2024 Oxlumo fachinformation

Oxlumo fachinformation

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August undefined, 2024

WebOXLUMO is a sterile, preservativefree, clear, colorless- -to-yellow solution. It is supplied in a single-dose vial, as a ready-to-use solution that does not require additional reconstitution … WebNov 24, 2024 · OXLUMO is an RNAi therapeutic targeting hydroxyacid oxidase 1 (HAO1) for the treatment of primary hyperoxaluria type 1 (PH1) to lower urinary oxalate levels in pediatric and adult patients. HAO1...

Nov 05, 2024 Press Release for Alnylam - Alnylam …

WebDec 9, 2024 · OXLUMO is a drug used to lower the level of urine oxalate in children and adults with primary hyperoxaluria type 1 (PH1). PH1 is a rare, inherited disorder in which … WebOXLUMO is intended for subcutaneous use and should be administered by a healthcare professional. Visually inspect the drug product solution. Do not use if it contains particulate matter or if it is cloudy or discolored. OXLUMO is a sterile, preservativefree, clear, colorless- -to-yellow solution. It is supplied in a dr thomas scalfarotto

Oxlumo European Medicines Agency

WebOXLUMO is a HAO1-directed small interfering ribonucleic acid (siRNA) indicated for the treatment of primary hyperoxaluria type1 (PH1) to lower urinary and plasma oxalate levels in pediatric and adult patients. (1)-----DOSAGE AND ADMINISTRATION----- •The recommended dose of OXLUMO by subcutaneous injection is based on ... WebLumasiran (Oxlumo™) is a subcutaneously administered small interfering RNA (siRNA) targeting the mRNA for hydroxyacid oxidase 1 gene (HAO1; encodes glycolate oxidase) and was developed by Alnylam Pharmaceuticals for the treatment of … WebMay 3, 2024 · For more information about OXLUMO, visit OXLUMO.com. About ILLUMINATE-A Phase 3 Study ILLUMINATE-A ( NCT03681184 ) is a six-month randomized, double-blind, placebo-controlled, global, multicenter Phase 3 study (with a 54-month extension period) to evaluate the efficacy and safety of lumasiran in 39 patients, age six and older, with a … dr. thomas scalea

Alnylam Pharmaceuticals Press Release Oct 06, 2024 Alnylam ...

WebAn overview of Oxlumo and why it is authorised in the EU What is Oxlumo and what is it used for? Oxlumo is a medicine used for treating primary hyperoxaluria type 1, an inherited disease in which a substance called oxalate builds up in the body, causing damage to the kidneys and other organs. Oxlumo contains the active substance lumasiran. WebOct 6, 2024 · OXLUMO ® (lumasiran) is indicated for the treatment of primary hyperoxaluria type 1 (PH1) to lower urinary and plasma oxalate levels in children and adults. Important Safety Information Adverse Reactions The most common (≥20%) adverse reaction reported in patients treated with OXLUMO was injection site reaction. columbia infant bunting snowsuitWebOct 11, 2024 · OXLUMO is intended for subcutaneous use and should be administered by a healthcare professional. Visually inspect the drug product solution. Do not use if it … dr thomas scalea baltimore

"WebPH1 causes the body to produce too much oxalate, which can lead to kidney stones and kidney damage. Oxalate is a waste product that is mostly removed by the kidneys. In PH1, too much oxalate is made in the body. As excess oxalate moves through the kidneys, it can form crystals that may cause kidney stones. " - Oxlumo fachinformation

Oxlumo fachinformation

Dosing & Administration OXLUMO® (lumasiran)

WebOXLUMO is a prescription medicine for the treatment of PH1 to lower oxalate in urine in children and adults. Tell Me About OXLUMO® Learn More About PH1. Natalie. Person … WebOct 14, 2024 · Oxlumo (lumasiran) is a HAO1-directed small interfering ribonucleic acid ( siRNA) used to treat primary hyperoxaluria type1 (PH1) to lower urinary oxalate levels in …

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WebNov 23, 2024 · Based on the stability data submitted to date, the expiry dating period for OXLUMO (lumasiran) Injection shall be 36 months from the date of manufacture when stored at 2°C–25°C (36°F–77° F) in the proposed commercial container closure system.

