Table 2 Guiding principles for use of IGRT in patients with PIDD
Guiding principle | Guiding principle rationale |
|---|---|
Indication of immunoglobulin therapy | IGRT is indicated for patients with PIDD characterized by absent or deficient antibody production; PIDD is an FDA-approved indication for IGRT, for which all currently available products are licensed |
Diagnoses | A large number of PIDD diagnoses exist for which IGRT is indicated and recommended; many present with low total levels of IgG, but some present with a normal level and documented specific antibody deficiency |
Frequency of IGRT treatment | Treatment is indicated as ongoing replacement therapy for PIDD; treatment should not be interrupted once a definitive diagnosis has been established |
Dose | IVIG is indicated for patients with PIDD at a starting dose of 400–600 mg/kg every 3–4 wks; SCIG is generally used at a starting dose of 100–200 mg/kg/wk; SCIG dosing frequency is flexible; less frequent treatment or use of lower doses is not substantiated by clinical data |
IgG trough levels | Baseline IgG levels should not be used as the sole criterion upon which to base treatment decisions and can be used in association with clinical and other patient-specific factors to guide IGRT dosing |
Site of care | The decision to infuse IVIG in a hospital, hospital outpatient, community office, or home-based setting must be based on clinical characteristics of the patient; SCIG is administered primarily in a home-based setting |
Route | Route of IGRT administration must be based on patient characteristics; throughout life, certain patients may be more appropriate for IV or SC therapy depending on many factors, and patients should have access to either route as needed |
Product | IVIG/SCIG are not generic drugs and products are not interchangeable; a specific product needs to be matched to patient characteristics to ensure patient safety; a change of product should occur only with the active participation of the prescribing physician |