The Lab and Diet Data Form is a helpful tool for the healthcare professional to include in the patient’s chart. It will provide a snapshot of the dietary Phe, protein, calorie, and formula intake to make
it easier to monitor KUVAN dosing and weight gain.
Indication
KUVAN® (sapropterin dihydrochloride) Tablets 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.
Important Safety Information
Prolonged exposure to elevated blood Phe levels in PKU patients can result in severe
neurologic damage. The initiation of KUVAN therapy does not eliminate the need for
careful monitoring of blood Phe levels and ongoing dietary management.
Some patients receiving KUVAN can experience significant drops in blood Phe levels.
Patients should be monitored closely to ensure that blood Phe levels do not fall
too low.
Not all patients with PKU respond to treatment with KUVAN. Response to treatment
can only be determined by a therapeutic trial of KUVAN.
KUVAN has not been studied in patients with liver or renal impairment. Patients
who have these conditions should be carefully monitored when receiving KUVAN. Caution
should be used with the administration of KUVAN to patients who are receiving levodopa
and drugs that affect nitric oxide–mediated vasorelaxation or folate metabolism.
The most serious adverse reactions reported during KUVAN administration (regardless
of relationship to treatment) were gastritis, spinal cord injury, streptococcal
infection, testicular carcinoma, and urinary tract infection. Mild to moderate neutropenia
was also noted. The most common adverse reactions were headache, diarrhea, abdominal
pain, upper respiratory tract infection, pharyngolaryngeal pain, vomiting, and nausea.
Please read the full Prescribing Information by clicking here.