Sapropterin

Generic name: Sapropterin
Drug class: Miscellaneous metabolic agents

Usage of Sapropterin

Sapropterin is used to lower blood levels of phenylalanine in adults and children at least one month old with a certain type of phenylketonuria (PKU).

Sapropterin may also be used for purposes not listed in this medication guide.

Sapropterin side effects

Get emergency medical help if you have signs of an allergic reaction: hives, rash, wheezing, cough, difficult breathing, nausea, feeling light-headed, flushing (warmth, redness, or tingly feeling), swelling of your face, lips, tongue, or throat.

Sapropterin may cause serious side effects. Call your doctor at once if you have:

behavior changes, seizures, or problems with speech;

fever, loss of appetite, difficulty swallowing, throat pain, severe stomach discomfort or pain, nausea, vomiting;

bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds; or

hyperactive behavior, such as fidgeting or moving around often, or talking too much.

Common side effects of sapropterin may include:

headache;

diarrhea;

vomiting; or

runny or stuffy nose, sore throat, cough.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Before taking Sapropterin

You should not use sapropterin if you are allergic to it.

Tell your doctor if you have ever had:

stomach ulcer or bleeding; or

loss of appetite, or if you are malnourished.

It is not known if sapropterin will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

If you are pregnant, your name may be listed on a pregnancy registry to track the effects of sapropterin on the baby.

Ask a doctor if it is safe to breastfeed while using sapropterin.

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How to use Sapropterin

Usual Adult Dose for Phenylketonuria:

Initial dose: 10 to 20 mg/kg orally once a day-Blood phenylalanine (Phe) levels should be measured after 1 week, and then periodically; dose should be increased to 20 mg/kg/day if blood Phe levels have not decreasedMaintenance dose: Once responsiveness has been established, dose should be adjusted within the range of 5 to 20 mg/kg/day according to biochemical response. Non-Responders: -Patients whose phenylalanine levels do not decrease with treatment at 20 mg/kg/day for 1 month should be considered non-responders and treatment should be discontinued. Comments:-This drug should be used in conjunction with a phenylalanine-restricted diet. -Existing dietary protein and Phe intake should not be modified during the evaluation period -Response to therapy is determined by change in blood phenylalanine levels. Use: To reduce blood phenylalanine levels in patients with hyperphenylalaninemia due to tetrahydrobiopterin- (BH4-) responsive phenylketonuria (PKU).

Usual Pediatric Dose for Phenylketonuria:

1 month to 6 years:-Initial dose: 10 mg/kg orally once a day7 years or older: -Initial dose: 10 to 20 mg/kg orally once a day-Measure blood phenylalanine levels after 1 week, and then periodically; dose should be increased to 20 mg/kg/day if blood phenylalanine levels have not decreasedMaintenance dose: Once responsiveness has been established, dose should be adjusted within the range of 5 to 20 mg/kg/day according to biochemical response. Non-Responders: -Patients whose phenylalanine levels do not decrease with treatment at 20 mg/kg/day for 1 month should be considered non-responders and treatment should be discontinued. Comments:-This drug should be used in conjunction with a phenylalanine-restricted diet. -Existing dietary protein and Phe intake should not be modified during the evaluation period -Response to therapy is determined by change in blood phenylalanine levels. Use: To reduce blood phenylalanine levels in patients with hyperphenylalaninemia due to tetrahydrobiopterin- (BH4-) responsive phenylketonuria (PKU).

Warnings

Use only as directed. Tell your doctor if you use other medicines or have other medical conditions or allergies.

What other drugs will affect Sapropterin

Tell your doctor about all your other medicines, especially:

Levodopa;

methotrexate, valproic acid, phenobarbital, trimethoprim; or

medicine to treat impotence or pulmonary arterial hypertension--sildenafil (Viagra, Revatio), avanafil (Stendra), tadalafil (Adcirca, Cialis) Vardenafil (Levitra, Staxyn).

This list is not complete. Other drugs may affect sapropterin, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.

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