Name of the Procedure:

Injection, Eculizumab, 10 mg (J1300) Common names: Soliris Injection

Summary

Eculizumab is a medication administered through an intravenous (IV) injection. It is a monoclonal antibody that helps block the activity of certain proteins in the body that can contribute to disease.

Purpose

Eculizumab is used to treat diseases where the immune system attacks the body's own cells, such as:

• Paroxysmal Nocturnal Hemoglobinuria (PNH)
• Atypical Hemolytic Uremic Syndrome (aHUS)
• Generalized Myasthenia Gravis (gMG)
• Neuromyelitis Optica Spectrum Disorder (NMOSD)

The goal of the procedure is to reduce symptoms, prevent disease progression, and improve the quality of life of patients.

Indications

• Hemolysis (destruction of red blood cells) in PNH
• Thrombosis (blood clots) in aHUS
• Muscle weakness in gMG
• Inflammatory damage in NMOSD

Preparation

• No specific fasting required.
• Inform the healthcare provider of any current medications or specific health conditions.
• Baseline blood tests to monitor kidney function and blood counts.
• Vaccination for meningitis is mandatory as eculizumab increases infection risk.

Procedure Description

1. A healthcare professional will confirm your identity and review your medical history.
2. The injection site will be cleaned to prevent infection.
3. Eculizumab will be administered via an IV drip over 35 minutes for adults (children may take up to 2 hours).
4. The patient will be monitored for any adverse reactions during and after the injection.

Duration

The infusion typically takes around 35 minutes for adults and up to 2 hours for children.

Setting

• Outpatient clinic or hospital infusion center.

Personnel

• Registered Nurse (RN)
• Healthcare provider overseeing the treatment (e.g., Hematologist, Neurologist)

Risks and Complications

• Common risks: Headache, upper respiratory infections, fatigue, nausea.
• Rare risks: Severe infections such as meningitis and sepsis.
• Management: Immediate antibiotics for any signs of serious infection.

Benefits

• Reduction in disease symptoms.
• Prevention of disease-related complications.
• Improved quality of life.
• Benefits can be typically seen within a few weeks of treatment initiation.

Recovery

• Patients can typically return to normal activities immediately after the procedure.
• Regular follow-up appointments to monitor disease progression and treatment effectiveness.
• Possible restrictions on activities if advised by the healthcare provider.

Alternatives

• Other monoclonal antibody treatments or immunotherapy.
• Immunosuppressive medications.
• Bone marrow transplants for specific conditions like PNH.
• Pros of alternatives: Less frequent dosing schedules.
• Cons: Potentially less effective or more side effects.

Patient Experience

• Patients might feel a slight prick from the IV insertion.
• Most patients do not experience significant discomfort during the infusion.
• Some patients may feel fatigued or have minor symptoms like headaches post-injection.
• Pain management and comfort measures are available and tailored based on the patient’s needs.