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OXLUMO works by reducing oxalate production
OXLUMO is the first FDA-approved prescription medication 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 in children and adults.
How OXLUMO works
OXLUMO targets oxalate production at the source.
In PH1, the liver produces too much oxalate.
- OXLUMO works in the liver to reduce the amount of oxalate produced by the liver
- Too much oxalate is the cause of PH1 symptoms
- OXLUMO reduces production of a substance that the body converts into oxalate. This decreases oxalate production
Watch a video that illustrates how OXLUMO works
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.
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 did not have severe kidney damage and were not on dialysis. During the study, 26 patients were given OXLUMO, and 13 patients received a placebo (an injection that did not contain any medication).
After 6 months, those initially on placebo were switched to OXLUMO, while patients who were receiving OXLUMO continued receiving OXLUMO for up to 54 months.
Results of the trial:
After 6 months of treatment, patients on OXLUMO had on average 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 12 months of treatment
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
- Most patients on placebo who switched to OXLUMO had normal or near-normal oxalate levels in their urine after 6 months of treatment
- After 12 months of treatment with OXLUMO, most patients continued to have normal or close-to-normal* levels of oxalate in their urine
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 elevated but within 1.5 times the higher end of the normal range.
How OXLUMO may be able to help
Talk with your doctor to find out if OXLUMO is the right choice for you.
For more information, download the patient brochure for OXLUMO.
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 severe kidney damage, and were not on dialysis:
- All patients in the study received treatment with OXLUMO for the initial 6 months, then continued receiving OXLUMO for up to 54 months
After 6 months, patients treated with OXLUMO had on average 72% less oxalate in their urine† compared to the start of the study.
Measured by the ratio of oxalate in the urine to creatinine level.
OXLUMO was effective in reducing levels of oxalate in urine in infants, children, and adults.
Safety profile of OXLUMO
Clinical trials evaluated the safety of OXLUMO in 77 people with primary hyperoxaluria type 1 (PH1). Patients were 4 months to 61 years old at first dose. Of those patients, 58 were treated for at least 6 months, and 18 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
In a separate study of infants and children younger than 6 years 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 that you experience.
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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