The First rfviii WITH A PROLONGED HALF-LIFE

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1 Visit ELOCTATEpro.com for more information The First rfviii WITH A PROLONGED HALF-LIFE Indications ELOCTATE [Antihemophilic Factor (Recombinant), Fc Fusion Protein] is a recombinant DNA derived, antihemophilic factor indicated in adults and children with Hemophilia A (congenital Factor VIII deficiency) for: control and prevention of bleeding episodes, perioperative management (surgical prophylaxis), and routine prophylaxis to prevent or reduce the frequency of bleeding episodes ELOCTATE is not indicated for the treatment of von Willebrand disease ELOCTATE is contraindicated in patients who have had life-threatening hypersensitivity reactions to ELOCTATE, including anaphylaxis Please see additional Important Safety Information on page 10 and full Prescribing Information.

2 ELOCTATE The First rfviii WITH A PROLONGED HALF-LIFE In Adult Patients MEAN TERMINAL HALF-LIFE AFTER A SINGLE DOSE (50 IU/kg) * ELOCTATE 19.7 HOURS (17.4, 22.0) Mean Terminal Half-life (Hours) In Pediatric and Adolescent Patients MEAN TERMINAL HALF-LIFE AFTER A SINGLE DOSE (50 IU/kg) * 16.4 HOURS Ages 12 to 17 (n=11) (14.1, 18.6) 14.6 HOURS Ages 6 to 11 (n=27) (11.5, 17.7) 12.0 HOURS Ages 2 to 5 (n=10) (9.55, 14.4) ELOCTATE * Presented in arithmetic mean (95% confidence interval). The pharmacokinetics of ELOCTATE were evaluated following a single dose of 50 IU/kg in the Phase 3 study of 28 adults and 11 adolescents (ages 12 to 17 years), and in an open-label, multicenter study of 37 pediatric, previously treated patients (ages 2 to 5 years and 6 to 11 years). Compared to adults and adolescents, clearance was higher in children 2 to 5 years of age, indicating a need for dose adjustments. For patients 6 years and older, dose adjustment is not required. Mean Terminal Half-life (Hours) Hypersensitivity reactions, including anaphylaxis, are possible with ELOCTATE. Immediately discontinue ELOCTATE and initiate appropriate treatment if hypersensitivity reactions occur Formation of neutralizing antibodies (inhibitors) to Factor VIII can occur following administration of ELOCTATE. Patients using ELOCTATE should be monitored for the development of Factor VIII inhibitors 2 Please see additional Important Safety Information on page 10 and full Prescribing Information.

3 5 Days With Factor LEVELS ABOVE 1% MEAN FACTOR ACTIVITY PROFILE AFTER A SINGLE DOSE (50 IU/kg) IN ADULTS* Mean Plasma FVIII Activity (IU/dL) ABOVE % Time (Hours) *The pharmacokinetics of ELOCTATE were evaluated following a single dose of 50 IU/kg in the Phase 3 study of 28 adults. COMPARABLE PK PROFILES AFTER REPEATED DOSING The PK profile of ELOCTATE was evaluated in a subgroup of patients after the first dose and after repeated dosing again at Week 14. Repeat evaluations showed comparable PK profiles. Clotting assays (e.g., one-stage) may be used to confirm that adequate Factor VIII levels have been achieved and maintained Common adverse reactions ( 1% of subjects) reported in clinical trials were arthralgia and malaise Please see additional Important Safety Information on page 10 and full Prescribing Information. 3

