s e n hyperimmune i c a gllobulobulinsigim v flu g i … · 2015. 10. 23. · the products you s c...
TRANSCRIPT
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the products youSC
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TO ORDER (800) 843-7477 | Fax (800) 418-4333 | www.FFFenterprises.com | www.MyFluVaccine.com | biosupply.fffenterprises.com
Product Size Manufacturer NDC# Code*
ANTI-INHIBITOR (HUMAN-PLASMA DERIVED)
FEIBA NF 500 IU VIAL W/BAXJECT II BAXALTA 64193-0423-02 J7198 1000 IU VIAL W/BAXJECT II 64193-0424-02 J7198 2500 IU VIAL W/BAXJECT II 64193-0425-02 J7198
FACTOR VIIa (RECOMBINANT)
NOVOSEVEN RT 1000 MCG VIAL NOVO NORDISK 00169-7201-01 J7189 WITH MIXPRO 2000 MCG VIAL 00169-7202-01 J7189 5000 MCG VIAL 00169-7205-01 J7189 8000 MCG VIAL 00169-7208-01 J7189
FACTOR VIII (HUMAN–PLASMA DERIVED)
KOATE DVI 250 IU VIAL KEDRION 76125-0250-20 J7190 500 IU VIAL 76125-0500-30 J7190 1000 IU VIAL 76125-0672-50 J7190
VON WILLEBRAND FACTOR / FACTOR VIII COMPLEX (HUMAN-PLASMA DERIVED)
ALPHANATE 250 IU VIAL+ GRIFOLS 68516-4601-01 J7186 500 IU VIAL+ 68516-4602-01 J7186 1000 IU VIAL+ 68516-4603-02 J7186 1500 IU VIAL+ 68516-4604-02 J7186 HUMATE-P 500 RCOF+ VIAL CSL BEHRING 63833-0615-02 J7187 1000 RCOF+ VIAL 63833-0616-02 J7187 2000 RCOF+ VIAL 63833-0617-02 J7187
WILATE 500 IU VIAL+ OCTAPHARMA 67467-0182-01 J7183 1000 IU VIAL+ 67467-0182-02 J7183
FACTOR VIII (RECOMBINANT)
ADVATE 2 ML 250 IU VIAL BAXALTA 00944-2921-02 J7192 500 IU VIAL 00944-2922-02 J7192 1000 IU VIAL 00944-2923-02 J7192 1500 IU VIAL 00944-2924-02 J7192
ADVATE 5 ML 2000 IU VIAL BAXALTA 00944-2964-10 J7192 3000 IU VIAL 00944-2965-10 J7192 4000 IU VIAL 00944-2948-10 J7192
ELOCTATE 250 IU VIAL BIOGEN IDEC 64406-0801-01 J7199 500 IU VIAL 64406-0802-01 J7199 750 IU VIAL 64406-0803-01 J7199 1000 IU VIAL 64406-0804-01 J7199 1500 IU VIAL 64406-0805-01 J7199 2000 IU VIAL 64406-0806-01 J7199 3000 IU VIAL 64406-0807-01 J7199
HELIXATE FS 250 IU VIAL CSL BEHRING 00053-8131-02 J7192 500 IU VIAL 00053-8132-02 J7192 1000 IU VIAL 00053-8133-02 J7192 2000 IU VIAL 00053-8134-02 J7192 3000 IU VIAL 00053-8135-02 J7192
KOGENATE FS 250 IU VIAL W/BIOSET BAYER 00026-3792-20 J7192 500 IU VIAL W/BIOSET 00026-3793-30 J7192 1000 IU VIAL W/BIOSET 00026-3795-50 J7192 2000 IU VIAL W/BIOSET 00026-3796-60 J7192
Coagulation Products
Continued*All codes should be verified between the provider and the payer.+Call (800) 843-7477 or check ordering screen for RCo values.
VIPc
VIPc340B
VIPc340B
VIPc340B
VIPc340B
VIPc340B
VIPc
VIPc
VIPc
VIPc
VIPc
VIPc Verified Inventory Program–Consignment eligible. Public Health Services 340B pricing available.340B
6
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Continued
Product Size Manufacturer NDC# Code*
FACTOR VIII (RECOMBINANT) CONTINUED KOGENATE FS VIAL ADAPTER 250 IU VIAL W/VIAL ADAPTER BAYER 00026-3782-25 J7192 500 IU VIAL W/VIAL ADAPTER 00026-3783-35 J7192 1000 IU VIAL W/VIAL ADAPTER 00026-3785-55 J7192 2000 IU VIAL W/VIAL ADAPTER 00026-3786-65 J7192
NOVOEIGHT 250 IU VIAL NOVO NORDISK 00169-7825-01 J7182 500 IU VIAL 00169-7850-01 J7182 1500 IU VIAL 00169-7815-01 J7182 2000 IU VIAL 00169-7820-01 J7182 3000 IU VIAL 00169-7830-01 J7182
RECOMBINATE 250 IU VIAL BAXALTA 00944-2841-10 J7192 500 IU VIAL 00944-2842-10 J7192 1000 IU VIAL 00944-2843-10 J7192 1500 IU VIAL 00944-2844-10 J7192 2000 IU VIAL 00944-2845-10 J7192
XYNTHA 250 IU VIAL PFIZER 58394-0012-01 J7185 500 IU VIAL 58394-0013-01 J7185 1000 IU VIAL 58394-0014-01 J7185 2000 IU VIAL 58394-0015-01 J7185 3000 IU VIAL 58394-0016-03 J7185
XYNTHA SOLOFUSE 250 IU/4ML DCS PFIZER 58394-0022-03 J7185 500 IU/4ML DCS 58394-0023-03 J7185 1000 IU/4ML DCS 58394-0024-03 J7185 2000 IU/4ML DCS 58394-0025-03 J7185
FACTOR VIII (MONOCLONAL PURIFIED)
HEMOFIL M 250 IU VIAL BAXALTA 00944-3940-02 J7190 500 IU VIAL 00944-3942-02 J7190 1000 IU VIAL 00944-3944-02 J7190 1500 IU VIAL 09444-3946-02 J7190
MONOCLATE-P 1000 IU VIAL CSL BEHRING 00053-7656-04 J7190 1500 IU VIAL 00053-7656-05 J7190
FACTOR IX (HUMAN–PLASMA DERIVED)
ALPHANINE SD 500 IU VIAL GRIFOLS 68516-3601-02 J7193 1000 IU VIAL 68516-3602-02 J7193 1500 IU VIAL 68516-3603-03 J7193
BEBULIN 500 IU VIAL BAXALTA 06419-3445-02 J7194
FACTOR IX (MONOCLONAL PURIFIED)
MONONINE 1000 IU VIAL CSL BEHRING 00053-6223-02 J7193
FACTOR IX (RECOMBINANT)
ALPROLIX 500 IU VIAL BIOGEN IDEC 64406-0911-01 J7199 1000 IU VIAL 64406-0922-01 J7199 2000 IU VIAL 64406-0933-01 J7199 3000 IU VIAL 64406-0944-01 J7199
BENEFIX RT 250 IU VIAL PFIZER 58394-0633-03 J7195 500 IU VIAL 58394-0634-03 J7195 1000 IU VIAL 58394-0635-03 J7195 2000 IU VIAL 58394-0636-03 J7195 3000 IU VIAL 58394-0637-03 J7195
RIXUBIS 250 IU VIAL BAXALTA 00944-3026-02 J7195 500 IU VIAL 00944-3028-02 J7195 1000 IU VIAL 00944-3030-02 J7195 2000 IU VIAL 00944-3032-02 J7195 3000 IU VIAL 00944-3034-02 J7195
Coagulation Products
*All codes should be verified between the provider and the payer.
