lumasiran (Rx)

Brand and Other Names:Oxlumo
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

injectable solution

  • 94.5mg/0.5mL; single-dose vial for SC injection

Hyperoxaluria

Indicated for primary hyperoxaluria type 1 (PH1) to lower urinary oxalate levels

Loading dose: 3 mg/kg SC once monthly x 3 doses  

Maintenance dose

  • Begin 1 month after last loading dose
  • 3 mg/kg SC every 3 months

Dosage Modifications

Renal impairment

  • eGFR ≥30 mL/min/1.73 m2: No dosage adjustment necessary
  • eGFR <30 mL/min/1.73 m2: Not studied

Hepatic impairment

  • Mild-to-moderate (total bilirubin ≤3x ULN with any AST): No dosage adjustment necessary
  • Severe (total bilirubin >3x ULN and any AST): Not studied

Dosage Forms & Strengths

injectable solution

  • 94.5mg/0.5mL; single-dose vial for SC injection

Hyperoxaluria

Indicated for primary hyperoxaluria type 1 (PH1) to lower urinary oxalate levels in pediatric and adult patients

Loading dose

  • <20 kg: 6 mg/kg SC once monthly x 3 doses  
  • ≥20 kg: 3 mg/kg SC once monthly x 3 doses

Maintenance dose

  • Begin 1 month after last loading dose
  • <10 kg: 3 mg/kg SC once monthly
  • 10 to <20 kg: 6 mg/kg SC once every 3 months
  • ≥20 kg: 3 mg/kg SC once every 3 months

Dosage Modifications

Renal impairment

  • eGFR ≥30 mL/min/1.73 m2: No dosage adjustment necessary
  • eGFR <30 mL/min/1.73 m2: Not studied

Hepatic impairment

  • Mild-to-moderate (total bilirubin ≤3x ULN with any AST): No dosage adjustment necessary
  • Severe (total bilirubin >3x ULN and any AST): Not studied
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Adverse Effects

>10%

Injection site reaction (38%)

Abdominal pain (15%)

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Warnings

Contraindications

None

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Pregnancy & Lactation

Pregnancy

No data available on use in pregnant females to evaluate a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes

Lactation

There are no data on drug presence in human milk, effects on breastfed children, or effects on milk production

Pregnancy Categories

A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA: Information not available.

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Pharmacology

Mechanism of Action

Lumasiran, a HAO1-directed double-stranded small interfering ribonucleic acid, reduces levels of glycolate oxidase (GO) enzyme by targeting the hydroxyacid oxidase 1 mRNA in hepatocytes through RNA interference

Decreased GO enzyme levels reduce the amount of available glyoxylate, a substrate for oxalate production

Absorption

Peak plasma concentration at steady-state: 462 ng/mL

AUC at steady-state: 6810 ng⋅hr/mL

Accumulation: None observed

Peak plasma time: 4 hr

Distribution

Vd: 4.9 L

Protein bound: 85%

Metabolism

Metabolized by endonucleases and exonucleases to oligonucleotides of shorter lengths

Elimination

Half-life: 5.2 hr

Estimated clearance: 26.5 L/hr

Excretion: Urine (<26%; unchanged with remaining excreted as inactive metabolite)

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Administration

SC Administration

SC administration only

Visually inspect solution; discard if it contains particulate matter or appears cloudy or discolored; solution should appear clear, colorless-to-yellow

Use aseptic technique

Injection volumes >1.5 mL: Divide equally into multiple syringes

Injection volumes <0.3 mL: Use sterile 0.3-mL syringe; if using a 0.3-mL (30-unit) insulin syringe, 1-unit markings indicate 0.01 mL

Administer into abdomen, thigh, or side or back of upper arms

Rotate injection sites; do not inject into scar tissue or areas that are reddened, inflamed, or swollen

If injecting into abdomen, avoid area around the navel

If >1 injection is needed for a single dose, injection sites should be at least 2-cm apart

Discard unused portion of drug

Missed dose

  • If dose delayed or missed, administer as soon as possible
  • Resume regular scheduled dose (eg, monthly, quarterly)

Storage

Preservative-free

Store at 2-25ºC (36-77ºF)

Store in original container until ready for use

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Formulary

FormularyPatient Discounts

Adding plans allows you to compare formulary status to other drugs in the same class.

To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.

Adding plans allows you to:

  • View the formulary and any restrictions for each plan.
  • Manage and view all your plans together – even plans in different states.
  • Compare formulary status to other drugs in the same class.
  • Access your plan list on any device – mobile or desktop.

The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

Tier Description
1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
NC NOT COVERED – Drugs that are not covered by the plan.
Code Definition
PA Prior Authorization
Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
QL Quantity Limits
Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
ST Step Therapy
Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
OR Other Restrictions
Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.