Immune Globulin Intravenous And Subcutaneous Dosage

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Usual Adult Dose for Primary Immunodeficiency Syndrome

Because there are significant differences in the half-life or IgG among patients with PI, the frequency and amount of immunoglobulin therapy may vary from one patient to another. The proper amount can be determined by monitoring clinical response.

IV: 300 to 600 mg/kg every 3 to 4 weeks adjusted over time to achieve desired trough levels and clinical response. The recommended initial infusion rate is 1 mg/kg/min and increased as tolerated to a maximum rate of 8 mg/kg/min.

If a patient routinely receives a dose of less than 400 mg/kg IV every 3 to 4 weeks, and is at risk of measles exposure (i.e., traveling to a measles endemic area), a dose of at least 400 mg/kg IV should be administered just prior to the expected measles exposure.

Subcutaneous: Begin treatment one week after receiving a regularly scheduled IGIV infusion. Initial dose: calculated by multiplying the previous IGIV dose (in grams) by 1.37, then dividing this dose into weekly doses based on the patient's previous IGIV treatment, administered subcutaneously; for example, if IGIV was administered every three weeks, divide by 3. Over time, the dose may need to be adjusted to achieve the desired clinical response and serum IgG trough level. To determine if a dose adjustment may be considered, the serum IgG trough level of the patient is measured on IGIV and as early as 5 weeks after switching from IGIV to subcutaneous. The target serum IgG trough level on weekly subcutaneous treatment is projected to be the last IGIV trough level plus 340 mg/dL. The IgG trough level should be monitored every 2 to 3 months to determine if further dose adjustments are necessary.

Gammagard (R) dosing:

IV administration:
Dose: 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:
Dose: 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 Adult Dose for Idiopathic (Immune) Thrombocytopenic Purpura

IV: 2 g/kg, divided into 2 doses of 1 g/kg given on 2 consecutive days or into 5 doses of 0.4 g/kg given on 5 consecutive days. If after administration of the first 2 daily 1 g/kg doses, an adequate increase in the platelet count is observed at 24 hours, the second dose of 1 gm/kg body weight may be withheld. The recommended initial infusion rate is 1 mg/kg/min and increased as tolerated to a maximum rate of 8 mg/kg/min.

Usual Adult Dose for Chronic Inflammatory Demyelinating Polyradiculoneuropathy

Loading dose: 2 g/kg IV, given as an infusion, in divided doses over 2 to 4 consecutive days.

Maintenance dose: 1 g/kg IV, given as an infusion, over 1 day or 0.5 g/kg IV infusion on 2 consecutive days, every 3 weeks.

The recommended initial infusion rate is 1 mg/kg/min and increased as tolerated to a maximum rate of 8 mg/kg/min.

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

Renal Dose Adjustments

Immune globulin injection has been associated with renal dysfunction, acute renal failure, osmotic nephrosis and death. Patients predisposed to acute renal failure include those with any degree of preexisting renal insufficiency, diabetes mellitus, age greater than 65, volume depletion, sepsis, paraproteinemia, or patients receiving known nephrotoxic drugs.

Liver Dose Adjustments

Data not available

Precautions

The different products of immune globulin IV differ in their content, production, composition, and properties. These factors can influence the tolerability, rate of infusion, stability, associated adverse effects, and efficacy of a product.

Immune globulin injection should be infused IV at the minimum rate practicable in patients judged to be at risk for renal dysfunction or thrombotic events.

An aseptic meningitis syndrome has occurred infrequently in association with immune globulin injection treatment. The syndrome usually begins within several hours to 2 days and is characterized by severe headache, nuchal rigidity, drowsiness, fever, photophobia, painful eye movements, and nausea and vomiting.

Immune globulin injection is made from human plasma and may contain infectious agents, such as viruses, that can cause disease.

Safety and effectiveness have not been established in pediatric patients below the age of 2 years.

Dialysis

Data not available

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