Primary hyperoxaluria type 1: SUBQ:
Loading dose: 3 mg/kg/dose once monthly for 3 doses.
Maintenance dose: 3 mg/kg/dose every 3 months, begin 1 month after last loading dose.
Missed dose: If scheduled dose is delayed or missed, administer as soon as possible then resume monthly or quarterly dosing from the most recently administered dose.
Altered kidney function: No dosage adjustment necessary for any degree of kidney function.
Hemodialysis, intermittent (thrice weekly): No dosage adjustment necessary; administer after hemodialysis if administered on dialysis days.
Peritoneal dialysis: There are no dosage adjustments provided in the manufacturer's labeling (has not been studied).
Mild to moderate impairment (total bilirubin ≤ ULN and AST > ULN; or total bilirubin ≤ 3× ULN): No dosage adjustment necessary.
Severe impairment (total bilirubin >3 times the ULN and any AST): There are no dosage adjustments provided in the manufacturer's labeling (has not been studied).
Refer to adult dosing.
(For additional information see "Lumasiran: Pediatric drug information")
Primary hyperoxaluria type 1:
Infants, Children, and Adolescents:
Weight <10 kg:
Loading dose: SUBQ: 6 mg/kg/dose once monthly for 3 doses.
Maintenance dose: SUBQ: 3 mg/kg/dose once monthly; begin 1 month after last loading dose.
Weight 10 to <20 kg:
Loading dose: SUBQ: 6 mg/kg/dose once monthly for 3 doses.
Maintenance dose: SUBQ: 6 mg/kg/dose every 3 months; begin 1 month after last loading dose.
Weight ≥20 kg:
Loading dose: SUBQ: 3 mg/kg/dose once monthly for 3 doses.
Maintenance dose: SUBQ: 3 mg/kg/dose every 3 months; begin 1 month after last loading dose.
Altered kidney function: Infants, Children, and Adolescents: SUBQ: No dosage adjustment necessary for any degree of kidney impairment.
Hemodialysis: Infants, Children, and Adolescents: SUBQ: No dosage adjustment necessary; administer after hemodialysis if administered on dialysis days.
Peritoneal dialysis: Infants, Children, and Adolescents: SUBQ: There are no dosage adjustments provided in the manufacturer's labeling (has not been studied).
Infants, Children, and Adolescents: SUBQ:
Mild impairment (total bilirubin >1 to 1.5 times ULN or AST >ULN): No dosage adjustment necessary.
Moderate impairment (total bilirubin >1.5 to 3 times ULN with any AST): No dosage adjustment necessary.
Severe impairment (total bilirubin >3 times ULN and any AST): There are no dosage adjustments provided in the manufacturer's labeling (has not been studied).
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.
>10%:
Dermatologic: Injection site pruritus
Gastrointestinal: Abdominal pain
Local: Injection site reaction (including erythema at injection site, pain at the injection site, swelling at injection site)
Frequency not defined: Immunologic: Antibody development
There are no contraindications listed in the manufacturer's US labeling.
Canadian labeling: Hypersensitivity to lumasiran or any component of the formulation.
Concerns related to adverse effects:
• Anti-lumasiran antibodies: Anti-drug antibodies were identified in 6% of patients during clinical trials, although no clinically significant differences in the safety, pharmacokinetic, or pharmacodynamic profiles were observed in patients who tested positive for anti-lumasiran antibodies.
• Injection site reactions: Injection site reactions, including erythema, pain, pruritus, and swelling, may occur; generally resolves within 1 day.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Solution, Subcutaneous, as sodium [preservative free]:
Oxlumo: 94.5 mg/0.5 mL (0.5 mL)
No
Solution (Oxlumo Subcutaneous)
94.5 mg/0.5 mL (per 0.5 mL): $70,018.80
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Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Solution, Subcutaneous, as sodium:
Oxlumo: 94.5 mg/0.5 mL (0.5 mL)
SUBQ: For SUBQ administration by a health care professional only. Inject into the abdomen (avoid area around the navel), thigh, or side or back of upper arms; rotate injection sites. Avoid injecting into scar tissue or areas that are reddened, inflamed, or swollen. Divide injection volumes >1.5 mL equally into multiple syringes; inject at least 2 cm apart. Discard unused portion.
Parenteral: SUBQ: For SUBQ use only; should be administered by health care professional. Do not use if solution is discolored, cloudy, or contains particulate matter. Administer SUBQ into the abdomen (avoid area around the navel), thigh, or side or back of the upper arms; rotate injection site. Do not inject into scar tissue or areas that are red, inflamed, or swollen. Dose volumes >1.5 mL should be equally divided into multiple syringes; each syringe should be administered at a separate site at least 2 cm apart. For dose volumes <0.3 mL, use a 0.3 mL syringe; if using a 0.3 mL (30 unit) insulin syringe, each unit is 0.01 mL.
Missed dose : If scheduled dose is delayed or missed, administer as soon as possible, then resume monthly or quarterly dosing from the most recently administered dose.
Primary hyperoxaluria type 1: Treatment of primary hyperoxaluria type 1 (PH1) to lower urinary and plasma oxalate levels in pediatric and adult patients.
Lumasiran may be confused with Lumigan.
None known.
There are no known significant interactions.
Adverse events were not observed in animal reproduction studies.
It is not known if lumasiran is present in breast milk.
According to the manufacturer, the decision to breastfeed during therapy should consider the risk of infant exposure, the benefits of breastfeeding to the infant, and the benefits of treatment to the mother.
Urinary oxalate concentrations.
Reduces the amount of available glyoxylate, a substrate for oxalate production, by targeting hydroxyacid oxidase 1 (HAO1) messenger RNA in hepatocytes through RNA interference, subsequently decreasing glycolate oxidase enzyme levels.
Onset: ≤2 weeks.
Distribution: Vd: 4.9 L.
Protein binding: 85%.
Metabolism: Primarily by endo- and exonucleases to oligonucleotides of shorter lengths.
Half-life elimination: 5.2 hours.
Time to peak: 4 hours (range: 0.5 to 12 hours).
Excretion: Urine (<26% as unchanged drug).
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