Molecule
Lumasiran is a prescription medicine indicated for the treatment of primary hyperoxaluria type 1 (PH1) to lower urinary and plasma oxalate levels in pediatric and adult patients. It is available as injection for subcutaneous use. MedsAcross supplies Lumasiran for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
From the regulator-approved product information. Each section names its source.
OXLUMO is indicated for the treatment of primary hyperoxaluria type 1 (PH1) to lower urinary and plasma oxalate levels in pediatric and adult patients. OXLUMO is a HAO1 -directed small interfering ribonucleic acid (siRNA) indicated for the treatment of primary hyperoxaluria type 1 (PH1) to lower urinary and plasma oxalate levels in pediatric and adult patients.
Source: US FDA prescribing information
Lumasiran reduces levels of glycolate oxidase (GO) enzyme by targeting the hydroxyacid oxidase 1 ( HAO1 ) messenger ribonucleic acid (mRNA) in hepatocytes through RNA interference. Decreased GO enzyme levels reduce the amount of available glyoxylate, a substrate for oxalate production. As the GO enzyme is upstream of the deficient alanine: glyoxylate aminotransferase (AGT) enzyme that causes PH1, the mechanism of action of lumasiran is independent of the underlying AGXT gene mutation. OXLUMO is not expected to be effective in primary hyperoxaluria type 2 (PH2) or type 3 (PH3) because its mechanism of action does not affect the metabolic pathways causing hyperoxaluria in PH2 and PH3.
Source: US FDA prescribing information
The recommended dose of OXLUMO by subcutaneous injection is based on body weight. Body Weight Loading Dose Maintenance Dose less than 10 kg 6 mg/kg once monthly for 3 doses 3 mg/kg once monthly, beginning 1 month after the last loading dose 10 kg to less than 20 kg 6 mg/kg once monthly for 3 doses 6 mg/kg once every 3 months (quarterly), beginning 1 month after the last loading dose 20 kg and above 3 mg/kg once monthly for 3 doses 3 mg/kg once every 3 months (quarterly), beginning 1 month after the last loading dose See Full Prescribing Information for important preparation and administration instructions.
Source: US FDA prescribing information
None. None.
Source: US FDA prescribing information
The most common adverse reaction (reported in ≥20% of patients) is injection site reactions.
Source: US FDA prescribing information
Store at 2°C to 25°C [36°F to 77°F]. Store OXLUMO in its original container until ready for use.
Source: US FDA prescribing information
For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
1 presentations of Lumasiran, sorted by availability.
| Medicine | Manufacturer | Register | Availability |
|---|---|---|---|
| Oxlumo 94.5 mg/0.5 mL injectionSubcutaneous | Alnylam Pharmaceuticals | US FDA | Available on request |
1 brand names across 1 markets.
United States
Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.
Yes, on request. MedsAcross lists 1 presentations of Lumasiran and sources them for licensed hospitals, importers and physicians against valid import documents.
The catalogue lists 1 brand names for Lumasiran, including Oxlumo.
Yes. The US FDA first approved Lumasiran on 23 November 2020, according to Drugs@FDA.
Yes. Lumasiran has a central EU marketing authorisation (status: authorised), according to European Medicines Agency data.
No listed presentation of Lumasiran is recorded as needing a cold chain. Storage conditions are shown on each presentation page.
Lumasiran is classified under ATC code A16AX18 (Lumasiran).
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