TO ORDER (800) 843-7477 | Fax (800) 418-4333 | www.FFFenterprises.com | www.MyFluVaccine.com | biosupply.fffenterprises.com
VIPc
VIPc
VIPc
VIPc
VIPc
VIPc
VIPc
VIPc
VIPc
VIPc
VIPc340B
VIPc340B
VIPc340B
VIPc Verified Inventory Program–Consignment eligible. Public Health Services 340B pricing available.340B
7
COAGUALATIONIM
MUNE
GLOBULINSHYPERIM
MUNES
INFLUENZA VACCINES& ANCILLARIES
OTHERVACCINES
ALBUMIN / PLASM
APROTEIN FRACTION
SPECIALTY& ONCOLOGY
GENERIC INJECTABLES& SURGICAL SEALANTS
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TO ORDER (800) 843-7477 | Fax (800) 418-4333 | www.FFFenterprises.com | www.MyFluVaccine.com | biosupply.fffenterprises.com
Product Size Manufacturer NDC# Code*
IMMUNE GLOBULINS SUBCUTANEOUS (SCIG)
HIZENTRA 1 GM VIAL CSL BEHRING 44206-0451-01 J1559 2 GM VIAL 44206-0452-02 J1559 4 GM VIAL 44206-0454-04 J1559 10 GM VIAL 44206-0455-10 J1559
HYQVIA 2.5 GM VIAL BAXALTA 00944-2510-02 5 GM VIAL 00944-2511-02 10 GM VIAL 00944-2512-02 20 GM VIAL 00944-2513-02 30 GM VIAL 00944-2514-02
GAMUNEX-C 1 GM VIAL GRIFOLS 13533-0800-12 J1561 2.5 GM VIAL 13533-0800-15 J1561 5 GM VIAL 13533-0800-20 J1561 10 GM VIAL 13533-0800-71 J1561 20 GM VIAL 13533-0800-24 J1561 40 GM VIAL 13533-0800-40 J1561
GAMMAGARD LIQUID 1 GM VIAL BAXALTA 00944-2700-02 J1569 2.5 GM VIAL 00944-2700-03 J1569 5 GM VIAL 00944-2700-04 J1569 10 GM VIAL 00944-2700-05 J1569 20 GM VIAL 00944-2700-06 J1569 30 GM VIAL 00944-2700-07 J1569
GAMMAKED 1 GM VIAL KEDRION 76125-0900-01 J1561 2.5 GM VIAL 76125-0900-25 J1561 5 GM VIAL 76125-0900-50 J1561 10 GM VIAL 76125-0900-10 J1561 20 GM VIAL 76125-0900-20 J1561
OTHER COAGULATION PRODUCTS
KCENTRA 500 IU VIAL CSL BEHRING 63833-0386-02 J3590 1000 IU VIAL 63833-0387-02 J3590
PROFILNINE SD 500 IU VIAL GRIFOLS 68516-3201-01 J7194 1000 IU VIAL 68516-3202-02 J7194 1500 IU VIAL 68516-3203-02 J7194
RIASTAP 1000 MG VIAL CSL BEHRING 63833-0891-51 J1680
STIMATE NASAL SPRAY 1.5 ML CSL BEHRING 00053-6871-00 J3490
Immune Globulins Subcutaneous (SCIG)
Product Size Manufacturer NDC# Code*
IMMUNE GLOBULIN INTRAMUSCULAR (IGIM) GAMASTAN S/D 2 ML VIAL GRIFOLS 13533-0635-04 J1460 10 ML VIAL 13533-0635-12 J1460
Immune Globulin Intramuscular (IGIM)
*All codes should be verified between the provider and the payer.
**Call Baxalta Reimbursement at (888) 229-8379 for the most up-to-date billing code.
J3490 or J3590** J3490 or J3590** J3490 or J3590** J3490 or J3590** J3490 or J3590**
Product Size Manufacturer NDC# Code*
Coagulation Products (CONTINUED)
VIPc
VIPc
VIPc
VIPc
VIPc
VIPc
VIPc
VIPc340B
VIPc340B
VIPc Verified Inventory Program–Consignment eligible. Public Health Services 340B pricing available.340B
8
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9TO ORDER (800) 843-7477 | Fax (800) 418-4333 | www.FFFenterprises.com | www.MyFluVaccine.com | biosupply.fffenterprises.com
Product Size Manufacturer NDC# Code*
IMMUNE GLOBULINS (HUMAN) LYOPHILIZED
CARIMUNE NF 6 GM VIAL CSL BEHRING 44206-0417-06 J1566 12 GM VIAL 44206-0418-12 J1566
GAMMAGARD S/D 5 GM VIAL BAXALTA 00944-2656-03 J1566(IGA
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Product Size Manufacturer NDC# Code*
ANTI-THYMOCYTE GLOBULIN
THYMOGLOBULIN 25 MG VIAL SANOFI AVENTIS 58468-0080-01 J7511
BOTULISM IGIV (HUMAN) (BIG-IV)
BABYBIG 100 MG VIAL CALIFORNIA DEPT. OF HEALTH 68403-1100-06 —
CYTOMEGALOVIRUS IMMUNE GLOBULIN INTRAVENOUS (HUMAN)
CYTOGAM 2.5 GM VIAL CSL BEHRING 44206-0532-11 J0850
HEPATITIS B IMMUNE GLOBULIN
HEPAGAM B 1 ML VIAL EMERGENT BIOSOLUTIONS 53270-0052-01 J1571 or J1573 5 ML VIAL 53270-0051-01 J1571 or J1573
HYPERHEP B S/D 0.5 ML SYRINGE GRIFOLS 13533-0636-03 90371 1 ML SYRINGE 13533-0636-02 90371 5 ML VIAL 13533-0636-05 90371
NABI-HB 1 ML SDV BIOTEST PHARMACEUTICALS 59730-4202-01 90371 5 ML SDV 59730-4203-01 90371
RABIES IMMUNE GLOBULIN
HYPERRAB S/D 2 ML 150 IU/ML VIAL GRIFOLS 13533-0618-02 90375 10 ML 150 IU/ML VIAL 13533-0618-10 90375
RHO(D) IMMUNE GLOBULIN
HYPERRHO S/D 50 MCG/0.17 ML SYRINGE GRIFOLS 13533-0661-06 J2788 300 MCG 1 ML SYRINGE 13533-0631-02 J2790
MICRHOGAM 50 MCG 1 ML SYRINGE KEDRION 00562-7806-01 J2788 50 MCG 1 ML SYRINGE/5-PK 00562-7806-05 J2788 50 MCG 1 ML SYRINGE/25-PK 00562-7806-25 J2788
RHOGAM 300 MCG 1 ML SYRINGE KEDRION 00562-7805-01 J2790 300 MCG 1 ML SYRINGE/5-PK 00562-7805-05 J2790 300 MCG 1 ML SYRINGE/25-PK 00562-7805-25 J2790
RHOPHYLAC 300 MCG SYRINGE CSL BEHRING 44206-0300-01 J2791 300 MCG SYRINGE/10-PK 44206-0300-10 J2791
WINRHO SDF 1500 IU 300 MCG VIAL EMERGENT BIOSOLUTIONS 53270-3300-01 J2792 2500 IU 500 MCG VIAL 53270-3500-01 J2792 5000 IU 1000 MCG VIAL 53270-3100-01 J2792 15,000 IU 3000 MCG VIAL 53270-3000-01 J2792
TETANUS IMMUNE GLOBULIN
HYPERTET S/D 250 UNIT SYRINGE GRIFOLS 13533-0634-02 J1670
VARICELLA ZOSTER IMMUNE GLOBULIN
VARIZIG LIQUID 125 UNIT VIAL EMERGENT BIOSOLUTIONS 53270-0126-02 90396
Hyperimmune Globulins
*All codes should be verified between the provider and the payer.
