Source: European Medicines Agency (EU) Revision Year: 2020 Publisher: Alnylam Netherlands B.V., Antonio Vivaldistraat 150, 1083 HP Amsterdam, Netherlands
Oxlumo 94.5 mg/0.5 mL solution for injection.
| Pharmaceutical Form |
|---|
|
Solution for injection. Clear, colourless to yellow solution (pH of approximately 7; osmolality 210 to 390 mOsm/kg). |
Each mL of solution contains lumasiran sodium equivalent to 189 mg lumasiran.
Each vial contains 94.5 mg lumasiran in 0.5 mL.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Lumasiran |
Lumasiran is a double-stranded small interfering ribonucleic acid (siRNA) that reduces levels of glycolate oxidase (GO). Decreased GO enzyme levels reduce the amount of available glyoxylate, a substrate for oxalate production. This results in reduction of urinary and plasma oxalate levels, the underlying cause of disease manifestations in patients with primary hyperoxaluria type 1 (PH1). |
| List of Excipients |
|---|
|
Sodium hydroxide (pH adjustment) |
Glass vial with a fluoropolymer-coated rubber stopper and an aluminium overseal with a flip-off button. Each vial contains 0.5 mL solution for injection.
Pack size of one vial.
Alnylam Netherlands B.V., Antonio Vivaldistraat 150, 1083 HP Amsterdam, Netherlands
EU/1/20/1496/001
| Drug | Countries | |
|---|---|---|
| OXLUMO | Austria, Brazil, Estonia, Spain, France, Croatia, Ireland, Israel, Italy, Lithuania, Poland, Romania, United Kingdom |
© 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.
