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HIGHLIGHTS OF PRESCRIBING INFORMATION |
KUVAN™ (sapropterin dihydrochloride) Tablets
These highlights do not include all the information needed to use KUVAN Tablets safely and effectively. See full prescribing information for KUVAN Tablets.
KUVAN (sapropterin dihydrochloride) Tablets for oral use
Initial U.S. Approval: 2007
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INDICATIONS AND USAGE
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Kuvan 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 (1).
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DOSAGE AND ADMINISTRATION
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The recommended starting dose of Kuvan is 10 mg/kg/day taken once daily.
Doses of Kuvan may be adjusted in the range of 5 to 20mg/kg taken once daily. Blood Phe must be monitored regularly (2.1).
Kuvan should be taken orally with food to increase the absorption. Kuvan Tablets should be dissolved in 4 to 8oz. (120-240mL) of water or apple juice and taken within 15 minutes (2.2).
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DOSAGE FORMS AND STRENGTHS
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100 mg tablets (3).
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CONTRAINDICATIONS
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None (4).
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WARNINGS AND PRECAUTIONS
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Monitor Blood Phe Levels During Treatment:
Prolonged exposure to elevated blood Phe levels can injure the brain and reduce brain function. To ensure adequate blood Phe control, blood Phe levels must still be carefully monitored even though patients are receiving Kuvan which can reduce blood Phe levels (5.1).
Treat All Patients With a Phe-restricted Diet:
The initiation of Kuvan therapy does not eliminate the need for ongoing dietary management (5.3).
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ADVERSE REACTIONS
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The most common adverse reactions (incidence ≥4%) in patients treated with Kuvan are headache, diarrhea, abdominal pain, upper respiratory tract infection, pharyngolaryngeal pain, vomiting, and nausea (6.1).
To report SUSPECTED ADVERSE REACTIONS, contact: BioMarin Pharmaceutical Inc. at 1-866-906-6100, or FDA at 1-800-FDA-1088 or go to www.fda.gov/medwatch
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USE IN SPECIFIC POPULATIONS
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Pregnancy Category C. This drug should be used during pregnancy only if clearly needed. There are no adequate and well-controlled studies in pregnant women. Women who are exposed to Kuvan during pregnancy are encouraged to enroll in the Kuvan patient registry (8.1, 17.5).
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See 17 for PATIENT COUNSELING INFORMATION |
Revised: 12/2007 |
Back to Highlights and Tabs
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FULL PRESCRIBING INFORMATION: CONTENTS* |
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1 INDICATIONS AND USAGE
2 DOSAGE AND ADMINISTRATION
2.1 Dosage
2.2 Administration
3 DOSAGE FORMS AND STRENGTHS
4 CONTRAINDICATIONS
5 WARNINGS AND PRECAUTIONS
5.1 Monitor Blood Phe Levels During Treatment
5.2Identify Non-Responders to Kuvan Treatment
5.3Treat All Patients With a Phe-restricted Diet
5.4Use With Caution in Patients With Hepatic Impairment
5.5Monitor for Allergic Reactions
5.6Use With Caution When Co-administering Kuvan and Medications Known to Inhibit Folate Metabolism
5.7Use With Caution When Co-administering Kuvan and Drugs Known to Affect Nitric Oxide-Mediated Vasorelaxation
5.8Use With Caution When Co-administering Kuvan and Levodopa
6 ADVERSE REACTIONS
6.1Clinical Trials Experience in PKU
6.2Safety Experience From Clinical Studies for Non-PKU Indications
6.3 Post-Marketing Experience
7 Drug Interactions
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
8.2 Labor and Delivery
8.3 Nursing Mothers
8.4 Pediatric Use
8.5 Geriatric Use
8.6 Patients With Renal Impairment
10 OVERDOSAGE
11 DESCRIPTION
12 CLINICAL PHARMACOLOGY
12.1Mechanism of Action
12.2Pharmacodynamics
12.3Pharmacokinetics
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
14 CLINICAL STUDIES
14.1 Clinical Studies in PKU
16. How Supplied/Storage and Handling
17 Patient Counseling Information
17.1 Important Information to Consider Prior to Prescribing Kuvan
17.2 Blood Phe Monitoring and Management
17.3 What Are the Benefits of Taking Kuvan?
17.4 What Are the Risks of Taking Kuvan?
17.5 BioMarin PKU Disease Registries
17.6 FDA- |
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