TO ORDER (800) 843-7477 | Fax (800) 418-4333 | www.FFFenterprises.com | www.MyFluVaccine.com | biosupply.fffenterprises.com
VIPc
VIPc
VIPc
VIPc340B
VIPc340B
VIPc340B
VIPc340B
VIPc340B
VIPc340B
VIPc340B
VIPc340B
VIPc340B
VIPc Verified Inventory Program–Consignment eligible. Public Health Services 340B pricing available.340B
VIPc340B
10
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11
Product Size Manufacturer NDC# Code*
INFLUENZA VACCINES 2015-16 FLUVIRIN 5 ML 10 DS VIAL NOVARTIS 66521-0118-10 90658/Q2037 0.5 ML PFS 66521-0118-02 90656 FLUCELVAX 0.5 ML PFS NOVARTIS 62577-0614-01 90661FLUZONE 5 ML 10 DS VIAL SANOFI PASTEUR 49281-0396-15 90657/90658/Q2038FLUZONE QUADRIVALENT 5 ML 10 DS VIAL SANOFI PASTEUR 49281-0623-15 90687/90688 0.25 ML PFS 49281-0515-25 90685 0.5 ML PFS 49281-0415-50 90686 0.5 ML SDV 49281-0415-10 90686FLUZONE HIGH DOSE 0.5 ML PFS SANOFI PASTEUR 49281-0397-65 90662FLUZONE INTRADERMAL QUADRIVALENT 0.1 ML PFS SANOFI PASTEUR 49281-0708-40 90630AFLURIA 5 ML 10 DS VIAL BIOCSL 33332-0115-10 90658/Q2035 0.5 ML PFS 33332-0015-01 90656FLULAVAL QUADRIVALENT 5 ML 10 DS VIAL GSK 19515-0898-11 90688FLUARIX QUADRIVALENT 0.5 ML PFS GSK 58160-0903-52 90686FLUMIST QUADRIVALENT 0.2 ML INTRANASAL SPRAYER MEDIMMUNE 66019-0302-10 90672FLUBLOK 0.5 ML SDV PROTEIN SCIENCES 42874-0015-10 90673ANTIVIRALS RELENZA ROTADISK 5 MG GSK 00173-0681-01 —TAMIFLU 75 MG CAP 10-PK GENENTECH 00004-0800-85 J8499TAMIFLU ORAL SUSP 6 MG/ML GENENTECH 00004-0822-05 J8499
Product Description Manufacturer
PHARMAJET® NEEDLE-FREE INJECTION PRODUCTS (AVAILABLE ONLY FOR AFLURIA 5 ML 10 DS VIAL)
INJECTOR STARTER KIT SUPPLIES 500 FLU SHOTS AND INCLUDES: PHARMAJET - (1) PHARMAJET INJECTOR - (5) BOXES OF NEEDLE-FREE SYRINGES – 100/BOX - (1) BOX OF VIAL ADAPTERS – 100/BOX - (1) RESET STATION - (1) PRACTICE KIT
NEEDLE-FREE SYRINGES 100/BOX PHARMAJETVIAL ADAPTERS 100/BOX PHARMAJETPHARMAJET INJECTOR SPRING-OPERATED INJECTOR, REQUIRING PHARMAJET NO EXTERNAL POWER SOURCE
RESET STATION PREPARES THE INJECTOR FOR VACCINE ADMINISTRATION PHARMAJET
DISPOSABLE CONTAINERS SHARPS RECOVERY SYSTEM® 1-QUART, 1.5-QUART, 1-GALLON SHARPS COMPLIANCE 2-GALLON, 3-GALLON, 20-GALLON SHARPS RECOVERY SYSTEM® 5-GALLON SHARPS COMPLIANCEFOR USE WITH NON-SHARPS BIOHAZARD WASTE ONLY
*All codes should be verified between the provider and the payer.
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COAGUALATIONIM
MUNE
GLOBULINSHYPERIM
MUNES
INFLUENZA VACCINES& ANCILLARIES
OTHERVACCINES
ALBUMIN / PLASM
APROTEIN FRACTION
SPECIALTY& ONCOLOGY
GENERIC INJECTABLES& SURGICAL SEALANTS
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A 250 ML KEDRION 76125-0785-25 P9045 250 ML 76125-0790-25 P9045
A 250 ML CSL BEHRING 00053-7670-31 P9045 500 ML 00053-7670-32 P9045
A 50 ML CSL BEHRING 00053-7680-32 P9047 100 ML 00053-7680-33 P9047
A 250 ML CSL BEHRING 44206-0310-25 P9045 500 ML 44206-0310-50 P9045
A 50 ML CSL BEHRING 44206-0251-05 P9047 100 ML 44206-0251-10 P9047
A 250 ML GRIFOLS 68516-5214-01 P9045 500 ML 68516-5214-02 P9045
A 50 ML GRIFOLS 68516-5216-01 P9047 100 ML 68516-5216-02 P9047
A 250 ML OCTAPHARMA 67467-0623-02 P9045 250 ML 68209-0623-02 P9045 500 ML 68209-0623-03 P9045 500 ML 67467-0623-03 P9045
A 50 ML OCTAPHARMA 67467-0643-01 P9047 50 ML 68209-0643-01 P9047 100 ML 67467-0643-02 P9047 100 ML 68209-0643-02 P9047
B 500 ML BAXALTA 00944-0491-02 P9045
B 20 ML BAXALTA 00944-0490-01 P9046 50 ML 00944-0490-02 P9047
F 250 ML BAXALTA 00944-0495-05 P9047
F 50 ML BAXALTA 00944-0493-01 P9047 100 ML 00944-0493-02 P9047
K 50 ML KEDRION 76179-0025-01 P9047 100 ML 76179-0025-04 P9047
P 50 ML GRIFOLS 13533-0685-20 P9041 250 ML 13533-0685-25 P9045
P 20 ML GRIFOLS 13533-0684-16 P9046 50 ML 13533-0684-20 P9047 100 ML 13533-0684-71 —
P 50 ML GRIFOLS 13533-0690-02 — 250 ML 13533-0690-25 —
P 20 ML GRIFOLS 13533-0692-16 — 50 ML 13533-0692-20 — 100 ML 13533-0692-71 —
P 50 ML PPF GRIFOLS 13533-0613-20 P9043 250 ML PPF 13533-0613-25 P9043
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P
12
Product Size Manufacturer NDC# Code*
OTHER VACCINES
