Idursulfase Side Effects

Some side effects of idursulfase may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to idursulfase: intravenous solution

Some people receiving a idursulfase injection have had a reaction to the infusion (when the medicine is injected into the vein). Tell your caregiver right away if you feel dizzy, light-headed, or have hives, seizure (convulsions), trouble breathing, or swelling of your face, lips, tongue, or throat.

It may still be possible for you to receive idursulfase even after you have had a reaction to it. There are other medications that can be given to you before your idursulfase infusion to help prevent any reaction symptoms.

Call your doctor at once if you have any of these serious side effects:

• worsened asthma;

• uneven heartbeats;

• blue lips or fingernails;

• fever;

• vision problems; or

• increased blood pressure (severe headache, blurred vision, trouble concentrating, chest pain, numbness, seizure).

Less serious side effects of idursulfase may include:

• joint pain;

• pain in your arms or legs;

• headache;

• itching, mild skin rash; or

• weakness.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect.

For Healthcare Professionals

Applies to idursulfase: intravenous solution

Hypersensitivity

Hypersensitivity side effects including anaphylactoid reactions have been observed in some patients during idursulfase infusions.

General

General side effects including pyrexia (63%), headache (59%), malaise (22%), and adverse events resulting from injury (13%) have been reported.

Immunologic

Immunologic side effects including anti-idursulfase IgG antibodies (51%) and abscess (16%) have been reported.

Musculoskeletal

Musculoskeletal side effects including arthralgia (31%), limb pain (28%), musculoskeletal dysfunction (16%), and chest wall musculoskeletal pain (16%) have been reported.

Dermatologic

Dermatologic side effects including pruritis (28%), urticaria (16%), superficial injury (13%), skin disorders (13%), and pruritic rash (13%) have been reported.

Cardiovascular

Cardiovascular side effects including hypertension (25%) and atrial abnormality (13%) have been reported.

Ocular

Ocular side effects including visual disturbances (22%) have been reported.

Respiratory

Respiratory side effects including wheezing (19%) have been reported.

Nervous system

Nervous system side effects including anxiety and irritability (13%) have been reported.

Gastrointestinal

Gastrointestinal side effects including dyspepsia (13%) have been reported.

Local

Local side effects including infusion site edema (13%) have been reported.

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