diminish of normal (4% vs 2%), and neutrophils <1.0 x 109/L (8% vs 6%). In a subset of subjects with clinical benefit of antiviral drugs. Prescribers should consider available information on serious influenza requiring hospitalization treated with RAPIVAB 600 mg as monotherapy influenza drug susceptibility patterns and treatment effects when deciding whether to use (N=101), the following adverse reactions were also reported more frequently with RAPIVAB as RAPIVAB. compared to placebo: constipation (4% versus 2%), insomnia (3% versus 0%), AST increased • The efficacy of RAPIVAB could not be established in patients with serious influenza requiring (3% versus 2%), and hypertension (2% versus 0%). hospitalization. The safety profile of RAPIVAB in subjects 2 to 17 years of age was generally similar to that observed in adults. Specific adverse reactions reported in pediatric subjects treated CONTRAINDICATIONS with RAPIVAB (occurring in ≥2% of subjects) and not reported in adults included vomiting RAPIVAB is contraindicated in patients with known serious hypersensitivity or anaphylaxis (3% versus 9% for oseltamivir), fever and tympanic membrane erythema (2% versus 0%, to peramivir or any component of the product. Severe allergic reactions have included respectively, for each of these events). The only clinically significant laboratory abnormality anaphylaxis, erythema multiforme and Stevens-Johnson Syndrome. (DAIDS Grade 2) occurring in ≥2% of pediatric subjects treated with RAPIVAB was proteinuria by dipstick analysis (3% versus 0% for oseltamivir). WARNINGS AND PRECAUTIONS • Rare cases of serious skin reactions, including erythema multiforme, have been reported CONCURRENT USE WITH LIVE ATTENUATED INFLUENZA VACCINE with RAPIVAB in clinical studies and in postmarketing experience. Cases of anaphylaxis Antiviral drugs may inhibit viral replication of a live attenuated influenza vaccine (LAIV) and and Stevens-Johnson Syndrome have been reported in postmarketing experience with thus may reduce vaccine efficacy). The concurrent use of Rapivab with LAIV intranasal has RAPIVAB. Discontinue RAPIVAB and institute appropriate treatment if anaphylaxis or a not been evaluated. Because of the potential for interference between these two products, serious skin reaction occurs or is suspected. The use of RAPIVAB is contraindicated in avoid use of Rapivab within 2 weeks after or 48 hours before administration of LAIV unless patients with known serious hypersensitivity or anaphylaxis to RAPIVAB. medically indicated. • Influenza can be associated with a variety of neurologic and behavioral symptoms that can include events such as hallucinations, delirium, and abnormal behavior, in some Please see accompanying full Prescribing Information for RAPIVAB. cases resulting in fatal outcomes. There have been postmarketing reports of delirium You are encouraged to report negative side effects of prescription drugs to the FDA. and abnormal behavior leading to injury in patients with influenza who were receiving Visit www.fda.gov/medwatch or call 1-800-FDA-1088. neuraminidase inhibitors, including Rapivab. Because these events were reported RAPIVAB is a registered trademark of Seqirus UK Limited or its affiliates. voluntarily during clinical practice, estimates of frequency cannot be made, but they 13 and accompanying full Prescribing Information. Prescribing full accompanying and October 2019 US/CORP/1016/0004(5) 2019 October 25 Deforest Ave, Summit NJ 07901 NJ Summit Ave, Deforest 25 Please see Important Safety Information on pages 6-8 and 13, 13, and 6-8 pages on Information Safety Important see Please © 2019 Seqirus USA Inc. All rights reserved. rights All Inc. USA Seqirus 2019 © are registered trademarks of Seqirus UK Limited or its affiliates. its or Limited UK Seqirus of trademarks registered are RAPIVAB and QUADRIVALENT, FLUCELVAX FLUAD, QUADRIVALENT, AFLURIA Services website. https://www.cms.gov/Regulations-and-Guidance/Guidance/Transmittals/downloads/r167cp.pdf. website. Services Accessed October 23, 2019. 