Select therapeutic use:

Bleeding disorders:

Indications for PANZYGA:

Chronic immune thrombocytopenia (ITP) to raise platelet counts to control or prevent bleeding.

Adult Dosage:

Give by IV infusion at an initial rate of 1mg/kg/min for first 30mins; if tolerated, may gradually increase every 15‒30mins up to max 8mg/kg/min. 2g/kg divided into 2 daily doses of 1g/kg given on 2 consecutive days. Renal dysfunction, thrombosis risk: give at the minimum infusion rate practicable; max 3.3mg/kg/min.

Children Dosage:

Not established.

PANZYGA Contraindications:

IgA deficiency with antibodies against IgA and history of hypersensitivity. Previous severe reaction to human immunoglobulin.

Boxed Warning:

Thrombosis. Renal dysfunction. Acute renal failure.

PANZYGA Warnings/Precautions:

Advanced age, prolonged immobilization, hypercoagulable conditions, history of venous or arterial thrombosis, use of estrogens, indwelling central vascular catheters, hyperviscosity, cardiovascular disorders: increased risk of thrombosis. Ensure adequate hydration. Monitor for signs/symptoms of thrombosis and assess blood viscosity in patients at risk for hyperviscosity. Pre-existing renal insufficiency, diabetes, >65yrs, hypovolemia, sepsis, paraproteinemia: increased risk of renal dysfunction and acute renal failure. Correct volume depletion; assess renal function, BUN, serum creatinine, urine output before and during therapy; discontinue if renal function deteriorates. Monitor for aseptic meningitis (esp. in those with a history of migraine), hemolysis, delayed hemolytic anemia. Consider lab testing including measurement of hemoglobin or hematocrit at baseline and approx. 36–96hrs post-infusion in patients with higher risk for hemolysis. Monitor for pulmonary dysfunction; perform tests for anti-HLA and anti-neutrophil antibodies if transfusion-related acute lung injury (TRALI) is suspected. History of hypertension. Monitor BP before, during, and after infusion. Risk of transmission of viral diseases. Have epinephrine inj available. Elderly. Pregnancy. Nursing mothers.

PANZYGA Classification:

Immune globulin.

PANZYGA Interactions:

May affect response to live viral vaccines; defer immunization for ≥3 months. Concomitant nephrotoxic drugs: increased risk of renal dysfunction. May interfere with serological testing (eg, false [+] Treponema pallidum test may result).

Adverse Reactions:

Headache, fever, nausea, fatigue, abdominal pain, vomiting, dizziness, anemia, dermatitis, increased BP; hypersensitivity, renal dysfunction, hyperproteinemia, hyponatremia, hemolytic anemia, aseptic meningitis syndrome (esp. with high doses ≥2g/kg and/or rapid infusion), TRALI, thrombosis.

Generic Drug Availability:

NO

How Supplied:

Single-use bottle (10mL, 25mL, 50mL, 100mL, 200mL, 300mL)—1

Miscellaneous immune disorders:

Indications for PANZYGA:

Chronic inflammatory demyelinating polyneuropathy (CIDP) to improve neuromuscular disability and impairment.

Adult Dosage:

Give by IV infusion at an initial rate of 1mg/kg/min for first 30mins; if tolerated, may gradually increase every 15‒30mins up to max 12mg/kg/min. Loading dose: 2g/kg divided into 2 daily doses of 1g/kg given on 2 consecutive days. Maintenance dose: 1‒2g/kg divided into 2 daily doses given on 2 consecutive days every 3 weeks. Renal dysfunction, thrombosis risk: give at the minimum infusion rate practicable; max 3.3mg/kg/min.

Children Dosage:

Not established.

PANZYGA Contraindications:

IgA deficiency with antibodies against IgA and history of hypersensitivity. Previous severe reaction to human immunoglobulin.

Boxed Warning:

Thrombosis. Renal dysfunction. Acute renal failure.

PANZYGA Warnings/Precautions:

Advanced age, prolonged immobilization, hypercoagulable conditions, history of venous or arterial thrombosis, use of estrogens, indwelling central vascular catheters, hyperviscosity, cardiovascular disorders: increased risk of thrombosis. Ensure adequate hydration. Monitor for signs/symptoms of thrombosis and assess blood viscosity in patients at risk for hyperviscosity. Pre-existing renal insufficiency, diabetes, >65yrs, hypovolemia, sepsis, paraproteinemia: increased risk of renal dysfunction and acute renal failure. Correct volume depletion; assess renal function, BUN, serum creatinine, urine output before and during therapy; discontinue if renal function deteriorates. Monitor for aseptic meningitis (esp. in those with a history of migraine), hemolysis, delayed hemolytic anemia. Consider lab testing including measurement of hemoglobin or hematocrit at baseline and approx. 36–96hrs post-infusion in patients with higher risk for hemolysis. Monitor for pulmonary dysfunction; perform tests for anti-HLA and anti-neutrophil antibodies if transfusion-related acute lung injury (TRALI) is suspected. History of hypertension. Monitor BP before, during, and after infusion. Risk of transmission of viral diseases. Have epinephrine inj available. Elderly. Pregnancy. Nursing mothers.

