Lumasiran

What Is Lumasiran?

• Lumasiran (OXLUMO) is a HAO1-directed small interfering ribonucleic acid (siRNA) indicated for the treatment of primary hyperoxaluria type 1 (PH1) to lower urinary oxalate levels in pediatric and adult patients.

What are the uses of this medicine?

• This medicine is is indicated for the treatment of primary hyperoxaluria type 1 (PH1) to lower urinary oxalate levels in pediatric and adult patients.

How does this medicine work?

• Lumasiran reduces levels of glycolate oxidase (GO) enzyme by targeting the hydroxyacid oxidase 1 (HAO1) messenger ribonucleic acid (mRNA) in hepatocytes through RNA interference.
• Decreased GO enzyme levels reduce the amount of available glyoxylate, a substrate for oxalate production.
• OXLUMO is not expected to be effective in primary hyperoxaluria type 2 (PH2) or type 3 (PH3) because its mechanism of action does not affect the metabolic pathways causing hyperoxaluria in PH2 and PH3.

Who Should Not Use this medicine ?

• OXLUMO is not expected to be effective in primary hyperoxaluria type 2 (PH2) or type 3 (PH3)

Is this medicine FDA approved?

• It was approved for use in the United States in 2020.

How should this medicine be used?

• The recommended dose of OXLUMO by subcutaneous injection is based on body weight.

For body weight less than 10 kg:

• Loading Dose is 6 mg/kg once monthly for 3 doses
• Maintenance Dose(begin 1 month after the last loading dose) is 3 mg/kg once monthly

For body weight 10 kg to less than 20 kg:

• Loading Dose is 6 mg/kg once monthly for 3 doses
• Maintenance Dose(begin 1 month after the last loading dose) is 6 mg/kg once every 3 months (quarterly)

For body weight 20 kg and above:

• Loading Dose is 3 mg/kg once monthly for 3 doses
• Maintenance Dose(begin 1 month after the last loading dose) is 3 mg/kg once every 3 months (quarterly)

Administration

• OXLUMO is intended for subcutaneous use and should be administered by a healthcare professional.
• 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 are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form: As an Injection: 94.5 mg/0.5 mL in a single-dose vial.

This medicine is available in fallowing brand namesː

• OXLUMO

What side effects can this medication cause?

Common possible side effects of this medicine include:

• Injection site reaction
• Abdominal pain

Can this medicine be used in pregnancy?

• 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.

Can this medicine be used in children?

• The safety and effectiveness of OXLUMO have been established in pediatric patients aged birth and older.

What should I know about storage and disposal of this medication?

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

• Dailymed label info on Lumasiran
• FDA Lumasiran

Lumasiran Resources
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