LEARN ABOUT OXLUMO™(lumasiran)

OXLUMO works by reducing oxalate production

Introducing the first and only FDA-approved prescription medication for infants, children and adults with primary hyperoxaluria type 1 (PH1).

How OXLUMO works

OXLUMO targets oxalate overproduction at the source.

  • In PH1, the liver produces too much oxalate
  • OXLUMO works in the liver to reduce the amount of oxalate being made
  • By reducing oxalate, OXLUMO targets the cause of PH1 symptoms
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Potential benefits of OXLUMO

OXLUMO was studied in the largest clinical trial of patients with PH1 ever done. OXLUMO was tested against placebo for 6 months in 39 adults and children (age 6 and up) diagnosed with PH1 who did not have severe kidney damage and were not on dialysis. During the study, 26 patients received OXLUMO, and 13 patients received a placebo (an injection that did not contain any medication).

 
Results of the trial:
 

53 REDUCTION

Patients on OXLUMO had 53% less oxalate in their urine from the start of treatment at month 6 compared to patients treated with placebo

84 OF PATIENTS

84% of patients on OXLUMO had normal (52%) or close-to-normal (32%) oxalate levels* in their urine at month 6 compared with no patients treated with placebo

A normal level of oxalate in the urine means that oxalate levels were no longer elevated. A close-to-normal level of oxalate in the urine means that oxalate levels were above the normal range, but were not more than 1.5 times above the normal range.


See below for safety results of this trial

OXLUMO™ (lumasiran) Patient Brochure Preview

How OXLUMO may be able to help

Talk with your doctor to find out if OXLUMO is the right choice for you.

OXLUMO™ (lumasiran) Patient Brochure PreviewFor more information, download the patient brochure for OXLUMO.

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OXLUMO was also studied in young children and infants

OXLUMO has also been tested in a trial of children younger than 6 years of age with PH1, including children as young as 4 months old who did not have severe kidney damage and were not on dialysis. These patients also had a reduction in the amount of oxalate in their urine at month 6.

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OXLUMO was effective in reducing levels of oxalate in urine in both children and adults.

Safety profile of OXLUMO

Clinical trials evaluated the safety of OXLUMO in 77 patients with PH1. Patients were 4 months to 61 years of age at first dose. Fifty-eight patients were treated for at least 6 months, and 18 patients for at least 12 months.

 

SIDE EFFECTS

In a 6-month clinical trial of 39 adults and children (age 6 and up), the side effects that occurred most frequently in patients treated with OXLUMO were:

Injection site reaction

Symptoms included redness, pain, itching, or swelling at the site of injection

Symptoms were generally mild, resolved within 1 day of injection, and did not result in stopping treatment

Abdominal pain

Symptoms included stomach pain or discomfort

Each patient will respond differently to treatment with OXLUMO. Talk to your doctor about any and all side effects that you experience.

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For more information about the potential side effects of OXLUMO, talk to your doctor.

You can also read the Prescribing Information.

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IMPORTANT SAFETY INFORMATION

The most common side effect of OXLUMO™ (lumasiran) is injection site reaction (redness, pain, itching, and swelling at the site of injection). These are not all the possible side effects of OXLUMO. Talk to your doctor about side effects that you experience. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1‑800‑FDA‑1088.

OXLUMO has not been studied in pregnant or breastfeeding women. Talk to your doctor about the risk of taking OXLUMO if you are pregnant, plan to become pregnant, are breastfeeding, or plan to breastfeed.

WHAT IS OXLUMO?

OXLUMO is a prescription medicine for the treatment of primary hyperoxaluria type 1 (PH1) to lower oxalate in urine in children and adults.  

For additional information about OXLUMO, please see full Prescribing Information.