PNEUMOVAX 23 is recommended y the CDC for ll your pproprite dult ptients t incresed risk for pneumococcl disese 1,2 : Adults ged <65 yers with certin chronic conditions including: Dietes mellitus Chronic hert disese Chronic lung disese Adults ged 65 yers s prt of 2-vccine regimen Plese see CDC Sequentil Dosing Recommendtion Guide (inside). Not ctul ptients. PNEUMOVAX 23 is vccine indicted for ctive immuniztion for the prevention of pneumococcl disese cused y the 23 serotypes contined in the vccine (1, 2, 3, 4, 5, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 17F, 18C, 19F, 19A, 20, 22F, 23F, nd 33F). PNEUMOVAX 23 is pproved for use in persons 50 yers of ge or older nd persons ged 2 yers who re t incresed risk for pneumococcl disese. PNEUMOVAX 23 will not prevent disese cused y cpsulr types of pneumococcus other thn those contined in the vccine. Do not dminister PNEUMOVAX 23 to individuls with history of hypersensitivity rection to ny component of the vccine. Defer vccintion with PNEUMOVAX 23 in persons with moderte or severe cute illness. Includes chronic ostructive pulmonry disese (COPD). CDC=Centers for Disese Control nd Prevention.
Adult ptients ged <65 yers: The CDC specificlly recommends 1 dose of PNEUMOVAX 23 for immunocompetent for pproprite dults dults with ged certin 65 chronic yers 7,, conditions, Persons including who dietes previously received mellitus, PNEUMOVAX chronic hert 23 efore disese, ge nd 65 chronic yers who lung re now disese ged 65 (COPD), yers t the time of dignosis 1 PNEUMOVAX 23 lredy received t ge <65 yers Compred to helthy dults of the sme ge, these ptients hve higher risk for invsive pneumococcl disese (IPD) 3, 5 yers Administer DIABETES MELLITUS PCV13 t ge 65 yers CHRONIC HEART DISEASE CHRONIC LUNG DISEASE Immunocompetent ptients ged 65 yers: The CDC recommends tht pproprite dults receive PNEUMOVAX 23 s prt of sequentil dministrtion of 2 pneumococcl vccines 2,7, * * Pneumococcl vccintion history will determine the use of ech vccine in this ptient popultion. Plese see CDC Sequentil Dosing Recommendtion Guide inside. Compred to helthy dults ged 50 64 yers, helthy ptients ged 65 yers hve higher risk for invsive pneumococcl disese (IPD) 3, AGED 65 YEARS ~3X Administer PNEUMOVAX 23 ~3X ~7X ~2X According to the updted CDC recommendtions, ll dults ged 65 yers should receive 2-vccine regimen of PCV13 nd PNEUMOVAX 23 7, * Persons who re immunocompromised, including persons receiving immunosuppressive therpy, my hve diminished immune response to PNEUMOVAX 23. Not ctul ptients. PNEUMOVAX 23 my not e effective in preventing pneumococcl meningitis in ptients who hve chronic cererospinl fluid (CSF) lekge resulting from congenitl lesions, skull frctures, or neurosurgicl procedures. Retrospective cohort study (dults ged 18 64 yers) using dt from Jnury 1, 2006, through Decemer 31, 2010, from 3 helth cre clims dtses representing >35 million insured dults. Risk for IPD ws compred to ge-mtched helthy counterprts. For sujects ged 65 yers or older in clinicl study, systemic dverse rections which were Multiple determined professionl y the investigtor orgniztions to e vccine-relted re consistent were higher with following the CDC s revccintion thn following initil vccintion. recommendtion of pneumococcl vccintion for pproprite dults with certin chronic conditions 1,4 6 DIABETES MELLITUS Americn Dietes Assocition CHRONIC HEART DISEASE Americn Hert Assocition Americn College of Crdiology COPD Glol Inititive for Chronic Ostructive Lung Disese Use cution nd pproprite cre in dministering PNEUMOVAX 23 to individuls with severely compromised crdiovsculr nd/or pulmonry function in whom systemic rection would pose significnt risk. PNEUMOVAX 23 should e given to pregnnt womn only if clerly needed. Retrospective cohort study using dt from Jnury 1, 2006, through Decemer 31, 2010, from 3 helth cre clims dtses representing >35 million insured dults 18 yers of ge. Rtes of IPD were compred etween helthy dults 65 yers of ge nd helthy dults 50 to 64 yers of ge. Cution should e exercised when PNEUMOVAX 23 is dministered to nursing womn. Since elderly individuls my not tolerte medicl interventions s well s younger individuls, higher frequency nd/or greter severity of rections in some older individuls cnnot e ruled out.
