Primary Hyperoxaluria Treatments
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Brand Name
Oxlumo
Generic Name
Lumasiran
View Brand Information FDA approval date: November 23, 2020
Form: Injection
What is Oxlumo (Lumasiran)?
OXLUMO is indicated for the treatment of primary hyperoxaluria type 1 to lower urinary and plasma oxalate levels in pediatric and adult patients [see Clinical Pharmacology (1.
Approved To Treat
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Related Clinical Trials
Retrospective and Prospective Follow-up of Patients With Primary Hyperoxaluria Type 1 Treated With Lumasiran in France - DAILY-LUMA
Summary: Primary hyperoxaluria type 1 (PH1) is a rare genetic disease caused by mutation in the AGXT gene encoding the hepatic peroxisomal enzyme AGT. Reduced AGT activity results in increased glyoxylate and oxalate production, causing the formation of kidney stones, nephrocalcinosis and renal failure. Clinical trials of Lumasiran have provided information on the efficacy and safety of Lumasiran in the tre...
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Brand Information
OXLUMO (lumasiran)
1INDICATIONS AND USAGE
OXLUMO is indicated for the treatment of primary hyperoxaluria type 1 (PH1) to lower urinary and plasma oxalate levels in pediatric and adult patients
2DOSAGE FORMS AND STRENGTHS
Injection: 94.5 mg/0.5 mL clear, colorless-to-yellow solution in a single-dose vial.
3CONTRAINDICATIONS
None.
4DESCRIPTION
OXLUMO injection contains lumasiran, a
The structural formula of lumasiran sodium is presented below:

The molecular formula of lumasiran sodium is C
OXLUMO is supplied as a sterile, preservative-free, clear, colorless-to-yellow solution for subcutaneous administration containing the equivalent of 94.5 mg of lumasiran (provided as lumasiran sodium) in 0.5 mL of water for injection and sodium hydroxide and/or phosphoric acid to adjust the pH to ~ 7.0.
5PRINCIPAL DISPLAY PANEL - 0.5 mL Vial Carton
NDC 71336-1002-1
OXLUMO™
94.5 mg/0.5 mL
For Subcutaneous Injection
1 Single-dose vial
Rx Only

