Posted from: Monday, June 04, 2018 - 09:58 AM - Present

Jynarque Approved to Treat Inherited Kidney Disease

April 24, 2018 – The U.S. FDA has approved Jynarque™ (tolvaptan) tablets, manufactured by Otsuka Pharmaceuticals, to treat adults who have rapidly progressing autosomal dominant polycystic kidney disease (ADPKD).

ADPKD, which affects approximately 140,000 Americans, is the most common form of polycystic kidney disease. The genetic disorder occurs when mutations in either PKD1 or PKD2 genes lead to the production of abnormal cells, causing cysts to form on the kidneys. ADPKD is typically identified in adulthood. Effects of the disease can include end-stage renal failure, and the need for dialysis and kidney transplants.

Jynarque is the first FDA-approved drug for the treatment of ADPKD. It works by slowing the decline of kidney function in adults who have a rapidly progressing form of the disease. Recommended dosing is 45mg in the morning, plus a second 15mg dose taken eight hours later in the evening, for the first week. Dosages are then adjusted weekly, first to 60mg/30mg and then finally to 90mg/30mg for maintenance.

A black box warning cautions that Jynarque may cause severe liver damage, and regular liver function tests should be performed before and during treatment. The drug will be available with limited distribution under a Risk Evaluation and Mitigation Strategy (REMS).

Jynarque is also available from Otsuka under the brand name Samsca®, approved in 2013 to treat low blood sodium (hyponatremia).

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.

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.


Last Updated Tuesday, October 15, 2019 - 01:50 AM.