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Immune Globulin IVIG Pediatric Dosing

Dosing:
Note: Not all products are interchangeable with regards to route of administration; consult manufacturers' labeling for additional information. Product-specific dosing is provided where applicable; some clinicians use ideal body weight or an adjusted ideal body weight in morbidly-obese patients to calculate an IVIG dose (Siegel 2010; Wimperis 2011). Dosage expressed as mg/kg or mL/kg and is dependent upon route of administration; use extra precaution to ensure accuracy.
Pediatric:
Acute disseminated encephalomyelitis (ADEM): Limited data available: Children and Adolescents: IV: 1,000 mg/kg/dose once daily for 2 days (Feasby 2007)
Colitis due to Clostridium difficile, chronic: Limited data available: Infants and Children: IV: 400 mg/kg/dose every 3 weeks resulted in resolution of colitis symptoms during treatment; duration of therapy was unclear (n=5; age range: 6 to 37 months) (Abougergi 2011; Leung 1991; McFarland 2000)
Dermatomyositis, refractory: Limited data available: Children: IV: 1,000 mg/kg/dose once daily for 2 days; Note: If maintenance therapy is required, the dose and frequency should be based on clinical response and doses should not exceed 2,000 mg/kg per treatment course (Feasby 2007).
Guillain-BarrĂ© syndrome: Various regimens have been used: Limited data available: Children: IV: 1,000 mg/kg/dose once daily for 2 days (Feasby 2007; Korinthenberg 2005) or 400 mg/kg/dose once daily for 5 days (El-Bayoumi 2011; Korinthenberg 2005)
Hematopoietic cell transplantation (HCT) with hypogammaglobulinemia (IgG <400 mg/dL), prevention of bacterial infection (Tomblyn 2009): Note:Increase dose or frequency to maintain IgG concentration >400 mg/dL.
Within first 100 days after HCT:
Infants and Children (Allogeneic HCT recipients): IV: 400 mg/kg/dose once monthly
Adolescents: IV: 500 mg/kg/dose once weekly
>100 days after HCT: Infants, Children, and Adolescents: IV: 500 mg/kg/dose every 3 to 4 weeks
Hepatitis A, prophylaxis: Infants, Children, and Adolescents: Note: Hepatitis A vaccine preferred for patients 12 months to 40 years (CDC 2017): Note: In adults, total dose volumes >10 mL should be split into multiple injections given at different sites; in pediatric patients, consider splitting doses <10 mL based on patient size.
Pre-exposure prophylaxis upon travel into endemic areas (CDC 2017):
Anticipated duration of risk ≤1 month: IM: 0.1 mL/kg/dose as a single dose
Anticipated duration of risk 1 to 2 months: IM: 0.2 mL/kg/dose
Anticipated duration of risk ≥2 months: IM: 0.2 mL/kg/dose every 2 months
Postexposure prophylaxis: IM: 0.1 mL/kg/dose as a single dose given within 14 days of exposure and prior to manifestation of disease; not needed if at least 1 dose of hepatitis A vaccine was given at ≥1 month before exposure (CDC 2006; CDC 2007; CDC 2017)
HIV infection (HHS [OI pediatric 2016]): Infants and Children:
Primary prophylaxis for serious bacterial infection in patients with hypogammaglobulinemia (IgG <400 mg/dL): IV: 400 mg/kg/dose every 2 to 4 weeks
Secondary prophylaxis for invasive bacterial infections: Should only be used if subsequent infections are frequent severe infections (>2 infections during a 1-year period): IV: 400 mg/kg/dose every 2 to 4 weeks
Immune thrombocytopenia (ITP):
General dosing: Note: Dosing regimens variable, consult product specific information if available: Infants, Children, and Adolescents:
Acute therapy: IV: 400 to 1,000 mg/kg/dose once daily for 2 to 5 consecutive days for a total cumulative dose of 2,000 mg/kg; in some cases, cumulative doses up to 3,000 mg/kg have been used
Chronic therapy: IV: 400 to 1,000 mg/kg/dose every 3 to 6 weeks based on clinical response and platelet count
Manufacturer's labeling:
Carimune NF: Infants, Children, and Adolescents:
Acute therapy: IV: 400 mg/kg/dose once daily for 2 to 5 days to maintain platelet count ≥30,000/mm3 and/or to control significant bleeding. If platelet response is adequate (30,000 to 50,000/mm3) after the first 2 doses, then may discontinue therapy.
