Name of the Procedure:

Injection, immune globulin (Gammaplex)
Technical Term: J1557 Injection, immune globulin, (Gammaplex), intravenous, non-lyophilized (e.g., liquid), 500 mg

Summary

This procedure involves the intravenous administration of Gammaplex, an immune globulin, to boost the body’s immune system. It’s done through an IV in a liquid, non-lyophilized form, specifically dosed at 500 mg.

Purpose

Medical Conditions: This treatment is used to address conditions where the immune system is compromised or deficient. Goals: To enhance the patient's immune response, providing necessary antibodies to fight infections and maintain overall health.

Indications

• Patients with primary immunodeficiency diseases (PIDD)
• Chronic inflammatory demyelinating polyneuropathy (CIDP)
• Immune thrombocytopenia (ITP)
• Multifocal motor neuropathy (MMN)
• Conditions that require immune modulation or boosting

Preparation

• Patients may need to refrain from eating or drinking for a few hours before the procedure
• Review of current medications, adjustments may be needed for blood thinners or immunosuppressants
• Pre-procedure blood tests to check for infections, kidney function, and other parameters

Procedure Description

1. Patient arrives at the setting and is seated or lying down.
2. An intravenous (IV) line is inserted into the patient's vein, typically in the arm.
3. Gammaplex is administered through the IV line slowly to ensure proper absorption and to monitor for adverse reactions.
4. Vital signs are monitored throughout the infusion to ensure patient safety.
5. After the administration, the IV is removed, and a bandage is applied to the insertion site.

Tools and Equipment:

• IV catheter and tubing
• Gammaplex solution
• Monitoring equipment for vital signs

Anesthesia or Sedation: Typically, no anesthesia or sedation is required, but local numbing may be used for IV insertion.

Duration

The infusion process usually takes about 2 to 4 hours, varying based on the patient's response and the specific dose required.

Setting

This procedure is typically performed in an outpatient clinic, hospital infusion center, or specialized treatment facility.

Personnel

• Trained nurses or infusion therapists administer the medication and monitor the patient
• Physicians oversee the procedure and are available for any complications
• Pharmacists prepare the Gammaplex solution

Risks and Complications

• Common Risks: Mild reactions like headaches, fever, chills, or dizziness
• Rare Risks: Severe allergic reactions, aseptic meningitis, kidney problems, or blood clots
• Management: Adverse effects are managed with medications, medical supervision, and adjusting the infusion rate

Benefits

• Improved immune system function
• Reduced frequency and severity of infections
• Overall better quality of life for individuals with immune deficiencies Timeframe for Benefits: Benefits can be noticed within a few days to weeks after treatment.

Recovery

• Monitoring for immediate post-infusion reactions is done for about 30-60 minutes after the procedure.
• Patients are advised to stay hydrated and rest for the remainder of the day.
• Follow-up appointments may be scheduled to monitor effectiveness and discuss any side effects.

Alternatives

• Other immunoglobulin products: May include subcutaneous immunoglobulin (SCIG) infusions
• Corticosteroids: For managing inflammation and immune response in specific conditions
• Pros and Cons: Alternatives may vary in administration methods, side effect profiles, and effectiveness based on individual conditions.

Patient Experience

• During Procedure: Patients may feel minor discomfort from the IV insertion, slight cold sensation from the infusion, and possible mild side effects like dizziness or headache
• After Procedure: Most side effects resolve within a day; hydration and rest are encouraged.
• Pain Management: Over-the-counter pain relievers can be used for minor side effects following consultation with a healthcare provider. Comfort measures like a warm blanket and a quiet environment can enhance patient comfort during the infusion.