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.
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
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 |
|
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 | 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