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
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:
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 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.
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.
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.
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
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.