ACTHIB 10 MCG W/DILUENT SANOFI PASTEUR 49281-0545-05 90648ADACEL (TDAP) 5 PFS/BX SANOFI PASTEUR 49281-0400-15 90715 10 SDV/BX 49281-0400-10 90715DAPTACEL 10 SDV/BX SANOFI PASTEUR 49281-0286-10 90700DIPHTHERIA AND TETANUS TOXOID 10 SDV PF PEDS SANOFI PASTEUR 49281-0225-10 90714GARDASIL HPV 10 - 0.5 ML SDV MERCK 00006-4045-41 90649 0.5 ML VIAL 00006-4045-00 90649GARDASIL 9 HPV 10 - 0.5 ML SDV MERCK 00006-4119-03 90651 10 - 0.5 ML PFS 00006-4121-02 90651IMOVAX IM 1 SDV W/DILUENT SANOFI PASTEUR 49281-0250-51 90675IPOL POLIO VIRUS 5 ML MDV SANOFI PASTEUR 49281-0860-10 90713MENACTRA SDV/5-PK SANOFI PASTEUR 49281-0589-05 90734MENOMUNE SDV SANOFI PASTEUR 49281-0489-01 90733MMR II MEASLES MUMPS 0.5 ML SDV/10-PK MERCK 00006-4681-00 90707PEDVAX HIB 0.5 ML SDV/10-PK MERCK 00006-4897-00 90647PENTACEL SDV/5-PK SANOFI PASTEUR 49281-0510-05 90698PNEUMOVAX 23 0.5 ML SDV/10-PK MERCK 00006-4943-00 90732 2.5 ML VIAL 00006-4739-00 90732PREVNAR 13 PFS/10-PK PFIZER 00005-1971-02 90670PROQUAD 0.5 ML SDV/10-PK MERCK 00006-4999-00 90710RECOMBIVAX HB ADULT 10 MCG/SDV MERCK 00006-4995-00 90746 10 MCG VIAL/10-PK 00006-4995-41 90743/90746 10 MCG PFS/6-PK 00006-4094-09 90743/90746RECOMBIVAX HB PED/ADOLESC 5 MCG/6-PK PFS MERCK 00006-4093-09 90744 5 MCG/0.5 ML 10-PK 00006-4981-00 90744RECOMBIVAX HB DIALYSIS 40 MCG SDV MERCK 00006-4992-00 90740/90747ROTATEQ ROTAVIRUS 2 ML TUBES/10-PK MERCK 00006-4047-41 90680 2 ML TUBES/25-PK 00006-4047-20 90680 TENIVAC 10 SDV/BX SANOFI PASTEUR 49281-0215-10 90714 10 PFS/BX 49281-0215-15 90714TICE BCG 50 MG SDV MERCK 00052-0602-02 TBDTRUMENBA 0.5 ML SDV PF/5-PK PFIZER 00005-0100-05 90621 0.5 ML SDV PF/10-PK 00005-0100-10 90621TUBERSOL 1 ML VIAL 10 TEST SANOFI PASTEUR 49281-0752-21 86580 5 ML VIAL 50 TEST 49281-0752-22 86580TYPHIM VI TYPHOID 10 ML MDV SANOFI PASTEUR 49281-0790-20 90691 0.5 ML/PFS 49281-0790-51 90691VAQTA 50 U/1 ML PFS/6-PK MERCK 00006-4096-09 90632 25 U/1 ML PFS/6-PK 00006-4095-09 90633 25 U/0.5 ML SDV/10-PK 00006-4831-41 90633VARIVAX 0.5 ML SDV/10-PK MERCK 00006-4827-00 90716VIVOTIF BLISTER PK OF 4 CAPSULES PAXVAX 58337-0003-01 90690ZOSTAVAX SDV/10-PK MERCK 00006-4963-41 90736 SDV 00006-4963-00 90736
Other Vaccines
*All codes should be verified between the provider and the payer.
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VIPc Verified Inventory Program–Consignment eligible.
VIPc
VIPc
VIPc
VIPc
VIPc
VIPc
VIPc
VIPc
VIPc
VIPc
VIPc
VIPc
VIPc
VIPc
VIPc
VIPc
VIPc
VIPc
VIPc
VIPc
VIPc
VIPc
VIPc
VIPc
12
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13
Product Size Manufacturer NDC# Code*
ALBUMIN / PLASMA PROTEIN FRACTION
ALBUKED 5% 250 ML KEDRION 76125-0785-25 P9045 250 ML 76125-0790-25 P9045
ALBUMINAR 5% 250 ML CSL BEHRING 00053-7670-31 P9045 500 ML 00053-7670-32 P9045
ALBUMINAR 25% 50 ML CSL BEHRING 00053-7680-32 P9047 100 ML 00053-7680-33 P9047
ALBURX 5% 250 ML CSL BEHRING 44206-0310-25 P9045 500 ML 44206-0310-50 P9045
ALBURX 25% 50 ML CSL BEHRING 44206-0251-05 P9047 100 ML 44206-0251-10 P9047
ALBUTEIN 5% 250 ML GRIFOLS 68516-5214-01 P9045 500 ML 68516-5214-02 P9045
ALBUTEIN 25% 50 ML GRIFOLS 68516-5216-01 P9047 100 ML 68516-5216-02 P9047
ALBUMIN 5% 250 ML OCTAPHARMA 67467-0623-02 P9045 250 ML 68209-0623-02 P9045 500 ML 68209-0623-03 P9045 500 ML 67467-0623-03 P9045
ALBUMIN 25% 50 ML OCTAPHARMA 67467-0643-01 P9047 50 ML 68209-0643-01 P9047 100 ML 67467-0643-02 P9047 100 ML 68209-0643-02 P9047
BUMINATE 5% 500 ML BAXALTA 00944-0491-02 P9045
BUMINATE 25% 20 ML BAXALTA 00944-0490-01 P9046 50 ML 00944-0490-02 P9047
FLEXBUMIN 5% 250 ML BAXALTA 00944-0495-05 P9047
FLEXBUMIN 25% 50 ML BAXALTA 00944-0493-01 P9047 100 ML 00944-0493-02 P9047
KEDBUMIN 25% 50 ML KEDRION 76179-0025-01 P9047 100 ML 76179-0025-04 P9047
PLASBUMIN 5% 50 ML GRIFOLS 13533-0685-20 P9041 250 ML 13533-0685-25 P9045
PLASBUMIN 25% 20 ML GRIFOLS 13533-0684-16 P9046 50 ML 13533-0684-20 P9047 100 ML 13533-0684-71 —
PLASBUMIN AFP 5% 50 ML GRIFOLS 13533-0690-02 — 250 ML 13533-0690-25 —
PLASBUMIN AFP 25% 20 ML GRIFOLS 13533-0692-16 — 50 ML 13533-0692-20 — 100 ML 13533-0692-71 —
PLASMANATE 5% (PPF) 50 ML PPF GRIFOLS 13533-0613-20 P9043 250 ML PPF 13533-0613-25 P9043
Albumin / Plasma Protein Fraction
*All codes should be verified between the provider and the payer.
