Special Warning : אזהרת שימוש

4.4    Special warnings and precautions for use

Dietary intake

Patients treated with Kuvan must continue a restricted phenylalanine diet and undergo regular clinical assessment (such as monitoring of blood phenylalanine and tyrosine levels, nutrient intake, and psycho-motor development).

Low blood phenylalanine and tyrosine levels

Sustained or recurrent dysfunction in the phenylalanine-tyrosine-dihydroxy-L-phenylalanine (DOPA) metabolic pathway can result in deficient body protein and neurotransmitter synthesis. Prolonged exposure to low blood phenylalanine and tyrosine levels during infancy has been associated with impaired neurodevelopmental outcome. Active management of dietary phenylalanine and overall protein intake while taking Kuvan is required to ensure adequate control of blood phenylalanine and tyrosine levels and nutritional balance.

Health disturbances
Consultation with a physician is recommended during illness as blood phenylalanine levels may increase.

Convulsions disorders

Caution should be exercised when prescribing Kuvan to patients receiving treatment with levodopa. Cases of convulsion, exacerbation of convulsion, increased excitability and irritability have been observed during co-administration of levodopa and sapropterin in BH4- deficient patients (see section 4.5).

Discontinuation of treatment

Rebound, as defined by an increase in blood phenylalanine levels above pre-treatment levels, may occur upon cessation of treatment.

There are limited data regarding the long-term use of Kuvan.

Sodium content
This medicine contains less than 1 mmol (23 mg) sodium per tablet, i.e. essentially “Sodium- free”.

Effects on Driving

4.7    Effects on ability to drive and use machines
Kuvan has no or negligible influence on the ability to drive and use machines.