Lumasiran: Preparation and Administration

Lumasiran: Preparation and Administration

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The full Prescribing Information for OXLUMO® (lumasiran) is provided here. Alnylam Pharmaceuticals does not recommend the use of its products in any manner that is inconsistent with the approved Prescribing Information. This resource may contain information that is not in the approved Prescribing Information.

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 Summary

Index

Label Information – Abbreviations - References

 OXLUMO PresCribing Information – Relevant content

The DOSAGE AND ADMINISTRATION section provides the following information1:

Recommended Dosage

The recommended dosing regimen of OXLUMO consists of loading doses (monthly for 3 doses) followed by maintenance doses (beginning 1 month after the last loading dose) administered subcutaneously as shown in Table 1.

Dosing is based on actual body weight.

Table 1. OXLUMO Weight-Based Dosing Regimen

For Patients on Hemodialysis

Administer OXLUMO after hemodialysis if administered on dialysis days.

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.

The HOW SUPPLIED/STORAGE AND HANDLING section provides the following information1:

How Supplied

OXLUMO is a clear, colorless‑to‑yellow solution available in single‑dose vials of 94.5 mg/0.5 mL in cartons containing one vial (NDC 71336‑1002‑1).

Storage and Handling

Store at 2°C to 25°C [36°F to 77°F].

Store OXLUMO in its original container until ready for use.

 Abbreviations

C = Celsius; cm = centimeter; F = Fahrenheit; kg = kilogram; mg = milligram; mL = milliliter.

Updated 20 March 2026

 References

1.  OXLUMO (lumasiran) Prescribing Information. Cambridge, MA: Alnylam Pharmaceuticals.