Chronic therapy: IV: 400 mg/kg/dose as a single infusion; may increase to 800 to 1,000 mg/kg/dose to maintain platelet count ≥30,000/mm3 and/or to control significant bleeding
Flebogamma DIF 10%: Children ≥2 years and Adolescents: Chronic therapy: IV: 1,000 mg/kg/dose once daily for 2 consecutive days
Gammaked: Infants, Children, and Adolescents: Acute or chronic therapy: IV: 400 to 1,000 mg/kg/dose once daily for 2 to 5 consecutive days for a total cumulative dose of 2,000 mg/kg; if an adequate platelet response is observed after the initial 1,000 mg/kg/dose, then the subsequent dose may be held
Gamunex-C: Infants, Children, and Adolescents: Acute or chronic therapy: IV: 1,000 mg/kg/dose once daily for 1 to 2 days based on patient response and/or platelet response or for fluid-restricted patients or other conditions sensitive to volume: 400 mg/kg once daily for 5 days
Privigen: Adolescents ≥15 years: Chronic therapy: IV: 1,000 mg/kg/dose once daily for 2 days
Kawasaki disease: Infants and Children: IV: 2,000 mg/kg as a single dose within 10 days of disease onset; must be used in combination with aspirin; if signs and symptoms persist ≥36 hours after completion of the infusion, retreatment with a second 2,000 mg/kg infusion may be considered (AHA [McCrindle 2017])
Measles, prophylaxis:
Pre-exposure prophylaxis (eg, during an outbreak, travel to endemic area):
Manufacturer's labeling: Patients with primary humoral immunodeficiency:
IV: Gammaked, Gamunex-C (Infants, Children, and Adolescents), Octagam 5% (Children and Adolescents, 6 to 16 years): ≥400 mg/kg/dose immediately before expected exposure; Note: Should only administer to patients whose routine dose is <400 mg/kg/dose.
SubQ infusion: Hizentra: Children ≥2 years and Adolescents:
Weekly dosing: ≥200 mg/kg/dose once weekly for 2 consecutive weeks
Biweekly dosing: ≥400 mg/kg for 1 dose
Alternate dosing: ACIP recommendations (CDC 2013): Immunocompromised patients: Infants, Children, and Adolescents:
IV: ≥400 mg/kg/dose within 3 weeks before anticipated exposure
SubQ: 200 mg/kg/dose once weekly for 2 consecutive weeks prior to anticipated exposure (CDC 2013); Note: Not all immune globulin preparations may be administered by the SubQ route; Hizentra is the only product currently approved for this indication that may be administered SubQ; consult product labeling for additional information as market availability may change
Postexposure prophylaxis:
Manufacturer's labeling: Patients with primary humoral immunodeficiency:
IV: Gammaked, Gamunex-C (Infants, Children, and Adolescents), Octgam 5% (Children and Adolescent, 6 to 16 years): 400 mg/kg/dose administered as soon as possible after exposure
SubQ infusion: Hizentra: Children ≥2 years and Adolescents:
Weekly dosing: ≥200 mg/kg/dose as soon as possible following exposure
Biweekly dosing: ≥400 mg/kg as soon as possible following exposure
Alternate dosing: ACIP guidelines (CDC 2013): Any person without evidence of measles immunity: Infants, Children, and Adolescents:
IM: 0.5 mL/kg/dose; maximum dose: 15 mL within 6 days of exposure; in adults, doses >10 mL should be split into multiple injections and administered at different sites; in pediatric patients, may also split doses <10 mL based on patient size. Note: Not all immune globulin preparations may be administered by the IM route; of the products currently available on the market, GamaSTAN S/D may be given IM; consult product labeling for additional information as market availability may change. GamaSTAN S/D manufacturer labeling suggests a lower IM dose of 0.25 mL/kg; however, this dosing was based on previous immune globulin donor potency concentrations; recent data indicates that potency from current donor populations has decreased (ie, measles immunity now from vaccinations instead of immunity from disease) requiring a higher IM immune globulin dose (0.5 mL/kg) in all patients without evidence of measles immunity to ensure adequate serum titers.
