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Safety Studies for KUVAN & BH4
Indication
KUVAN (sapropterin dihydrochloride) Tablets are approved to reduce blood Phe levels in patients with hyperphenylalaninemia (HPA) due to BH4-responsive PKU. KUVAN is to be used with a low-Phe diet.
- The safety of KUVAN has been confirmed in 579 PKU patients for up to 136 weeks13
- In a 2-year study of PKU patients, KUVAN was shown to be well tolerated13
KUVAN is a pharmaceutical version of BH4. BH4 is a natural substance found in the body that helps reduce Phe to safe levels in the blood. Scientists have studied BH4 for over 30 years. The safety of BH4 has been confirmed in many studies.
- Two PKU studies in 2004 investigated the safety of BH4. In one, a 2-year study of children with PKU, BH4 was shown to be well tolerated.14 The other study, in Japan, followed patients with PKU treated with BH4 for up to 4 years.15 No serious side effects or treatment discontinuation related to BH4 were seen in either study
- In another study of young children with PKU, BH4 treatment was given for periods of up to 2 years with no reported serious side effects or treatment discontinuation16
- Finally, a 2005 study looked at the results of treatment with BH4 for up to 5 years. The study included children up to age 6. BH4 helped reduce Phe levels, with no reported serious side effects or treatment discontinuation17
More recently, KUVAN has been tested in 579 PKU patients for periods from 1 to 136 weeks.13
In these studies, side effects in patients taking KUVAN generally occurred at a similar rate as they did in patients who received placebo (a pill without any medicine in it). The most common side effects reported when taking KUVAN included:
- Headache
| - Throat pain
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- Diarrhea
| - Vomiting
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- Abdominal pain
| - Nausea
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- Upper respiratory tract infection (like a cold)
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The side effects listed above are not all the side effects seen with KUVAN. You should talk to your doctor or pharmacist if you have concerns about these or other side effects.
You should also inform your doctor if you experience any side effects when taking KUVAN.
For more information, download: KUVAN Patient Package Insert
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How to take KUVAN  |
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Indication
KUVAN
® (sapropterin dihydrochloride) Tablets are approved to reduce blood Phe levels in patients with hyperphenylalaninemia (HPA) due to tetrahydrobiopterin- (BH4-) responsive Phenylketonuria (PKU). KUVAN is to be used in conjunction with a low-Phe diet.
Important Safety Information
High blood Phe levels are toxic to the brain and can lead to lower intelligence and decrease in the ability to focus, remember and organize information. Any change you make to your diet may impact your blood Phe level. Follow your doctor's instructions carefully. Your doctor and dietitian will continue to monitor your diet and blood Phe levels throughout your treatment with KUVAN.
If you have a fever, or if you are sick, your Phe level may go up. Tell your doctor and dietitian as soon as possible so they can see if they have to adjust your treatment to help keep your blood Phe levels in the desired range.
KUVAN is a prescription medicine and should not be taken by people who are allergic to any of its ingredients. Tell your doctor if you have ever had liver or kidney problems, are nursing or pregnant or may become pregnant, have poor nutrition or are anorexic. Your doctor will decide if KUVAN is right for you. Tell your doctor about all the medicines you take.
The most common side effects reported when using KUVAN are headache, diarrhea, abdominal pain, upper respiratory tract infection (like a cold), throat pain, vomiting, and nausea.
To report SUSPECTED ADVERSE REACTIONS, contact BioMarin Pharmaceutical Inc. at 1-866-906-6100, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Please read the full Patient Information by clicking here.
