Lumasiran
What Is Lumasiran?[edit | edit source]
- 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?[edit | edit source]
- 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?[edit | edit source]
- 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 ?[edit | edit source]
- OXLUMO is not expected to be effective in primary hyperoxaluria type 2 (PH2) or type 3 (PH3)
Is this medicine FDA approved?[edit | edit source]
- It was approved for use in the United States in 2020.
How should this medicine be used?[edit | edit source]
- 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?[edit | edit source]
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?[edit | edit source]
Common possible side effects of this medicine include:
- Injection site reaction
- Abdominal pain
What special precautions should I follow?[edit | edit source]
What to do in case of emergency/overdose?[edit | edit source]
Can this medicine be used in pregnancy?[edit | edit source]
- 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?[edit | edit source]
- 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?[edit | edit source]
- Store at 2°C to 25°C [36°F to 77°F].
- Store OXLUMO in its original container until ready for use.
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