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| FREHEMGO® (denecimig-mima) injection is indicated for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients with hemophilia A (congenital factor VIII deficiency) with or without factor VIII inhibitors. |
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| 1 pen. Once monthly. |
| Proven bleed protection.1,a |
| The first-and-only, potent FVIIIa mimetic in single-use, prefilled pens.1-3 |
| aDosing frequency may vary; FREHEMGO® is available for once-monthly, once-every-2-weeks, and once-weekly dosing.1 |
| FVIIIa=Activated Factor VIII. |
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| FREHEMGO® (denecimig-mima) injection is now FDA approved for adult and pediatric patients with hemophilia A with or without FVIII inhibitors for routine prophylaxis to prevent or reduce the frequency of bleeding episodes. |
| FVIIIa=Activated Factor VIII. |
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| Keep scrolling to learn more about FREHEMGO® |
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| Important Safety Information for FREHEMGO® |
| Contraindications |
| FREHEMGO® is contraindicated in patients with: |
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| Warnings & Precautions |
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Ut rutrum sollicitudin vulputate. Nunc tincidunt blandit tempor. Maecenas at tincidunt diam. Etiam urna erat, ullamcorper egestas nunc accumsan |
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| FREHEMGO®: LONG-LASTING BLEED PROTECTION IN ONE EASY PEN1 |
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| NORMALIZED THROMBIN GENERATION |
| A potent FVIIIa mimetic that generates thrombin levels in the normal range1 |
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| SUSTAINED BLEED PROTECTION |
| Up to 31 days with once-monthly dosing1 |
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| QUICK, EASY ADMINISTRATION |
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Low-volume (0.8 mL) pens that take <1 minute to prep and inject1,4,b |
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93% (N=70) of patients said the FREHEMGO® pen was either easier or much easier to use than emicizumab vial and syringe (5% said neither more difficult nor easier and 1% said more difficult)4,b |
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| LOW RATE |
of thromboembolic events (XX patients experienced a TE)2 |
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| NO |
clinical evidence of neutralizing anti-denecimig-mima antibodies1,a |
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| Most common adverse reactions (≥10%)1: |
| Injection site reactions (12%) |
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Across >18,000 FREHEMGO® injections in clinical trials, 1.6% led to injection site reactions2 |
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Pain and/or burning reported in 0.2% of injections2 |
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All injection site reactions were mild, and none led to discontinuation |
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| Prothrombin fragment 1+2 increased (10%) |
| ~9/10 |
| PATIENTS WERE FREE OF INJECTION SITE REACTIONS |
| while using FREHEMGO®1 |
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| aOf 448 patients, 2 (0.4%) developed transient neutralizing anti-denecimig-mima antibodies without identified clinically significant impact on safety or effectiveness. |
| TE=thromboembolic event. |
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| Review key clinical information, dosing and administration details, and practice resources. |
| Learn more
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| Connect with a Novo Nordisk Rare Blood Therapy Manager in your area. They can help you with: |
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Clinical product information |
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Rare bleeding education for patients |
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Resources for starting treatment |
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General questions & inquiries |
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| Complete a simple registration to receive the latest product news and education from Novo Nordisk. |
| Register
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| With a novoMEDLINK™ account you can: |
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Order educational materials |
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Access the latest product information |
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Receive personalized updates |
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| Indications and Usage for FREHEMGO® |
