Duzallo Approved for Gout
August 18, 2017 – The U.S. FDA has approved Duzallo® (lesinurad/allopurinol), manufactured by Ironwood Pharmaceuticals, for the treatment of high blood levels of uric acid (hyperuricemia) associated with gout in patients who have not achieved target serum uric acid levels through the use of medically appropriate daily doses of allopurinol alone. Lesinurad is a uric acid transporter (URAT1) inhibitor that increases elimination of uric acid, while allopurinol is a xanthine oxidase inhibitor that decreases uric acid production.
Duzallo will be available in two dosage forms: either 200mg of lesinurad combined with 200mg of allopurinol, or 200mg of lesinurad combined with 300mg of allopurinol. The recommended dosing is one tablet taken each morning with food and water, and patients are advised to drink a minimum of two liters (or roughly a half gallon) of fluids daily.
Patients should have their kidney function tested before they begin Duzallo. Further kidney function tests should be conducted periodically during treatment with the drug or any other product that contains lesinurad, such as Zurampic®. Duzallo carries a black box warning that lesinurad use has been associated with sudden kidney failure.
Launch is planned for the fourth quarter of 2017. Pricing information for Duzallo is not yet available.
Adverse reactions or quality problems experienced with the use of a recalled product may be reported to the FDA’s MedWatch Adverse Event Reporting Program either online, by U.S. mail or by fax.
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- U.S. Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
Actual drug patent expiration dates and availability of new medications are subject to change due to patent litigation, settlement agreements, additional patents, exclusivities, and final FDA approval. Distribution and availability of new medications at pharmacies may not occur immediately following FDA approval. Patients are advised to speak with their healthcare professional or pharmacist regarding appropriateness as well as actual availability.
*This is provided for information only. The reference to any medication above does not mean the medication is covered by your plan.