1.2. Pediatrics

Select immune globulins are FDA-approved for use in pediatric patients to manage immune thrombocytopenic purpura and primary immunodeficiencies^1-15. Hyqvia was recently approved for pediatric use (2 years and older) for primary immunodeficiencies^1,14. Maximum recommended dosages for pediatric patients are summarized in Tables 3 and 4.

Table 3. Pediatric Immune Globulin Recommended Dosages: Intravenous Products^1,2,4-9,11

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 Products^{1,2,6-8,12-14,16}

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, 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), 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: 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	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