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Clinical data | |
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Trade names | Kuvan, Biopten, other |
Other names | Tetrahydrobiopterin, Sapropterin hydrochloride (JAN JP), Sapropterin dihydrochloride (USAN US) |
AHFS/Drugs.com | Monograph |
MedlinePlus | a608020 |
License data |
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Pregnancy category |
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Routes of administration | By mouth |
Legal status | |
Legal status | |
Pharmacokinetic data | |
Elimination half-life | 4 hours (healthy adults) 6–7 hours (PKU patients) |
Duration of action | 24 hours[2] |
Identifiers | |
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Chemical and physical data | |
Formula | C9H15N5O3 |
Molar mass | 241.251 g·mol−1 |
3D model (JSmol) | |
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Sapropterin, also known as tetrahydrobiopterin (BH4, THB), is a medication used to treat phenylketonuria or tetrahydrobiopterin deficiency.[2][3] It is used together with dietary changes.[2] Levels of phenylalanine in the blood are measured during the first month to determine if it is effective.[2] It is taken by mouth.[2]
Common side effects include headache and runny nose.[3] Other side effects may include anaphylaxis, stomach inflammation, and hyperactivity.[2] Use may be considered in pregnancy if diet alone does not control phenylalanine levels.[5] It is a cofactor which improves the activity of phenylalanine hydroxylase (PAH), which breaks down phenylalanine.[2]
Sapropterin was approved for medical use in the United States in 2007,[2] Europe in 2008,[3] and Canada in 2010.[6] In Canada it costs about 48,000 to 168,000 CAD a year for a 68 kg person in 2017.[4] In the United States this amount costs 38,000 to 152,000 USD per year while in the United Kingdom it is about £25,000 to £100,000 as of 2021.[7][8] It is sold under the brand names Kuvan and Biopten.[9]
References
edit- ^ a b "Sapropterin (Kuvan) Use During Pregnancy". Drugs.com. 17 May 2019. Archived from the original on 29 October 2020. Retrieved 4 March 2020.
- ^ a b c d e f g h i j "Sapropterin Monograph for Professionals". Drugs.com. Archived from the original on 29 August 2021. Retrieved 10 October 2021.
- ^ a b c d e "Kuvan". Archived from the original on 14 August 2020. Retrieved 10 October 2021.
- ^ a b "Sapropterin dihydrochloride (Kuvan)" (PDF). CADTH. September 2017. Archived (PDF) from the original on 11 February 2020. Retrieved 10 October 2021.
- ^ "Sapropterin (Kuvan) Use During Pregnancy". Drugs.com. Archived from the original on 29 October 2020. Retrieved 10 October 2021.
- ^ Patient Group Input Submissions: sapropterin dihydrochloride (Kuvan) for Phenylketonuria (PKU). Canadian Agency for Drugs and Technologies in Health. 2017. Archived from the original on 12 October 2021. Retrieved 10 October 2021.
- ^ "Sapropterin Prices, Coupons & Patient Assistance Programs". Drugs.com. Archived from the original on 29 August 2021. Retrieved 10 October 2021.
- ^ BNF (80 ed.). BMJ Group and the Pharmaceutical Press. September 2020 – March 2021. p. 1139. ISBN 978-0-85711-369-6.
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: CS1 maint: date format (link) - ^ "Australian Public Assessment Report for Sapropterin dihydrochloride" (PDF). Archived (PDF) from the original on 12 October 2021. Retrieved 10 October 2021.