*All codes should be verified between the provider and the payer.TO ORDER (800) 843-7477 | Fax (800) 418-4333 | www.FFFenterprises.com | www.MyFluVaccine.com | biosupply.fffenterprises.com
Public Health Services 340B pricing available.340B
340B
340B
340B
340B
340B
340B
340B
340B
340B
340B
340B
13
COAGUALATIONIM
MUNE
GLOBULINSHYPERIM
MUNES
INFLUENZA VACCINES& ANCILLARIES
OTHERVACCINES
ALBUMIN / PLASM
APROTEIN FRACTION
SPECIALTY& ONCOLOGY
GENERIC INJECTABLES& SURGICAL SEALANTS
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*All codes should be verified between the provider and the payer.
Product Size Manufacturer NDC# Code*
ONCOLOGY (GENERICS)CLOLAR 20 MG/ML VIAL SANOFI AVENTIS 58468-0100-01 J9027GEMCITABINE** 200 MG SUN PHARMA 47335-0153-40 J9201 1 GM 47335-0154-40 J9201ONDANSETRON INJECTION** 4 MG/2 ML 25-PK HERITAGE PHARMA 23155-0196-43 J2405OXALIPLATIN** 50 MG/10 ML SDV SUN PHARMA 47335-0046-40 J9263 100 MG/20 ML 47335-0047-40 J9263ZALTRAP 100 MG/4 ML VIAL SANOFI AVENTIS 00024-5840-01 J9400 200 MG/ 8 ML VIAL 00024-5841-01 J9400ZOLINZA 100 MG ORAL CAPSULE MERCK 00006-0568-40 J8999
Oncology
Continued
Product Size Manufacturer NDC# Code*
SPECIALTY BIOPHARMACEUTICALS AND PHARMACEUTICALSACTIVASE 50 MG/50 ML VIAL GENENTECH 50242-0044-13 J2997 100 MG/100 ML VIAL 50242-0085-27 J2997
AMPICILLIN/SULBACTAM** 3 GM 10/PK AURO MEDICS 55150-0117-20 J0295ATRYN 525 IU VIAL REVO BIOLOGICS 42976-0121-01 J7196 1750 IU VIAL 42976-0121-02 J7196BERINERT 500 IU VIAL CSL BEHRING 63833-0825-02 J0597CROFAB 2 VIAL PK BTG INTERNATIONAL 50633-0110-12 J0840CUBICIN 500 MG SDV/10-PK MERCK 67919-0011-01 J0878DIGIFAB 40 MG VIAL BTG INTERNATIONAL 50633-0120-11 J1162FOLLISTIM AQ 75 IU SDV MERCK 00052-0308-02 J3490 300 IU CARTRIDGE 00052-0313-01 J3490 600 IU CARTRIDGE 00052-0316-01 J3490 900 IU CARTRIDGE 00052-0326-01 J3490FUROSEMIDE** 20 MG/2 ML 25-PK HERITAGE PHARMA 23155-0521-41 J1940 40 MG/4 ML 25-PK 23155-0521-42 J1940 100 MG/10 ML 25-PK 23155-0521-44 J1940GANIRELIX ACETATE 250 MCG/0.5 ML PFS MERCK 00052-0301-51 S0132HEMABATE 1 ML VIAL/10-PK PFIZER 00009-0856-08 J3490INTEGRILIN 75 MG/ML 100 ML VIAL MERCK 00085-1136-01 J1327 2 MG/ML 10 ML VIAL 00085-1177-01 J1327 2 MG/ML 100 ML VIAL 00085-1177-02 J1327MEROPENEM** 20 ML/500 MG 25/PK FRESENIUS KABI 63323-0507-20 J2185 30 ML/1 GM 25/PK 63323-0508-30 J2185 MIACALCIN 2 ML MDV MYLAN INSTITUTIONAL 54766-0149-23 J0630MOZOBIL 20 MG/1.2 ML VIAL SANOFI AVENTIS 58468-0140-01 J2562NAFCILLIN** 1 GM VIAL-10PK AURO MEDICS 55150-0122-15 S0032 2 GM VIAL-10PK 55150-0123-15 S0032 10 GM SDV 55150-0124-99 S0032OXACILLIN** 1 GM VIAL-10PK AURO MEDICS 55150-0127-15 TBD 2 GM VIAL-10PK 55150-0128-24 TBD 10 GM SDV 55150-0129-99 TBDSIVEXTRO TEDIZOLID PHOSPHATE 200 MG IV VIALS X 6 MERCK 67919-0041-02 P0300 200 MG IV VIALS X 10 67919-0040-01 P0300 200 MG IV VIALS X 30 67919-0041-01 P0300 THROMBATE III 500 IU VIAL GRIFOLS 13533-0603-20 J7197TNKASE 50 MG VIAL GENENTECH 50242-0120-01 J3101ZERBAXA 1.5 GM/10-VL MERCK 67919-0030-01 J3490/C9452
Specialty Biopharmaceuticals and Pharmaceuticals
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VIPc
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VIPcVIPc
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VIPc340B
VIPc340B
340B
VIPc Verified Inventory Program–Consignment eligible. Public Health Services 340B pricing available.340B
14
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-
Manufacturer NDC# Code*
O J9027
G 47335-0154-40 J9201O
47335-0047-40 J9263Z J9400 00024-5841-01 J9400Z J8999
O
50242-0085-27 J2997
J7196
42976-0121-02 J7196B J0597C J0840C J0878D J1162F 00052-0313-01 J3490 00052-0316-01 J3490 00052-0326-01 J3490F 23155-0521-42 J1940 23155-0521-44 J1940G S0132H J3490I J1327 00085-1177-01 J1327 00085-1177-02 J1327M 63323-0508-30 J2185
J2562
N 55150-0123-15 S0032 55150-0124-99 S0032O 55150-0128-24 TBD 55150-0129-99 TBDS 67919-0040-01 P0300 67919-0041-01 P0300 T J7197T
MERCK 67919-0030-01 J
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V
P
*All codes should be verified between the provider and the payer.
