Name of the Procedure:

Injection, Vedolizumab, 1 mg
Common names: Vedolizumab injection, Entyvio injection
Medical terms: Subcutaneous or intravenous administration of vedolizumab

Summary

Vedolizumab injection (J3380) is a medical procedure where vedolizumab, a monoclonal antibody used to treat certain gastrointestinal conditions, is administered directly into the bloodstream. It is often used for patients with moderate to severe ulcerative colitis or Crohn's disease.

Purpose

Medical Conditions Addressed:

• Ulcerative colitis
• Crohn's disease

Goals/Outcomes:

• Reduce inflammation in the gastrointestinal tract
• Induce and maintain remission of symptoms
• Improve quality of life for patients
• Minimize the need for corticosteroids and other immunosuppressants

Indications

• Moderate to severe ulcerative colitis or Crohn's disease that hasn't responded well to conventional treatments
• Patients showing symptoms such as abdominal pain, frequent diarrhea, weight loss, and fatigue
• Patients with contraindications or adverse reactions to other immunosuppressive therapies

Preparation

Pre-Procedure Instructions:

• Typically, no specific fasting or preparation is needed.
• Inform the healthcare provider of any current medications or allergies.
• Routine blood work might be ordered to ensure liver and kidney functions are normal.

Diagnostic Tests:

• Baseline blood tests and a possible tuberculosis screening
• Assessment of disease activity and severity through endoscopy or imaging studies

Procedure Description

1. Patient Arrival: Patient arrives at the clinic or hospital setting.
2. Initial Assessment: Vital signs are checked; intravenous access is established.
3. Administration: Vedolizumab is administered either intravenously (IV) over 30 minutes or subcutaneously by injection.
4. Monitoring: Patient is monitored for any adverse reactions during and after the infusion, typically for 30 minutes to one hour.

Tools/Technology:

• IV infusion set or subcutaneous injection equipment
• Vedolizumab solution
• Monitoring equipment for vital signs

Anesthesia/Sedation:

• Generally, no anesthesia or sedation is required.

Duration

The procedure typically takes about 30-45 minutes, including monitoring time.

Setting

This procedure can be performed in:

• Outpatient infusion clinics
• Hospital outpatient departments
• Specialty care centers

Personnel

• Infusion nurse or registered nurse to administer the injection
• Gastroenterologist overseeing the treatment plan
• Support staff for monitoring and patient comfort

Risks and Complications

Common Risks:

• Infusion reactions (e.g., headache, nausea, fever)
• Injection site reactions (e.g., redness, swelling)

Rare Risks:

• Severe allergic reactions (anaphylaxis)
• Infections due to immunosuppression

Complications Management:

• Immediate medical attention and management with antihistamines, steroids, or epinephrine for severe reactions
• Close monitoring for signs of infection

Benefits

Expected Benefits:

• Reduction in gastrointestinal inflammation
• Symptom relief and increased periods of remission
• Potential for decreasing the need for other medications

Realization Time:

• Initial benefits may be observed within weeks, with maximum effects typically seen in 10-14 weeks.

Recovery

Post-Procedure Care:

• Patients are usually able to resume normal activities immediately after the procedure.
• Monitoring for delayed allergic reactions or side effects over the next 24-48 hours.

Recovery Time:

• No downtime is required; normal activities can be maintained.

  Follow-Up:

• Regular follow-up appointments to monitor disease activity and treatment response.

Alternatives

Other Treatment Options:

• Other biologic therapies (e.g., anti-TNF agents like infliximab)
• Immunosuppressive therapy (e.g., azathioprine, methotrexate)
• Corticosteroids

Pros and Cons of Alternatives:

• Biologic therapies may offer similar benefits but differ in administration frequency and potential side effects.
• Immunosuppressive drugs generally have broader immune system effects compared to vedolizumab.
• Corticosteroids are effective but have significant long-term side effects.

Patient Experience

During the Procedure:

• Minimal discomfort; insertion of IV line or needle prick for subcutaneous injection.
• Patient might feel slight chills or warmth during the infusion.

After the Procedure:

• Most patients feel normal and can go about their daily routines.
• Pain management not typically necessary, but over-the-counter analgesics can be used if needed for injection site discomfort.
• Comfort measures such as warm compresses may be suggested for site reactions.

By understanding the injection of vedolizumab, patients can feel more informed and prepared for their treatment journey.