Idursulfase

Idursulfase is an enzyme used to treat some of the symptoms of a genetic condition called Hunter syndrome (also called mucopolysaccharidosis). Idursulfase may improve walking ability in people with this condition. Idursulfase is not a cure for Hunter syndrome.

• Idursulfase is available under the following different brand names: Elaprase

Common side effects of Idursulfase include:

• joint pain
• pain in the arms or legs
• headache
• itching
• mild skin rash
• weakness
• diarrhea
• cough
• hives

Serious side effects of Idursulfase include:

• hives
• difficulty breathing
• swelling of the face, lips, tongue, or throat
• seizures

Rare side effects of Idursulfase include:

• none

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, coordination loss, unsteady, very stiff muscles, high fever, profuse sweating, or tremors
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, light-headedness, or passing out

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult and pediatric dosage

Injectable solution

• 2 mg/mL (as 6 mg/3 mL single-use vial)

Hunter syndrome

Adult dosage

• 0.5 mg/kg IV every week; infuse over 1-3 hours every week

Pediatric dosage

• Children aged younger than 5 years: Safety and efficacy not established
• Children aged 5 years and older: 0.5 mg/kg IV every week; infuse over 1-3 hours

Dosage Considerations – Should be Given as Follows:

• See "Dosages"

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, healthcare provider, or pharmacist first.

• Idursulfase has no noted severe interactions with any other drugs.
• Idursulfase has no noted serious interactions with any other drugs.
• Idursulfase has no noted moderate interactions with any other drugs.
• Idursulfase has no noted minor interactions with any other drugs.

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all the products you use. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your healthcare professional or doctor for additional medical advice, health questions, or concerns.

Contraindications

• None listed in the manufacturer's label

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Idursulfase?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Idursulfase?”

Cautions

• Risk for anaphylactoid reactions; monitor patients with compromised respiratory function/acute respiratory disease
• Patients with compromised respiratory function or acute febrile or respiratory illness at the time of infusion may be at a higher risk for life-threatening complications from hypersensitivity reactions
• Risk for hypersensitivity and antibody development is higher in individuals with severe genetic mutations (ie, complete gene deletion, large gene rearrangement, nonsense, frameshift, or splice site mutations)
• Caution when administering to patients susceptible to fluid overload or patients with acute underlying respiratory illness or compromised cardiac and/or respiratory function for whom fluid restriction is indicated; risk for serious exacerbation of cardiac or respiratory status during infusions
• Development of anti-idursulfase IgG antibodies reported in 51% of patients, which may increase the incidence of infusion-related reactions
• A registry has been created to track adverse effects, and monitor therapeutic responses during long-term treatment; may contact 1-866-888-0660 or www.eleprase.com

Pregnancy and Lactation

• There are no adequate and well-controlled studies in pregnant women; available data from a small number of postmarketing cases in pregnancy are insufficient to inform drug-associated risks for major birth defects, miscarriage, or adverse maternal or fetal outcomes
• Lactation
  • There are no data on the presence of the drug in human milk, its effects on the breastfed infant, or milk production; the drug was excreted in the breast milk of lactating rats; the drug's presence in animal milk makes it likely that it will be present in human milk; consider developmental and health benefits of breastfeeding along with mother's clinical need for therapy and any potential adverse effects on the breastfed child from therapy or underlying maternal condition