Immune Globulin Intravenous And Subcutaneous Dosage

Usual Adult Dose for Primary Immunodeficiency Syndrome

Intravenously:
300 to 600 mg/kg, IV, every 3 to 4 weeks
-Initial infusion rate: 1 mg/kg/min
-Maximum infusion rate (if tolerated): 8 mg/kg/min

Subcutaneously:
1.37 x current IV dose in grams / number of weeks between IV doses; administer weekly
-Infuse subcutaneously at 20 mL/hr/site
-Use up to 8 infusion sites simultaneously
-Ensure infusion sites are at least 2 inches (5 cm) apart

Comments:
-Begin subcutaneous dosing one week after the patient's last IV infusion.
-For subcutaneous administration: convert the previous IV dose (in grams) by multiplying by 1.37, then dividing this dose into weekly doses based on the previous IV interval.

Use: Treatment of primary humoral immunodeficiency including, but not limited to, congenital agammaglobulinemia, common variable immunodeficiency, X-linked agammaglobulinemia, Wiskott-Aldrich syndrome, and severe combined immunodeficiencies.

Usual Adult Dose for Idiopathic (Immune) Thrombocytopenic Purpura

1 g/kg, IV, on two consecutive days (high dose regimen)
or
0.4 g/kg, IV, on five consecutive days
(total dose 2 g/kg)
-Initial infusion rate: 1 mg/kg/min; increase gradually if tolerated
-Maximum infusion rate: 8 mg/kg/min

Comments:
-If after administration of the first 1 g/kg (high dose regimen), an adequate increase in platelet count is seen at 24 hours, the second dose may be withheld.
-High dose regimen is not recommended if expanded fluid volumes exist or if fluid volume may be a concern.
-Do not administer subcutaneously in idiopathic thrombocytopenic purpura (ITP) patients.

Use: Treatment of patients with idiopathic thrombocytopenic purpura to raise platelet counts to prevent bleeding or allow surgery to be performed.

Usual Adult Dose for Chronic Inflammatory Demyelinating Polyradiculoneuropathy

Loading dose: 2 g/kg, IV, in divided doses, over 2 to 4 consecutive days
Maintenance dose: 1 g/kg, IV, over 1 day; OR 0.5 g/kg, IV, given on 2 consecutive days
-Initial infusion rate: 2 mg/kg/min
-Maintenance infusion rate (if tolerated): 8 mg/kg/min every 3 weeks

Comments:
-Patients at risk of renal dysfunction or thrombosis: administer at the minimum infusion rate practicable.

Uses: Treatment of chronic inflammatory demyelinating polyneuropathy to improve neuromuscular disability and impairment, and for maintenance therapy to prevent relapse.

Usual Adult Dose for Multifocal Motor Neuropathy

Gammagard (R):

IV administration:
Dose range 0.5 to 2.4 grams/kg/month based on clinical response
Initial infusion rate: 0.5 mL/kg/hr (0.8 mg/kg/min)
Maintenance infusion rate: Infusion rate may be advanced if tolerated to 5.4 mL/kg/hr (9 mg/kg/min)

Subcutaneous administration:
Initial Dose is 1.37 x previous intravenous dose divided by # of weeks between intravenous doses.
Maintenance dose is based on clinical response and target IgG trough level.
Initial infusion rate:
40 kg body weight (BW) and greater:
30 mL/site at 20 mL/hr/site.
Under 40 kg BW:
20 mL/site at 15 mL/hr/site
Maintenance infusion rate:
40 kg BW and greater:
30 mL/site at 20 to 30 mL/hr/site.
Under 40 kg BW:
20 mL/site at 15 to 20 mL/hr/site

Usual Pediatric Dose for Primary Immunodeficiency Syndrome

Intravenously:
300 to 600 mg/kg, IV
-Initial infusion rate: 1 mg/kg/min
-Maintenance infusion rate (if tolerated): 8 mg/kg/min every 3 to 4 weeks

Subcutaneously:
1.37 x current IV dose in grams / number of weeks between IV doses; administer weekly
-Initial infusion rate: 10 mL/hr/site
-Maintenance infusion rate; patients under 25 kg: 10 mL/hr/site
-Maintenance infusion rate; patients 25 kg and over: 20 mL/hr/site
-Use up to 6 infusion sites simultaneously
-Ensure infusion sites are at least 2 inches (5 cm) apart

Comments:
-Begin subcutaneous dosing one week after the patient's last IV infusion.
-Convert the previous IV dose (in grams) by multiplying by 1.37, then dividing this dose into weekly doses based on the previous IV interval.

