Name of the Procedure:

Injection, Natalizumab, 1 mg (HCPCS Code J2323)

Common name(s): Tysabri Injection

Summary

Natalizumab is a medication administered via injection to help manage certain autoimmune conditions by reducing inflammation and preventing immune cells from attacking healthy body tissues.

Purpose

Medical Conditions:

• Multiple Sclerosis (MS)
• Crohn's Disease

Goals/Expected Outcomes:

• Improve symptoms
• Reduce the frequency of relapses in MS
• Induce or maintain remission in Crohn's Disease

Indications

Specific symptoms or conditions:

• Relapsing forms of Multiple Sclerosis
• Moderate to severe Crohn's Disease not responding to standard therapies

Patient criteria:

• Confirmed diagnosis of MS or Crohn's Disease
• Physician-assessed disease severity and treatment resistance

Preparation

Pre-procedure instructions:

• No fasting typically required
• Instructions on any medication adjustments
• Verify no existing infections

Diagnostic tests:

• Blood tests to check for infections or other contraindications
• MRI (in the case of MS) to assess disease activity

Procedure Description

Step-by-Step:

1. Patient checks in at the treatment facility.
2. A healthcare provider prepares the injection site, usually in the arm.
3. Natalizumab is injected intravenously over approximately 1 hour.
4. Patient is observed for any adverse reactions for another hour.

Tools/Equipment:

• Sterile injection kit
• Infusion pump

Anesthesia or Sedation:

• Generally not required

Duration

The procedure usually takes about 2 hours including post-injection observation.

Setting

This injection is typically performed in a hospital or outpatient clinic specializing in infusion therapies.

Personnel

• Registered Nurse or Infusion Specialist to administer the injection
• Physician or Specialist to supervise and manage any complications
• Possible involvement of an Allergist or Immunologist

Risks and Complications

Common risks:

• Headache
• Fatigue
• Joint pain

Rare risks:

• Progressive multifocal leukoencephalopathy (PML), a serious brain infection
• Allergic reactions

Management:

• Immediate medical attention for signs of an allergic reaction or serious infection

Benefits

Expected benefits:

• Reduced symptoms of MS and Crohn's Disease
• Decreased relapse frequency in MS

Realization:

• Benefits may be observed within a few weeks to months after the injection

Recovery

Post-procedure care:

• Monitor for side effects
• Maintain hydration

Recovery time:

• Patients can often resume normal activities the same day
• Follow-up appointments every 4 to 6 weeks

Alternatives

Other treatment options:

• Oral or injectable disease-modifying therapies for MS
• Different biologics or immunosuppressants for Crohn's Disease

Pros/Cons:

• Alternatives might have different side effect profiles and durations of effectiveness
• Natalizumab may be chosen for its effectiveness when other treatments fail

Patient Experience

During the procedure:

• Mild discomfort at the injection site
• Possible mild side effects like headache or dizziness

After the procedure:

• Close monitoring for any adverse reactions
• Pain management provided if necessary

Comfort measures:

• Warm blankets and hydration offered during the procedure
• Support from healthcare professionals throughout the process