Rx Item-Kuvan 100Mg Powder Packe 30 By Biomarin Pharma

KUVAN- sapropterin dihydrochloride tablet
KUVAN- sapropterin dihydrochloride powder, for solution
BioMarin Pharmaceutical Inc.

1 INDICATIONS AND USAGE

Kuvan� (sapropterin dihydrochloride) is indicated to reduce blood phenylalanine (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.

2 DOSAGE AND ADMINISTRATION

2.1 Dosage


Patients 1 month to 6 years: The recommended starting dose of Kuvan is 10 mg/kg taken once daily [see Warnings and Precautions (5.3)].

Patients 7 years and older: The recommended starting dose of Kuvan is 10 to 20 mg/kg taken once daily.

If a 10 mg/kg per day starting dose is used, then response to therapy is determined by change in blood Phe following treatment with Kuvan at 10 mg/kg per day for a period of up to 1 month. Blood Phe levels should be checked after 1 week of Kuvan treatment and periodically for up to a month. If blood Phe does not decrease from baseline at 10 mg/kg per day, the dose may be increased to 20 mg/kg per day. Patients whose blood Phe does not decrease after 1 month of treatment at 20 mg/kg per day are non-responders and treatment with Kuvan should be discontinued in these patients.

If a 20 mg/kg per day starting dose is used, then response to therapy is determined by change in blood Phe following treatment with Kuvan at 20 mg/kg per day for a period of 1 month. Blood Phe levels should be checked after 1 week of Kuvan treatment and periodically during the first month. Treatment should be discontinued in patients who do not respond to Kuvan.

Once responsiveness to Kuvan has been established, the dosage may be adjusted within the range of 5 to 20 mg/kg per day according to response to therapy. Periodic blood Phe monitoring is recommended to assess blood Phe control [see Warnings and Precautions (5.3, 5.6)].

RX ITEM-Kuvan 100Mg Powder Packe 30 By B
NDC 68135-0300-02 UPC/GTIN No.3-68135-30002-1 Mfg.Part No.30002

Kuvan 100Mg Powder Packe 30 By Biomarin
BRAND: KUVAN NDC: 68135-0301-22,68135030122 UPC: 3-68135-30122-6,368135301226 Biomarin Pharma

SAPROPTERIN DIHYDROCHLORI
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