1. Development of National Guidelines for Immunoglobulin Therapy
M. Elizabeth M. younger CRNP, ph.D
The johns hopkins university
Baltimore, maryland

2. Disclosures CSL Behring: Consultant and Research Support
RMS: Clinical Advisory Panel
Immune Deficiency Foundation: Chair, Nurse Advisory Committee

3. Immunoglobulin Replacement Therapy
The Standard of Care for treatment of those immunodeficiencies characterized by hypogammaglobulinemia and impaired antibody responses to antigenic stimuli

4. Immunodeficiencies requiring Ig replacement
Primary Immunodeficiencies:
Common variable immunodeficiency
Agammaglobulinemia (X-linked or autosomal recessive)
Severe combined immunodeficiency (pre-transplant and post transplant until humoral immune reconstitution occurs)
Hyper IgM deficiency
Secondary immunodeficiencies
Agammaglobulinemia secondary to monoclonal antibody therapy (e.g. rituximab)
Hypogammaglobulinemia secondary to CLL

5. Goal of Therapy
To deliver therapy safely and effectively To achieve this goal: therapy should be facilitated by professionals who have been educated regarding the rationale for therapy and its administration

6. Considerations Site of care Mode of Administration Home Hospital
Infusion Suite
Medical Office
Mode of Administration
Intravenous
Peripheral Line
Central Venous Line
Subcutaneous
Pump
Push
Facilitated subcutaneous

7. More Considerations Administered by Physician Nurse Practitioner
Registered Nurse
Vocational Nurse
Patient
Other trained lay person

8. And Still More Intravenous Infusions Frequency: every 2-4 weeks
Product (excipients, stabilizers)
Product Concentration (5, 6, 10%)
Rate of Infusion
Pre-medications (?)
Patient risk factors/co-morbidities

9. Still More… Subcutaneous Infusions Frequency: Daily to every 4 weeks
Product Concentration (10, 16 or 20%)
Number of Sites (1 to ……)
Time of Infusion (rapid push to hours)
Premedication?

10. Process
Guidelines were developed to achieve the goal for therapy while taking into account all the considerations

12. Process Literature review Explore regional variations
Evidence based practice
Draft guidelines
Circulate guidelines
Come together to reach
consensus

15. Beth Younger, Kris Epland, Amy Meyer, Maggie Dodds, Carla Duff, Deb Sedlak, William Blouin, Jeanette Scott, Loris Aro