What is Zurampic - Lesinurad and what is it used for?
Zurampic is a medicine used in adults with gout to reduce high levels of uric acid in the blood. It is used in combination with a xanthine oxidase inhibitor, another type of gout medicine, when the xanthine oxidase inhibitor alone cannot control uric acid levels sufficiently.
Gout is caused by the accumulation of uric acid crystals in and around the joints, especially in the toes, which causes pain and swelling.
Zurampic contains the active substance lesinurad.
How is Zurampic - Lesinurad used?
Zurampic is available in the form of 200 mg tablets. The recommended dose is 200 mg once a day, taken in the morning at the same time as the xanthine oxidase inhibitor medicine such as allopurinol or febuxostat.
Patients need to drink plenty of fluids throughout the day. If the treatment with the xanthine oxidase inhibitor is stopped, then the treatment with Zurampic should also be stopped in the same way.
The medicine can only be obtained with a prescription
How does Zurampic - Lesinurad work?
The active substance in Zurampic, lesinurad, helps remove uric acid from the body. Lesinurad works by blocking a protein called 'uric acid transporter 1' (URAT1) in the kidneys. URAT1 normally allows some of the uric acid to escape return to the blood after the kidneys have filtered it. By blocking URAT1, more uric acid is passed into the urine and less remains in the blood.
Zurampic is used in combination with a xanthine oxidase inhibitor such as allopurinol or febuxostat. Xanthine oxidase inhibitors reduce the production of uric acid in the body. Hence, adding Zurampic to treatment with a xanthine oxidase inhibitor further lowers uric acid levels. This prevents uric acid build-up in the joints where it can cause pain, swelling and joint damage.
What benefits of Zurampic - Lesinurad have been shown in studies?
Zurampic has been studied in two main studies involving more than 1,200 adults with gout who had previously been treated with allopurinol. Their blood uric acid level was not sufficiently controlled with allopurinol alone and was above 60 mg / liter at the start of the study. These studies compared the effect of adding Zurampic or placebo (a dummy treatment) in patients treated with allopurinol. The main measure of effectiveness was the number of patients whose blood uric acid level fell below 60 mg / liter after 6 months of treatment. Addition of Zurampic 200 mg once daily was effective in 55% of patients (222 out of 405), compared with 26% of patients (104 out of 407) who took placebo in addition to allopurinol.
A third major study involved 324 adults who had at least one measurable tophus (a large deposit of uric acid in or around a joint or under the skin) and with elevated blood uric acid levels (over 80 mg / liter). without medication for gout or above 60 mg / liter despite treatment with allopurinol or febuxostat). Patients were first treated with febuxostat alone for three weeks and then with febuxostat plus or Zurampic or placebo. The main measure of effectiveness was the number of patients whose blood uric acid level dropped below 50 mg / liter after 6 months of treatment. Overall, Zurampic 200 mg once daily was effective in 57% of patients (60 out of 106). This compared to 47% of patients (51 out of 109) who were given placebo. Looking only at patients whose blood uric acid level did not decrease sufficiently when treated with febuxostat alone, the level fell to less than 50 mg / liter in 44% of patients (26 out of 59) who took Zurampic compared to 24% of patients (12 out of 51) who took placebo.
What are the risks associated with Zurampic - Lesinurad?
The most common side effects with Zurampic (which may affect up to 1 in 10 people) are flu, headache, heartburn and (gastroesophageal reflux) backflow of stomach acids into the mouth, and blood tests showing increased creatinine levels in the blood (a marker of kidney function). The most serious adverse reactions were renal failure, reduced kidney function, and kidney stones, affecting less than 1 in 100 patients. For the full list of side effects reported with Zurampic, see the package leaflet.
Patients should not take Zurampic if they have tumor lysis syndrome (a complication due to the rapid breakdown of cancer cells during cancer treatment) or a rare inherited disease known as Lesch-Nyhan syndrome, both of which increase uric acid levels in the blood. Patients with very poor kidney function or who have had a kidney transplant should also not take Zurampic. For the full list of restrictions, see the package leaflet.
Why has Zurampic - Lesinurad been approved?
The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Zurampic's benefits are greater than its risks and recommended that it be approved for use in the EU. In combination with a xanthine oxidase inhibitor, Zurampic has reduced blood uric acid levels in gout patients whose elevated uric acid levels were not sufficiently controlled by a xanthine oxidase inhibitor. Over time, visible uric acid deposits disappeared in an increasing number of patients who continued treatment with Zurampic and febuxostat, and fewer patients have had recurrence of gout attacks Risks such as kidney damage or heart problems are included in the product information.
What measures are being taken to ensure the safe and effective use of Zurampic - Lesinurad?
Patients' kidney function will be monitored regularly during Zurampic treatment and the doctor will advise the patient to drink sufficient fluids during the day and to always take Zurampic with either allopurinol or febuxostat, to prevent damage to the kidneys caused by Zurampic.
A risk management plan has been developed to ensure that Zurampic is used as safely as possible. Based on this plan, safety information has been added to the summary of product characteristics and package leaflet for Zurampic, including the appropriate precautions to be followed by healthcare professionals and patients.
The company that markets Zurampic will carry out a study on the risk of heart, circulatory or kidney disorders in patients treated with Zurampic, particularly those who have previously suffered from these disorders. This is because these disorders have occurred during treatment with Zurampic.
Further information can be found in the summary of the risk management plan.
More information about Zurampic - Lesinurad
For more information about Zurampic therapy, read the package leaflet (included with the EPAR) or contact your doctor or pharmacist.
Information on Zurampic - Lesinurad published on this page may be out of date or incomplete. For a correct use of this information, see the Disclaimer and useful information page.
