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Kuvan Side Effects Center
Medical Editor: John P. Cunha, DO, FACOEP
Kuvan (saproterin dihydrochloride tablets) is used to help the body activate the enzyme needed to control blood levels of phenylalanine. This medication is used in people with phenylketonuria (PKU). It is a synthetic form of a natural salt that contributes to the function of a certain enzyme in the body. Common side effects include nausea, vomiting, stomach pain, diarrhea, runny or stuffy nose, cough, headache, feeling agitated, dizziness, or joint pain.The recommended starting dose of Kuvan is 10 mg/kg/day taken once daily. Kuvan may interact with levodopa, methotrexate, sildenafil, tadalafil, or vardenafil. Tell your doctor all medications and supplements you use. During pregnancy, Kuvan should be used only when prescribed. It may be harmful to a fetus. It is unknown if this drug passes into breast milk or if it could harm a nursing baby. Consult your doctor before breastfeeding. Our Kuvan (saproterin dihydrochloride) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
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.
What is Patient Information in Detail?
Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.
Kuvan in Detail - Patient Information: Side Effects
If sapropterin is not controlling your condition properly, you may have symptoms such as behavior changes, numbness or tingling, or problems with speech, vision, or balance. Call your doctor right away if you have any of these symptoms.
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have any of the serious side effects below:
- seizure (convulsions);
- chest pain or heavy feeling, pain spreading to the arm or shoulder, general ill feeling;
- easy bruising or bleeding;
- fever, chills, body aches, flu symptoms;
- swelling in your hands or feet;
- pain or burning when you urinate;
- weakness or fainting;
- black, bloody, or tarry stools; or
- coughing up blood or vomit that looks like coffee grounds.
Less serious side effects may include:
- nausea, vomiting, stomach pain, diarrhea;
- runny or stuffy nose, cough;
- headache, feeling agitated;
- dizziness; or
- joint pain.
This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.
Read the entire detailed patient monograph for Kuvan (Saproterin Dihydrochloride Tablets) »
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Kuvan FDA Prescribing Information: Side Effects
Clinical Trials Experience in PKU
In clinical trials, Kuvan (saproterin dihydrochloride tablets) has been administered to 579 patients with PKU in doses ranging from 5 to 20 mg/kg/day for lengths of treatment ranging from 1 to 30 weeks. Patients were aged 4 to 49 years old. The patient population was nearly evenly distributed in gender, and approximately 95% of patients were Caucasian.
The most serious adverse reactions during Kuvan (saproterin dihydrochloride tablets) administration (regardless of relationship to treatment) were gastritis, spinal cord injury, streptococcal infection, testicular carcinoma, and urinary tract infection. Mild to moderate neutropenia was noted during Kuvan (saproterin dihydrochloride tablets) administration in 24 of 579 patients (4%). The most common ( ≥ 4% of patients treated with Kuvan (saproterin dihydrochloride tablets) ) across all studies (n=579) were headache, diarrhea, abdominal pain, upper respiratory tract infection, pharyngolaryngeal pain, vomiting, and nausea.
The data described below reflect exposure of 74 patients with PKU to Kuvan (saproterin dihydrochloride tablets) at doses of 10 to 20 mg/kg/day for 6 to 10 weeks in 2 double-blind, placebo-controlled clinical trials. The overall incidence of adverse reactions in patients receiving Kuvan (saproterin dihydrochloride tablets) was similar to that reported with patients receiving placebo.
Because clinical trials were conducted under varying conditions, the observed adverse reaction rates may not predict the rates observed in patients in clinical practice. Table 1 enumerates treatment-emergent adverse reactions (regardless of relationship) that occurred in at least 4% of patients treated with Kuvan (saproterin dihydrochloride tablets) in the double-blind, placebo-controlled clinical trials described above. Reported frequency of adverse reactions was classified by MedDRA terms (Table 1).
Table 1: Summary of Adverse Reactions by Preferred Term Occurring in ≥ 4% of Patients in Controlled Clinical Studies With Kuvan (saproterin dihydrochloride tablets)
|Patients Treated||N = 74||N = 59|
|Preferred Term||N (%)||N (%)|
|Any Adverse Reaction||47 (64)||42 (71)|
|Headache||11 (15)||8 (14)|
|Upper respiratory tract infection||9 (12)||14 (24)|
|Pharyngolaryngeal pain||7(10)||1 (2)|
|Diarrhea||6 (8)||3 (5)|
|Vomiting||6 (8)||4 (7)|
|Cough||5 (7)||3 (5)|
|Pyrexia||5 (7)||4 (7)|
|Contusion||4 (5)||1 (2)|
|Abdominal pain||4 (5)||5 (8)|
|Rash||4 (5)||4 (7)|
|Nasal congestion||3 (4)||0|
In open-label, uncontrolled clinical trials in which all patients received Kuvan (saproterin dihydrochloride tablets) in doses of 5 to 20 mg/kg/day, adverse reactions were similar in type and frequency to those reported in the double-blind, placebo-controlled clinical trials.
Safety Experience From Clinical Studies for Non-PKU Indications
Approximately 800 healthy volunteers and patients with disorders other than PKU, some of whom had underlying neurologic disorders or cardiovascular disease, have been administered a different formulation of the same active ingredient (sapropterin) in approximately 19 controlled and uncontrolled clinical trials. In these clinical trials, subjects were administered sapropterin at doses ranging from 1 to 20 mg/kg/day for lengths of exposure from 1 day to 2 years. Serious and severe adverse reactions (regardless of relationship) during sapropterin administration were convulsions, exacerbation of convulsions [see Warnings and PRECAUTIONS], dizziness, gastrointestinal bleeding, post-procedural bleeding, headache, irritability, myocardial infarction, overstimulation, and respiratory failure. Common adverse reactions were headache, peripheral edema, arthralgia, polyuria, agitation, dizziness, and upper respiratory tract infection.
The following adverse reactions have been identified during a 10-year post-approval safety surveillance program in Japan of another formulation of the same active ingredient (sapropterin). This safety surveillance program was conducted in 30 patients, 27 of whom had disorders other than PKU and had an underlying neurologic condition. The most common adverse reactions were convulsions and exacerbation of convulsions in 3 of the non-PKU patients [see Warnings and PRECAUTIONS], and increased gamma-glutamyltransferase (GGT) in 2 of the non-PKU patients.
Read the entire FDA prescribing information for Kuvan (Saproterin Dihydrochloride Tablets) »
Additional Kuvan Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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