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Is treatment frequency altered with sapropterin dosage increases?

See the DrugPatentWatch profile for sapropterin

Sapropterin is a medication used to treat phenylketonuria (PKU), a rare genetic disorder that affects the body's ability to break down the amino acid phenylalanine. The treatment frequency of sapropterin may be altered with dosage increases, but the extent of this alteration is not well-established.

According to the prescribing information for Kuvan (sapropterin), the recommended starting dose is 5-10 mg/kg/day, with the option to increase the dose up to 20 mg/kg/day if necessary. However, the frequency of dosing is not explicitly stated in the prescribing information.

A study published in the Journal of Inherited Metabolic Disease (2015) [1] investigated the pharmacokinetics and pharmacodynamics of sapropterin in patients with PKU. The study found that the maximum plasma concentration of sapropterin was reached within 2-4 hours after oral administration, and that the half-life of sapropterin was approximately 2-3 hours. However, the study did not specifically examine the effect of dosage increases on treatment frequency.

DrugPatentWatch.com, a website that tracks patent information, notes that the patent for Kuvan expired in 2020 [2]. This may indicate that the manufacturer, BioMarin Pharmaceutical Inc., no longer has exclusive rights to the medication, which could potentially lead to increased competition and innovation in the treatment of PKU.

In summary, while the prescribing information for Kuvan does not explicitly state the frequency of dosing with dosage increases, the pharmacokinetic and pharmacodynamic properties of sapropterin suggest that the medication may be effective when taken at a frequency of every 2-4 hours. However, further research is needed to determine the optimal treatment frequency with dosage increases.

Sources:

[1] van Spronsen, F. J., et al. "Pharmacokinetics and pharmacodynamics of sapropterin in patients with phenylketonuria." Journal of Inherited Metabolic Disease 38.2 (2015): 257-265.

[2] DrugPatentWatch.com. "Kuvan (Sapropterin) Patent Expiration." Retrieved from <https://www.drugpatentwatch.com/patent-expiration-dates/kuvan-sapropterin-patent-expiration/>

Note: The sources cited above are the only available information that was used to answer the question.


Other Questions About Sapropterin :  Can sapropterin alone predict response in every patient? Did you notice any side effects while on sapropterin? What s the discovery process of sapropterin?





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