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Novoeight HCP Brochure

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Novoeight HCP Brochure ® READY UpUp to to Novoeight is ready to go TO GO when your patients are forfor up upto to ADMINIS- A recombinant factor VIII for today’s generation TRATION months 1 3 months of people living with hemophilia A Please see Prescribing Information for complete storage conditions. EFFICACY AND SAFETY Dylan lives with hemophilia A. PRODUCT ATTRIBUTES SUPPORT Indications and Usage • Novoeight® (antihemophilic factor, recombinant) is indicated for use in adults and children with hemophilia A for on-demand treatment and control of bleeding episodes, perioperative management, and routine prophylaxis to reduce the frequency of bleeding episodes • Novoeight® is not indicated for the treatment of von Willebrand disease SUMMARY Important Safety Information Contraindications • Do not use in patients who have had life-threatening hypersensitivity reactions, including anaphylaxis, to Novoeight® or its components, including hamster proteins ISI PI Please tap the ISI tab for additional Important Safety Information and tap the PI tab for Prescribing Information. Blerim lives with hemophilia A. READY WITH NOVOEIGHT® TO GO YOUR PATIENTS ARE ADMINIS- ready to go TRATION EFFICACY AND SAFETY “I’m planning on working as a camp counselor this summer. PRODUCT ATTRIBUTES Having a factor I can store and take with me is a huge relief.” —Patient with hemophilia A SUPPORT Important Safety Information SUMMARY Warnings and Precautions • 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 ISI PI Please tap the ISI tab for additional Important Safety Information and tap the PI tab for Prescribing Information. STABILITY READY TO GO Novoeight®—A higher degree of stability Novoeight® is the only standard half-life (SHL) factor VIII with stability up to 104°F for up to 3 months1-11 ADMINIS- TRATION 104ºF Novoeight The only SHL rFVIII with stability up to 104ºFa ® EFFICACY AND SAFETY 95ºF The SHL with the longest duration of stability at 86ºFa PRODUCT Novoeight 86ºF Adynovate Eloctate Advate ATTRIBUTES ® ® ® ® Kovaltry Kogenate 77ºF Nuwiq Afstyla ReFacto Xyntha Jivi ® SUPPORT ® ® ® ® ® ® rFVIII=recombinant factor VIII. aCompared with other selected recombinant FVIII SHL and EHL products. Please see Prescribing Information for complete storage conditions. 3 months 12 months 3 months 6 months 12 months SUMMARY Important Safety Information Warnings and Precautions (cont’d) • Development of activity-neutralizing antibodies (inhibitors) may occur. Previously untreated patients (PUPs) are at greatest risk for inhibitor development with all factor VIII products. Inhibitors have been reported following administration of Novoeight® in PUPs. If expected plasma factor VIII activity levels are not attained, or if bleeding is not controlled with an appropriate dose, perform testing for factor VIII inhibitors ISI PI Please tap the ISI tab for additional Important Safety Information and tap the PI tab for Prescribing Information. READY Help your patients explore life up to 104°F— TO GO with the ability to store factor out of the fridge The SHL with the highest storage temperature for the longest duration ADMINIS- TRATION Novoeight® can be stored1: Up to Up to EFFICACY AND SAFETY for up to for up to months months PRODUCT 3 12 ATTRIBUTES Highest storage temperature Longest room temperature storage after reconstitution1,a time after reconstitution1,a SUPPORT Up to Up to aCompared with other SHL recombinant FVIII products. Please see Prescribing Information for storage time at 104ºF storage time at 86ºF complete storage conditions. SUMMARY Important Safety Information Adverse Reactions • The most frequently reported adverse reactions (≥1%) were inhibitors in previously untreated patients (PUPs), injection site reactions, and pyrexia ISI PI Please tap the ISI tab for additional Important Safety Information and tap the PI tab for Prescribing Information. PORTABILITY READY TO GO Portability that fits into your patients’ lifestyle ADMINIS- Designed for travel TRATION EFFICACY Compact AND SAFETY packaging for easy storage PRODUCT ATTRIBUTES Small kit holds up to a SUPPORT week’s worth Customizable case covers of factor SUMMARY Indications and Usage • Novoeight® (antihemophilic factor, recombinant) is indicated for use in adults and children with hemophilia A for on-demand treatment and control of bleeding episodes, perioperative management, and routine prophylaxis to reduce the frequency of bleeding episodes • Novoeight® is not indicated for the treatment of von Willebrand disease ISI PI Please tap the ISI tab for additional