4 ELOCTATE With Individualized Prophylaxis PROVEN PROTECTION* FROM BLEEDS Median Annualized Bleed Rate Overall Bleeds Joint Bleeds 1.60 (0.00, 4.69) 0.0 (0.00, 3.11) On-Demand On-Demand (21.14, 48.69) (15.07, 39.02) 0 bleeds in 45% of patients Spontaneous Bleeds 0.0 (0.00, 2.03) On-Demand (12.21, 36.81) *Protection is the prevention of bleeding episodes using a prophylaxis regimen. Median (interquartile range 25th and 75th percentiles). A-LONG, a multicenter, prospective, open-label, Phase 3 study (N=165), evaluated the safety and efficacy of ELOCTATE in previously treated male patients aged 12 to 65 years with severe Hemophilia A (<1% endogenous FVIII activity or a genetic mutation consistent with severe Hemophilia A) and compared the efficacy of each of 2 prophylactic treatment regimens (individualized interval and fixed weekly) to episodic (on-demand) treatment. Hemostatic efficacy was determined in both: treatment of bleeding episodes and during perioperative management in subjects undergoing major surgical procedures. 164 and 163 subjects were evaluable for safety and efficacy, respectively. 146 and 23 subjects were treated for at least 26 weeks and 39 weeks, respectively. 98% of Bleeds Treated WITH 1 OR 2 INFUSIONS 87.3 % 1 infusion (n=661) 98 % 10.4 % 2 infusions (n=79) IU/kg Median dose per infusion to treat a bleed (IQR 22.73, 32.71) 757 bleeding episodes. 1.7 % 3 infusions (n=13) 0.5 % 4 infusions (n=4) ELOCTATE is contraindicated in patients who have had life-threatening hypersensitivity reactions to ELOCTATE, including anaphylaxis Hypersensitivity reactions, including anaphylaxis, are possible with ELOCTATE. Immediately discontinue ELOCTATE and initiate appropriate treatment if hypersensitivity reactions occur 4 Please see additional Important Safety Information on page 10 and full Prescribing Information.

5 Prophylaxis Starting With 50 IU/kg EVERY 4 DAYS Regimen may be adjusted based on patient response in the range of IU/kg at 3-5 day intervals More frequent or higher doses up to 80 IU/kg may be required in children <6 years of age The 1-stage clotting assay or chromogenic assay can be used to monitor plasma Factor VIII levels after administering ELOCTATE Potential for MORE TIME BETWEEN INFUSIONS Number of Routine Prophylaxis Infusions Per Year Every 3 days RECOMMENDED STARTING REGIMEN 91 Every 4 days 73 Every 5 days Among 112 subjects treated for 6 months, during the last 3 months on study: 99% achieved a dosing interval of 3 days or longer 35% achieved a dosing interval of 4 days or longer 29% achieved a dosing interval of 5 days ELOCTATE Recommended Prophylaxis Regimens* * Number of infusions vary per individual. Formation of neutralizing antibodies (inhibitors) to Factor VIII can occur following administration of ELOCTATE. Patients using ELOCTATE should be monitored for the development of Factor VIII inhibitors Clotting assays (e.g., one-stage) may be used to confirm that adequate Factor VIII levels have been achieved and maintained Please see additional Important Safety Information on page 10 and full Prescribing Information. 5

6 Safety from A-LONG 164 subjects were evaluable for safety in A-LONG. 146 people were treated for at least 26 weeks and 23 people were treated for at least 39 weeks Zero Inhibitors in the Clinical Trial Monitor all patients for the development of FVIII inhibitors by appropriate clinical observations and laboratory tests One subject had a transient, positive, neutralizing antibody of 0.73 BU at Week 14, which was not confirmed upon repeat testing 18 days later and thereafter No Anaphylaxis Was Reported Hypersensitivity reactions, including anaphylaxis, are possible with ELOCTATE. Early signs of hypersensitivity reactions that can progress to anaphylaxis may include angioedema, chest tightness, dyspnea, wheezing, urticaria, and pruritus. Immediately discontinue administration and initiate appropriate treatment if hypersensitivity reactions occur Low Incidence of Adverse Reactions (ARs) The most common ARs in the Phase 3 clinical study were arthralgia and malaise (each 1.2%) and: abdominal pain, lower; abdominal pain, upper; angiopathy*; bradycardia; chest pain; cough; dizziness; dysgeusia; feeling cold; feeling hot; headache; hypertension; joint swelling; myalgia; procedural hypotension; and rash (each 0.6%) Two subjects were withdrawn from study due to ARs of rash and arthralgia *Vascular pain after injection of study drug. 6 Please see additional Important Safety Information on page 10 and full Prescribing Information.

