Now is the time to try KUVAN® (sapropterin dihydrochloride) Tablets or Powder for Oral Solution to see if it can work for you.
Eligible patients with PKU can try KUVAN to see if it will help lower their blood Phe levels in combination with a low-Phe diet.1 Adults and children who have been diagnosed with PKU in the United States and have not tried KUVAN are eligible for a free 30-day trial.
KUVAN is available by prescription only. Talk to your doctor to see if KUVAN is right for you.
The most common side effects reported when using KUVAN are headache, runny nose and nasal congestion, sore throat, diarrhea, vomiting, and cough.
Please see Important Safety Information below.
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- The FREE trial of KUVAN for up to 30 days is available only to individuals in the United States who are affiliated with a participating clinic and diagnosed with hyperphenylalaninemia (HPA) due to tetrahydrobiopterin (BH4)-responsive phenylketonuria (PKU)
- This program is offered through BioMarin Pharmaceutical Inc. and is managed by BioMarin RareConnections™. If you and your doctor determine KUVAN is right for you or your child, your FREE trial for up to 30 days will be arranged by BioMarin RareConnections
- Upon receipt of your completed form, you will be contacted by a representative from BioMarin to complete a Patient Authorization to Share Health Information form. You must be 18 years of age or older to complete this form. A parent or guardian can submit the form on behalf of his/her child
- Before the FREE trial period ends, you will be evaluated by your clinic to see if you should continue taking KUVAN
- KUVAN [package insert]. Novato, CA: BioMarin Pharmaceutical Inc; 2021.
What is KUVAN?
KUVAN® (sapropterin dihydrochloride) Tablets for Oral Use and Powder for Oral Solution are prescription medicines used to lower blood Phe levels in adults and children over one month of age with a certain type of Phenylketonuria (PKU). KUVAN is to be used along with a Phe-restricted diet.
What is the most important information I should know about KUVAN?
KUVAN can cause serious side effects, including:
- Severe allergic reactions including anaphylaxis. Stop taking KUVAN and get medical help right away if you develop any of these signs or symptoms of a severe allergic reaction:
- Inflammation of the lining of the esophagus or stomach (esophagitis and gastritis). Your doctor will monitor you for symptoms of inflammation in your upper gastrointestinal tract, including your stomach and esophagus. If untreated that inflammation can lead to serious side effects including narrowing of the esophagus, ulcers, and bleeding. Call your doctor right away if you have any of these signs or symptoms:
- Phe levels that are too low. Patients have experienced low blood Phe during treatment with KUVAN. Low blood phe is more common in children under the age of 7 who take high doses of KUVAN each day.
- Too much or constant activity (hyperactivity) can happen with KUVAN. Tell your doctor if you have any signs of hyperactivity, including:
What should I tell my doctor before I take KUVAN?
Before you take KUVAN, tell your doctor about all your medical conditions, including if you:
- Are allergic to sapropterin dihydrochloride or any of the ingredients in KUVAN
- Have poor nutrition or have a loss of appetite
- Are pregnant or plan to become pregnant
- Are breastfeeding or plan to breastfeed. It is not known if KUVAN passes into your breast milk. Talk to your doctor about the best way to feed your baby if you take KUVAN.
Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal and dietary supplements. KUVAN and other medicines may interact with each other. Especially tell your doctor if you take:
- A medicine that contains levodopa
- An antifolate medicine such as methotrexate, valproic acid, phenobarbital, trimethoprim
- Sildenafil (Revatio, Viagra), tadalafil (Adcirca, Cialis), vardenafil (Staxyn, Levitra)
Tell your doctor if you are not sure if your medicine is one that is listed above. Know the medicines you take. Keep a list of them to show your doctor and pharmacist when you get a new medicine.
How should I take KUVAN?
See the detailed “Instructions for Use” that comes with KUVAN for information about the correct way to dissolve and take a dose of KUVAN tablets or KUVAN powder for oral solution.
- KUVAN does not work for everyone. It is not possible to know if KUVAN will work for you until you start taking KUVAN. Your doctor will check your blood Phe levels when you start taking KUVAN to see if the medicine is working.
- Take KUVAN exactly as your doctor tells you
- You can swallow KUVAN tablets whole or dissolve the tablets in water or apple juice
- KUVAN powder for oral solution should be dissolved in water or apple juice
- KUVAN should be taken with a PKU-specific diet. 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 without first talking with your doctor. Even if you take KUVAN, if your blood Phe levels are not well controlled, you can develop severe neurologic problems.
- Your doctor should continue to monitor your blood Phe levels often during your treatment with KUVAN to make sure that your blood Phe levels are not too high or too low and frequent monitoring for pediatric patients is recommended. Both high and low Phe can result in serious problems. Active management of dietary Phe intake while taking KUVAN is required.
- If you have a fever, or if you are sick, your blood Phe level may go up. Tell your doctor as soon as possible so he or she can change your dose of KUVAN to help keep your blood Phe levels in the desired range.
- If you forget to take your dose of KUVAN, take it as soon as you remember that day. Do not take 2 doses in a day.
- If you take too much KUVAN, call your doctor for advice
The most common side effects of KUVAN are: headache, runny nose and nasal congestion, sore throat, diarrhea, vomiting, and cough.
These are not all the possible side effects of KUVAN. For more information, ask your doctor or pharmacist. Call your doctor for medical advice about side effects.
You may report side effects to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. You may also report side effects to BioMarin Pharmaceutical Inc. at 1-866-906-6100.
Please read the full Prescribing Information by clicking here.