Usual Adult Dose for Chronic Lymphocytic Leukemia

Gammagard S/D(R):

400 mg/kg, IV, every 3 to 4 weeks

Use: Prevention of bacterial infections in hypogammaglobulinemia and/or recurrent bacterial infections associated with B-cell chronic lymphocytic leukemia (CLL).

Usual Adult Dose for Idiopathic (Immune) Thrombocytopenic Purpura

Carimune(R): 400 mg/kg, IV, daily for 2 to 5 consecutive days

• Initial infusion rate is 0.5 mg/kg/min for 30 minutes.
• If initial infusion is tolerated, may increase to 1 mg/kg/min, and gradually increased step-wise as tolerated.
• Maximum infusion rate is 3 mg/kg/min.
• Chronic ITP maintenance: if, after induction therapy, platelet count falls to less than 30,000/microliter and/or there is clinically significant bleeding, 400 mg/kg may be given as a single infusion. If response is inadequate, dose can be increased to 800 to 1,000 mg/kg given as a single infusion.

Gammagard S/D(R): 1 gram/kg, IV
Maximum dose: Up to 3 separate doses on alternate days

Gammaplex(R): 1 gram/kg, IV, daily for 2 consecutive days

• Initial infusion rate is 0.5 mg/kg/min.
• May increase rate gradually every 15 minutes.
• Maximum infusion rate is 4 mg/kg/min.

Octagam(R): 1 gram/kg, IV, daily for 2 consecutive days

• Initial infusion rate is 1 mg/kg/min.
• Maximum infusion rate is 12 mg/kg/min.

Privigen(R): 1 gram/kg, IV, daily for 2 consecutive days (total dose of 2 grams/kg)

• Initial infusion rate is 0.5 mg/kg/min.
• Maximum infusion rate is 4 mg/kg/min.

Comments:

• The need for additional doses is determined by clinical response and platelet count.

Use: Prevention and/or control of bleeding in adult chronic idiopathic purpura (ITP) patients.

Usual Adult Dose for Primary Immunodeficiency Syndrome

Bivigam(R): 300 to 800 mg/kg, IV, every 3 to 4 weeks

• Infuse at 0.5 mg/kg/min for the first 10 minutes of the infusion.
• If tolerated, may increase infusion rate by 0.8 mg/kg/min every 20 minutes.
• Maximum infusion rate is 6 mg/kg/min.

Carimune(R): 400 to 800 mg/kg, IV, every 3 to 4 weeks

• Initial infusion rate is 0.5 mg/kg/min for 30 minutes.
• If tolerated, may increase to 1 mg/kg/min; gradually increase step-wise as tolerated.
• Maximum infusion rate is 3 mg/kg/min.

Flebogamma(R): 300 to 600 mg/kg, IV, every 3 to 4 weeks

• Initial infusion rate is 0.5 mg/kg/min.
• Maximum infusion rate is 5 mg/kg/min.

Gammaplex(R): 300 to 800 mg/kg, IV, every 3 to 4 weeks

• Initial infusion rate is 0.5 mg/kg/min.
• May increase rate gradually every 15 minutes.
• Maximum infusion rate is 4 mg/kg/min.

Gammagard S/D(R): 300 to 600 mg/kg, IV, every 3 to 4 weeks

Privigen(R): 200 to 800 mg/kg, IV, every 3 to 4 weeks

• Initial infusion rate is 0.5 mg/kg/min.
• Maximum infusion rate is 8 mg/kg/min

Comments:

• Adjust dose according to clinical response.
• Dose and dosing frequency may vary from patient to patient.
• No optimum target serum IgG level has been determined.
• Target a trough level of 600 mg/dL or higher of IgG; consider dose adjustments if trough IgG levels are less than 500 mg/dL.

Use: Treatment of primary immunodeficiency

Usual Pediatric Dose for Idiopathic (Immune) Thrombocytopenic Purpura

Carimune(R): 400 mg/kg, IV, daily for 2 to 5 consecutive days

• Initial infusion rate is 0.5 mg/kg/min for 30 minutes.
• If initial infusion is tolerated, may increase to 1 mg/kg/min, and gradually increased step-wise as tolerated.
• Maximum infusion rate is 3 mg/kg/min.
• Acute Childhood ITP: if platelet count response to the first 2 doses is adequate (30 to 50,000/microliter), may discontinue after the second day.
• Chronic ITP maintenance: if, after induction therapy, platelet count falls to less than 30,000/microliter and/or there is clinically significant bleeding, 400 mg/kg may be given as a single infusion. If response is inadequate, dose can be increased to 800 to 1,000 mg/kg given as a single infusion.

Gammaplex(R): 1 gram/kg, IV, daily for 2 consecutive days

• Initial infusion rate is 0.5 mg/kg/min.
• May increase rate gradually every 15 minutes.
• Maximum infusion rate is 4 mg/kg/min.

Privigen(R) (15 years and older): 1 gram/kg, IV, daily for 2 consecutive days (total dose of 2 grams/kg)

• Initial infusion rate is 0.5 mg/kg/min.
• Maximum infusion rate is 4 mg/kg/min.