7 A-LONG: One of the Largest Pivotal Trials in Hemophilia A A multicenter, prospective, open-label, Phase 3 study (N=165), evaluated the safety and efficacy of ELOCTATE in previously treated male patients aged 12 to 65 years with severe Hemophilia A (<1% endogenous FVIII activity or a genetic mutation consistent with severe Hemophilia A). This study compared the efficacy of each of 2 prophylactic treatment regimens (individualized interval and fixed weekly) to episodic (on-demand) treatment. Hemostatic efficacy was determined in both: treatment of bleeding episodes and during perioperative management in subjects undergoing major surgical procedures. 164 and 163 subjects were evaluable for safety and efficacy, respectively. 146 and 23 subjects were treated for at least 26 weeks and 39 weeks, respectively. Additional Dosing Regimen Studied MEDIAN ANNUALIZED BLEED RATE* Median Annualized Bleed Rate (1.86, 8.36) (21.14, 48.69) OVERALL BLEEDS 1.93 (0.00, 7.62) JOINT BLEEDS Once-Weekly Prophylaxis (n=23) On-Demand (n=23) (15.07, 39.02) (12.21, 36.81) 1.93 (0.00, 4.78) SPONTANEOUS BLEEDS *Median (interquartile range 25th and 75th percentiles). Common adverse reactions (> 1% of subjects) reported in clinical trials were arthralgia and malaise ELOCTATE is contraindicated in patients who have had life-threatening hypersensitivity reactions to ELOCTATE, including anaphylaxis Please see additional Important Safety Information on page 10 and full Prescribing Information. 7

8 A Broad Range of Vial Options AVAILABLE WITH A 3-ML DILUENT VOLUME 7 different potencies, with the potential for single-vial dosing Reconstitution with pre-filled syringe, needleless transfer system, and distinct vial adapter Graphic not representative of actual drug product vials. Packaging Designed WITH YOUR PATIENTS IN MIND Please see Instructions for Use for Storage and Handling. Comes in a small, hard case Helps with portability For travel or home use Press the arrows on both sides and lift up on the half circles It s stackable Addresses storage concerns Everything is neatly packaged 1 single-use vial containing lyophilized powder for reconstitution 1 pre-filled diluent syringe with plunger rod 1 sterile vial adapter reconstitution device 8 Please see additional Important Safety Information on page 10 and full Prescribing Information.

9 RESOURCES TO HELP YOU HELP YOUR PATIENTS ONE NUMBER. ONE CONTACT MyELOCTATE ( ) Monday through Friday 8 AM to 8 PM ET Free Trial Plus Program Free 30-day trial of ELOCTATE. Patients can continue to receive free product for up to 1 year if health insurance does not cover ELOCTATE. Insurance Counseling A dedicated coordinator can help you verify insurance coverage, including challenges such as denials, deductibles, copays, and pharmacy benefits. R x Copay Program Up to $12,000 per year in copay assistance with no income requirements or caps. Factor Access Program Free ELOCTATE for patients who are between jobs, have a lapse in insurance, or have insurance that does not cover ELOCTATE. Hypersensitivity reactions, including anaphylaxis, are possible with ELOCTATE. Immediately discontinue ELOCTATE and initiate appropriate treatment if hypersensitivity reactions occur. Please see additional Important Safety Information on page 10 and full Prescribing Information. 9

10 Visit ELOCTATEpro.com for more information ELOCTATE THE FIRST rfviii WITH A PROLONGED HALF-LIFE In A-LONG: 5 days with factor levels above 1% in adults 19.7-hour half-life in adults Proven protection* from bleeds with individualized prophylaxis 98% of bleeds treated with 1 or 2 infusions Common adverse reactions ( 1% of subjects) reported in clinical trials were arthralgia and malaise * Protection is the prevention of bleeding episodes using a prophylaxis regimen. Indications and Important Safety Information Indications: ELOCTATE [Antihemophilic Factor (Recombinant), Fc Fusion Protein] is a recombinant DNA derived, antihemophilic factor indicated in adults and children with Hemophilia A (congenital Factor VIII deficiency) for: control and prevention of bleeding episodes, perioperative management (surgical prophylaxis), and routine prophylaxis to prevent or reduce the frequency of bleeding episodes. ELOCTATE is not indicated for the treatment of von Willebrand disease. Contraindications: ELOCTATE is contraindicated in patients who have had life-threatening hypersensitivity reactions to ELOCTATE, including anaphylaxis. Warnings and Precautions: Hypersensitivity reactions, including anaphylaxis, are possible with ELOCTATE. Immediately discontinue ELOCTATE and initiate appropriate treatment if hypersensitivity reactions occur. Formation of neutralizing antibodies (inhibitors) to Factor VIII can occur following administration of ELOCTATE. Patients using ELOCTATE should be monitored for the development of Factor VIII inhibitors. Clotting assays (e.g., one-stage) may be used to confirm that adequate Factor VIII levels have been achieved and maintained. Adverse Reactions: Common adverse reactions (> 1% of subjects) reported in clinical trials were arthralgia and malaise. Please see full Prescribing Information Biogen. All rights reserved. ELO-US-0098v2 11/15