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