1.1. Adults
Immune globulins, solutions comprised primarily of human immunoglobulin (Ig) G with minute concentrations of IgA and IgM, are obtained from pooled plasma from a variety of donors to guarantee a diverse antibody collection with variable antigen-binding sites. Immune globulins work by providing adequate antibody concentrations against an extensive selection of different pathogens. Immune globulins are FDA-approved to manage primary and secondary immunodeficiencies, prevent infectious diseases, and treat other inflammatory and autoimmune disorders1-15. Hyperimmune globulins like cytomegalovirus immune globulin are prepared from pooled donor serum with high antibody titers to specific infectious organisms and are used to prevent or mitigate the targeted infection1-2. Immune globulins are administered by the intravenous or subcutaneous routes1-15. Maximum recommended dosage regimens in adult patients for available immune globulins and hyperimmune globulins are summarized in Tables 1 and 2.
| Drug Name | Dosage Form/Strength | Treatment Indication | Maximum Recommended Dosage |
|---|---|---|---|
| cytomegalovirus immune globulin, human (Cytogam) | 50 mg/mL single-use vial (50 mL) | Prevention of cytomegalovirus disease in heart, kidney, lung, liver and pancreas transplant recipients |
|
| immune globulin, human (Flebogamma 5% DIF) | 0.5 g, 2.5 g, 5 g, 10 g, 20 g single-use vials | Primary Humoral immunodeficiency (PI) | 300 to 600 mg/kg as IV infusion every 3 to 4 weeks (maximum 5 mg/kg/min) |
| immune globulin, human (Flebogamma 10% DIF) | 5 g, 10 g, 20 g single-use vials | PI | 300 to 600 mg/kg as IV infusion every 3 to 4 weeks (maximum 8 mg/kg/min) |
| Chronic primary immune thrombocytopenia | 1 g/kg as IV daily for 2 consecutive days (maximum 8 mg/ kg/ min) | ||
| immune globulin, human (Gammagard Liquid) | 1 g protein, 2.5 g protein, 5 g protein, 10 g protein, 20 g protein, 30 g protein (100 mg/mL) as single-use bottles | chronic inflammatory demyelinating polyneuropathy (CIDP) | 0.5 to 2.4 g/kg/month as IV infusion based on clinical response (maximum 9 mg/kg/min) |
| PI | 300 to 600 mg/kg as IV infusion every 3 to 4 weeks based on clinical response (maximum 8 mg/kg/min) | ||
| immune globulin, human [Gammaked 10% (sucrose-free)] | 1 g protein, 5 g protein, 10 g protein, 20 g protein, single-use vials | idiopathic thrombocytopenic purpura (ITP) | 2 g/kg in two divided doses (1 g/kg) over two consecutive days, or five divided doses (0.4 g/kg) over five consecutive days^ (maximum 8 mg/kg/min) |
| CIDP | 2 g/kg as IV loading dose in divided doses over 2-4 consecutive days followed by 1 g/kg IV maintenance dose as single dose or two divided doses (0.5 g/kg) over two consecutive days every 3 weeks (maximum 8 mg/kg/min) | ||
| immune globulin, human (Gamunex-C) | 1 g protein, 2.5 g protein, 5 g protein, 10 g protein, 20 g protein, 40 g protein single use vials | CIDP | 2 g/kg as IV loading dose in divided doses over 2-4 consecutive days followed by 1 g/kg IV maintenance dose as single dose or two divided doses (0.5 g/kg) over two consecutive days every 3 weeks (maximum 8 mg/kg/min) |
| ITP | 2 g/kg in two divided doses (1 g/kg) over two consecutive days, or five divided doses (0.4 g/kg) over five consecutive days^ (maximum 8 mg/kg/min) | ||
| PI | 300 mg/kg to 600 mg/kg every 3-4 weeks (maximum 8 mg/kg/min) | ||
| immune globulin, human (Octagam 5%) | 1 g, 2.5 g, 5 g, 10 g, 25 g single use vials | PI | 300 to 600 mg/kg as IV infusion every 3 to 4 weeks (maximum 3.3 mg/kg/min) |
| immune globulin, human (Octagam 10%) | 2 g, 5 g, 10 g, 20 g, 30 g single use vials | chronic ITP | 2 g/kg IV as total dose, given as two 1 g/kg IV doses on 2 consecutive days (maximum 12 mg/kg/min) |
| dermatomyositis | 2 g/kg IV divided in equal doses given over 2-5 consecutive days every 4 weeks (maximum 4 mg/kg/min) | ||
