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Important Safety Information   |   Prescribing Information
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.
 
NOW APPROVED!
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.
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.
Review the data   View the press release
Keep scrolling to learn more about FREHEMGO®
Important Safety Information for FREHEMGO®
Contraindications
FREHEMGO® is contraindicated in patients with:
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Warnings & Precautions
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FREHEMGO®: LONG-LASTING BLEED PROTECTION IN ONE EASY PEN1
 
NORMALIZED THROMBIN GENERATION
A potent FVIIIa mimetic that generates thrombin levels in the normal range1
 
SUSTAINED BLEED PROTECTION
Up to 31 days with once-monthly dosing1
 
QUICK, EASY ADMINISTRATION
• Low-volume (0.8 mL) pens that take <1 minute to prep and inject1,4,b
• 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
For more information, please read the Instructions for Use.
 
PROVEN SAFETY PROFILE1
Across FRONTIER trials1:
 
LOW RATE
of thromboembolic events
(XX patients experienced a TE)2
 
 
NO
clinical evidence of neutralizing
anti-denecimig-mima antibodies1,a
Most common adverse reactions (≥10%)1:
Injection site reactions (12%)
  • Across >18,000 FREHEMGO® injections in clinical trials, 1.6% led to injection site reactions2
  • Pain and/or burning reported in 0.2% of injections2
  • All injection site reactions were mild, and none led to discontinuation
Prothrombin fragment 1+2 increased (10%)
~9/10
PATIENTS WERE FREE OF INJECTION SITE REACTIONS
while using FREHEMGO®1
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.
Review key clinical information, dosing and administration details, and practice resources.
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Indications and Usage for FREHEMGO®
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Important Safety Information (cont’d)
Warnings and Precautions (cont’d)
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Adverse Reactions
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Drug Interactions
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Use in Specific Populations
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Please click here for FREHEMGO® Prescribing Information.
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.
6. FRONTIER2 publication (to be published)
7. FRONTIER3 publication (to be published)
8. FRONTIER4 publication (to be published)
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