Use: Treatment of primary humoral immunodeficiency including, but not limited to, congenital agammaglobulinemia, common variable immunodeficiency, X-linked agammaglobulinemia, Wiskott-Aldrich syndrome, and severe combined immunodeficiencies.

Renal Dose Adjustments

Data not available

-Ensure patients with preexisting renal insufficiency are not volume depleted.
-Discontinue if renal function deteriorates.
-Administer at the minimum infusion rate practicable.

Liver Dose Adjustments

Data not available

Dose Adjustments

-Adjust dose over time to achieve desired clinical response and serum IgG trough level.
-Clinical response is the primary consideration in dose adjustment.
-Measure serum IgG trough as soon as 5 weeks after switching from IV to subcutaneous (SC) to determine if dose adjustment is warranted.
-Target IgG troughs on weekly SC dosing = last IV IgG trough level plus 340 mg/dL.
-Monitor trough IgG every 2 to 3 months to determine if additional dose adjustments are needed.

Measles:
-Patients on routine doses less than 400 mg/kg every 3 to 4 weeks, and at risk of measles exposure (e.g. traveling to a measles endemic area): administer a dose of at least 400 mg/kg just prior to expected measles exposure.
-If a patient has been exposed to measles, administer 400 mg/kg as soon as possible after the exposure.

Precautions

BOXED WARNINGS:
THROMBOSIS, RENAL DYSFUNCTION and ACUTE RENAL FAILURE
-Thrombosis may occur.
-Thrombosis risk factors include: advanced age, prolonged immobilization, hypercoagulable conditions, history of venous or arterial thrombosis, use of estrogens, indwelling vascular catheters, hyperviscosity, and cardiovascular risk factors.
-For patients at risk of thrombosis, administer at the minimum dose and infusion rate practicable.
-Ensure adequate hydration in patients before administration.
-Monitor for thrombosis signs and symptoms.
-Assess blood viscosity in patients at risk of hyperviscosity.
-Renal dysfunction, acute renal failure, osmotic nephrosis, and death may occur in predisposed patients with use of immune globulin intravenous (IGIV).
-Renal dysfunction and acute renal failure occur more commonly in IGIV products containing glucose. This product does not contain sucrose.
-For patients at risk of renal dysfunction or failure, administer at the minimum concentration available and minimum infusion rate practicable.

Safety and efficacy have not been established in patients younger than 2 years.

-All infections suspected to have been transmitted by this product should be reported to the manufacturer.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration advice:
-Do not give subcutaneously in ITP patients because of the risk of hematoma formation.
-Administer at the minimum infusion rate practicable for patients at risk of renal dysfunction or thrombosis.

Storage requirements:
-Refrigerate; do not freeze

Reconstitution/preparation techniques:
-The manufacturer product information should be consulted.

IV compatibility:
-Incompatible with heparin; do not flush line with heparin.
-The manufacturer product information should be consulted.

Monitoring:
-Periodic renal function and urine output monitoring is particularly important in patients at increased risk of developing acute renal failure.
-Assess renal function, including BUN and serum creatinine at baseline and periodically thereafter.
-Consider baseline assessment of serum viscosity in patients at risk of hyperviscosity, including those with cryoglobulins, markedly high triglycerides, or monoclonal gammopathies, due to increased thrombosis risk.
-Perform confirmatory testing for signs of hemolysis.
-If TRALI is suspected, test for anti-neutrophil antibodies and anti-HLA antibodies in both the product and the patient's serum.