Generic Injectables Product Size Manufacturer NDC# Code*
GENERIC INJECTABLESCIDOFOVIR** 375 MG HERITAGE PHARMA 23155-0216-31 J0740ENOXAPARIN** 30 MG/0.3 ML TEVA PHARMA 00703-8530-23 J1650 60 MG/0.6 ML 00703-8560-23 J1650 80 MG/0.8 ML 00703-8680-23 J1650 120 MG/0.8 ML 00703-8610-23 J1650HYDRALAZINE** 20 MG/ML 25-PK FRESENIUS KABI 63323-0614-01 J0360LEVETIRACETAM** 500 MG/5 ML SUN PHARMA 62756-0513-44 TBD
PIPERACILLIN & TAZOBACTAM** 2.25 GM 10-PK FRESENIUS KABI 63323-0309-20 J2543 3.375 GM 10-PK 63323-0300-30 J2543 4.5 GM 10-PK 63323-0320-50 J2543PROCHLORPERAZINE EDISYLATE** 2 ML 10 MG VL 10-BX HERITAGE PHARMA 23155-0294-42 TBDVANCOMYCIN** 10 GM 1-PK FRESENIUS KABI 63323-0314-61 J3370 1 GM 10-PK 63323-0284-20 J3370 500 MG 25-PK 63323-0221-10 J3370 5 GM SDV 1-PK 63323-0295-61 J3370VASOPRESIN** 20 UNITS/ML FRESENIUS KABI 63323-0302-01 TBDVECURONIUM BROMIDE** 10 MG SUN PHARMA 47335-0391-44 TBD
ONCOLOGY (BIOSIMILARS)ZARXIO** 300 MCG/0.5 ML PFS SANDOZ 61314-0304-01 TBD 300 MCG/0.5 ML PFS 10-BX 61314-0304-10 TBD 480 MCG/0.8 ML PFS 61314-0312-01 TBD 480 MCG/0.8 ML PFS 10-BX 61314-0312-10 TBD
TO ORDER (800) 843-7477 | Fax (800) 418-4333 | www.FFFenterprises.com | www.MyFluVaccine.com | biosupply.fffenterprises.com
* All codes should be verified between the provider and the payer. ** Call for eligibility through your GPO affiliation.
Surgical Sealants Product Size Manufacturer NDC# Code*
SURGICAL SEALANT GEL COSEAL 2 ML BAXTER BIOSCIENCE 01376-5404-61 — 4 ML 01376-5404-62 — 8 ML 01376-5404-63 —HEMOSTATIC MATRIX FLOSEAL 5 ML BAXTER BIOSCIENCE 08541-2096-10 — 10 ML 08541-2096-12 —FIBRIN SEALANT TOPICAL TISSEEL VHSD KIT 2 ML BAXTER BIOSCIENCE 00944-4301-02 J3590/C9399 VHSD KIT 4 ML 00944-4302-04 J3590/C9399 VHSD KIT 10 ML 00944-4303-10 J3590/C9399 2 ML VHSD VALUPAK 00944-4201-03 J3590/C9399 4 ML VHSD VALUPAK 00944-4211-04 J3590/C9399 10 ML VHSD VALUPAK 00944-4212-10 J3590/C9399FIBRIN SEALANT FROZENARTISS 2 ML BAXTER BIOSCIENCE 00944-8503-02 — 4 ML 00944-8503-04 — 10 ML 00944-8503-10 —TISSEEL 2 ML BAXTER BIOSCIENCE 00944-8402-02 — 4 ML 00944-8402-04 — 10 ML 00944-8402-10 —
Product Size Manufacturer NDC# Code*
Oncology (CONTINUED)
15
COAGUALATIONIM
MUNE
GLOBULINSHYPERIM
MUNES
INFLUENZA VACCINES& ANCILLARIES
OTHERVACCINES
ALBUMIN / PLASM
APROTEIN FRACTION
SPECIALTY& ONCOLOGY
GENERIC INJECTABLES& SURGICAL SEALANTS
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BIVIGAM® [Immune Globulin Intravenous (Human), 10% Liquid] Rx onlyBrief summary: Consult the full Prescribing Information for complete product information WARNING: THROMBOSIS, RENAL DYSFUNCTION, AND ACUTE RENAL FAILURE Thrombosis may occur with immune globulin (IGIV) products, including BIVIGAM. Risk factors may include: advanced age, prolonged immobilization, hypercoagulable conditions, a history of venous or arterial thrombosis, the use of estrogens, indwelling central vascular catheters, hyperviscosity and cardiovascular risk factors. Thrombosis may occur in the absence of known risk factors. Use of Immune Globulin Intravenous (IGIV) products, particularly those containing sucrose, has been reported to be associated with renal dysfunction, acute renal failure, osmotic nephrosis, and death. Patients at risk of acute renal failure include those with any degree of pre-existing renal insufficiency, diabetes mellitus, advanced age (above 65 years of age), volume depletion, sepsis, paraproteinemia, or receiving known nephrotoxic drugs. Renal dysfunction and acute renal failure occur more commonly in patients receiving IGIV products containing sucrose. BIVIGAM does not contain sucrose. For patients at risk of thrombosis, renal dysfunction, or renal failure, administer BIVIGAM at the minimum dose and infusion rate practicable. Ensure adequate hydration in patients before administration. Monitor for signs and symptoms of thrombosis and assess blood viscosity in patients at risk for hyperviscosity.Indication and Usage: BIVIGAM is an Immune Globulin Intravenous (Human), 10% Liquid, indicated for the treatment of primary humoral immunodeficiency (PI). Contraindications: BIVIGAM is contraindicated in patients who have had an anaphylactic or severe systemic reaction to the administration of human immune globulin. BIVIGAM is contraindicated in IgA deficiency patients with antibodies to IgA and a history of hypersensitivity. Warnings and Precautions: Thrombosis: Thrombosis may occur following treatment with IGIV products, including BIVIGAM. Risk factors may include: advanced age, prolonged immobilization, hypercoagulable conditions, history of venous or arterial thrombosis, use of estrogens, indwelling central vascular catheters, hyperviscosity and cardiovascular risk factors. Thrombosis may occur in the absence of known risk factors. Consider baseline assessment of blood viscosity in patients at risk for hyperviscosity, including those with cryoglobulins, fasting chylomicronemia/markedly high triacylglycerols (triglycerides), or monoclonal gammopathies. For patients at risk of thrombosis, administer BIVIGAM at the minimum dose and infusion rate practicable. Ensure adequate hydration in patients before administration. Monitor for signs and symptoms of thrombosis and assess blood viscosity in patients at risk for hyperviscosity. Hypersensitivity: Severe hypersensitivity reactions may occur with IGIV products, including BIVIGAM. In case of hypersensitivity, discontinue BIVIGAM infusion immediately and institute appropriate treatment. Medications such as epinephrine should be available for immediate treatment of acute hypersensitivity reactions.
