Product image of Oxlumo (lumasiran) (Lumasiran) 94.5 mg/.5mL INJECTION, SOLUTION supplied by GNH India

Oxlumo (lumasiran)

Active Ingredient:
Lumasiran
Form:
INJECTION, SOLUTION
Brand:
Oxlumo
Origin:
USA

Oxlumo (lumasiran) (Lumasiran INJECTION, SOLUTION) 94.5 mg/.5mL

Oxlumo (lumasiran) is an FDA-approved orphan drug developed by Alnylam Pharmaceuticals for the treatment of Primary Hyperoxaluria Type 1 (PH1). It represents a novel therapeutic approach using RNA interference technology to address this rare genetic disorder. Oxlumo is administered via subcutaneous injection and belongs to the therapeutic category of genetic disorder treatments within nephrology.

Strength

94.5 mg/.5mL

Pack Size

1 VIAL, SINGLE-USE in 1 CARTON (71336-1002-1) / .5 mL in 1 VIAL, SINGLE-USE

Manufacturer / TM Owner

Alnylam Pharmaceuticals

1
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Indications & Clinical Uses

  • Oxlumo is indicated for the treatment of Primary Hyperoxaluria Type 1 (PH1), a rare autosomal recessive genetic disorder characterized by excessive oxalate production in the liver. PH1 results from deficiency of the enzyme alanine-glyoxylate aminotransferase (AGT), leading to accumulation of oxalate in the kidneys and urinary tract, causing nephrolithiasis, nephrocalcinosis, and progressive chronic kidney disease. Oxlumo works through RNA interference (RNAi) technology, specifically targeting and silencing glycolate oxidase (GLYOXL), an enzyme upstream in the oxalate synthesis pathway. By reducing oxalate production at its source, Oxlumo decreases urinary oxalate excretion, thereby reducing kidney stone formation and slowing progression of renal disease. The drug is suitable for pediatric and adult patients with PH1, including those with advanced kidney disease or those who have undergone kidney transplantation.

Side Effects

  • Common adverse events associated with Oxlumo include injection site reactions (erythema, pain, induration), which are typically mild to moderate. Serious adverse events are rare but may include glomerulonephritis and immune-mediated kidney injury. Laboratory abnormalities such as elevated liver enzymes and reduced platelet counts have been observed in clinical trials. Patients require regular monitoring of renal function, urinary oxalate levels, liver function tests, and platelet counts. Immunogenicity monitoring is recommended as some patients may develop anti-drug antibodies. Healthcare providers should assess for signs of systemic immune responses and adjust treatment accordingly.

Precautions & Warnings

  • Oxlumo is contraindicated in patients with known hypersensitivity to lumasiran or any excipient. Caution is advised in patients with severe hepatic impairment or thrombocytopenia. Pregnancy category data is limited; use only if potential benefits justify risks to the fetus. Pediatric patients require dose adjustments based on body weight; safety and efficacy have been established in children. Patients with advanced chronic kidney disease or end-stage renal disease require careful monitoring and may need dose modifications. Immunosuppressed patients should be evaluated before initiating therapy. Live vaccines should be avoided during treatment due to potential immunological effects.

Avoid Interactions

  • No major drug-drug interactions have been identified with Oxlumo. However, concurrent use with other hepatotoxic agents warrants caution and enhanced monitoring of liver function. Patients receiving immunosuppressive therapy may have altered immune responses to Oxlumo. NSAIDs and other nephrotoxic medications should be used cautiously in PH1 patients on Oxlumo due to additive renal effects. Dietary oxalate restriction remains an important adjunctive measure and should be maintained during Oxlumo therapy. Adequate hydration is recommended to support renal function.

Frequently Asked Questions

Oxlumo is used to treat Primary Hyperoxaluria Type 1 (PH1), a rare genetic disorder that causes excessive oxalate production in the liver. This leads to kidney stones, kidney damage, and progressive kidney disease. By reducing oxalate production, Oxlumo helps prevent kidney complications and slows disease progression.

Oxlumo is administered as a subcutaneous injection. The dosing schedule typically involves a loading phase followed by maintenance injections. Dose adjustments are based on patient body weight, particularly in pediatric patients. Patients can be trained to self-administer injections at home after proper instruction.

Common side effects include injection site reactions such as redness, pain, and swelling at the injection site. Most injection site reactions are mild to moderate and resolve without intervention. Serious adverse events are uncommon but may include immune-mediated kidney injury, requiring medical attention.

Oxlumo is manufactured by Alnylam Pharmaceuticals, a leading biopharmaceutical company specializing in RNA interference therapeutics.

Yes, Oxlumo has been designated and approved as an orphan drug by the FDA. This designation recognizes its use in treating Primary Hyperoxaluria Type 1, a rare disease affecting fewer than 200,000 people in the United States. Orphan drug status provides regulatory incentives and market exclusivity to encourage development of treatments for rare diseases.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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