Kuvan (Sapropterin Dihydrochloride)

(℞) Prescription Required

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Kuvan 100mg

Product of New Zealand
Manufactured by: Biomarin
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Kuvan 100mg
Product of New Zealand
Manufactured by Biomarin
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Kuvan (Sapropterin Dihydrochloride)

Kuvan is used in combination with a Phe-restricted diet to reduce blood phenylalanine (Phe) levels in patients with high blood Phe levels due to tetrahydrobiopterin (BH4)-responsive Phenylketonuria (PKU).

Warnings and Precautions

Kuvan should be prescribed by a doctor experienced in management of PKU. Patients with PKU who are taking Kuvan should also be treated with a Phe-restricted diet, because high blood Phe levels with PKU can result in severe neurologic damage.

Not all patients with PKU respond to treatment with Kuvan. Before you start taking Kuvan, let your doctor know about all of your medical conditions, including if you:

  • Have a fever
  • Are pregnant or planning to become pregnant
  • Are breast feeding
  • Have liver or kidney problems
  • Are allergic to Kuvan or any other medications
  • Have poor nutrition or are anorexic
  • Are taking levodopa
  • Are taking drugs that inhibit folate metabolism (e.g., methotrexate) because these drugs could affect how Kuvan works in your body
  • Are taking medicines for erectile dysfunction like Viagra (sildenafil), Levitra (vardenafil), or Cialis (tadalafil)

Side Effects

The most common side effects reported when using Kuvan are:

  • Headache
  • Diarrhoea
  • Abdominal pain
  • Upper respiratory tract infection (like a cold)
  • Throat pain
  • Vomiting
  • Nausea

These are not all the side effects seen with Kuvan. If you are concerned about these or any other side effects you experience while taking Kuvan, ask your doctor or pharmacist for more information.

Be sure to tell your doctor if you have any side effects when you are taking Kuvan.

Interactions with this medication

Tell your doctor about all the medicines you take, including prescription and nonprescription medicines and herbal and dietary supplements. Kuvan and many other medicines may interact with each other. Your doctor needs to know what medicines you take so he or she can decide if Kuvan is right for you.

Know the medicines you take. Keep a list of your medicines with you to show your doctor. Do not take other medicines while taking Kuvan without first talking to your doctor.

Proper Use of this medication

When you are taking Kuvan, any change you make to your diet may affect your blood Phe level. Follow your doctor's instructions carefully and do not make any changes to your dietary Phe intake before discussing with your doctor. Your doctor will continue to monitor your blood Phe levels during your treatment with Kuvan.


In the event of a suspected overdose, please contact your health care provider, hospital emergency department or regional poison control centre immediately.

Missed dose:

If you forget to take your dose of Kuvan, take it as soon as you remember that day. If you miss a day, do not double your dose the next day, just skip the missed dose.

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The above information is an educational aid only. It is not intended as medical advice for individual conditions or treatments. Talk to your doctor, nurse or pharmacist before following any medical regimen to see if it is safe and effective for you.

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