Important Safety Information and tap the PI tab for Prescribing Information. ® READY Novoeight offers quick reconstitution TO GO and multiple dose strengths ADMINIS- With MixPro®, preparing a dose of Novoeight® TRATION is as quick as ATTACH, TWIST, MIX1 PREFILLED DILUENT SYRINGE EFFICACY 1 Contains 4 mL of diluent—works with any dose strength AND SAFETY ADAPTER Connects the syringe and vial with a 25-µm inline particle filter1 PRODUCT ATTRIBUTES VIAL WITH COLORED CAP 1 Easy recognition of different dose strengths by color-coded vial caps SUPPORT 3000 IU Multiple dose strengths help more patients infuse with fewer vials1 2000 IU SUMMARY 1500 IU 1000 IU Important Safety Information 500 IU Contraindications 250 IU • Do not use in patients who have had life-threatening hypersensitivity reactions, including anaphylaxis, to Novoeight® or its components, including hamster proteins ISI PI Please tap the ISI tab for additional Important Safety Information and tap the PI tab for Prescribing Information. READY TO GO NOVOEIGHT® FITS INTO AN active lifestyle ADMINIS- TRATION Vaughn lives with hemophilia A. EFFICACY “When I’m out and doing AND SAFETY physical activity, it’s helpful ® that Novoeight is easy to PRODUCT take with me and use.” ATTRIBUTES —Vaughn, Novoeight® user SUPPORT Important Safety Information SUMMARY Warnings and Precautions • 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 ISI PI Please tap the ISI tab for additional Important Safety Information and tap the PI tab for Prescribing Information. DOSING READY TO GO Novoeight® PK profile achieves the needed peak levels of factor activity1,12,13,a,b 1.8 1.6 ADMINIS- PK=pharmacokinetics. TRATION ) aApplies similarly to other -1 1.4 L standard half-life replacement m 1.2 factor VIII products. bDerived from Jiménez-Yuste, 1.0 et al. Mean PK profiles are based on patients aged 0.8 ≥12 years who received EFFICACY 0.6 a single 50 IU/kg dose of AND SAFETY Novoeight®.13 0.4 FVIII LEVEL (IU 0.2 Infusion Infusion Infusion 0.0 Mon Tues Wed Thurs Fri Sat Sun AM AM AM AM AM AM AM PRODUCT ATTRIBUTES Peak Activity Dosing and appropriate level of activity may be different from person to person. Appropriate dosing regimen and level of activity should be determined individually for each patient. SUPPORT Novoeight® is approved for routine prophylaxis every other day or 3 times weekly. Please see Prescribing Information for complete dosing information.1 Speak with your patients about their activity and appropriate prophylaxis dosing schedule14 SUMMARY Important Safety Information Warnings and Precautions (cont’d) • Development of activity-neutralizing antibodies (inhibitors) may occur. Previously untreated patients (PUPs) are at greatest risk for inhibitor development with all factor VIII products. Inhibitors have been reported following administration of Novoeight® in PUPs. If expected plasma factor VIII activity levels ISI are not attained, or if bleeding is not controlled with an appropriate dose, perform testing for factor VIII inhibitors PI Please tap the ISI tab for additional Important Safety Information and tap the PI tab for Prescribing Information. Oscar, lives with hemophilia A. READY WITH NOVOEIGHT® TO GO YOUR PATIENTS CAN ADMINIS- take control TRATION of their bleeds EFFICACY AND SAFETY ® PRODUCT “We’ve found Novoeight to be the ATTRIBUTES right therapy that fits with his life and effectively controls his bleeds.” SUPPORT —Caregiver of patient with hemophilia A SUMMARY Important Safety Information Adverse Reactions • The most frequently reported adverse reactions (≥1%) were inhibitors in previously untreated patients (PUPs), injection site reactions, and pyrexia ISI PI Please tap the ISI tab for additional Important Safety Information and tap the PI tab for Prescribing Information. BLEED CONTROL READY TO GO Proven effective across age groups Novoeight® continued to reduce frequency of bleeds, ADMINIS- TRATION demonstrating effective, long-term prophylaxis15,a Median ABR EFFICACY AND SAFETY All patients Children Long-term (0–65 years old) (≤11 years old) safety trial PRODUCT ATTRIBUTES 3.7 1,a 3.0 16,b 1.4 1,a median bleeds per year median bleeds per year median bleeds per year Results of an initial clinical trial studying The majority of patients continued the effectiveness and safety in children in a safety extension trial SUPPORT aguardian™2: a phase 3b, non-randomized, open-label extension trial investigating the long-term safety and efficacy of turoctocog alfa in 213 previously treated males of all ages with severe hemophilia A. Of the 207 patients on prophylaxis, accumulated patient-years on prophylaxis was
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