23, October Accessed 2004. 30, April Published 13. CMS manual system. Publication 100-04 Medicare claims processing. Centers for Medicare and Medicaid Medicaid and Medicare for Centers processing. claims Medicare 100-04 Publication system. manual CMS 2019. 23, October Accessed 2015. April Published CHEST%20Physician/Vol%2010%202015/0415.ashx. 12. 12. Nelson ME. ICD-10 cometh. CHEST Physician website. http://www.chestnet.org/~/media/chesnetorg/Publications/Documents/ website. Physician CHEST cometh. ICD-10 ME. Nelson 2019. 23, October Accessed 2017. Published Reimbursement-Coding-Update-2017.pdf. 11. Parman C. Oncology reimbursement coding update. 2017. Association of Community Cancer Centers website. https://www.accc-cancer.org/publications/pdf/Oncology- website. Centers Cancer Community of Association 2017. update. coding reimbursement Oncology C. Parman 2018. Inc; USA Seqirus NJ: Summit, insert]. 10. 10. diseases and injuries. Centers for Medicare and Medicaid Services website. https://www.cms.gov/Medicare/Coding/ICD10/Downloads/2018-ICD-10-Table-And-Index.zip. Accessed October 23, 2019. 2019. 23, October Accessed https://www.cms.gov/Medicare/Coding/ICD10/Downloads/2018-ICD-10-Table-And-Index.zip. website. Services Medicaid and Medicare for Centers injuries. and diseases Rapivab [package [package Rapivab 9. 9. website. https://www.acep.org/administration/reimbursement/ed-facility-level-coding-guidelines/#sm.000005vd05555heczqbvu9txsrjf3. Published 2011. Accessed October 23, 2019. 2019. 23, October Accessed 2011. Published https://www.acep.org/administration/reimbursement/ed-facility-level-coding-guidelines/#sm.000005vd05555heczqbvu9txsrjf3. website. ICD-10-CM tabular list of of list tabular ICD-10-CM 7. 7. 8. 8. Procedural Coding Expert: The Ultimate Guide to CPT to Guide Ultimate The Expert: Coding Procedural 2019. 23, October Accessed ED facility level coding guidelines. American College of Emergency Physicians Physicians Emergency of College American guidelines. coding level facility ED 2012. Media; Contexo UT: City, Lake Salt Coding. ® hepatitis B. Centers for Medicare and Medicaid Services website. https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNProducts/downloads/qr_immun_bill.pdf. Published January 2018. 2018. January Published https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNProducts/downloads/qr_immun_bill.pdf. website. Services Medicaid and Medicare for Centers B. hepatitis 6. 6. Pediatrics website. https://www.aap.org/en-us/Documents/coding_preventive_care.pdf. Published 2019. Accessed October 23, 2019. 2019. 23, October Accessed 2019. Published https://www.aap.org/en-us/Documents/coding_preventive_care.pdf. website. Pediatrics Medicare part B immunization billing: seasonal influenza virus, pneumococcal, and and pneumococcal, virus, influenza seasonal billing: immunization B part Medicare 5. 5. 4. 3. FLUCELVAX QUADRIVALENT [package insert]. Summit, NJ: Seqirus USA Inc; 2019. 2019. Inc; USA Seqirus NJ: Summit, insert]. [package QUADRIVALENT FLUCELVAX 2019. Inc; USA Seqirus NJ: Summit, insert]. [package FLUAD Coding for pediatric preventive care, 2018. American Academy of of Academy American 2018. care, preventive pediatric for Coding 2. 1. References: Afluria Quadrivalent [package insert]. Summit, NJ: Seqirus USA Inc; 2019. 2019. Inc; USA Seqirus NJ: Summit, insert]. [package Quadrivalent Afluria http://www.immunize.org. website. Coalition Action Immunization season. influenza 2019-2020 for products vaccine Influenza INFLUENZA SEASON INFLUENZA 2019-2020 CODING GUIDE CODING #3 OPTION 855-358-8966, CALL SUPPORT REIMBURSEMENT FOR treatment and BILLING AND BILLING @seqirus.com of influenza vaccines influenza of customerservice.us about our portfolio portfolio our about flu.seqirus.com service at at service account manager manager account Email customer customer Email at online Order Contact your Seqirus Seqirus your Contact 3 EASY ORDERING METHODS: ORDERING EASY 3 This influenza season, count on the Seqirus the on count season, influenza This portfolio of influenza products.