Name of the Procedure:

Injection, infliximab-abda, biosimilar, (Renflexis), 10 mg (Q5104)

Summary

This procedure involves administering the biosimilar drug infliximab-abda (Renflexis) via injection. It's a treatment commonly used to reduce inflammation and manage symptoms associated with various autoimmune conditions.

Purpose

Medical Conditions Addressed:

• Rheumatoid arthritis
• Crohn's disease
• Ulcerative colitis
• Ankylosing spondylitis
• Psoriatic arthritis
• Plaque psoriasis

Goals/Expected Outcomes: To relieve inflammation, reduce pain and swelling, improve joint function, and help manage overall symptoms of autoimmune diseases.

Indications

Conditions Warranting the Procedure:

• Severe and active autoimmune disease symptoms not adequately managed by other treatments.
• Patients experiencing flare-ups or worsening of their condition.

Patient Criteria:

• Diagnosis of a qualifying autoimmune disorder.
• Unresponsive or intolerant to conventional therapy.
• Assessment by a healthcare provider confirming the necessity for infliximab-abda treatment.

Preparation

Pre-Procedure Instructions:

• Discuss medical history and current medications with your healthcare provider.
• Undergo any necessary blood tests or screenings.
• Inform the doctor about any signs of infection or recent vaccinations.
• No specific fasting required, but follow specific instructions from the healthcare provider.

Procedure Description

1. Initial Assessment: Medical history and vital signs are reviewed.
2. Injection Preparation: The healthcare provider prepares the precise dosage of infliximab-abda (Renflexis), 10 mg.
3. Administration: The drug is injected intravenously (IV) or as prescribed by the healthcare provider, typically over a period of 2 hours.
4. Monitoring: The patient is monitored for any adverse reactions during and after the injection.

Tools and Equipment:

• Sterile needles and syringes
• IV infusion setup (if applicable)

Anesthesia/Sedation:

• Not typically required, but comfort measures may be provided.

Duration

The administration usually takes about 2 hours, but the total time at the clinic may be longer depending on observation requirements post-injection.

Setting

The procedure is usually performed in:

• Outpatient clinic
• Hospital infusion center

Personnel

Involved Healthcare Professionals:

• Nurse or trained healthcare provider for administration
• Possibly a physician or specialist overseeing the procedure

Risks and Complications

Common Risks:

• Injection site reactions (pain, redness, swelling)

Rare Risks:

• Allergic reactions
• Infections due to immune suppression
• Liver dysfunction
• Heart problems

Management of Complications:

• Immediate medical attention if severe reactions occur.
• Pre-treatment assessments to mitigate risks.

Benefits

Expected Benefits:

• Reduction in autoimmune disease activity
• Improved quality of life
• Symptom management within a few days to weeks

Recovery

Post-Procedure Care:

• Monitoring for immediate adverse reactions
• Routine follow-up appointments as needed

Recovery Time:

• Minimal downtime; normal activities can usually resume shortly after monitoring.

Restrictions:

• Avoid activities that might increase the risk of infection.
• Follow specific instructions from your healthcare provider.

Alternatives

Other Treatment Options:

• Other biologics (e.g., adalimumab, etanercept)
• Conventional therapy (e.g., methotrexate, corticosteroids)

Comparative Pros and Cons:

• Alternative biologics may offer similar benefits with different side effect profiles.
• Conventional therapies may be less expensive but might not be as effective for severe cases.

Patient Experience

During the Procedure:

• Some discomfort at the injection site.
• Possible mild side effects like headache, nausea, or fatigue.

After the Procedure:

• Most patients feel well enough to resume their daily activities after observation.
• Pain management and supportive care are provided as needed.

Always consult with your healthcare provider for personalized medical advice tailored to your specific condition and treatment needs.