What is Oxlumo, and how does it work?

Oxlumo (lumasiran) is a HAO1-directed small interfering ribonucleic acid (siRNA) used to treat primary hyperoxaluria type 1 (PH1), which is a type of kidney disease, to lower urinary oxalate levels in pediatric and adult patients.

What are the side effects of Oxlumo?

Side effects of Oxlumo include:

What is the dosage for Oxlumo?

Recommended Dosage

The recommended dosing regimen of Oxlumo consists of loading doses followed by maintenance doses administered subcutaneously as shown in Table 1.

Dosing is based on actual body weight.

Table 1: Oxlumo Weight-Based Dosing Regimen

Body WeightLoading DoseMaintenance Dose (begin 1 month after the last loading dose)
Less than 10 kg6 mg/kg once monthly for 3 doses3 mg/kg once monthly
10 kg to less than 20 kg6 mg/kg once monthly for 3 doses6 mg/kg once every 3 months (quarterly)
20 kg and above3 mg/kg once monthly for 3 doses3 mg/kg once every 3 months (quarterly)

Missed Dose
  • If a dose is delayed or missed, administer Oxlumo as soon as possible. Resume prescribed monthly or quarterly dosing, from the most recently administered dose.

Administration Instructions

  • Oxlumo is intended for subcutaneous use and should be administered by a healthcare professional.
  • Visually inspect the drug product solution. Do not use if it contains particulate matter or if it is cloudy or discolored. Oxlumo is a sterile, preservative-free, clear, colorless-to-yellow solution. It is supplied in a single-dose vial, as a ready-to-use solution that does not require additional reconstitution or dilution prior to administration.
    • Use aseptic technique.
    • Divide injection volumes greater than 1.5 mL equally into multiple syringes.
    • For volumes less than 0.3 mL, a sterile 0.3-mL syringe is recommended. If using a 0.3 mL (30 unit) insulin syringe, 1-unit markings indicate 0.01 mL.
    • Administer subcutaneous injection into the abdomen, thigh, or the 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 of Oxlumo, the injection sites should be at least 2 cm apart.
    • Discard unused portion of the drug.

What drugs interact with Oxlumo?

  • No Information provided

Is Oxlumo safe to use while pregnant or breastfeeding?

  • There are no available data with the use of Oxlumo in pregnant women to evaluate a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes.
  • There are no data on the presence of Oxlumo in human milk, the effects on the breastfed child, or the effects of the drug on milk production.
  • The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for Oxlumo and any potential adverse effects on the breastfed child from Oxlumo or from the underlying maternal condition.

QUESTION

The only purpose of the kidneys is to filter blood. See Answer

Summary

Oxlumo (lumasiran) is a HAO1-directed small interfering ribonucleic acid (siRNA) used to treat primary hyperoxaluria type 1 (PH1) to lower urinary oxalate levels in pediatric and adult patients. Side effects of Oxlumo include injection site reactions (redness, pain, itching, and swelling) and abdominal pain.

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Medically Reviewed on 12/18/2020
References
All sections courtesy of the U.S. Food and Drug Administration