Overview
Indications
ELAPRASE is indicated for patients with Hunter syndrome (Mucopolysaccharidosis II, MPS II). ELAPRASE has been shown to improve walking capacity in patients 5 years and older. In patients 16 months to 5 years of age, no data are available to demonstrate improvement in disease-related symptoms or long term clinical outcome; however, treatment with ELAPRASE has reduced spleen volume similarly to that of adults and children 5 years of age and older. Use in Specific Populations (8.4) [see]. The safet
Boxed Warning
FDA Black Box Warning
Warnings and Precautions (5.1 5.3) Adverse Reactions (6) [see,and] Life-threatening anaphylactic reactions have occurred in some patients during and up to 24 hours after ELAPRASE infusions. Anaphylaxis, presenting as respiratory distress, hypoxia, hypotension, urticaria and/or angioedema of throat o
Contraindications
When this intervention should not be used
None.
Indications & Related Conditions
Conditions associated via SNOMED clinical relationships
Administration & Protocol
Dosing, route, and treatment protocol
Detailed dosage and administration information is available in the full FDA drug label.
View full prescribing information on DailyMedMonitoring & Follow-Up
Biomarkers relevant to this intervention via related conditions
No monitoring biomarkers have been mapped yet. Biomarker-intervention linkages are derived through related conditions and will expand as the knowledge graph grows.
Clinical Trials
3 trials linked to this intervention
Recent Trials
Long-term Evaluation on Height and Weight in Patients With MPS II Who Started Treatment at < 6 Years of Age
A Study of Elaprase in Children and Adults With Hunter Syndrome (Mucopolysaccharidosis II) in India
Safety and Clinical Outcomes in Hunter Syndrome Patients 5 Years of Age and Younger Receiving Idursulfase Therapy
Research Evidence
Published studies and systematic reviews
Research data from MEDLINE/PubMed
Benefits & Expected Outcomes
Benefits, expected outcomes, efficacy data, and NNT (Number Needed to Treat) are pending physician authorship and evidence review.
Risks & Side Effects
Adverse reaction and safety data for this drug is sourced from the FDA-approved label.
View adverse reactions & drug interactions on DailyMedRelated Symptoms
Symptoms associated with conditions this intervention addresses
No related symptoms have been mapped yet. Symptom linkages are derived through associated conditions.
Alternatives & Comparisons
Alternative treatments, comparison data, and clinical decision support are pending physician authorship.
This information is for educational purposes only and does not constitute medical advice, diagnosis, or treatment. Always consult with a qualified healthcare provider regarding any medical condition or treatment plan.
Do not start, stop, or change any treatment without consulting your healthcare provider.
Quick Facts
- Type
- Substance / Medication
- Fully Specified Name
- Idursulfase (substance)
- SNOMED CT
- 84524005
- UMLS CUI
- C1739462
- RxNorm CUI
- 644101
- Labeler
- Takeda Pharmaceuticals America, Inc.
Clinical Data
This intervention maps to 1 entities in the Healos knowledge graph.
Data is sourced from SNOMED CT, UMLS, and the Healos clinical knowledge graph. Content sections marked as pending require physician authorship. Consult a healthcare provider before starting any treatment.