IV: 400 mg/kg/dose within 6 days of exposure
Multiple sclerosis (relapsing-remitting, when other therapies cannot be used): Limited data available: Children and Adolescents: Dosage regimen variable; optimal dose not established: IV: 1,000 mg/kg/dose once monthly, with or without an induction of 400 mg/kg/day for 5 days (Feasby 2007)
Myasthenia gravis, severe exacerbation: Limited data available: Children: IV: 400 to 1,000 mg/kg/dose once daily over 2 to 5 days for a total dose of 2,000 mg/kg; if additional therapy required, dose should be based on clinical response and titrated to minimum effective dose (Feasby 2007)
Myocarditis, acute: Limited data available: Infants, Children, and Adolescents: IV: 2000 mg/kg as a single dose. A cohort study of 21 children showed improvement in LVF recovery and survival at 1 year as compared to untreated historical cohort (Drucker 1994); efficacy results are variable (English 2004; Hia 2004; Klugman 2010); the largest data analysis did not show clear clinical benefit nor positive impact on survival (Klugman 2010)
Primary immunodeficiency disorders: Adjust dose/frequency based on desired IgG concentration and clinical response; a trough IgG concentration of ≥500 mg/dL has been recommended by some experts (Bonilla 2005); consult product specific labeling for appropriate age groups.
IV:
General dosing: Infants, Children, and Adolescents: 200 to 800 mg/kg/dose every 3 to 4 weeks
Manufacturer's labeling:
Carimune NF: Infants, Children, and Adolescents: 400 to 800 mg/kg/dose every 3 to 4 weeks
Flebogamma DIF 5%, Gammagard Liquid, Gammagard S/D (Children ≥2 years and Adolescents), Gammaked, Gamunex-C (Infants, Children, and Adolescents), Octagam 5% (Children and Adolescents 6 to 16 years): 300 to 600 mg/kg/dose every 3 to 4 weeks
Bivigam (Children ≥6 years and Adolescents), Gammaplex 5% (Children ≥2 years and Adolescents): 300 to 800 mg/kg/dose every 3 to 4 weeks
Privigen: Children ≥3 years and Adolescents: 200 to 800 mg/kg/dose every 3 to 4 weeks
SubQ infusion:
Cuvitru: Children ≥2 years and Adolescents:
Patients switching from IGIV therapy: Begin 1 week after last immune globulin IV dose. Use the following equations to calculate initial dose:
Initial weekly dosing: Dose (grams) = (IV dose [grams] divided by IV dose interval [weeks]), then multiply this dose by 1.3 (dose adjustment factor)
Biweekly dosing (grams): Multiply the calculated weekly dose by 2
Frequent dosing (2 to 7 times per week) (grams): Divide the calculated weekly dose by the desired number of times per week
Note: For subsequent dose adjustments, refer to product labeling.
Patients switching from another IG SubQ product: SubQ infusion:
Weekly dosing (grams): Weekly dose is the same as the prior immune globulin subcutaneous weekly dose
Biweekly dosing (grams): Multiply the calculated weekly dose by 2
Frequent dosing (2 to 7 times per week) (grams): Divide the calculated weekly dose by the desired number of administration times per week
Note: For subsequent dose adjustments, refer to product labeling.
Gammagard Liquid, Gammaked, Gammunex-C: Children ≥2 years and Adolescents: Begin 1 week after last IV dose. Use the following equation to calculate initial dose:
Initial weekly dose: Dose (grams) = (1.37 x IV dose [grams]) divided by (IV dose interval [weeks]); Note: For subsequent doses, refer to product labeling.
Hizentra: Children ≥2 years and Adolescents: For weekly dosing or frequent (up to daily), begin 1 week after last IV or SubQ infusion. For biweekly dosing, begin 1 or 2 weeks after last IV infusion or 1 week after the last SubQ weekly infusion. Note: Patient should have received an IV immune globulin routinely for at least 3 months before switching to SubQ. Use the following equation to calculate initial dose:
Initial weekly dose: Dose (grams) = (Previous IV dose [grams]) divided by (IV dose interval [weeks]) then multiply by 1.37; if switching from a different SubQ formulation to Hizentra, maintain previous weekly SubQ dose initially. Note: To convert the dose (in grams) to mL, multiply the calculated dose (in grams) by 5.
Note: Provided the total weekly dose is maintained, any dosing interval from daily up to biweekly (every 2 weeks) may be used. Use the following calculations to calculate frequent or biweekly dosing:
Biweekly dose (grams): Dose = Calculated or previous weekly SubQ dose (grams) multiplied by 2
Frequent (2 to 7 times per week) dosing: Dose (grams) = Calculated or previous weekly dose (grams) divided by the desired number of times per week (eg, for 3 times per week dosing, divide weekly dose by 3)
Note: For subsequent doses refer to product labeling.
