SAPROPTERIN DIHYDROCHLORIDE

Electrolyte / Mineral

Brand names: Sapropterin Dihydrochloride

Oral

Mechanism of Action

12.1 Mechanism of Action Sapropterin dihydrochloride is a synthetic form of BH4, the cofactor for the enzyme phenylalanine hydroxylase (PAH). PAH hydroxylates Phe through an oxidative reaction to form tyrosine. In patients with PKU, PAH activity is absent or deficient. Treatment with BH4 can activate residual PAH enzyme activity, improve the normal oxidative metabolism of Phe, and decrease Phe levels in some patients.

Indications

See full prescribing information

Contraindications

• 4 CONTRAINDICATIONS None. None. ( 4 )

FDA Warnings

5 WARNINGS AND PRECAUTIONS Hypersensitivity Reactions Including Anaphylaxis : Sapropterin dihydrochloride is not recommended in patients with a history of anaphylaxis to sapropterin dihydrochloride; discontinue treatment in patients who experience anaphylaxis and initiate appropriate medical treatment
2 ) Hypophenylalaninemia : Pediatric patients younger than 7 years treated with sapropterin dihydrochloride doses of 20 mg/kg per day are at increased risk for low levels of blood Phe compared with patients 7 years and older
Serious adverse reactions included esophagitis and gastritis [see Adverse Reactions (6

Known Side Effects

10 documented side effects by frequency

Drug Not Working

>10%

Headache

>10%

Vomiting

1-10%

Diarrhea

1-10%

Nausea

1-10%

Anxiety

1-10%

Cough

0.1-1%

Upper Respiratory Infection

0.1-1%

Joint Pain

0.1-1%

Dizziness

0.1-1%

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Formulations

Dosage Forms

Tablet

Route

Oral