Name of the Procedure:

Injection, Factor IX, Albumin Fusion Protein, (Recombinant), Idelvion, 1 i.u. (J7202)

Summary

This procedure involves the injection of a recombinant Factor IX protein, fused with albumin (trade name: Idelvion), to help individuals with Hemophilia B manage their condition. Factor IX is essential for blood clotting, and this treatment helps replace the missing or low levels of Factor IX in these patients.

Purpose

• Medical Conditions: Primarily used to treat Hemophilia B.
• Goals/Outcomes: To prevent and control bleeding episodes, and to support perioperative management in individuals with Hemophilia B.

Indications

• Symptoms: Frequent bleeding episodes, especially in joints and muscles.
• Conditions: Confirmed diagnosis of Hemophilia B (Factor IX deficiency).
• Patient Criteria: Suitable for both adults and children, as indicated by their healthcare provider.

Preparation

• Pre-Procedure Instructions: No specific fasting or extensive preparation needed. Patients should inform their doctor of any current medications or health issues.
• Diagnostic Tests: Blood tests to determine the baseline level of Factor IX and overall health assessment.

Procedure Description

1. Step-by-Step Process:
   • The healthcare provider prepares the injection.
   • The injection site is cleaned with an antiseptic.
   • Idelvion is injected intravenously.
2. Tools/Equipment: Sterile syringe, needle, and recombinant Idelvion solution.
3. Anesthesia/Sedation: Not typically necessary, as it's a simple intravenous injection.

Duration

The injection itself takes only a few minutes. However, the entire appointment may last about 30 minutes to an hour for preparation and monitoring afterward.

Setting

Typically performed in a hospital, outpatient clinic, or a specialized treatment center.

Personnel

• Healthcare Professionals Involved: A trained nurse or physician administers the injection. Hematologists may oversee the treatment plan.

Risks and Complications

• Common Risks: Mild irritation at the injection site, headache, dizziness.
• Rare Risks: Allergic reactions, development of inhibitors (antibodies) to Factor IX, blood clots.
• Management: Immediate treatment of any allergic reactions or side effects by the medical team.

Benefits

• Benefits: Reduction in bleeding episodes, improved quality of life, and potential for fewer hospital visits. Benefits are often realized quickly, sometimes within hours to days after the injection.

Recovery

• Post-Procedure Care: Patients can usually resume normal activities soon after the injection but should follow specific advice from their healthcare provider.
• Recovery Time: Minimal to no downtime. Patients should monitor for any adverse effects and report them to their healthcare provider.
• Follow-up: Regular follow-up appointments to monitor the Factor IX levels and adjust dosage if necessary.

Alternatives

• Other Treatment Options:
  • Plasma-derived Factor IX concentrates.
  • Other recombinant Factor IX therapies.
  • Gene therapy (experimental).
• Pros and Cons:
  • Plasma-Derived: Higher risk of infections, but can be an alternative if recombinant products are not available.
  • Other Recombinant Therapies: Similar in function but may differ in dosing schedules and duration of action.
  • Gene Therapy: Potentially long-term solution but still under research.

Patient Experience

• What to Expect: Mild discomfort at the injection site; otherwise, the procedure is typically painless.
• Pain Management: Generally, no pain management is required. Any discomfort can usually be managed with over-the-counter painkillers.
• Comfort Measures: Relaxation techniques or the presence of a support person can help ease any anxiety during the procedure.