CDC-recommended sequentil dministrtion nd intervls for immunocompetent dults ged 65 yers 7,, Pneumococcl vccine-nïve persons ged 65 yers Administer PCV13 t ge 65 yers Persons who previously received PNEUMOVAX 23 t ge 65 yers PNEUMOVAX 23 lredy received t ge 65 yers Persons who previously received PNEUMOVAX 23 efore ge 65 yers who re now ged 65 yers PNEUMOVAX 23 lredy received t ge <65 yers Immunocompetent ptients ged 65 yers: The CDC recommends tht pproprite dults receive PNEUMOVAX 23 s prt of sequentil dministrtion of 2 pneumococcl vccines 2,7, * * Pneumococcl vccintion history will determine the use of ech vccine in this ptient popultion. Plese see CDC Sequentil Dosing Recommendtion Guide inside. Compred to helthy dults ged 50 64 yers, helthy ptients ged 65 yers hve higher risk for invsive pneumococcl disese (IPD) 3, Administer PNEUMOVAX 23 (PPSV23) Administer PCV13 Administer PCV13 t ge 65 yers 5 yers AGED 65 YEARS PCV13=13-vlent pneumococcl conjugte vccine. PPSV23=23-vlent pneumococcl polyscchride vccine. If dose of PNEUMOVAX 23 is given erlier thn the recommended intervl, the dose need not e repeted. PNEUMOVAX 23 nd PCV13 should not e codministered. Administer PNEUMOVAX 23 ~2X According to the updted CDC recommendtions, ll dults ged 65 yers should receive 2-vccine regimen of PCV13 nd PNEUMOVAX 23 7, * Importnt considertions: There re limited dt on the sequentil dministrtion of PNEUMOVAX 23 with other vccines, including PCV13. An immunogenicity study descried in the Prescriing Informtion for PCV13 evluted the sequentil dministrtion with PNEUMOVAX 23 in dults ged 60 64 yers 8 : Diminished immune response with one dose of PNEUMOVAX 23 followed y dose of PCV13 one yer lter vs PCV13 lone Noninferior immune response with one dose of PCV13 followed y dose of PNEUMOVAX 23 one yer lter vs PNEUMOVAX 23 lone The levels of ntiodies tht correlte with protection ginst pneumococcl disese hve not een clerly defined. Routine revccintion of immunocompetent persons previously vccinted with 23-vlent vccine is not recommended. For sujects ged 65 yers in clinicl study, systemic dverse rections which were determined y the investigtor to e vccine-relted were higher following revccintion with PNEUMOVAX 23 thn following initil vccintion with PNEUMOVAX 23. Persons who re immunocompromised, including persons receiving immunosuppressive therpy, my hve diminished immune response to PNEUMOVAX 23. PNEUMOVAX 23 my not e effective in preventing pneumococcl meningitis in ptients who hve chronic cererospinl fluid (CSF) lekge resulting from congenitl lesions, skull frctures, or neurosurgicl procedures. For sujects ged 65 yers or older in clinicl study, systemic dverse rections which were determined y the investigtor to e vccine-relted were higher following revccintion thn following initil vccintion. Retrospective cohort study using dt from Jnury 1, 2006, through Decemer 31, 2010, from 3 helth cre clims dtses representing >35 million insured dults 18 yers of ge. Rtes of IPD were compred etween helthy dults 65 yers of ge nd helthy dults 50 to 64 yers of ge. Cution should e exercised when PNEUMOVAX 23 is dministered to nursing womn. Since elderly individuls my not tolerte medicl interventions s well s younger individuls, higher frequency nd/or greter severity of rections in some older individuls cnnot e ruled out.