Comments:

• The need for additional doses is determined by clinical response and platelet count.

Use: Prevention and/or control of bleeding in chronic idiopathic purpura (ITP) patients.

Usual Pediatric Dose for Primary Immunodeficiency Syndrome

Bivigam(R): 300 to 800 mg/kg, IV, every 3 to 4 weeks

• Infuse at 0.5 mg/kg/min for the first 10 minutes of the infusion.
• If tolerated, may increase infusion rate by 0.8 mg/kg/min every 20 minutes.
• Maximum infusion rate is 6 mg/kg/min.

Carimune(R): 400 to 800 mg/kg, IV, every 3 to 4 weeks

• Initial infusion rate is 0.5 mg/kg/min for 30 minutes.
• If tolerated, may increase to 1 mg/kg/min; gradually increase step-wise as tolerated.
• Maximum infusion rate is 3 mg/kg/min.

Flebogamma(R) (2 years and older): 300 to 600 mg/kg, IV, every 3 to 4 weeks

• Initial infusion rate is 0.5 mg/kg/min.
• Maximum infusion rate is 5 mg/kg/min.

Gammaplex(R) (2 years and older): 300 to 800 mg/kg, IV, every 3 to 4 weeks

• Initial infusion rate is 0.5 mg/kg/min.
• May increase rate gradually every 15 minutes.
• Maximum infusion rate is 4 mg/kg/min.

Gammagard S/D(R) (2 years and older): 300 to 600 mg/kg, IV, every 3 to 4 weeks

Privigen(R): 200 to 800 mg/kg, IV, every 3 to 4 weeks

• Initial infusion rate is 0.5 mg/kg/min.
• Maximum infusion rate is 8 mg/kg/min

Comments:

• Adjust dose according to clinical response.
• Dose and dosing frequency may vary from patient to patient.
• No optimum target serum IgG level has been determined.
• Target a trough level of 600 mg/dL or higher of IgG; consider dose adjustments if trough IgG levels are less than 500 mg/dL.

Use: Treatment of primary immunodeficiency

Usual Pediatric Dose for Kawasaki Disease

Gammagard S/D(R):

1 gram/kg, IV, once
or
400 mg/kg, IV, for 4 consecutive days

Comments:

• Begin within 7 days of onset of fever.
• Administer concomitant aspirin (80 to 100 mg/kg/day in 4 divided doses).

Use: Prevention of coronary artery aneurysms associated with Kawasaki syndrome in pediatric patients.

Renal Dose Adjustments

Data not available for preexisting renal impairment.

• For patients at risk of renal dysfunction or failure, administer at the minimum concentration available and the minimum infusion rate practicable.
• Consider discontinuation for renal impairment that develops during treatment.

Liver Dose Adjustments

Data not available

Precautions

US BOXED WARNING(S):
THROMBOSIS, RENAL DYSFUNCTION, and ACUTE RENAL FAILURE

• THROMBOSIS may occur with immune globulin products.
• 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 this product at the minimum dose and infusion rate practicable.
• Ensure adequate hydration in patients before administration.
• Monitor for signs and symptoms of thrombosis and assess blood viscosity in at-risk patients.
• RENAL DYSFUNCTION, acute renal failure, osmotic nephrosis, and death may occur with immune globulin intravenous (IGIV) products in predisposed patients.
• Patients predisposed to renal dysfunction include those with any degree of preexisting renal insufficiency, diabetes mellitus, age greater than 65, volume depletion, sepsis, paraproteinemia, or patients on known nephrotoxic drugs.
• Renal dysfunction and acute renal failure occur more commonly in patients receiving IGIV products containing sucrose. The manufacturer product information should be consulted.
• For patients at risk of renal dysfunction or failure, administer at the minimum concentration available and the minimum infusion rate practicable.

CONTRAINDICATIONS:

• Anaphylactic or severe systemic reaction to human immune globulin
• IgA deficiency patients with antibodies to IgA and a history of hypersensitivity

Safety and efficacy of Bivigam(R) have not been established in PI patients younger than 6 years.
Safety and efficacy of Gammagard S/D(R) have not been established in pediatric ITP patients.
Safety and efficacy of Gammaplex(R) have not been established in PI patients younger than 2 years.
Safety and efficacy of Octagam(R) have not been established in pediatric ITP patients.
Safety and efficacy of Privigen(R) have not been established in ITP patients younger than 3 years.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration advice:

• Monitor vital signs throughout the infusion.
• Stop or slow the infusion for adverse reactions; if symptoms subside promptly, may resume infusion at a lower rate.
• Ensure patients are not volume depleted.
• Administer at the minimum dose and rate practicable in patients at risk of renal dysfunction or thrombosis.

Patient advice:

• Instruct patients to immediately report decreased urine output, sudden weight gain, fluid retention, and/or shortness of breath (which may suggest kidney damage).
• Instruct patients to report thrombosis symptoms, e.g. pain or swelling with warmth of a limb, limb discoloration, unexplained shortness of breath, chest pain or discomfort that worsens on deep breathing, unexplained rapid pulse, numbness or weakness on one side of the body.