Delivery 7–10 daysOxlumo (lumasiran) injection, single-dose vial
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Description
💊 Prescription HAO1-directed small interfering RNA for primary hyperoxaluria type 1, to lower urinary and plasma oxalate in paediatric and adult patients with no lower age limit.
▪︎ Lumasiran 94.5 mg/0.5 mL, one single-dose vial; subcutaneous injection on a loading-then-maintenance schedule — three monthly loading doses, then maintenance dosing (3 mg/kg every three months from 20 kg)
▪︎ Manufacturer: Alnylam Pharmaceuticals
▪︎ FDA approval: November 2020
🔬 How it works: in type 1 disease a fault in the AGXT gene leaves the liver unable to convert glyoxylate into harmless glycine, so it is oxidised into oxalate instead — a metabolic dead end the body can neither break down nor reuse, leaving the kidneys as the only exit, where it precipitates with calcium. Lumasiran does not touch the broken enzyme. It silences the HAO1 messenger RNA in liver cells, lowering glycolate oxidase — the intact enzyme one step above that supplies glyoxylate. Less raw material reaches the fault, so the fault stops mattering, and the mechanism is independent of which AGXT mutation the patient carries. 📊 Evidence: in ILLUMINATE-A (NEJM 2021) in 39 patients aged 6 and over, 24-hour urinary oxalate fell by 65.4%, a difference from placebo of 53.5 percentage points (p<0.001), visible within a month; 84% reached excretion no higher than 1.5× the upper limit of normal versus 0% on placebo. Over 60 months (CJASN 2026) the reduction held at 54%, estimated GFR stayed stable and nephrocalcinosis grade improved in 21 of 28 patients.
⚠️ Prescription-only, prescribed by a nephrology centre. It is ineffective in primary hyperoxaluria types 2 and 3, whose pathways the mechanism does not touch, and in secondary hyperoxaluria. The drug reduces oxalate production but does not dissolve existing stones, and stopping treatment restores production. The label carries no boxed warning, no contraindications and no warnings section; injection-site reactions are the only common adverse reaction.
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