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Kuvan (Sapropterin Dihydrochloride) - Summary

 
 



KUVAN SUMMARY

Sapropterin dihydrochloride, the active pharmaceutical ingredient in Kuvan Tablets, is a synthetic preparation of the dihydrochloride salt of naturally occurring tetrahydrobiopterin (BH4).

KuvanTM (sapropterin dihydrochloride) Tablets is indicated to reduce blood phenylalanine (Phe) levels in patients with hyperphenylalaninemia (HPA) due to tetrahydrobiopterin- (BH4-) responsive Phenylketonuria (PKU). Kuvan is to be used in conjunction with a Phe-restricted diet.


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NEWS HIGHLIGHTS

Published Studies Related to Kuvan (Sapropterin)

Effects of sapropterin on endothelium-dependent vasodilation in patients with CADASIL: a randomized controlled trial. [2014]
endothelium-dependent vasodilation in CADASIL patients... CONCLUSIONS: Sapropterin was safe and well-tolerated at the average dose of 5

Olmesartan medoxomil/amlodipine. [2009]
black triangle Olmesartan medoxomil/amlodipine is a fixed-dose combination of olmesartan medoxomil and amlodipine, both established antihypertensive agents. Dose titration with the individual constituent drugs is recommended before switching to the equivalent fixed-dose combination... Peripheral oedema was significantly less common in olmesartan medoxomil/amlodipine 40 mg/10 mg per day than amlodipine monotherapy 10 mg/day recipients.

Efficacy of sapropterin dihydrochloride (tetrahydrobiopterin, 6R-BH4) for reduction of phenylalanine concentration in patients with phenylketonuria: a phase III randomised placebo-controlled study. [2007]
blood phenylalanine concentration... INTERPRETATION: In some patients with phenylketonuria who are responsive to BH4,

Oral sapropterin acutely augments reflex vasodilation in aged human skin through nitric oxide-dependent mechanisms. [2013]
Functional constitutive nitric oxide synthase (NOS) and its cofactor tetrahydrobiopterin (BH4) are required for full reflex cutaneous vasodilation and are attenuated in primary aging.These data suggest oral sapropterin increases bioavailable BH4 in aged skin microvasculature sufficiently to increase NO synthesis through NOS and that sapropterin may be a viable intervention to increase skin blood flow during hyperthermia in healthy aged humans.

Relative bioavailability of sapropterin from intact and dissolved sapropterin dihydrochloride tablets and the effects of food: a randomized, open-label, crossover study in healthy adults. [2010]
food on the oral bioavailability of sapropterin administered as intact tablets... CONCLUSIONS: Administration of sapropterin as intact tablets and with a

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Clinical Trials Related to Kuvan (Sapropterin)

Open-Label Extension Study of Kuvan for Autism [Completed]
This is an open-label extension study available only to subjects who completed an earlier double-blind, placebo-controlled study of sapropterin in children with autism. During this protocol, all subjects will be receiving brand-name Kuvan 20 mg/kg/day for 16 weeks; subject who complete the first 16 weeks will have the option of continuing on Kuvan at the same dose for up to 90 days after the last subject has completed the first 16 weeks of this protocol. The purpose of the study primarily is to gather additional information on safety and efficacy in this population.

Kuvan« in Phenylketonuria Patients Less Than 4 Years Old [Active, not recruiting]
This is a Phase 3b, multicenter, open-label, randomized, controlled study to evaluate efficacy, safety and population pharmacokinetics of sapropterin dihydrochloride (Kuvan®) in less than 4 year-old infants and children with Phenylketonuria (PKU).

Effect of Kuvan on Neurocognitive Function, Blood Phenylalanine Level, Safety, and Pharmacokinetics in Children With PKU [Active, not recruiting]
This multicenter, open label study is designed to evaluate the safety of Kuvan« and its effect on neurocognitive function, blood Phe concentration, and growth in children with PKU who are 0-6 years old.

Response to Kuvan´┐Ż in Subjects With Phenylketonuria (PKU) in a 4 Weeks Testing Period [Completed]
The primary objective of the study is to evaluate the proportion of responders (that is, greater than or equal to [>=] 30 percent reduction from Baseline in blood phenylalanine [Phe] level) to treatment with Kuvan« (sapropterin dihydrochloride) 20 milligram per kilogram per day (mg/kg/day) for 28 days.

Phenylketonuria, Oxidative Stress, and BH4 [Terminated]
The purpose of this study is to see how tetrahydrobiopterin therapy (BH4; also known as sapropterin dihydrochloride or Kuvan) affects measures of oxidative stress and endothelial function in patients with Phenylketonuria (PKU).

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Reports of Suspected Kuvan (Sapropterin) Side Effects

Maternal Exposure During Pregnancy (12)Abortion Spontaneous (9)Nephrolithiasis (4)Aspiration (4)Pneumonia (4)Microcephaly (4)Abdominal Pain (3)Laryngitis (3)Suicidal Ideation (3)Decreased Appetite (3)more >>


Page last updated: 2015-08-10

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