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| IMMUNE GLOBULINS | |||||
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The following is a list of immune globulins (IG) specifically for the treatment of primary immune deficiency.1,2 |
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| Brand | Strength | Form | Dose | ||
| Immune Globulin (Human) 5% | |||||
| Flebogamma DIF 5%3 | 0.5g/10mL, 2.5g/50mL, 5g/100mL, 10g/200mL, 20g/400mL | liq for IV infusion | Adults and Children: <2yrs: not established. Individualize. ≥2yrs: 300–600mg/kg IV every 3–4wks at initial rate of 0.01mL/kg/min (0.5mg/kg/min) for first 30mins. Maintenance: may gradually increase to max 0.10mL/kg/min (5mg/kg/min) if tolerated.4 | ||
| Gammaplex 5%5 | 5g/100mL, 10g/200mL, 20g/400mL | liq for IV infusion | Adults and Children: <2yrs: not established. Individualize. ≥2yrs: 300–800mg/kg IV every 3–4wks at initial rate of 0.5mg/kg/min for 15mins; if tolerated, may increase at 15min intervals up to max 4mg/kg/min.4 | ||
| Octagam 5%6 | 1g/20mL, 2.5g/50mL, 5g/100mL, 10g/200mL, 25g/500mL | liq for IV infusion | Adults and Children: Individualize. 300–600mg/kg IV every 3–4wks at initial rate of 0.5mg/kg/min for the first 30min; if tolerated, may increase at 30min intervals to 1mg/kg/min, then 2mg/kg/min, then up to max 3.33mg/kg/min. Risk of measles exposure and receives <530mg/kg every 3–4wks: may increase to at least 530mg/kg; if exposed, give as soon as possible (within 6 days of exposure). Risk of renal dysfunction/failure or thrombosis: max rate <3.3mg/kg/min. | ||
| Immune Globulin (Human) 10% | |||||
| Asceniv3 | 100mg/mL | liq for IV infusion | Adults and Children: <12yrs: insufficient data. Individualize. ≥12yrs: 300–800mg/kg IV every 3–4wks at initial rate of 0.5mg/kg/min for first 15mins. Maintenance: increase gradually every 15mins (if tolerated) up to 8mg/kg/min.4 | ||
| Bivigam3 | 100mg/mL | liq for IV infusion | Adults and Children: <6yrs: not established. Individualize. ≥6yrs: 300–800mg/kg IV every 3–4wks at initial rate of 0.5mg/kg/min for first 10mins. Maintenance: increase every 20mins (if tolerated) by 0.8mg/kg/min up to 6mg/kg/min.4 | ||
| Flebogamma DIF 10%3 | 5g/50mL, 10g/100mL, 20g/200mL | liq for IV infusion | Adults: Individualize. 300–600mg/kg IV every 3–4wks at initial rate of 0.01mL/kg/min (1mg/kg/min) for first 30mins. Maintenance: may gradually increase to 0.08mL/kg/min (8mg/kg/min) if tolerated.4 Children: Not established. |
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| Gammagard3 | 100mg/mL | liq for IV or SC infusion | Adults and Children: <2yrs: not established. ≥2yrs: IV infusion: 300–600mg/kg IV every 3–4wks at initial rate of 0.5mL/kg/hr (0.8mg/kg/min) for 30mins; maintenance: increase every 30mins (if tolerated) up to 5mL/kg/hr (8mg/kg/min). Risk of renal dysfunction/failure or thrombosis4: max rate <3.3mg/kg/min. SC infusion: initial dose = (1.37 x previous IV dose) / number of weeks between IV doses. Maintenance dose is based on clinical response and target IgG trough level. Initial infusion rate: ≥40kg: 30mL/site at 20mL/hr/site; <40kg: 20mL/site at 15mL/hr/site. Maintenance infusion rate: ≥40kg: 30mL/site at 20–30mL/hr/site; <40kg: 20mL/site at 15–20mL/hr/site. | ||
| Gammaked3,7 | 1g/10mL, 2.5g/25mL, 5g/50mL, 10g/100mL, 20g/200mL | soln for IV or SC infusion | Adults and Children: <2yrs: not established. ≥2yrs: IV infusion: 300–600mg/kg IV every 3–4wks at initial rate of 1mg/kg/min; may gradually increase to max 8mg/kg/min if tolerated4. Risk of measles exposure with routine dose of <400mg/kg every 3–4wks: give at least 400mg/kg dose just prior to expected exposure; if exposed, give 400mg/kg dose as soon as possible. SC infusion9: start 1 week after last IGIV infusion. May use up to 6 (children) or 8 (adults) infusion sites (at least 2 inches apart) simultaneously. Initial weekly dose = (1.37 x previous IGIV dose [in grams]) / number of weeks between IGIV doses. Infusion rate: adults: 20mL/hr/site; children/adolescents (if <25kg): 10mL/hr/site; (if ≥25kg): initially 15mL/hr/site, then increase up to 20mL/hr/site. | ||