Rubella, prophylaxis during pregnancy (postexposure): GamaSTAN S/D: Adolescents: IM: 0.55 mL/kg/dose as a single dose within 72 hours of exposure (Watson 1998); Note: Not recommended for routine use; may reduce, but not eliminate, risk for rubella. In adults, total dose volumes >10 mL should be split into multiple injections given at different sites.
Stevens-Johnson syndrome (SJS)/toxic epidermal necrolysis (TEN): Limited data available: Infants, Children, and Adolescents: IV: Usual dose: 1500 to 2000 mg/kg total dose as a single dose or divided over 2 to 4 days; dosing based on retrospective reviews and case reports; efficacy results are variable (Koh 2010; Morci 2000; Tristani-Firouzi 2002)
Varicella-zoster, postexposure prophylaxis (independent of HIV-status):Infants, Children, and Adolescents: Note: Use only if varicella-zoster immune globulin is unavailable.
IV: 400 mg/kg as a single infusion as soon as possible and within 10 days of exposure; ideally within 96 hours of exposure (HHS [OI pediatric 2016]; Red Book [AAP 2015])

IM: GamaSTAN S/D: 0.6 to 1.2 mL/kg/dose as a single dose within 72 hours of exposure (Gershon 1978); Note: In adults, injections >10 mL should be split into multiple injections given at different sites; in pediatric patients, consider splitting doses <10 mL based on patient size.

Dosing: Neonatal
Note: Not all products are interchangeable with regards to route of administration; consult manufacturers' labeling for additional information. Consider osmolarity and concentration during product selection; infuse as slowly as indication and stability allow. Dosage expressed as mg/kg or mL/kg dependent upon route of administration; use extra precaution to ensure accuracy.

Immune thrombocytopenia (ITP): IV: 400 to 1000 mg/kg/day for 2 to 5 consecutive days (total dose: 2000 mg/kg); maintenance dose: 400 to 1000 mg/kg/dose every 3 to 6 weeks based on clinical response and platelet count
Isoimmune hemolytic disease (Rh-incompatibility): IV: GA ≥35 weeks: 500 to 1000 mg/kg/dose once over 2 hours; if needed, dose may be repeated in 12 hours; most effective when administered as soon as possible after diagnosis (AAP Subcommittee on Hyperbilirubinemia, 2004; Girish, 2008; Gottstein, 2003; Miqdad, 2004)
Measles, prophylaxis (CDC, 2013):
Pre-exposure prophylaxis (eg, during an outbreak, travel to endemic area): Immunocompromised patients: IV: ≥400 mg/kg/dose within 3 weeks before anticipated exposure
Postexposure prophylaxis: Any neonate without evidence of measles immunity:
IM: 0.5 mL/kg/dose within 6 days of exposure; Note: Not all immune globulin preparations may be administered by the IM route; of the products currently available on the market, GamaSTAN S/D may be given IM; consult product labeling for additional information as market availability may change.
IV: 400 mg/kg/dose within 6 days of exposure
Myasthenia gravis (severe exacerbation): IV: 400 to 1000 mg/kg/dose once daily over 2 to 5 days for a total dose of 2000 mg/kg; if additional therapy required, dose should be based on clinical response and titrated to minimum effective dose (Bassan, 1998; Feasby, 2007)
Myocarditis, acute: IV: 2000 mg/kg as a single dose. A cohort study of 21 young patients, including neonates, showed improvement in LVF recovery and survival at 1 year as compared to untreated historical cohort (Drucker, 1994); efficacy results are variable (English, 2004; Hia, 2004; Klugman, 2010); the largest data analysis did not show clear clinical benefit nor positive impact on survival (Klugman, 2010).
Sepsis, adjunctive treatment: IV: Limited data available; efficacy results variable: Usual dose: 500 to 1000 mg/kg/dose once daily for 1 to 3 days (Jenson, 1997; Ohlsson, 2010). The largest trial, INIS (n=3493), reported no difference in outcomes (including incidence of subsequent sepsis, death, or major disability at 2 years) between treatment and control groups using 500 mg/kg/day for 2 days (INIS Collaborative Group, 2011).