. Patients with known antibodies to IgA may have a greater risk of developing potentially severe hypersensitivity and anaphylactic reactions. BIVIGAM is contraindicated in IgA deficient patients with antibodies against IgA and a history of hypersensitivity reaction. Acute Renal Dysfunction and Acute Renal Failure: Acute renal dysfunction/failure, osmotic nephrosis, and death may occur upon use of human IGIV products. Ensure that patients are not volume depleted before administering BIVIGAM. Periodic monitoring of renal function and urine output is particularly important in patients judged to be at increased risk of developing acute renal failure. Assess renal function, including measurement of blood urea nitrogen (BUN) and serum creatinine, before the initial infusion of BIVIGAM and at appropriate intervals thereafter. If renal function deteriorates, consider discontinuing BIVIGAM. In patients who are at risk of developing renal dysfunction, because of pre-existing renal insufficiency or predisposition to acute renal failure (such as diabetes mellitus, hypovolemia, overweight, use of concomitant nephrotoxic medicinal products or age of >65 years), administer BIVIGAM at the minimum infusion rate practicable. Hyperproteinemia, Increased Serum Viscosity, and Hyponatremia: Hyperproteinemia, increased serum viscosity, and hyponatremia may occur in patients receiving IGIV therapy, including BIVIGAM. It is critical to clinically distinguish true hyponatremia from a pseudohyponatremia that is associated with or causally related to hyperproteinemia with concomitant decreased calculated serum osmolality or elevated osmolar gap, because treatment aimed at decreasing serum free water in patients with pseudohyponatremia may lead to volume depletion, a further increase in serum viscosity, and a possible predisposition to thrombotic events. Aseptic Meningitis Syndrome (AMS): AMS may occur infrequently with IGIV treatments including BIVIGAM. AMS usually begins within several hours to 2 days following IGIV treatment. Discontinuation of IGIV treatment has resulted in remission of AMS within several days without sequelae. AMS is characterized by the following signs and symptoms: severe headache, nuchal rigidity, drowsiness, fever, photophobia, painful eye movements, nausea, and vomiting.Cerebrospinal fluid (CSF) studies frequently reveal pleocytosis up to several thousand cells per cubic millimeter, predominantly from the granulocytic series, and elevated protein levels up to several hundred mg/dL, but negative culture results. Conduct a thorough neurological examination on patients exhibiting such signs and symptoms, including CSF studies, to rule out other causes of meningitis. AMS may occur more frequently in association with high doses (2 g/kg) and/or rapid infusion of IGIV. Hemolysis: IGIV products, including BIVIGAM, may contain blood group antibodies that can act as hemolysins and induce in vivo coating of red blood cells (RBCs) with immunoglobulin, causing a positive direct antiglobulin reaction and, rarely, hemolysis. Delayed hemolytic anemia can develop subsequent to IGIV therapy due to enhanced RBC sequestration,13 and acute hemolysis, consistent with intravascular hemolysis, has been reported. Monitor patients for clinical signs and symptoms of hemolysis. If these are present after BIVIGAM infusion, perform appropriate confirmatory laboratory testing. If transfusion is indicated for patients who develop hemolysis with clinically compromising anemia after receiving IGIV, perform adequate cross-matching to avoid exacerbating on-going hemolysis. Transfusion-Related Acute Lung Injury (TRALI): Noncardiogenic pulmonary edema may occur in patients following IGIV treatment including BIVIGAM. TRALI is characterized by severe respiratory distress, pulmonary edema, hypoxemia, normal left ventricular function, and fever. Symptoms typically appear within 1 to 6 hours following treatment. Monitor patients for pulmonary adverse reactions. If TRALI is suspected, perform appropriate tests for the presence of anti- . TRALI may be managed using oxygen therapy with adequate ventilatory support. Transmissible
Infectious Agents: Because BIVIGAM is made from human blood, it may carry a risk of transmitting infectious agents, e.g., viruses, and theoretically, the Creutzfeldt-Jakob disease (CJD) agent. No cases of transmission of viral diseases or CJD have been associated with the use of BIVIGAM. All infections suspected by a physician possibly to have been transmitted by this product should be reported by the physician or other healthcare provider to Biotest Pharmaceuticals Corporation at 1-800-458-4244. Before prescribing BIVIGAM, the physician should discuss the risks and benefits of its use with the patient. Monitoring Laboratory Tests: Periodic monitoring of renal function and urine output is particularly important in patients judged to be at increased risk of developing acute renal failure. Assess renal function, including measurement of blood urea nitrogen (BUN) and serum creatinine, before the initial infusion of BIVIGAM and at appropriate intervals thereafter. Because of the potentially increased risk of thrombosis with IGIV treatment, consider baseline assessment of blood viscosity in patients at risk for hyperviscosity, including those with cryoglobulins, fasting chylomicronemia/markedly high triacylglycerols (triglycerides), or monoclonal gammopathies. If signs and/or symptoms of hemolysis are present after an infusion of BIVIGAM, perform appropriate laboratory testing for confirmation. If TRALI is suspected, perform appropriate tests for the presence of anti-neutrophil antibodies in both the
Interference with Laboratory Tests: After infusion of immunoglobulin, the transitory rise of the various passively transferred antibodies in the
sitive serological testing results, with the potential for misleading interpretation. Passive transmission of antibodies to erythrocyte antigens (e.g., A,
ADVERSE REACTIONS: Serious adverse reactions observed in clinical trial subjects receiving BIVIGAM were vomiting and dehydration in one subject. The most common
fatigue, infusion site reaction, nausea, sinusitis, blood pressure increased, diarrhea, dizziness, and lethargy. Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in clinical trials cannot be directly compared to rates in the clinical trials of another product and may not reflect the rates observed in clinical practice. In a multicenter, open-label, non-randomized clinical trial, 63 subjects with PI, on regular IGIV replacement therapy, received doses of BIVIGAM ranging from 254 to 1029 mg/kg (median dose 462.8 mg/kg) every 3 weeks or 4 weeks for up to 12 months (mean 317.3 days; range 66 – 386 days). The use of pre-medication was discouraged; however, if subjects required pre-medication (antipyretic, antihistamine, or antiemetic agent) for recurrent reactions to immune globulins, they were allowed to continue those medications for this trial. Of the 746 infusions administered, 41 (65%) subjects received premedication prior to 415 (56%) infusions. Fifty-nine subjects (94%) had an adverse reaction at some time during the study. The proportion of subjects who had at least one adverse reaction was the same for both the 3- and 4-week cycles. The most common adverse reactions observed in this clinical trial were headache (32 subjects, 51%), sinusitis (24 subjects, 38%), fatigue (18 subjects, 29%), upper respiratory tract infection (16 subjects, 25%), diarrhea (13 subjects, 21%), cough (14 subjects, 22%), bronchitis (12 subjects, 19%), pyrexia (12 subjects, 19%), and nausea (9 subjects, 14%). Adverse reactions (ARs) are those occurring during or within 72 hours after the end of an infusion. In this study, the upper bound of the 1-sided 95% confidence interval for the proportion of BIVIGAM infusions with one or more temporally associated adverse reactions was 31%. The total number of adverse reactions was 431 (a rate of 0.58 ARs per infusion). Seven subjects (11.1%) experienced 11 serious ARs. Two of these were related serious Table: Adverse Reactions (ARs) (within 72 hours after the end of a BIVIGAM infusion) in
aSymptoms occurring under pre-existing fibromyalgia
ARs (vomiting and dehydration) that occurred in one subject. One subject withdrew from the study due to ARs related to BIVIGAM (lethargy, headache, tachycardia and pruritus). All 63
During the study, no subjects showed clinical evidence of hemolytic anemia. No cases of transmission of viral diseases or CJD have been associated with the use of BIVIGAM. During the clinical trial no subjects tested positive for infection due to human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV). There was a single positive finding for parvovirus (B19 virus) during the study. This subject came in contact with acute B19 virus from working at a school greeting children where a child was reported to have symptomatic Fifth's disease. There was no cluster (no other cases in other subjects) of B19 virus transmission with the IGIV batch concerned.DRUG INTERACTIONS Live Virus Vaccines Immunoglobulin administration may transiently impair the efficacy of live attenuated virus vaccines such as measles, mumps, rubella, and varicella because the continued presence of high levels of passively acquired antibody may interfere with an active antibody response. The immunizing physician should be informed of recent therapy with BIVIGAM so that appropriate measures may be taken.
