patients that reduction of blood Phe levels through dietary control is an important determinant of long-term neurologic outcome in PKU patients. Advise patients that the effect of Kuvan on long-term neurologic function in patients with PKU has not been assessed.
Advise patients that Kuvan may cause hypersensitivity reactions including anaphylaxis and rash [see Warnings and Precautions (5.1)].
Advise patients to notify their physician for symptoms of severe gastritis [see Warnings and Precautions (5.2)].
Advise patients that blood Phe levels that are too high for prolonged periods of time can result in neurologic impairment.
Advise patients that adequate blood Phe control needs to be maintained to avoid blood Phe levels that are too high or too low.
Advise patients that to ensure maintenance of adequate blood Phe control, close monitoring is recommended and that the dose of Kuvan should be adjusted if necessary.
Advise patients with hepatic impairment and patients who are taking Kuvan in combination with drugs that inhibit folate metabolism, drugs that affect nitric oxide-mediated vasorelaxation, or levodopa that they may require additional clinical monitoring while taking Kuvan[see Warnings and Precautions (5.7, 5.8, 5.9, 5.10)].
Advise patients that Kuvan may cause hyperactivity [see Warnings and Precautions (5.11)].
Advise patients that BioMarin has a product registry for PKU patients to collect data on women who become pregnant while receiving Kuva
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PATIENT INFORMATION
Kuvan (COO-van)
(sapropterin dihydrochloride)
tablets
Kuvan (COO-van)
(sapropterin dihydrochloride)
powder for oral solution
What is Kuvan?
Kuvan is a prescription medicine used to lower blood levels of phenylalanine (Phe), in people with a certain type of Phenylketonuria (PKU). Kuvan is used along with a Phe-restricted diet.
What should I tell my doctor before taking Kuvan?
Before you take Kuvan, tell your doctor if you:
have a fever
have liver or kidney problems
are allergic to sapropterin dihydrochloride or any of the ingredients in Kuvan. See the list of ingredients in Kuvan at the end of this leaflet.
have poor nutrition or have loss of appetite
are pregnant or plan to become pregnant.
Pregnancy Registry: There is a pregnancy registry for women who take Kuvan during pregnancy. The purpose of this registry is to collect information about the health of you and your baby. Talk to your doctor about how you can take part in this registry.
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, 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
avanafil (Stendra), 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?
Take Kuvan exactly as your doctor tells you. Your doctor should tell you how much Kuvan to take a
