Oxlumo

About Oxlumo

The active substance in Oxlumo is Lumasiran (100 mg/ml) indicated for primary hyperoxaluria which is a rare disease and Oxlumo was designated as an orphan medicine. It acts by reducing glycolate oxidase (GO) enzyme and through ribonucleic acid (RNA) interference, it targets HAO1 messenger ribonucleic acid (mRNA) in hepatocytes. High levels of oxalate can cause stones in the kidney as well as injury to certain organs. Thereby, this mechanism blocks the production of the enzyme, thereby reducing the amount of glyoxylate and oxalate, helping to relieve the symptoms of the disease.

Strength:

• Oxlumo injection is a 94.5 mg/0.5 mL clear, colorless-to-yellow solution in a single-dose vial.

Recommended Dosage:

Dosing is based on actual body weight. The recommended dosing regimen of OXLUMO consists of loading doses followed by maintenance doses (begin 1 month after the last loading dose) and it is administered subcutaneously.

• For less than 10 kg weight: loading dose is 6 mg/kg once monthly for 3 doses and maintenance dose is 3 mg/kg once monthly.
• For 10 to 20 kg weight: loading dose is 6 mg/kg once monthly for 3 doses and maintenance dose is 6 mg/kg once every 3 months (quarterly).
• For weight above 20 kg: loading dose is 3 mg/kg once monthly for 3 doses and maintenance dose is 3 mg/kg once every 3 months (quarterly).
• It should be administered following aseptic technique by a healthcare professional.
• It should be visually inspected for any particulate matter, or cloudy or discolored liquid.
• It does not require any additional reconstitution or dilution prior to administration.
• Injection volumes should be divided with 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 a 0.3 mL (30 unit) insulin syringe is used, a 1-unit marking indicates 0.01 mL.
• Subcutaneous injection is administered into the abdomen, thigh, side, or back of the upper arms, and injection sites should be rotated.
• It should not be injected into scar tissue or reddened, inflamed, swollen areas.
• Navel area should be avoided if injected into the abdomen.
• Injection sites should be at least 2 cm apart if more than one injection is needed for a single dose.
• An unused portion of the drug should be discarded.

Important: If a dose is delayed or missed, Oxlumo should be administered as soon as possible. Resume prescribed monthly or quarterly dosing, from the last administered dose.

Contraindications: None

Common Oxlumo Side Effects

• Injection site reactions
• Abdominal pain

Use in Specific Population

• Pregnancy: No available data with the use of Lumasiran in pregnant women. The estimated background risk of major birth defects and miscarriage in the indicated population is unknown.
• Pediatric use: The safety and effectiveness Lumasiran have been established in pediatric patients aged birth and older

Storage and Handling

• 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.
• Store at 2°C to 25°C [36°F to 77°F].
• Oxlumo should be stored in its original container until ready for use.