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 pathogens1,2 . Immune globulins are FDA-approved to manage primary and secondary immunodeficiencies, prevent infectious diseases, and treat other inflammatory and autoimmune disorders1-16. 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 infection1-3. Immune globulins are administered by the intravenous or subcutaneous routes1-16. Maximum recommended dosage regimens in adult patients for available immune globulins and hyperimmune globulins are summarized in Tables 1 and 2.

Table 1. Adult Immune Globulin Recommended Dosages: Intravenous Products1-11
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
  • kidney allograft recipients:
    • 150 mg/kg as IV infusion given within 72 hours after transplant, followed by 100 mg/kg as single IV dose at 2, 4, 6 and 8 weeks posttransplant; 50 mg/kg at weeks 12 and 16 after transplant
  • heart, liver, lung, pancreas allograft recipients:
    • 150 mg/kg as IV infusion given within 72 hours after transplant, followed by 150 mg/kg as single IV dose at 2, 4, 6 and 8 weeks posttransplant; 100 mg/kg at weeks 12 and 16 after transplant
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 multifocal motor neuropathy 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)
    chronic inflammatory demyelinating polyneuropathy (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
Table 2. Adult Immune Globulin Recommended Dosages: Subcutaneous Products1,2,6-8,12-16
Drug Name Dosage Form/Strength Treatment Indication Maximum Recommended Dosage 
immune globulin, human (Cutaquig®) 165 mg/1 mL Primary humoral immunodeficiency (PI)
  • For patients receiving IVIG for at least 3 months, dose based off previous IVIG dose in grams divided by the number of weeks between IVIG doses, then multiply by 1.3; begin one week after last IVIG dose## 
  • For patients receiving subcutaneous immune globulin (SCIG) for at least 3 months, maintain the previous SCIG dose##
immune globulin, human (Cuvitru®) 1 g, 2 g, 4 g, 8 g, 10 g single use vials PI
  • dose based on previous IVIG or Hyqvia® dose in grams divided by weeks treated with previous immune globulin x 1.3 and administered weekly or every two weeks; based on clinical response and serum IgG trough levels+
  • for patients receiving SCIG, weekly dose should be the same as previous SCIG therapy+
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; 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 (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 chronic inflammatory demyelinating polyneuropathy (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; 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
  • patients switching from previous IVIG treatment:  administer same dose and frequency as previous IVIG treatment as SC doses, after initial SC dose ramp-up**
  • treatment-naïve patients: 300 to 600 mg/kg every 3 to 4 weeks SC, 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: 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 

1.2. Pediatrics

Select immune globulins are FDA-approved for use in pediatric patients to manage immune thrombocytopenic purpura and primary immunodeficiencies1-16. Pediatric safety and efficacy have not yet been established for Hyqvia®1,2,15 . Maximum recommended dosages for pediatric patients are summarized in Tables 3 and 4.

Table 3. Pediatric Immune Globulin Recommended Dosages: Intravenous Products1,2,4-9,11
Drug Name Dosage Form/Strength Treatment Indication Maximum Recommended Dosage 
immune globulin, human (Flebogamma® 5% DIF) 0.5 g, 2.5 g, 5 g, 10 g, 20 g single-use vials PI 2 years to less than 18 years: 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 chronic primary immune thrombocytopenia 2 years to less than 18 years: 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 PI 2 years to less than 18 years:  300 to 600 mg/kg as IV infusion every 3 to 4 weeks (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 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 2 years to less than 18 years: 300 to 600 mg/kg as IV infusion every 3 to 4 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 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 2 years to less than 18 years: 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 6 years to less than 18 years: 300 to 600 mg/kg as IV infusion every 3 to 4 weeks
immune globulin, human (Privigen®) 5 g, 10 g, 20 g, 40 g single use vials chronic ITP 15 years to less than 18 years: 1 g/kg IV daily for two consecutive days (maximum 4 mg/kg/min)
    PI 3 years to less than 18 years: 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
Table 4. Pediatric Immune Globulin Recommended Dosages: Subcutaneous Products1,2,6-8,12-14,16
Drug Name Dosage Form/Strength Treatment Indication Maximum Recommended Dosage
immune globulin, human (Cutaquig®) 1 g, 2 g, 4 g, 8 g single use vials PI
  • 2 years to 16 years of age: for patients receiving IVIG for at least 3 months, dose based off previous IVIG dose in grams divided by the number of weeks between IVIG doses, then multiply by 1.3; begin one week after last IVIG dose## 
  • for patients receiving subcutaneous immune globulin (SCIG) for at least 3 months, maintain the previous SCIG dose##
immune globulin, human (Cuvitru®) 1 g, 2 g, 4 g, 8 g, 10 g single use vials PI
  • 2 years to less than 18 years: dose based on previous IVIG or Hyqvia® dose in grams divided by weeks treated with previous immune globulin x 1.3 and administered weekly or every two weeks; based on clinical response and serum IgG trough levels+
  • for patients receiving SCIG, weekly dose should be the same as previous SCIG therapy+
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 2 years to less than 18 years: SC dose based on previous IVIG dose x 1.37 divided by number of weeks between doses; dosage adjustments 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 2 years to less than 18 years: 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 (Gamunex®-C) 1 g protein, 2.5 g protein, 5 g protein, 10 g protein, 20 g protein, 40 g protein single-use vials PI 2 years to less than 18 years: 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 PI 2 years to less than 18 years:  may be given after patient has received IVIG for at least 3 months; 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; based on clinical response and serum IgG trough levels@
immune globulin, human (Xembify®) 1 g, 2 g, 4 g, 10 g single use vials PI 2 years to less than 18 years: for patients already receiving IVIG. Divide 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 Gammagard Liquid® package insert for specific SC dosage requirements
  • ++consult Gammaked® 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
  • @@consult Xembify® package insert for specific SC dosage requirement