BH4 has been studied for over 15 years, including a 10-year safety study. Since 1992, more than 1100 patients have been treated with BH4 in clinical trials.

More recently, KUVAN (sapropterin dihydrochloride) has been tested in 579 PKU patients for periods from 1 to 30 weeks. In 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
  • Diarrhea
  • Abdominal pain
  • Upper respiratory tract infection (like a cold)
  • Throat pain
  • Vomiting
  • Nausea

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.

Please see KUVAN Patient Package Insert for more information.

Next: Taking KUVAN

 

Indication

KUVAN® (sapropterin dihydrochloride) Tablets is 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 Phe-restricted 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 and may adjust your diet 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.

BIOMARIN