ARsNo. Subjects
Reporting ARs(% of Subjects)[n=63]
No. Infusions With ARs(% of Infusions)[n=746]
Headache 27 (43%) 115 (15.4%)Fatigue 15 (24%) 59 (7.9%)Infusion Site Reaction 5 (8%) 5 (0.7%)Nausea 5 (8%) 8 (1.1%)Sinusitis 5 (8%) 5 (0.7%)Blood Pressure Increased 4 (6%) 5 (0.7%)Diarrhea 4 (6%) 4 (0.5%)Dizziness 4 (6%) 4 (0.5%)Lethargy 4 (6%) 4 (0.5%)Back Pain 3 (5%) 3 (0.4%)Blood Pressure Diastolic Decreased
3 (5%) 5 (0.7%)
Fibromyalgiaa 3 (5%) 17 (2.3%)Migraine 3 (5%) 8 (1.1%)Myalgia 3 (5%) 4 (0.5%)Pharyngolaryngeal Pain 3 (5%) 3 (0.4%)
Dec-2013, [10760-90-IGG-032013_R01]
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Visit NovoeightPro.com today to learn more.
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Indications and UsageNovoeight® (Antihemophilic Factor [Recombinant]) is indicated for use in adults and children with hemophilia A for control and prevention of bleeding, perioperative management, and routine prophylaxis to prevent or reduce the frequency of bleeding episodes.
Novoeight® is not indicated for the treatment of von Willebrand disease.
Important Safety InformationDo not use in patients who have had life-threatening hypersensitivity reactions, including anaphylaxis, to Novoeight® or its components, including hamster proteins.
Anaphylaxis and severe hypersensitivity reactions are possible. Patients may develop hypersensitivity to hamster proteins, which are present in trace amounts in the product. Should symptoms occur, discontinue Novoeight® and administer appropriate treatment.
Development of activity-neutralizing antibodies (inhibitors) may occur. If expected plasma factor VIII activity levels are not attained, or if bleeding is not controlled with an appropriate dose, perform an assay that measures factor VIII inhibitor concentration.
The most frequently reported adverse reactions (≥0.5%) were injection site reactions, increased hepatic enzymes, and pyrexia.
1
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Multiple dose strengths help infuse patients with fewer vials1
Novoeight® — a proven safe and effective treatment for hospital patients with hemophilia A1
Indicated for use in adults and children with hemophilia A for:
• Control and prevention of bleeding
• Perioperative management
• Routine prophylaxis to prevent or reduce the frequency of bleeding episodes
Novoeight® (Antihemophilic Factor [Recombinant]) — an evolution in treatment for hospital patients with hemophilia A
Please see Prescribing Information for complete storage instructions.
36˚F to 46˚F
30
6
USABILITY
FLEXIBILITY
STORAGE
VALUE
UP TO MONTHS
refrigerated storage1
VIAL SIZESRoom temperature storage
FOR 12 MONTHS
UP TO 86 FO after reconstitution1
• Longest of all recombinant factor VIII products1-7
4-HOUR STORAGE TIME
Please see Brief Summary of Prescribing Information on the adjacent page.
References: 1. Novoeight® [package insert]. Plainsboro, NJ: Novo Nordisk Inc.; 2014. 2. ADVATE™ [package insert]. Westlake Village, CA: Baxter Healthcare Corp.; 2014. 3. ELOCTATE® [package insert]. Cambridge, MA: Biogen Idec Inc.; 2014. 4. Helixate® FS [package insert]. Whippany, NJ: Bayer HealthCare LLC; 2014. 5. Kogenate® FS [package insert]. Tarrytown, NY: Bayer HealthCare LLC; 2014. 6. RECOMBINATE™ [package insert]. Westlake Village, CA: Baxter Healthcare Corp.; 2014. 7. XYNTHA® [package insert]. Philadelphia, PA: Wyeth Pharmaceuticals Inc., 2014.
I
a
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1Facilitates quick reconstitution and consistent preparation of treatment
SYRINGE4 mL pre-�lled diluent
Talk to your authorized distributor to learn more about Novoeight® or visit NovoeightPro.com for answers and resources. FFF Enterprises • 1-800-843-7477
© 2015 Novo Nordisk All rights reserved. 0315-00026032-1 April 2015
Novo Nordisk Inc., 800 Scudders Mill Road, Plainsboro, New Jersey 08536 U.S.A.
Novoeight® is a registered trademark of Novo Nordisk Health Care AG.
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Novoeight®, Antihemophilic Factor (Recombinant)
Rx Only
BRIEF SUMMARY: Please consult package insert for full prescribing information
INDICATIONS AND USAGE: Novoeight®, Antihemophilic Factor (Recombinant), is indicated for use in adults and children with hemophilia A (congenital factor VIII de�ciency or classic hemophilia) for: control and prevention of bleeding episodes; Perioperative management; routine prophylaxis to prevent or reduce the frequency of bleeding episodes. Novoeight® is not indicated for the treatment of von Willebrand disease.
CONTRAINDICATIONS: Do not use in patients who have had life-threatening hypersensitivity reactions, including anaphylaxis, to Novoeight® or its components (including traces of hamster proteins).
WARNINGS AND PRECAUTIONS: Hypersensitivity Reactions: Hypersensitivity reactions, including anaphylaxis, are possible with Novoeight®. Novoeight® contains trace amounts of hamster proteins. Patients treated with this product may develop hypersensitivity to these non-human mammalian proteins. Early signs of hypersensitivity reactions that can progress to anaphylaxis include angioedema, chest tightness, dyspnea, wheezing, urticaria, and pruritus. Immediately discontinue administration and initiate appropriate treatment if allergic- or anaphylactic-type reactions occur. Neutralizing Antibodies: Formation of neutralizing antibodies (inhibitors) to factor VIII can occur following administration of Novoeight®. Monitor all patients for the development of inhibitors by appropriate clinical observation and laboratory testing. If the expected plasma levels of factor VIII activity are not attained, or if bleeding is not controlled with an appropriate dose, perform testing for factor VIII inhibitors. Monitoring Laboratory Tests: Monitor plasma factor VIII activity levels by the one-stage clotting assay or the chromogenic substrate assay to con�rm that adequate factor VIII levels have been achieved and maintained, when clinically indicated. Perform assay to determine if factor VIII inhibitor is present if expected plasma factor VIII activity levels are not attained, or if bleeding is not controlled with the expected dose of Novoeight®. Determine inhibitor levels in Bethesda Units.
ADVERSE REACTIONS: The most frequently reported adverse reactions (≥ 0.5%) were injection site reactions, increased hepatic enzymes, and pyrexia. Clinical Trials Experience: Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in clinical trials of another drug and may not re�ect the rates observed in clinical practice. During the clinical development of Novoeight®, 214 male previously treated patients (PTPs; exposed to a factor VIII-containing product for ≥150 days) with severe hemophilia A (factor VIII level ≤1%) received at least one dose of Novoeight® as part of either routine prophylaxis, on-demand treatment of bleeding episodes, perioperative
management of major and minor surgical, dental, or other invasive procedures, or pharmacokinetic evaluation of Novoeight®. Thirty-one subjects (14%) were
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