How effective is tolvaptan for PKD?
How effective is tolvaptan for PKD?
Tolvaptan slowed a loss of renal function bŷ25% compared to placebo, with a reduction in the rate of deterioration of 1.20 mg/mL/year (95% CI: 0.62–1.78; p<0.001).
Is tolvaptan approved?
On April 24, 2018, the U.S. Food and Drug Administration (FDA) granted approval of tolvaptan to be the first treatment in the United States for adult patients with autosomal dominant polycystic kidney disease (ADPKD), the most common form of polycystic kidney disease (PKD).
How long can you take tolvaptan?
[04-30-2013] The U.S. Food and Drug Administration (FDA) has determined that the drug Samsca (tolvaptan) should not be used for longer than 30 days and should not be used in patients with underlying liver disease because it can cause liver injury, potentially requiring liver transplant or death.
Does tolvaptan lower GFR?
The TEMPO 3:4 trial and post hoc analysis of the TEMPO 3:4 trial showed that tolvaptan reduced the annual eGFR decline in ADPKD by 26% (from 3.70 to 2.72 mL/min/1.73 m2) [3]. Tolvaptan induced an acute decrease in eGFR during initiation of treatment.
When do you stop tolvaptan?
Recommendation 1.2: We recommend not to start tolvaptan in patients with an eGFR indexed for age suggesting slowly progressive disease (<40 years, no eGFR limit; 40–44 years, ≥90 mL/min/1.73 m2; 45–49 years, ≥75 mL/min/1.73 m2; 50–55 years, ≥60 mL/min/1.73 m2).
Is tolvaptan approved in the US?
Otsuka Pharmaceutical Co., Ltd. (Otsuka) announces that the U.S. Food and Drug Administration (FDA) has approved JYNARQUE™ (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 quickly does tolvaptan work?
The onset of effect is two to four hours after a dose is taken, and peak effects occur four to eight hours after administration. Taking tolvaptan with food does not appear to affect the drug’s bioavailability or its onset or duration of effect.
Does tolvaptan increase creatinine?
In this study, we demonstrated that tolvaptan produced significant diuretic effects and reduced body weight in CKD patients. The urine osmolality was also decreased significantly. There was a slight increase in serum creatinine level, but improvement for hyponatremia was observed.
Can tolvaptan be taken daily?
Tolvaptan dose started from 7.5 mg once daily, with maximum dose no more than 30 mg daily.
Is tolvaptan expensive?
At a drug cost of $5,760 per month, tolvaptan cost $744,100 per QALY gained compared to standard care.
What is tolvaptan 15 mg used for?
Tolvaptan is used to treat hyponatremia (low sodium in the blood) in patients with heart failure or syndrome of inappropriate antidiuretic hormone (SIADH). Tolvaptan is also used to slow kidney function decline in adults who are at risk of rapidly progressing autosomal dominant polycystic kidney disease (ADPKD).
Where is tolvaptan approved?
Tolvaptan was first approved by the FDA in 2009 as Samsca (Otsuka Pharmaceutical Co., Ltd.)…Development timeline for Jynarque.
| Date | Article |
|---|---|
| Apr 24, 2018 | Approval FDA Approves Jynarque (tolvaptan) to Slow Kidney Function Decline in Rapidly Progressing Autosomal Dominant Polycystic Kidney Disease |