Webo Oxlumo is prescribed by, or in consultation with, a specialist (e.g., geneticist, nephrologist, urologist) with expertise in the treatment of PH1; and o Oxlumo dosing is in accordance with the United States Food and Drug Administration approved labeling; and Related Commercial Policy • Provider Administered Drugs – Site of Care WebNov 5, 2024 · OXLUMO is indicated for the treatment of primary hyperoxaluria type 1 (PH1) to lower urinary oxalate levels in pediatric and adult patients. Important Safety Information. Adverse Reactions. The most common adverse reaction that occurred in patients treated with OXLUMO was injection site reaction (38%).

WebNov 19, 2024 · OXLUMO should be administered by a healthcare professional. About Primary Hyperoxaluria Type 1 (PH1) PH1 is an ultra-rare disease in which excessive oxalate production results in the deposition of calcium oxalate crystals in the kidneys and urinary tract and can lead to the formation of painful and recurrent kidney stones and … WebOxlumo wird zur Behandlung der primären Hyperoxalurie Typ 1 (PH1) in allen Altersgruppen angewendet. 4.2 Dosierung und Art der Anwendung Die Therapie sollte unter der Aufsicht …

WebOXLUMO is a prescription medicine for the treatment of PH1 to lower oxalate in urine in children and adults. How OXLUMO works OXLUMO targets oxalate production at the …

WebNov 24, 2024 · Oxlumo, producted by Alnylam Pharmaceuticals, represents the first approved treatment for PH1. 3 Prior to this approval, therapy consisted of symptomatic treatment such as hyperhydration, inhibitors of crystallization, pyridoxine, and renal transplant. 6 Lumasiran was granted FDA approval on 23 November 2024. 3 Type Biotech … dr. thomas scammellWebIn-home nursing support. If your insurance coverage allows, you may be able to have a healthcare professional administer OXLUMO in your home. †. We’re here to help. Please reach out with questions. Call: 1-833-256-2748 Monday-Friday, 8 AM-6 PM ET. dr. thomas scandalisWebOxlumo wird als subkutane Injektion verabreicht. Die empfohlene Dosis Oxlumo besteht aus Initialdosen, die während 3 Monaten als monatliche Dosen gegeben werden, gefolgt von Erhaltungsdosen, beginnend einen Monat nach der letzten Initialdosis, gemäß Tabelle 1. Die jeweilige Dosis richtet sich nach dem Körpergewicht. columbia industries shredWebOct 13, 2024 · Overview Oxlumo is a medicine used for treating primary hyperoxaluria type 1, an inherited disease in which a substance called oxalate builds up in the body, causing … columbia infant outerwearWebOxlumo wird zur Behandlung der primären Hyperoxalurie Typ 1 (PH1) in allen Alters-gruppen angewendet. 4.2 Dosierung und Art der Anwendung Die Therapie sollte unter der Aufsicht … dr thomas scalea salaryWebDec 11, 2024 · OXLUMO ™ (lumasiran) is the first small interfering ribonucleic acid (RNAi) therapeutics indicated for the treatment of primary hyperoxaluria type 1 (PH1) to reduce urinary oxalate levels in paediatric and adult patients.. OXLUMO (lumasiran) is available as a sterile, clear, colourless-to-yellow solution in 94.5mg/0.5ml strength in a single-dose vial … columbia infant fleece buntingWebNov 24, 2024 · OXLUMO is administered via subcutaneous injection once monthly for three months, then once quarterly thereafter at a dose based on actual body weight. For … dr. thomas scalea of md shock trauma