Different serotypes cn cuse pneumococcl disese PNEUMOVAX 23 is the only pneumococcl vccine indicted to prevent disese cused y 23 serotypes 8 In ptients ged <65 yers Serotypes contined in PCV13 nd PNEUMOVAX 23 8 Percentge of ll IPD cses cused y serotypes in ech vccine United Sttes, 2008 9 Represents 100 % of IPD cses PCV13 contins 13 serotypes, of which 1 is unique 6A 78 % 76 % The serotypes in PNEUMOVAX 23 ccounted for ~25% more IPD cses compred to the percentge of IPD cses cused y serotypes in PCV13. PNEUMOVAX 23 contins 23 serotypes, of which 11 re unique 1 2 3 4 5 6B 7F 8 9N 9V 10A 11A 12F 14 15B 17F 18C 19A 19F 20 22F 23F 33F 53 % 49 % The figure depicts CDC epidemiologic dt nd does not reflect the efficcy of the respective vccines. Serotypes in PNEUMOVAX 23 Serotypes in PCV13 Serotypes contined in oth vccines Serotypes unique to PNEUMOVAX 23 Serotypes unique to PCV13 Ptients ged 18 49 yers Ptients ged 50 64 yers PCV13=13-vlent pneumococcl conjugte vccine. In ptients ged 65 yers PNEUMOVAX 23 will not prevent disese cused y cpsulr types of pneumococcus other thn those contined in the vccine. ~40 % of IPD ws cused y the 11 unique serotypes in PNEUMOVAX 23, ccording to the CDC in 2013. 7 The most common dverse rections, reported in >10% of sujects vccinted with PNEUMOVAX 23 in clinicl trils, were: injection-site pin/soreness/tenderness, injection-site swelling/indurtion, hedche, injection-site erythem, stheni nd ftigue, nd mylgi. Vccintion with PNEUMOVAX 23 my not offer 100% protection from pneumococcl infection. Do not dminister PNEUMOVAX 23 to individuls with history of hypersensitivity rection to ny component of the vccine. Defer vccintion with PNEUMOVAX 23 in persons with moderte or severe cute illness.
In 14-yer retrospective study, PNEUMOVAX 23 demonstrted reduction of disese in dults 10, Effectiveness demonstrted ginst invsive pneumococcl cused y serotypes in the vccine 10,, infections 57 % Overll in ll popultions (n=2,837) Dietes Mellitus Coronry Vsculr Disese Congestive Hert Filure Chronic Pulmonry Disese Aged 65 yers (immunocompetent) 84 % 73 % 69 % 65 % 75 % Effectiveness ws evluted using the 14- nd 23-cpsulr pneumococcl polyscchride vccine. Vccine effectiveness could not e confirmed for certin groups of immunocompromised ptients. Study Design: A US retrospective, indirect cohort study covering 14-yer period (1978 1992), in 54 hospitls, nd 26 sttes. 2 yers of ge with known vccintion sttus/dte, who were monitored for illness during this period, nd from whom cererospinl fl uid (CSF). The medin ge of vccinted ptients ws 57 yers; the medin ge of unvccinted ws 50 yers. compring the distriution of disese-cusing pneumococcl serotypes in vccinted (eg, received either the 14-vlent or vccines) nd unvccinted persons. Vccine effectiveness ws lso estimted for study prticipnts with underlying medicl Ptients eligile for inclusion were pneumococcus ws isolted from lood or Vccine effectiveness ws estimted y 23-vlent pneumococcl polyscchride conditions. 10 Not n ctul ptient. Use cution nd pproprite cre in dministering PNEUMOVAX 23 to individuls with severely compromised crdiovsculr nd/or pulmonry function in whom systemic rection would pose significnt risk. PNEUMOVAX 23 should e given to pregnnt womn only if clerly needed. Cution should e exercised when PNEUMOVAX 23 is dministered to nursing womn. Since elderly individuls my not tolerte medicl interventions s well s younger individuls, higher frequency nd/or greter severity of rections in some older individuls cnnot e ruled out.
