LEARN ABOUT OXLUMO®(lumasiran)
GraceChild with PH1*

*Alnylam is proud to feature real patients in our advertising. Patients may or may not be on an Alnylam therapy.

OXLUMO works by reducing oxalate production

OXLUMO is the first approved treatment for infants, children, and adults with primary hyperoxaluria type 1 (PH1).

OXLUMO is a prescription medicine for the treatment of PH1 to lower oxalate in urine and blood in children and adults.

Image

Watch a video that illustrates how OXLUMO works

Image

CONNECT WITH AN ALNYLAM EDUCATOR

Learn about primary hyperoxaluria type 1 (PH1) and treatment with OXLUMO® from one of our trained Alnylam Patient Education Liaisons (PELs).

PELs are employees of Alnylam Pharmaceuticals. They are not acting as healthcare providers and are not part of your healthcare team.

Let’s Connect

How OXLUMO was tested in adults and children 6 years and older

OXLUMO was studied in the largest clinical trial of patients with PH1 ever done. It was a 6-month study with 39 adults and children 6 years and older who were diagnosed with PH1, did not have advanced kidney disease, and were not on hemodialysis. During the study, 26 patients received treatment with OXLUMO, and 13 patients received a placebo (an injection containing no medication).

After 6 months, those initially on placebo were switched to OXLUMO, while patients who were receiving OXLUMO continued receiving OXLUMO.

Because urine is the main way oxalate is removed by the kidneys, the trial looked at the amount of oxalate in urine.

 
Results of the trial:

OXLUMO lowered urinary oxalate levels
Image

After 6 months of treatment, patients on OXLUMO had 53% less oxalate in their urine than patients on placebo

  • Patients initially on placebo who switched to OXLUMO had similar reductions in urinary oxalate after 6 months of treatment
  • Patients initially on OXLUMO continued to have reduced urinary oxalate after 24 months of treatment
Most patients treated with OXLUMO had normal or close-to-normal urinary oxalate levels*
84%
of patients treated with OXLUMO had normal (52%) or close-to-normal (32%) oxalate levels* in their urine after 6 months of treatment vs 0% of patients on placebo

 

A normal level of oxalate in the urine means that oxalate levels were no longer elevated above the normal range. A close-to-normal level of oxalate in the urine means that oxalate levels were elevated but within 1.5 times the higher end of the normal range.

OXLUMO 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 Patient Brochure PreviewFor more information, download the patient brochure for OXLUMO.

Download

Image

How OXLUMO was tested in infants and children younger than 6 years

In another clinical trial, OXLUMO was studied in 18 patients (infants and children younger than 6 years old) diagnosed with PH1, who did not have advanced kidney disease, and were not on hemodialysis:

  • All patients in the study received treatment with OXLUMO for the initial 6 months, then continued receiving OXLUMO

Because urine is the main way oxalate is removed by the kidneys, the trial looked at the amount of oxalate in urine.

Patients treated with OXLUMO had 72% less urinary oxalate after 6 months of treatment compared to the start of the study and continued to have less urinary oxalate through month 12.

Measured by the ratio of oxalate in the urine to creatinine level.

OXLUMO was also tested in patients with advanced disease, including people on hemodialysis

In an additional clinical trial, OXLUMO was studied in 21 patients of all ages (including infants younger than 1 year old) diagnosed with PH1 who had advanced kidney disease. The patients were divided into 2 groups:

  • Group A was made up of 6 patients who were not on hemodialysis
  • Group B was made up of 15 patients who were on hemodialysis

All patients in the study received treatment with OXLUMO for the initial 6 months, then continued receiving OXLUMO

The trial looked at the amount of oxalate in blood, which is where it collects in patients who have advanced kidney disease.

Image
OXLUMO reduced blood oxalate levels in patients with advanced disease, including those on hemodialysis
Group A:
Patients treated with OXLUMO had 33% less blood oxalate after 6 months of treatment compared to the start of treatment
Group B:
Patients treated with OXLUMO had 42% less blood oxalate (measured before hemodialysis session) after 6 months compared to the start of treatment
Image


OXLUMO was effective in reducing levels of oxalate in urine in infants, children, and adults, as well as reducing oxalate in blood in patients with advanced kidney disease.

Safety profile of OXLUMO

Clinical trials evaluated the safety profile of OXLUMO in 98 patients with PH1. Patients were 4 months to 61 years old at first dose. Ninety-two patients were treated for at least 6 months, and 78 patients for at least 12 months, and 29 patients for at least 24 months.

The most common side effect in OXLUMO clinical trials was injection site reaction. Symptoms included redness, swelling, pain, bruising, itching, and discoloration at the site of the injection. Symptoms were generally mild, resolved within one day of injection, and did not result in stopping treatment.

 

The most common side effects in a 6-month clinical trial of 39 adults and children (age 6 and up) treated with OXLUMO were:

Injection site reaction

Abdominal pain
Symptoms included stomach pain or discomfort

In two separate studies, one of infants and children younger than 6 years and another of patients with advanced kidney disease including patients on hemodialysis who all received OXLUMO, OXLUMO had a similar safety profile to the study above.

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

Image

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

You can also read the Prescribing Information.

Image

We're here to help you access therapy

Find support services that can help you and your family during treatment with OXLUMO.

Let’s Go

Image

Sign up for updates

Learn more by signing up to receive important content.

Sign Me Up

IMPORTANT SAFETY INFORMATION

The most common side effect of OXLUMO® (lumasiran) is injection site reaction (redness, swelling, pain, bruising, itching, and discoloration 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 and blood in children and adults.  

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