Oxlumo (lumasiran sodium)
Oxalosis Agent - Oxalate Inhibitor Subcutaneous Vial (Ml)
Last reviewed · Source: First Databank (FDB) drug data
Overview
Lumasiran is a small interfering ribonucleic acid (siRNA) that targets hydroxyacid oxidase 1 (HAO1).
Lumasiran is a liver-directed RNA interfering (RNAi) agent that targets the hydroxyacid oxidase 1 (HAO1) mRNA, silencing the gene that encodes glycolate oxidase. As a result, it reduces oxalate synthesis by decreasing the amount of glycolate oxidase available for hepatic oxalate production. Lumasiran is not expected to be effective in patients with primary hyperoxaluria (PH)2 or PH3, since its mechanism of action does not affect the same metabolic pathways that lead to hyperoxaluria in PH2 and PH3.
Lumasiran exhibits approximately dose-proportional increases in plasma exposure following a single subcutaneous administration when doses range from 0.3 to 6 mg/kg, and it has time-dependent pharmacokinetics with multiple doses of 1 and 3 mg/kg once monthly or 3 mg/kg every 3 months. Lumasiran does not accumulate in plasma after repeated administration monthly or quarterly. The maximum concentration of lumasiran was higher in children weighing <20 kg due to high loading doses and a fast absorption rate.
When administered at the recommended dose,AUC of lumasiran was similar across different body weights ranging from 6.2-110 kg. The time to maximum concentration of lumasiran ranges from 0.5 to 12 hours with a median of 4 hours. Lumasiran is 85% protein bound.
The apparent elimination half-life is 5.2 hours. The primary metabolic pathway of lumasiran is conversion to oligonucleotides by endonucleases or exonucleases. Most of the administered dose of lumasiran is excreted as the inactive metabolite, with less than 26% excreted unchanged into the urine within 24 hours.
Generic name: lumasiran sodium
Drug class: Oxalosis Agent - Oxalate Inhibitor
Therapeutic class: Genitourinary Therapy
Reference product & biosimilars
No reference, biosimilar or interchangeable associated with this drug.
Today’s intelligence on Oxlumo
Indications
The following indications are listed for Oxlumo:
- Primary Hyperoxaluria Type I
Also known as: 2-Oxoglutarate Glyoxylate Carboligase Deficiency, Alanine-Glyoxylate Aminotransferase Deficiency, Glycolic Aciduria, Hepatic Agt Deficiency, Oxalosis Type I, Primary Hyperoxaluria Type 1.
Dosing
No dosing information is available for this tab.
Lumasiran is administered subcutaneously by a healthcare professional only. Lumasiran is commercially available as a ready-to-use solution in a single-dose vial that does not require reconstitution or dilution before administration.
When preparing lumasiran for administration, divide injection volumes equally into multiple syringes if they are greater than 1.5 mL. Use sterile 0.3-mL syringes for volumes less than 0.3 mL. If using a 0.3 mL insulin syringe for administration, 1-unit markings indicate 0.01 mL. Administer lumasiran injection with aseptic technique into the abdomen, thigh, or the side or back of the upper arms, and avoid administration into scar tissue, inflamed or swollen areas, or around the area of the navel. Rotate injection sites and separate each injection site by at least 2 cm if more than 1 injection is required for a single dose of lumasiran. Following administration, discard any unused portion of the drug.
If a dose of lumasiran is missed, administer the dose as soon as possible; resume monthly or quarterly dosing from the time of the most recently administered dose.
Store lumasiran solution in its original container at 2-25degreesC until ready for use.
| Drug label | Dosing type | Instructions |
|---|---|---|
| Oxlumo 94.5 Mg/0.5 Ml Vial | Maintenance | Inject 3 mg/kg by subcutaneous route every 3 months. |
No dosing information is available for this tab.
Drug interactions
No clinical studies evaluating the drug interaction potential of lumasiran have been conducted. Lumasiran is not a substrate, inhibitor, or inducer of cytochrome P-450 (CYP) enzymes, and does not modulate the activities of drug transporters.
There are no contraindication interactions for this drug.
There are no severe interactions for this drug.
There are no moderate interactions for this drug.
Contraindications
*None.
There are no contraindication contraindications for this drug.
There are no severe contraindications for this drug.
- No disease contraindications
Adverse reactions
The most common adverse reaction (reported in >=20% of patients in clinical trials) is injection site reactions.
There are no severe adverse reactions for this drug.
More Frequent
- Injection site sequelae
Less Frequent
- Acute abdominal pain
- Erythema
- Localized edema
- Pruritus of skin
Rare or Very Rare
- Hypersensitivity drug reaction
Precautions
No enhanced messaging available.
Safety and efficacy of lumasiran have been established in pediatric patients from birth based on one randomized, placebo-controlled trial in patients 6 years of age and older with PH1 (ILLUMINATE-A), one single-arm trial in patients younger than 6 years of age with PH1 (ILLUMINATE-B), and one single-arm trial in pediatric and adult patients with PH1 and advanced chronic kidney disease, including patients on hemodialysis.
No data are available to assess the risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes with the use of lumasiran in pregnancy. In animal studies, no adverse effects on pregnancy or embryofetal development were found when lumasiran was administered to pregnant rats or rabbits at 45 or 90 times the maximum recommended human dose in women.
It is not known whether lumasiran or its metabolites are distributed into human milk. The effects of the drug on breast-fed infants or on the production of milk are also unknown. Consider the developmental and health benefits of breastfeeding with the mother's need for lumasiran and any potential adverse reactions on the breast-fed child from lumasiran or the underlying maternal condition.
The manufacturer makes no specific dosage recommendations for geriatric patients.
It is not known whether geriatric patients respond differently to lumasiran from younger patients due to insufficient numbers of patients65 years of age or older in the clinical studies.
ICD codes
| Code | Type | Description |
|---|---|---|
| Primary hyperoxaluria type I | ||
| E72.53 | ICD10CM | Primary hyperoxaluria |
| E72.530 | ICD10CM | Primary hyperoxaluria, type 1 |
| E72.538 | ICD10CM | Other specified primary hyperoxaluria |
| E72.539 | ICD10CM | Primary hyperoxaluria, unspecified |
ICD code information from First Databank (FDB).
Formulary status
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Last reviewed · Source: First Databank (FDB) drug data
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