Source: European Medicines Agency (EU) Revision Year: 2022 Publisher: Alnylam Netherlands B.V., Antonio Vivaldistraat 150, 1083 HP Amsterdam, Netherlands
Amvuttra 25 mg solution for injection in pre-filled syringe.
| Pharmaceutical Form |
|---|
|
Solution for injection (injection). Clear, colourless-to-yellow solution (pH of approximately 7; osmolality 210 to 390 mOsm/kg). |
Each pre-filled syringe contains vutrisiran sodium equivalent to 25 mg vutrisiran in 0.5 mL solution.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Vutrisiran |
Vutrisiran is covalently linked to a ligand containing three N-acetylgalactosamine (GalNAc) residues to enable delivery of the siRNA to hepatocytes. Through a natural process called RNA interference (RNAi), vutrisiran causes the catalytic degradation of TTR mRNA in the liver, resulting in the reduction of variant and wild-type serum TTR protein levels. |
| List of Excipients |
|---|
|
Sodium dihydrogen phosphate dihydrate |
Pre-filled syringe (Type I glass) with stainless steel 29-gauge needle with a needle shield.
Amvuttra is available in packs containing one single-use pre-filled syringe.
Alnylam Netherlands B.V., Antonio Vivaldistraat 150, 1083 HP Amsterdam, Netherlands
EU/1/22/1681/001
| Drug | Countries | |
|---|---|---|
| AMVUTTRA | Croatia, Japan, Lithuania, Romania, United Kingdom, United States |
© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.
