ELAPRASE® (Idursulfase) Injection

ELAPRASE® is a brand-name medication that contains the active ingredient idursulfase. It is used to treat a rare genetic disorder called mucopolysaccharidosis II (MPS II), also known as Hunter syndrome. ELAPRASE® is an enzyme replacement therapy that helps address the underlying cause of MPS II by replacing the deficient enzyme iduronate-2-sulfatase. This enzyme deficiency leads to the accumulation of certain complex sugars in the body, causing a range of physical and cognitive symptoms.

Indications and Uses

ELAPRASE® is indicated for the following purposes:

• Treatment of mucopolysaccharidosis II (MPS II) or Hunter syndrome.

• It is used to replace the missing or deficient iduronate-2-sulfatase enzyme to alleviate the symptoms and slow the progression of the disorder.

Dosage and Administration

The dosage of ELAPRASE® is determined by a healthcare provider based on the patient's age, weight, and the severity of the disease.The medication is administered through intravenous (IV) infusion. The frequency and duration of treatment are individualized.

Contraindications

ELAPRASE® should not be used in individuals with known hypersensitivity to idursulfase or any of its components. It is essential to discuss any allergies or potential reactions with a healthcare provider.

Adverse Effects and Side Effects

Common side effects of ELAPRASE® may include:

• Fever.

• Headache.

• Skin rash or hives.

• Nausea.

• Diarrhea.

Serious side effects are less common but may include:

• Anaphylactic reactions, which can be life-threatening and may manifest as difficulty breathing, hives, swelling, and a drop in blood pressure.

• Encephalopathy, which can cause symptoms like changes in behavior, seizures, and difficulties with coordination.

• Thrombocytopenia, a decrease in platelet count, which can lead to easy bruising and bleeding.

It is crucial to report any side effects, especially severe or unusual ones, to your healthcare provider.

Storage and Shelf Life

Store ELAPRASE® in the refrigerator at 2-8°C (36-46°F). Do not freeze. Protect it from light. Do not use ELAPRASE® after the expiration date.

Packaging and Presentation

ELAPRASE® is available in vials as a sterile solution for IV infusion.

Regulatory Information

ELAPRASE® is subject to regulation by health authorities to ensure its safety and efficacy. It is essential to use this medication as directed by a healthcare professional and in accordance with local regulations.

References

Always consult with your healthcare provider and refer to the official prescribing information and product labeling for the most up-to-date and comprehensive information on ELAPRASE®. Your healthcare provider will guide you in the proper use of this medication, monitor your progress, and tailor the treatment to your specific medical condition.