Keep in mind the CDC recommendtions for PNEUMOVAX 23 for ll pproprite dults 1,7 : Adults ged <65 yers with certin chronic conditions, including dietes mellitus, chronic hert disese, nd chronic lung disese (COPD): Vccinte with 1 dose of PNEUMOVAX 23 t time of dignosis. 1 Not ctul ptients. Immunocompetent dults ged 65 yers: Vccinte pproprite ptients with PNEUMOVAX 23 s prt of 2-vccine sequentil regimen. Plese see CDC Sequentil Dosing Recommendtion Guide (inside). 7 PNEUMOVAX 23 is vccine indicted for ctive immuniztion for the prevention of pneumococcl disese cused y the 23 serotypes contined in the vccine (1, 2, 3, 4, 5, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 17F, 18C, 19F, 19A, 20, 22F, 23F, nd 33F). PNEUMOVAX 23 is pproved for use in persons 50 yers of ge or older nd persons ged 2 yers who re t incresed risk for pneumococcl disese. PNEUMOVAX 23 will not prevent disese cused y cpsulr types of pneumococcus other thn those contined in the vccine. Persons who re immunocompromised, including persons receiving immunosuppressive therpy, my hve diminished immune response to PNEUMOVAX 23. Vccintion with PNEUMOVAX 23 my not offer 100% protection from pneumococcl infection. Before dministering PNEUMOVAX 23, plese red the ccompnying Prescriing Informtion. The Ptient Informtion lso is ville. For dditionl copies of the Prescriing Informtion, plese cll 800-672-6372, visit MerckVccines.com, or contct your Merck representtive. References: 1. Centers for Disese Control nd Prevention (CDC). Use of 13-vlent pneumococcl conjugte vccine nd 23-vlent pneumococcl polyscchride vccine for dults with immunocompromising conditions: recommendtions of the Advisory Committee on Immuniztion Prctices (ACIP). MMWR Mor Mortl Wkly Rep. 2012;61(40):816 819. 2. Centers for Disese Control nd Prevention (CDC). Use of 13-vlent pneumococcl conjugte vccine nd 23-vlent pneumococcl polyscchride vccine mong dults ged 65 yers: recommendtions of the Advisory Committee on Immuniztion Prctices (ACIP). MMWR Mor Mortl Wkly Rep. 2014;63(37):822 825. 3. She KM, Edelserg J, Weycker D, et l. Rtes of pneumococcl disese in dults with chronic medicl conditions. Open Forum Infect Dis. 2014;1(1):1 9. 4. Americn Dietes Assocition. Stndrds of medicl cre in dietes 2016. Dietes Cre. 2016;39(suppl 1):S1 S112. 5. Amsterdm EA, Wenger NK, Brindis RG, et l. 2014 AHA/ACC Guideline for the Mngement of Ptients With Non ST-Elevtion Acute Coronry Syndromes. J Am Coll Crdiol. 2014;64(24):e139 e228. 6. Glol Inititive for Chronic Ostructive Lung Disese. Glol strtegy for the dignosis, mngement, nd prevention of chronic ostructive pulmonry disese. Updted 2016. http://www.goldcopd.org/guidelines-glol-strtegy-for-dignosis-mngement.html. Accessed Ferury 1, 2016. 7. Centers for Disese Control nd Prevention (CDC). Intervls etween PCV13 nd PPSV23 vccines: recommendtions of the Advisory Committee on Immuniztion Prctices (ACIP). MMWR Mor Mortl Wkly Rep. 2015;64(34):944 947. (Errtum Notice: CDC. MMWR Mor Mortl Wkly Rep. 2015;64(42):1204.) 8. Prevnr 13 [pckge insert]. Phildelphi, PA: Wyeth Phrmceuticls Inc; 2015. 9. Centers for Disese Control nd Prevention (CDC); Advisory Committee on Immuniztion Prctices. Updted recommendtions for prevention of invsive pneumococcl disese mong dults using the 23-vlent pneumococcl polyscchride vccine (PPSV23). MMWR Mor Mortl Wkly Rep. 2010;59(34):1102 1106. 10. Butler JC, Breimn RF, Cmpell JF, et l. Pneumococcl polyscchride vccine efficcy: n evlution of current recommendtions. JAMA. 1993;270(15):1826 1831. Copyright 2016 Merck Shrp & Dohme Corp., susidiry of Merck & Co., Inc. All rights reserved. VACC-1153347-0000 02/16 Printed in USA Minimum 10% Recycled Pper