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Development timeline for Jynarque DateArticleApr 24, 2018Approval FDA Approves Jynarque (tolvaptan) to Slow Kidney Function Decline in Rapidly Progressing Autosomal Dominant Polycystic Kidney Disease Mar 2, 2021
Is Jynarque FDA approved?
(Otsuka) announces that the U.S. Food and Drug Administration (FDA) has approved JYNARQUE\u2122 (tolvaptan) as the first drug treatment available to slow kidney function decline in adults at risk of rapidly progressing autosomal dominant polycystic kidney disease (ADPKD).
When was tolvaptan approved by the FDA?
Samsca (tolvaptan) was approved in May 2009 for the treatment of clinically significant euvolemic and hypervolemic hyponatremia. Patients should be in a hospital for initiation and re-initiation of therapy to evaluate the therapeutic response before subsequently receiving Samsca in the outpatient setting.
How long do you take Jynarque?
COVID-19 UPDATE JYNARQUE® (tolvaptan) can cause serious and potentially fatal liver injury. ... Measure transaminases (ALT, AST) and bilirubin before initiating treatment, at 2 weeks and 4 weeks after initiation, then monthly for the first 18 months and every 3 months thereafter.
How effective is Jynarque?
JYNARQUE decreased the relative rate of ADPKD-related composite events by 13.5% The results were driven by effects on worsening kidney function pain events. In contrast, tolvaptan had no effect on progression of either hypertension or albuminuria.
Common side effects of Jynarque include: thirst, increased urination (both in volume and frequency), nighttime urination, indigestion, decreased appetite, bloating, dry skin, rash,
Is tolvaptan a REMS drug?
Due to the risks of liver injury, JYNARQUE® (tolvaptan) is available only through a REMS Program.
How many patients are on Jynarque?
Over 5500 people have been prescribed and have taken JYNARQUE.
Is Jynarque FDA approved?
(Otsuka) announces that the U.S. Food and Drug Administration (FDA) has approved JYNARQUE\u2122 (tolvaptan) as the first drug treatment available to slow kidney function decline in adults at risk of rapidly progressing autosomal dominant polycystic kidney disease (ADPKD).
How many people are diagnosed with ADPKD?
Autosomal dominant polycystic kidney disease (ADPKD) is the most common form of PKD. ADPKD affects 1 in every 400 to 1,000 people and is the most common kidney disorder passed down through family members.
jynarque patient status form
Tolvaptan (Oral Route) Proper Use - Mayo Clinic
1 Apr 2022 — Jynarque™ is available only under a restricted distribution program called the Jynarque™ REMS (Risk Evaluation and Mitigation Strategy) ...
Approved Risk Evaluation and Mitigation Strategies (REMS)
Nov 25, 2020 — The goal of the JYNARQUE REMS is to mitigate the risk of serious and potentially fatal liver injury by: Ensuring that healthcare providers ...
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