| immune globulin, human (Privigen) | 5 g, 10 g, 20 g, 40 g single use vials | CIDP | 2 g/kg as loading dose in divided doses over 2-5 consecutive days followed by 1 g/kg maintenance dose as single dose or two divided doses (0.5 g/kg) over two consecutive days every 3 weeks (maximum 8 mg/kg/min) |
| chronic ITP | 1 g/kg IV daily for two consecutive days (maximum 4 mg/kg/min) | ||
| PI | 200 to 800 mg/kg IV every 3 to 4 weeks; adjust dose based on clinical response and serum IgG trough levels (maximum 8 mg/kg/min) |
Legend:
- ^ if platelet counts return to normal after first 1 g/kg dose, the second 1g/kg dose does not need to be administered
| Drug Name | Dosage Form/Strength | Treatment Indication | Maximum Recommended Dosage |
|---|---|---|---|
| immune globulin, human (Cutaquig) | 165 mg/1 mL | Primary humoral immunodeficiency (PI) |
|
| immune globulin, human (Cuvitru) | 1 g, 2 g, 4 g, 8 g, 10 g single use vials | PI |
|
| immune globulin, human (Gammagard Liquid) | 1 g protein, 2.5 g protein, 5 g protein, 10 g protein, 20 g protein, 30 g protein (100 mg/mL) as single-use bottles | PI | begin one week after last IVIG infusion; dose based on previous IVIG dose in grams x 1.37 divided by number of weeks between doses; dosages based on clinical response and serum IgG trough levels^^ |
| immune globulin, human [Gammaked 10% (sucrose-free)] | 1 g protein, 5 g protein, 10 g protein, 20 g protein, single-use vials | PI | begin one week after last IVIG infusion ; SC dose based on previous IVIG dose in grams x 1.37 divided by number of weeks between doses; based on clinical response and serum IgG trough levels# |
| immune globulin, human (Gamunex-C) | 1 g protein, 2.5 g protein, 5 g protein, 10 g protein, 20 g protein, 40 g protein single use vial | PI | SC dose based on previous IVIG dose in grams x 1.37 divided by number of weeks between doses; based on clinical response and serum IgG trough levels# |
| immune globulin, human (Hizentra) | 1 g, 2 g, 4 g, 10 g single use vials; 1 g, 2 g, 4 g, 10 g prefilled syringe | CIDP | begin 1 week after last IVIG infusion; 0.4 g/kg/week SC given in 1 or 2 sessions over 1 to 2 consecutive days |
| PI | may be given after patient has received IVIG for at least 3 months; SC dose based on previous IVIG dose in grams divided by number of weeks between doses x 1.37 and administered weekly (or every two weeks with the dose multiplied by two); based on clinical response and serum IgG trough levels@ | ||
| immune globulin, human with recombinant human hyaluronidase (Hyqvia) | 2.5 g, 5 g, 10 g, 20 g, 30 g single use vials | PI |
|
| immune globulin, human (Xembify) | 1 g, 2 g, 4 g, 10 g single use vials | PI | patients switching from previous IVIG treatment: divide the previous monthly IVIG dose in grams by the number of weeks between IVIG doses, then multiply by 1.37@@ |
| CIPD | patients switching from previous IVIG treatment: begin 2 weeks after last IVIG infusion; dose based on previous IVIG dose in grams divided by number of weeks between doses, after initial SC dose ramp-up** | ||
| immune globulin, human (Xembify) | 1 g, 2 g, 4 g, 10 g single use vials | PI | patients switching from previous IVIG treatment: begin one week after last IVIG infusion , divide the previous monthly IVIG dose in grams by the number of weeks between IVIG doses, then multiply by 1.37@@ |
Legend:
- ## consult Cutaquig package insert for specific SC dosage requirements
- + consult Cuvitru package insert for specific SC dosage requirements
- # consult Gamunex - C package insert for specific SC dosage requirements
- @ consult Hizentra package insert for specific SC dosage requirements
- ** Hyqvia dose ramp-up requires graduated dose increase over 3 to 4 weeks to targeted dose
- ++ consult Gammaked package insert for specific SC dosage requirements
- ^^ consult Gammagard Liquid package insert for specific SC dosage requirements
- @@ consult Xembify package insert for specific SC dosage requirements