| Gammaplex 10%5 | 5g/50mL, 10g/100mL, 20g/200mL | liq for IV infusion | Adults and Children: <2yrs: not established. Individualize. ≥2yrs: 300–800mg/kg IV every 3–4wks at a rate of 0.5mg/kg/min for 15mins; if tolerated, may increase at 15min intervals up to max 8mg/kg/min4. | ||
| Gamunex-C3 | 1g/10mL, 2.5g/25mL, 5g/50mL, 10g/100mL, 20g/200mL, 40g/400mL | soln for IV or SC infusion | Adults and Children: <2yrs: not established. ≥2yrs: IV infusion: 300–600mg/kg IV every 3–4wks at initial rate of 1mg/kg/min for first 30mins; if tolerated, may increase gradually to max 8mg/kg/min4. SC infusion9: start 1 week after last IGIV infusion. May use up to 6 (children) or 8 (adults) infusion sites (at least 2 inches apart) simultaneously. Initial weekly dose = (1.37 x previous IGIV dose [in grams]) / number of weeks between IGIV doses. To convert dose to mL, multiply calculated SC dose (in grams) by 10. Infusion rate: adults: 20mL/hr/site; children/adolescents (if <25kg): 10mL/hr/site;(if ≥25kg): initially 15mL/hr/site, then increase up to 20mL/hr/site. | ||
| Panzyga3 | 100mg/mL | soln for IV infusion | Adults and Children: <2yrs: not established. ≥2yrs: 300–600mg/kg IV every 3–4wks at initial rate of 1mg/kg/min for first 30mins; if tolerated, may gradually increase every 15–30mins up to max 14mg/kg/min. Risk of renal dysfunction/failure or thrombosis4: max rate 3.3mg/kg/min. | ||
| Privigen3,8 | 0.1g/mL | soln for IV infusion | Adults and Children: <3yrs: not established. ≥3yrs: 200–800mg/kg IV every 3–4wks at initial rate of 0.5mg/kg/min; if tolerated, may increase to 8mg/kg/min.4 | ||
| Immune Globulin (Human) 16.5% | |||||
| Cutaquig6 | 165mg/mL | soln for SC infusion | Adults and Children: <2yrs: not established. Individualize. ≥2yrs: Start 1 week after last IGIV or IGSC infusion (for weekly or frequent dosing), or 1–2wks after last IGIV infusion or 1wk after last IGSC infusion (for biweekly dosing).4,9 May use up to 6 infusion sites (at least 2 inches apart) simultaneously; rotate sites. Switching from IGIV: Initial weekly dose = (previous IGIV dose [in grams] x 1.30) / number of weeks between IGIV doses. Switching from other IGSC: maintain previous IGSC weekly dose (in grams). Biweekly dose: multiply the calculated weekly dose by 2. Frequent dosing (2–7 times/week): divide calculated weekly dose by the desired number of infusions per week. Dose adjustments: based on serum IgG trough levels after 2–3mos of initiation and desired clinical response (see full labeling). Risk of measles exposure and receives <245mg/kg weekly: may increase to 245mg/kg; if exposed, give as soon as possible and within 6 days of exposure. | ||
| Immune Globulin (Human) 20% | |||||
| Cuvitru3 | 200mg/mL | soln for SC infusion | Adults and Children: <2yrs: not evaluated. Individualize. ≥2yrs: Administer at regular intervals daily up to every 2wks.9 May use up to 4 sites simultaneously; rotate sites. Infuse as tolerated up to max 60mL/site at 10-20mL/hr/site for first 2 infusions, then up to 60mL/hr/site for subsequent infusions; max 240mL/hr (across 4 sites).4 Switching from IGIV or Hyqvia: initiate 1 week after last IGIV or Hyqvia infusion; convert monthly dose into equivalent weekly dose. Initial weekly dose = (previous IGIV or Hyqvia dose [g] / number of weeks between IGIV or Hyqvia doses) x 1.3. Switching from IGSC: use same weekly dose (g) as prior IGSC treatment. | ||
