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Kuvan: Everything you Need to Know

If you or somebody you know has been diagnosed with PKU, chances are you’ve heard of Kuvan, one of the leading prescriptions on the market made to treat PKU. Finding data can be tricky, so we’ve made it our job to tackle all the most common questions to hopefully save you some time in your research.

Disclaimer: We are not in any way affiliated with Kuvan or BioMarin Pharmaceutical Inc. This is simply for research purposes to compile some of the most frequently sought-after answers to questions regarding the popular PKU treatment. We’re also not doctors, just people with a love for data on all things PKU related.

What is Kuvan?

Kuvan is cited as the first and only prescription medication available at the time for the treatment of PKU. The prescription works primarily to lower the blood’s Phe levels into a controlled range between 2-6 mg/dL or 120-360 μmol/L.

The drug has been designed to supplement a low-Phe diet; this isn’t by any means a “cure” or a replacement for such a diet, but instead helps with the regulation of the blood’s Phe levels, thus allowing a bit reassurance that the proper levels are being maintained.

What form is Kuvan in?

Currently there are three different forms available: 100 mg tablets, 100 mg powder packets, and 500 mg powder packets. The tablets are to be taken with water as one would take any other pill, and the powder packets are made to be dissolved within a mixture of water/juice, or a smaller portion of soft food such as apple sauce or pudding.

How much does Kuvan cost?

While costs can vary widely due to insurance coverage differences, the yearly price was cited by BioMarin in 2007 to cost an average of $57,000. This price is referenced as being lower for for small children that would require a lower dose, but potentially up to $200,000 per year for large adults that are receiving the highest dose.

The company reports that most insurance companies cover the drug with an average co-payment of roughly $50 per month, varying by type of insurance.

How often do I have to take Kuvan?

Kuvan is taken once a day at the same time each and every day, preferably with the day’s largest meal. Infants and children younger than 7 adhere to a dosing regimen that follows a weight-based dosage format, and patients older than 7 are recommended to start at roughly 10/20 mg/kg once daily that is adjusted depending on tolerance and effectiveness.

What are some of the side effects of Kuvan?

The most common side effects, as reported by the FDA, include: headache, diarrhea, abdominal pain, upper respiratory tract infections, pharyngolaryngeal pain, vomiting, and nausea.

Where can I find the Kuvan package insert?

The prescribing information can be found here, and the instructions for use can be found here.

Who makes Kuvan?

Kuvan is made by BioMarin Pharmaceutical Inc.

Is Kuvan safe to take while pregnant?

There have as of yet been no adequate and well-controlled studies on the effects of the drug while pregnant, and thus should only be used if clearly needed and approved by a doctor. There hasn’t yet been enough research on whether sapropterin, one of the primary ingredients, gets passed on through breast milk, therefore it is important to speak with a doctor regarding discontinuing either nursing or the drug whilst taking into account the importance of the drug to the mother.

What can I eat while on Kuvan?

While taking Kuvan it is important that users maintain a low-Phe diet. Individual response to Kuvan can vary from person to person, so you don’t necessarily want to dive right into eating cheeses and meats. Some may be able to to tolerate small tastes of each, others more, and others none at all. This is not a substitute for a low-Phe diet in any way, but instead a means to provide some reassurance (when effective) that Phe levels are in check.

What is the generic equivalent of Kuvan?

There are currently no FDA approved generic equivalents of Kuvan on the market.  The patents on Kuvan are expected to expire between 2024 and 2026.

 

Didn’t find your answer here? Get in touch via support@fitfunner.com to send us your question, and we’ll do our best to answer it and add it to our list.

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