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OXLUMO (lumasiran)
Primary hyperoxaluria type 1 (PH1) to lower urinary oxalate levels in pediatric and adult patients.(199-201)
|
Body Weight |
Loading Dose |
Maintenance Dose (begin 1 month after the last loading dose) |
|
Less than 10 kg |
6 mg/kg once monthly for 3 doses |
3 mg/kg once monthly |
|
10 kg to less than 20 kg |
6 mg/kg once monthly for 3 doses |
6 mg/kg once every 3 months (quarterly) |
|
20 kg and above |
3 mg/kg once monthly for 3 doses |
3 mg/kg once every 3 months (quarterly |
Missed Dose: If a dose is delayed or missed, administer OXLUMO as soon as possible. Resume prescribed monthly or quarterly dosing, from the most recently administered dose. (199-201)
Injection: 94.5 mg/0.5 mL in a single-dose vial.
Subcutaneous (SC) injection.
The most common adverse reaction (reported in ≥20% of patients) is injection site reactions.
1b
199. Randomized Clinical Trial on the Long-Term Efficacy and Safety of Lumasiran in Patients With Primary Hyperoxaluria Type 1. Sally A Hulton, Jaap W Groothoff, Yaacov Frishberg, Michael J Koren et al., Kidney Int Rep . 2021 Dec 11;7(3):494-506. doi: 0.1016/j.ekir.2021.12.001. eCollection 2022 Mar.
200. Michael M, Groothoff JW, Shasha-Lavsky H, Lieske JC, Frishberg Y, Simkova E et al. Lumasiran for Advanced Primary Hyperoxaluria Type 1: Phase 3 ILLUMINATE-C Trial. Am J Kidney Dis. 2023 Feb;81(2):145-155.e1. doi: 10.1053/j.ajkd.2022.05.012. Epub 2022 Jul 14.
PMID: 35843439.
201. Garrelfs SF, Frishberg Y, Hulton SA, Koren MJ, O'Riordan WD, Cochat P, Deschênes G, et al. Lumasiran, an RNAi Therapeutic for Primary Hyperoxaluria Type 1. N Engl J Med. 2021 Apr 1;384(13):1216-1226. doi: 10.1056/NEJMoa2021712. PMID: 33789010.
