Kuvan Side Effects

Please note - some side effects for Kuvan may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Side Effects of Kuvan - for the Consumer

Kuvan

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Kuvan:

Diarrhea; headache; nausea; runny or stuffy nose; sore throat; stomach pain; vomiting.

Seek medical attention right away if any of these SEVERE side effects occur when using Kuvan:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); blood in the stool; chest pain; fainting; fever, chills, or persistent sore throat; numbness of an arm or leg; seizures; severe or persistent stomach pain; shortness of breath; signs of urinary tract infection (eg, back pain; difficult, frequent, or painful urination); sudden severe headache or vomiting; swelling of the hands, ankles, or feet.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

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Kuvan Side Effects - for the Professional

Kuvan

Clinical Trials Experience in PKU

In clinical trials, Kuvan 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 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 administration in 24 of 579 patients (4%). The most common (≥4% of patients treated with Kuvan) 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 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 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 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

	Treatment
	Kuvan	Placebo
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)
Rhinorrhea	8 (11)	0
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 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 [seeWarnings and Precautions (5.8)], 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.

  Post-Marketing Experience

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 [seeWarnings and Precautions (5.8)] and increased gamma-glutamyltransferase (GGT) in 2 of the non-PKU patients.

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Side Effects by Body System - for Healthcare Professionals

Nervous system

Nervous system side effects including headache (15%), convulsions, exacerbation of convulsions, irritability, overstimulation, agitation, and dizziness have been reported.

Respiratory

Respiratory side effects including upper respiratory tract infection (12%), rhinorrhea (11%), cough (7%), nasal congestion (4%), and respiratory failure have been reported.

Other

Other side effects including pharyngolaryngeal pain (10%), contusion (5%), abdominal pain (5%), and postprocedural bleeding have been reported.

Gastrointestinal

Gastrointestinal side effects including diarrhea (8%), vomiting (8%), and gastrointestinal bleeding have been reported.

General

General side effects including pyrexia (7%) have been reported.

Dermatologic

Dermatologic side effects including rash (5%) have been reported.

Cardiovascular

Cardiovascular side effects including myocardial infarction and peripheral edema have been reported.

Musculoskeletal

Musculoskeletal side effects including arthralgia have been reported.

Renal

Renal side effects including polyuria have been reported.

Hepatic

Hepatic side effects including two cases of increased gamma-glutamyltransferase have been reported in non-PKU patients.

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