Lumasiran Sodium

Drug class: Antineoplastic Agents

Usage of Lumasiran Sodium

Primary Hyperoxaluria Type 1

Used for treatment of primary hyperoxaluria type 1 (PH1) in adult and pediatric patients to lower urinary and plasma oxalate levels.

Has been designated an orphan drug by FDA for treatment of PH1.

European guidelines on the management of primary hyperoxaluria generally recommend lumasiran and other RNA interfering agents as second-line treatment of PH1 in select patients following conservative management with hyperhydration, potassium citrate, and pyridoxine supplementation.

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How to use Lumasiran Sodium

Administration

Sub-Q Administration

Administer by sub-Q injection by a healthcare professional. Commercially available as a ready-to-use solution in a single-dose vial that does not require reconstitution or dilution before administration.

When preparing for administration, divide injection volumes equally into multiple syringes if >1.5 mL. Use sterile 0.3-mL syringes for volumes <0.3 mL. If using a 0.3 mL insulin syringe for administration, 1-unit markings indicate 0.01 mL.

Administer sub-Q into the abdomen, thigh, or the side or back of the upper arms; 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. Following administration, discard any unused portion of the drug.

If a dose is missed, administer as soon as possible; resume monthly or quarterly dosing from the time of the most recently administered dose.

Dosage

Available as lumasiran sodium; dosage expressed in terms of lumasiran.

Pediatric Patients

Primary Hyperoxaluria Type 1 Sub-Q

Administer as 3 monthly loading doses followed by maintenance doses starting 1 month after the last loading dose. Dosing regimen is based on actual body weight (see Table 1).

Table 1. Recommended Lumasiran Dosing Regimen Based on Actual Body Weight1

Body Weight (kg)

Loading Dose

Maintenance Dose

<10

6 mg/kg once monthly for 3 doses

3 mg/kg once monthly, begninning 1 month after the last loading dose

10 to <20

6 mg/kg once monthly for 3 doses

6 mg/kg once every 3 months, beginning 1 month after the last loading dose

≥20

3 mg/kg once monthly for 3 doses

3 mg/kg once every 3 months, beginning 1 month after the last loading dose

Adults

Primary Hyperoxaluria Type 1 Sub-Q

Administer as 3 monthly loading doses followed by maintenance doses starting 1 month after the last loading dose.

Dosing regimen is based on actual body weight (See Table 1).

Special Populations

Hepatic Impairment

No dosage adjustment recommended in patients with mild (total bilirubin >ULN to 1.5 times the ULN or AST above the ULN) or moderate (total bilirubin >1.5–3 times the ULN with any AST) hepatic impairment.

Not studied in patients with severe (total bilirubin >3 times the ULN with any AST) hepatic impairment.

Renal Impairment

Dosage adjustment not necessary in patients with renal impairment, including patients treated with hemodialysis.

In patients receiving hemodialysis, administer after dialysis if given on dialysis days. Not studied in patients on peritoneal dialysis.

Geriatric Patients

No specific dosage recommendations.

Warnings

Contraindications

  • None.

    • Warnings/Precautions

    Immunogenicity

    Anti-drug antibodies (ADA) detected; no clinically significant differences in safety, pharmacokinetics, or pharmacodynamics of lumasiran in patients who tested positive for ADA.

    Specific Populations

    Pregnancy

    No data available to assess risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes with use of lumasiran in pregnancy.

    Lactation

    Not known whether drug or its metabolites are distributed into human milk; effects on breast-fed infants or on production of milk also unknown. Consider developmental and health benefits of breastfeeding with the mother's need for lumasiran and any potential adverse reactions on the breast-fed child from the drug or underlying maternal condition.

    Pediatric Use

    Safety and efficacy established in pediatric patients from birth.

    Geriatric Use

    Not known whether geriatric patients respond differently than younger patients due to insufficient numbers of patients ≥65 years of age in clinical trials.

    Hepatic Impairment

    No clinically significant differences in lumasiran pharmacokinetics/pharmacodynamics in patients with mild or moderate hepatic impairment; effect of severe hepatic impairment unknown.

    Renal Impairment

    No clinically significant differences in lumasiran pharmacokinetics/pharmacodynamics in patients with renal impairment or on hemodialysis; safety and efficacy not established in patients receiving peritoneal dialysis.

    Common Adverse Effects

    Most common adverse reaction (≥20%) is injection site reactions.

    What other drugs will affect Lumasiran Sodium

    No drug interaction studies conducted. Lumasiran is not a substrate, inhibitor, or inducer of CYP enzymes and does not modulate the activities of drug transporters.

    Specific Drugs

    Drug

    Interaction

    Pyridoxine

    Concomitant use did not affect pharmacokinetics or pharmacodynamics of lumasiran

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