Buy Oxlumo (lumasiran)

What is Oxlumo (lumasiran) for?

Oxlumo (lumasiran) is a HAO1-directed RNA interference medicine indicated for primary hyperoxaluria type 1 (PH1) to lower urinary oxalate levels in adults and children.^[1]

It is available in injection form containing 94.5 mg/0.5 mL lumasiran per vial.^[1]

How does Oxlumo (lumasiran) work?

PH1 is an ultra-rare, life-threatening disease in which a genetic defect in the liver causes an excess of oxalate (hyperoxaluria). Oxalate is an end product of metabolism that, when there is too much, accumulates in the kidneys. This can cause kidney function to deteriorate and ultimately to kidney failure.^[2]

Lumasiran targets the hydroxyacid oxidase 1 (HAO1) gene, which encodes the glycolate oxidase (GO) enzyme. GO is responsible for the production of oxalate.^[2]

Lumasiran is a small interfering ribonucleic acid (siRNA). It is designed to silence the HAO1 gene, which means that the GO enzyme will not be produced. As a result oxalate levels can return back to normal.^[2,3]

Where has Oxlumo (lumasiran) been approved?

Oxlumo (lumasiran) was approved for the treatment of PH1 in all age groups by:

• The European Medicines Agency (EMA), on November 19, 2020.^[4]
• The Food and Drug Administration (FDA), on November 24, 2020.^[5]

It is the first approved prescription medication for the treatment of PH1 to lower oxalate in urine.^[5]

Oxlumo (lumasiran) received Breakthrough Therapy Designation from FDA, Priority Medicines (PRIME) Designation from EMA, and Orphan Drug Designations from both FDA and EMA.^[4]

Please note that this medicine may have also been approved in other regions than the ones we’ve listed. If you have a question about its approval in a specific country feel free to contact our support team.

How is Oxlumo (lumasiran) taken?

The standard dosage:^[1]

• Administered as an under-the-skin (subcutaneous) injection given once a month for 3 months
• Then monthly for patients weighing less than 10 kg, and quarterly for patients weighing more than 10 kg.

Dosing is based on body weight, and the dose (in mg) and injected volume (in mL) is calculated as follows:^{[1 ]}

• Patient body weight (kg) × dose (mg/kg) = total amount (mg) of lumasiran to be administered.
• Total amount (mg) / concentration (189 mg/mL) = total volume of lumasiran solution (mL) to be injected.

Complete information about Oxlumo (lumasiran) dosage (based on body weight) and administration can be found in the official prescribing information listed in our references section.^[1]

Note: Please consult with your treating doctor for personalised dosing.

Are there any known adverse reactions or side effects of Oxlumo (lumasiran)?

Common adverse reactions

The most common side effects (≥10% of patients) listed in the prescribing information include:^[1]

• • Injection site reactions
  • Stomach pain or discomfort (abdominal pain)

Use in a specific population

Oxlumo (lumasiran) can cause fetal harm when administered to a pregnant woman, it is advised to avoid pregnancies and breastfeeding.^[1]

For a comprehensive list of side effects and adverse reactions please refer to the official prescribing information.^[1]

References

1. Full prescribing information [EMA]: Oxlumo (lumasiran) [PDF] Alnylam, Nov 19, 2020

2. Lumasiran – An Investigational RNAi Therapeutic for Primary Hyperoxaluria Type 1 (PH1)
Alnylam, cited on Dec 2, 2020

3. siRNA
Alnylam, cited on Dec 2, 2020

4. Alnylam Receives Approval for OXLUMO™ (lumasiran) in the European Union for the Treatment of Primary Hyperoxaluria Type 1 in All Age Groups
Alnylam, Nov 19, 2020

5. Alnylam Announces U.S. Food and Drug Administration (FDA) Approval of OXLUMO™ (lumasiran), the First and Only Treatment Approved for Primary Hyperoxaluria Type 1 to Lower Urinary Oxalate Levels in Pediatric and Adult Patients
FDA press release, Nov 24, 2020