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16.  HOW SUPPLIED/STORAGE AND HANDLING

Kuvan tablets, 100 mg, are round, off-white to light yellow, mottled, and debossed with “177”. The tablets are supplied as follows:

NDC 68135-300-02    Bottle of 120 tablets

Kuvan powder for oral solution is an off-white to yellow powder packaged in unit dose packets as follows:

100 mg Kuvan per packet:

NDC 68135-301-22    Carton of 30 unit dose packets

NDC 68135-301-11    Single unit dose packet

500 mg Kuvan per packet:

NDC 68135-482-11    Carton of 30 unit dose packets

NDC 68135-482-10    Single unit dose packet

Storage

Store Kuvan tablets at 20ºC to 25ºC (68ºF to 77ºF); excursions allowed between 15ºC to 30ºC (59ºF to 86ºF) [see USP Controlled Room Temperature]. Keep container tightly closed. Protect from moisture.

Store Kuvan powder for oral solution at 20ºC to 25ºC (68ºF to 77ºF); excursions allowed between 15ºC to 30ºC (59ºF to 86ºF) [see USP Controlled Room Temperature]. Protect from moisture.

Manufactured for:

BioMarin Pharmaceutical Inc.

Novato, CA 94949

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17.  PATIENT COUNSELING INFORMATION

See FDA-approved patient labeling (Patient Information and Instructions for Use)

Patients should be advised of the following information before beginning treatment with Kuvan:

Advise patients that Kuvan may cause low blood Phe levels.  Advise patients that children younger than 7 years treated with Kuvan doses of 20 mg/kg per day are at increased risk for low levels of blood Phe compared with children 7 years and older. Blood Phe levels that are too low for prolonged periods of time may be associated with catabolism and protein breakdown [see Warnings and Precautions (5.3)].
Advise patients that Kuvan is to be used in conjunction with a Phe-restricted diet [see Warnings and Precautions (5.6)].
Advise patients that not all patients with PKU respond to treatment with Kuvan and that response to Kuvan can only be determined by a therapeutic trial [see Warnings and Precautions (5.4, 5.5)].
Advise patients that they must be eva luated for changes in blood Phe after being treated with Kuvan at the recommended dose(s) for age to determine if they are a responder and that  blood Phe levels and dietary Phe intake should be measured frequently during the first month [see Warnings and Precautions (5.4, 5.5)].
Advise patients that they should have frequent blood Phe measurements and nutritional counseling with their physician and other members of the health care team knowledgeable in the management of PKU to ensure maintenance of blood Phe levels in the desirable range [see Warnings and Precautions (5.4)].
Advise patients not to modify their existing dietary Phe intake during the eva luation period in order to get an accurate assessment of the effect of Kuvan on blood Phe levels.
Advise patients not to continue treatment with Kuvan if they are determined to be a non-responder during the eva luation period [see Dosage and Administration (2.1)].
Advise