PANZYGA Classification:

Immune globulin.

PANZYGA Interactions:

May affect response to live viral vaccines; defer immunization for ≥3 months. Concomitant nephrotoxic drugs: increased risk of renal dysfunction. May interfere with serological testing (eg, false [+] Treponema pallidum test may result).

Adverse Reactions:

Headache, fever, nausea, fatigue, abdominal pain, vomiting, dizziness, anemia, dermatitis, increased BP; hypersensitivity, renal dysfunction, hyperproteinemia, hyponatremia, hemolytic anemia, aseptic meningitis syndrome (esp. with high doses ≥2g/kg and/or rapid infusion), TRALI, thrombosis.

Generic Drug Availability:

NO

How Supplied:

Single-use bottle (10mL, 25mL, 50mL, 100mL, 200mL, 300mL)—1

Primary immune deficiency:

Indications for PANZYGA:

Primary humoral immunodeficiency (eg, congenital agammaglobulinemia, common variable immunodeficiency, X-linked agammaglobulinemia, Wiskott-Aldrich syndrome, severe combined immunodeficiencies).

Adults and Children:

<2yrs: not established. ≥2yrs: Give by IV infusion 300‒600mg/kg every 3‒4 weeks at an initial rate of 1mg/kg/min for first 30mins; if tolerated, may gradually increase every 15‒30mins up to max 14mg/kg/min. Renal dysfunction, thrombosis risk: give at the minimum infusion rate practicable; max 3.3mg/kg/min. Adjust subsequent dose based on serum IgG trough levels and clinical response. Measles exposure: see full labeling.

PANZYGA Contraindications:

IgA deficiency with antibodies against IgA and history of hypersensitivity. Previous severe reaction to human immunoglobulin.

Boxed Warning:

Thrombosis. Renal dysfunction. Acute renal failure.

PANZYGA Warnings/Precautions:

Advanced age, prolonged immobilization, hypercoagulable conditions, history of venous or arterial thrombosis, use of estrogens, indwelling central vascular catheters, hyperviscosity, cardiovascular disorders: increased risk of thrombosis. Ensure adequate hydration. Monitor for signs/symptoms of thrombosis and assess blood viscosity in patients at risk for hyperviscosity. Pre-existing renal insufficiency, diabetes, >65yrs, hypovolemia, sepsis, paraproteinemia: increased risk of renal dysfunction and acute renal failure. Correct volume depletion; assess renal function, BUN, serum creatinine, urine output before and during therapy; discontinue if renal function deteriorates. Monitor for aseptic meningitis (esp. in those with a history of migraine), hemolysis, delayed hemolytic anemia. Consider lab testing including measurement of hemoglobin or hematocrit at baseline and approx. 36–96hrs post-infusion in patients with higher risk for hemolysis. Monitor for pulmonary dysfunction; perform tests for anti-HLA and anti-neutrophil antibodies if transfusion-related acute lung injury (TRALI) is suspected. History of hypertension. Monitor BP before, during, and after infusion. Risk of transmission of viral diseases. Have epinephrine inj available. Elderly. Pregnancy. Nursing mothers.

PANZYGA Classification:

Immune globulin.

PANZYGA Interactions:

May affect response to live viral vaccines; defer immunization for ≥3 months. Concomitant nephrotoxic drugs: increased risk of renal dysfunction. May interfere with serological testing (eg, false [+] Treponema pallidum test may result).

Adverse Reactions:

Headache, fever, nausea, fatigue, abdominal pain, vomiting, dizziness, anemia, dermatitis, increased BP; hypersensitivity, renal dysfunction, hyperproteinemia, hyponatremia, hemolytic anemia, aseptic meningitis syndrome (esp. with high doses ≥2g/kg and/or rapid infusion), TRALI, thrombosis.

Generic Drug Availability:

NO

How Supplied:

Single-use bottle (10mL, 25mL, 50mL, 100mL, 200mL, 300mL)—1