Zurampic - Lesinurad

What is Zurampic - Lesinurad used for 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 medicine for gout, when the xanthine oxidase inhibitor alone cannot sufficiently control uric acid levels.

Gout is due to the accumulation of uric acid crystals in and around the joints, especially in the toes, which causes pain and swelling.

Zurampic contains the active ingredient lesinurad.

How is Zurampic used - Lesinurad?

Zurampic is available as 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 must drink plenty of fluids during the day. If treatment with the xanthine oxidase inhibitor is stopped, then Zurampic treatment must also be stopped in the same way.

The medicine can only be obtained with a prescription

How does Zurampic - Lesinurad work?

The active ingredient 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 part of the uric acid to 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. Thus, adding Zurampic to treatment with a xanthine oxidase inhibitor further lowers uric acid levels. This prevents the accumulation of uric acid in the joints where it can cause pain, swelling and joint damage

What benefits of Zurampic - Lesinurad have been shown in studies?

Zurampic was analyzed 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) on 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. The addition of Zurampic 200 mg once a day was effective in 55% of patients (222 out of 405). This compared to 26% of patients (104 of 407) who took placebo in addition to allopurinol.

A third important study involved 324 adults who had at least one measurable tofo (a large deposit of uric acid in or around a joint or under the skin) and with high levels of uric acid in the blood (over 80 mg / liter without medication for gout or greater than 60 mg / liter despite treatment with allopurinol or febuxostat). Patients were first treated with febuxostat only for three weeks and then with more febuxostat 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 of 109) who were given the placebo. Looking only at patients whose blood uric acid level did not fall sufficiently when treated with febuxostat alone, the level dropped to less than 50 mg / liter in 44% of patients (26 out of 59) who took Zurampic compared to 24% of patients (12 of 51) who took the placebo.

What are the risks associated with Zurampic - Lesinurad?

The most common side effects of Zurampic (which may affect up to 1 in 10 people) are flu, headache, heartburn and (gastro-oesophageal reflux) return to the mouth of stomach acids, and blood tests that show higher levels of creatinine in the blood (a marker of renal function). The most serious adverse reactions were renal failure, reduced renal function, and kidney stones, which affected 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 are suffering from tumor lysis syndrome (a complication due to the rapid rupture of cancer cells during cancer treatment) or a rare inherited disorder known as Lesch-Nyhan syndrome, both of which increase blood uric acid levels. Even patients with very poor kidney function or who have had a kidney transplant should not take Zurampic. For the full list of limitations, 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 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 deposits of uric acid disappeared in a growing number of patients who continued treatment with Zurampic and febuxostat, and fewer patients had recurrent 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 treatment with Zurampic and the doctor will advise the patient to take sufficient fluids during the day and always take Zurampic either with allopurinol or with febuxostat, to prevent kidney damage 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 included in the summary of product characteristics and the 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 cardiac, circulatory or renal disorders in patients treated with Zurampic, particularly in those who have previously suffered such disorders. This is because these disorders occurred during treatment with Zurampic.

Further information is available in the summary of the risk management plan.