lumasiran

Therapeutic Classification: none assigned

Pharmacologic Classification: Hydroxyacid oxidase 1 (HAO1) directed small interfering RNA (siRNA)

Indications ⬆ ⬇

REMS

Primary hyperoxaluria type 1.

Action ⬆ ⬇

Reduces levels of glycolate oxidase enzyme by targeting the hydroxyacid oxidase 1 messenger ribonucleic acid in hepatocytes through RNA interference, which leads to a reduction in production of oxalate.

Therapeutic effects:

Reduction in urinary and plasma oxalate levels.

Pharmacokinetics ⬆ ⬇

Absorption: Rapidly absorbed following SUBQ administration.

Distribution: Minimally distributed to extravascular tissues.

Metabolism/Excretion: Metabolized by endonucleases and exonucleases to oligonucleotides of shorter length. Primarily excreted in urine as inactive metabolites (74%), with <26% excreted unchanged in urine.

Half-Life: 5.2 hr.

Time/Action Profile ⬆ ⬇

(↓ in oxalate levels)

ROUTE	ONSET	PEAK	DURATION
SUBQ	days	2–3 mo	unknown

Contraind./Precautions ⬆ ⬇

Contraindicated in:

None.

Use Cautiously in:

Severe hepatic impairment;
OB: Safety not established in pregnancy;
Lactation: Safety not established in breastfeeding.

Adv. Reactions/Side Effects ⬆ ⬇

GI: abdominal pain

Local: injection site reaction

Interactions ⬆ ⬇

Drug-drug:

None reported.

Route/Dosage ⬆ ⬇

SC (Adults and Children ≥20 kg): 3 mg/kg once monthly for 3 doses (loading dose), followed by 3 mg/kg every 3 mo (maintenance dose).
SC (Adults and Children 10–<20 kg): 6 mg/kg once monthly for 3 doses (loading dose), followed by 6 mg/kg every 3 mo (maintenance dose).
SC (Adults and Children <10 kg): 6 mg/kg once monthly for 3 doses (loading dose), followed by 3 mg/kg once monthly (maintenance dose).

Availability ⬆ ⬇

Solution for injection: 94.5 mg/0.5 mL

Assessment ⬆ ⬇

Monitor for signs and symptoms of injection site reactions (pain, pruritus, swelling, erythema, bruising, burning, hematoma, warmth, rash). Provide symptomatic care as indicated.
Monitor for signs and symptoms of allergic reactions (rash, urticaria, pruritus, flushing, dizziness, vomiting, abdominal pain) and angioedema (swelling of throat, lips, tongue, and face; dyspnea; wheezing; hoarseness). Discontinue lumasiran immediately and provide supportive care.

Lab Test Considerations:

Monitor urine oxalate and predialysis plasma oxalate levels regularly during therapy.

Implementation ⬆ ⬇

SC: Divide injection volumes >1.5 mL equally into multiple syringes; for volumes <0.3 mL, use a sterile 0.3-mL syringe. Administer into the abdomen, thigh, or side or back of the upper arms. Rotate injection sites. Do not inject into scar tissue or areas that are reddened, inflamed, or swollen. If injecting into the abdomen, avoid the area around the navel. If more than one injection is needed for a single dose, the injection sites should be ≥2 cm apart. Discard the unused portion of the drug.
- Administer missed dose as soon as possible. Resume monthly or quarterly dosing from the most recently administered dose.

Patient/Family Teaching ⬆ ⬇

Explain purpose and side effects of lumasiran to patient. Do not stop receiving drug without consulting health care professional. If an appointment is missed, contact health care professional as soon as possible to reschedule. Advise patient to read Medication Guide before starting and periodically during therapy in case of changes.
Explain need for continued medical follow-up to assess effectiveness and possible side effects of medication. Periodic lab tests will be needed.
Inform patient that side effects may include injection site reactions and abdominal pain.
Advise patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and to consult health care professional before taking other medications.
Rep: Advise patient to notify health care professional if pregnancy is planned or suspected or if breastfeeding.

Evaluation/Desired Outcomes ⬆ ⬇

Reduction in urinary and plasma oxalate levels.

US Brand Names ⬆ ⬇

Code ⬆

NDC Code

70596- Agilent Technologies Inc.
- 70596-1003-
  - 70596-1003-1- 50 g in 1 BOTTLE (70596-1003-1)

71336- Alnylam Pharmaceuticals, Inc.
- 71336-1002- OXLUMO
  - 71336-1002-1- 1 VIAL, SINGLE-USE in 1 CARTON (71336-1002-1) / .5 mL in 1 VIAL, SINGLE-USE

82613- BioSpring GmbH
- 82613-001-
  - 82613-001-01- 1 BOTTLE in 1 BAG (82613-001-01) / 150 g in 1 BOTTLE

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Pronunciation ⬇

Classifications ⬆ ⬇