| Hizentra5,8 | 0.2g/mL | liq for SC infusion | Adults and Children: <2yrs: not established. Individualize. ≥2yrs: Ensure patients have received IGIV at regular intervals for at least 3mos before initiation. Start 1 week after last IGIV or IGSC infusion (for weekly or frequent dosing), or 1–2wks after last IGIV infusion or 1 week after last weekly IGSC infusion (for biweekly dosing). Infuse as tolerated up to max 15mL/site at max 15mL/hr/site for first dose; may increase to 25mL/site at max 25mL/hr/site for subsequent doses.4,9 May use up to 8 infusion sites (at least 2 inches apart) simultaneously; rotate sites. Switching from IGIV: Initial weekly dose = (1.37 x previous IGIV dose [in grams]) / number of weeks between IGIV doses. Switching from IGSC: maintain previous IGSC weekly dose. Biweekly dose: multiply the calculated weekly dose by 2. Frequent dosing (2–7 times/week): divide calculated weekly dose by the desired number of times per week. Dose adjustments: based on serum IgG trough levels after 2–3mos of initiation and desired clinical response (see full labeling). Risk of measles exposure: give a minimum total weekly dose of 0.2g/kg for 2 consecutive weeks; if biweekly dosing: give one infusion at minimum of 400mg/kg. | ||
| Xembify3 | 200mg/mL | soln for SC infusion | Adults and Children: <2yrs: not established. Individualize. ≥2yrs: Infuse as tolerated up to max 25mL/site at max rate 25mL/hr/site.4,9 May use up to 6 infusion sites (≥2 inches apart) simultaneously; rotate sites. Switching from IGIV: initiate 1 week after last IGIV infusion; convert monthly dose into equivalent weekly dose. Initial weekly dose = (prior IGIV [in grams] / number of weeks between IGIV doses) × 1.37. Switching from IGSC: use same weekly dose (in grams) as prior IGSC treatment. For frequent dosing (2–7 times/week): divide calculated weekly dose by desired number of times per week. Dose adjustments: measure serum IgG trough levels as early as 5wks after initiation and every 2–3mos based on adequate clinical response (see full labeling). | ||
| Immune Globulin (Human) 10% + Recombinant Human Hyaluronidase | |||||
| Hyqvia3 | 2.5g/200U, 5g/400U, 10g/800U, 20g/1600U, 30g/2400U | soln for SC infusion | Adults and Children: <2yrs: not established. Individualize. ≥2yrs: Start treatment 1 week after last IgG infusion; increase dose and frequency from 1-week dose to a 3- or 4-week dose. Infuse 2 components sequentially into abdomen or thighs using an infusion pump, beginning with recombinant human hyaluronidase then immune globulin within 10mins. Initial interval/dosage ramp-up: 7.5g on Week 1, then 15g on Week 2, then 22.5g on Week 4, then 30g on Week 7. Initial infusion rate (recombinant human hyaluronidase): 1–2mL/min per site or as tolerated; (immune globulin): see full labeling.4 Volume per site: (<40kg): may administer up to 300mL/site; (≥40kg): up to 600mL/site. Switching from IGIV: give at same dose and frequency as previous IV treatment after initial dose ramp-up. Switching from IGSC or if IGSC-naive: 300–600mg/kg at 3–4wk intervals after initial ramp-up. Exposed to measles: give 400mg/kg as soon as possible and within 6 days of exposure. At risk for future measles exposure: give at least 530mg/kg every 3–4wks. | ||
| NOTES | |||||
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Key: IgG = immunoglobulin G; IGIV = immune globulin intravenous; IGSC = immune globulin subcutaneous; IV = intravenous; SC = subcutaneous 1 Congenital or X-linked agammaglobulinemia, common variable immunodeficiency, Wiskott-Aldrich syndrome, or severe combined immunodeficiencies. 2 Other indications for immune globulins include, but not limited to, chronic immune thrombocytopenic purpura (ITP), chronic inflammatory demyelinating polyneuropathy (CIPD), and dermatomyositis (DM). 3 Sucrose- and preservative-free. 4 Risk of renal dysfunction/failure, volume overload, or thrombosis: give at the minimum dose and/or infusion rate practicable; see full labeling. 5 Sucrose-, maltose-, preservative- and latex-free. 6 Contains maltose; sucrose- and preservative-free. 7 Caprylate/chromatography purified. 8 Contains L-proline. 9 Give by using an infusion pump into abdomen, thigh, upper arm, and/or lateral hip areas. Prior to treatment, obtain serum IgG trough level to guide subsequent dose adjustments. Not an inclusive list of medications and/or official indications. Please see drug monograph at www.eMPR.com and/or contact company for full drug labeling. Created 9/2023 |
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