| Lorem ipsum dolor sit amet, consectetur adipiscing elit. Curabitur eget ante ut eros porttitor semper eget leo. Vivamus quis ex sit amet nibh semper euismod. Etiam aliquet nibh ut molestie tempus. Quisque porttitor rutrum lacus, non aliquet erat ullamcorper vitae. Duis sit amet dictum nisl. Integer nec purus aliquam, interdum nulla ut, varius neque. Sed feugiat convallis lorem a tincidunt. |
| Lorem ipsum dolor sit amet, consectetur adipiscing elit. Curabitur eget ante ut eros porttitor semper eget leo. Vivamus quis ex sit amet nibh semper euismod. Etiam aliquet nibh ut molestie tempus. |
| Important Safety Information (cont’d) |
| Warnings and Precautions (cont’d) |
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Lorem ipsum dolor sit amet, consectetur adipiscing elit. Curabitur eget ante ut eros porttitor semper eget leo. Vivamus quis ex sit amet nibh semper euismod. Etiam aliquet nibh ut molestie tempus. Quisque porttitor rutrum lacus, non aliquet erat ullamcorper vitae. Duis sit amet dictum nisl. Integer nec purus aliquam, interdum nulla ut, varius neque. Sed feugiat convallis lorem a tincidunt. |
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Ut rutrum sollicitudin vulputate. Nunc tincidunt blandit tempor. Maecenas at tincidunt diam. Etiam urna erat, ullamcorper egestas nunc accumsan |
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| Adverse Reactions |
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Lorem ipsum dolor sit amet, consectetur adipiscing elit. Curabitur eget ante ut eros porttitor semper eget leo. Vivamus quis ex sit amet nibh semper euismod. Etiam aliquet nibh ut molestie tempus. Quisque porttitor rutrum lacus, non aliquet erat ullamcorper vitae. Duis sit amet dictum nisl. Integer nec purus aliquam, interdum nulla ut, varius neque. Sed feugiat convallis lorem a tincidunt. |
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Ut rutrum sollicitudin vulputate. Nunc tincidunt blandit tempor. Maecenas at tincidunt diam. Etiam urna erat, ullamcorper egestas nunc accumsan |
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| Drug Interactions |
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Lorem ipsum dolor sit amet, consectetur adipiscing elit. Curabitur eget ante ut eros porttitor semper eget leo. Vivamus quis ex sit amet nibh semper euismod. Etiam aliquet nibh ut molestie tempus. Quisque porttitor rutrum lacus, non aliquet erat ullamcorper vitae. Duis sit amet dictum nisl. Integer nec purus aliquam, interdum nulla ut, varius neque. Sed feugiat convallis lorem a tincidunt. |
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Ut rutrum sollicitudin vulputate. Nunc tincidunt blandit tempor. Maecenas at tincidunt diam. Etiam urna erat, ullamcorper egestas nunc accumsan |
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| Use in Specific Populations |
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Lorem ipsum dolor sit amet, consectetur adipiscing elit. Curabitur eget ante ut eros porttitor semper eget leo. Vivamus quis ex sit amet nibh semper euismod. Etiam aliquet nibh ut molestie tempus. Quisque porttitor rutrum lacus, non aliquet erat ullamcorper vitae. Duis sit amet dictum nisl. Integer nec purus aliquam, interdum nulla ut, varius neque. Sed feugiat convallis lorem a tincidunt. |
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Ut rutrum sollicitudin vulputate. Nunc tincidunt blandit tempor. Maecenas at tincidunt diam. Etiam urna erat, ullamcorper egestas nunc accumsan |
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| Please click here for FREHEMGO® Prescribing Information. |
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| References: |
| 1. |
FREHEMGO [package insert]. Plainsboro, NJ; Novo Nordisk Inc. |
| 2. |
Østergaard H, Lund J, Greisen PJ, et al. A factor VIIIa-mimetic bispecific antibody, Mim8, ameliorates bleeding upon severe vascular challenge in hemophilia A mice. Blood. 2021;138(14):1258-1268. |
| 3. |
Lentz SR, Chowdary P, Gil L, et al. FRONTIER1: a partially randomized phase 2 study assessing the safety, pharmacokinetics, and pharmacodynamics of Mim8, a factor VIIIa mimetic. J Thromb Haemost. 2024;22(4):990-1000. |
| 4. |
Lauritzen B, Bjelke M, Björkdahl O, et al. A novel next-generation FVIIIa mimetic, Mim8, has a favorable safety profile and displays potent pharmacodynamic effects: results from safety studies in cynomolgus monkeys. J Thromb Haemost. 2022;20(6):1312-1324. |
| 5. |
Data on file. Novo Nordisk Inc; Plainsboro, NJ. |
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FRONTIER2 publication (to be published) |
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FRONTIER3 publication (to be published) |
| 8. |
FRONTIER4 publication (to be published) |
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FREHEMGO® is a registered trademark of Novo Nordisk Health Care AG. novoMEDLINK™ is a trademark of Novo Nordisk A/S. Novo Nordisk is a registered trademark of Novo Nordisk A/S. © 2026 Novo Nordisk All rights reserved. US26DENE00013 September 2026 |
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