Bleeding disorders:
Indications for: PANZYGA
Chronic immune thrombocytopenia (ITP) to raise platelet counts to control or prevent bleeding.
Clinical Trials:
Treatment of Chronic Immune Thrombocytopenia (ITP) in Adults
The approval was based on data from a prospective, open-label, single-arm, multicenter study that evaluated the efficacy, safety, and tolerability of Panzyga in 40 subjects with chronic ITP and a platelet count of 20 x 109 /L or less. Patients received Panzyga 2 g/kg administered as 2 daily 1 g/kg intravenous doses, given on 2 consecutive days. Platelet counts were measured on Days 1 to 8, 15, and 22.
The study was designed to determine the response rate, defined as the percentage of subjects with an increase in platelet count to at least 50 x 109 /L within 7 days after the first infusion (responders). Additionally, maximum platelet count, the time to reach a platelet count of at least 50 x 109 /L within the first 7 days, the duration of that response (i.e., the number of days the platelet count remained in excess of 50 x 109 /L), and the regression of hemorrhages in subjects who had bleeding at baseline were observed.
Among 36 patients in the full analysis set, 29 (81% [95% CI, 64%-92%]) responded to Panzyga with a rise in platelet count to at least 50 x 109 /L within 7 days after the first infusion. The lower bound of the overall 95% confidence interval for the response rate in all 36 subjects (64%) is above the predefined response rate of 60%.
Of the 36 subjects, 23 (64%) subjects had bleeding at baseline. Bleeding was minor in 14 subjects (39%), mild in 2 subjects (6%) and moderate in 7 subjects (19%). On Day 7, only 14% of subjects were bleeding (5/36). Persistent bleeding was mild in 1 and minor in 2 subjects. Information regarding bleeding resolution was missing in 2 subjects with moderate 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.
Clinical Trials:
Treatment of Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) in Adults
The approval was based on data from a prospective, double-blind, multicenter study that compared 2 different maintenance dosages of Panzyga in 142 adults (ages 18 to 83 years) with CIDP. Patients were randomly assigned 1:2:1 to receive first a loading dose of 2g/kg, and then 0.5g/kg, 1 g/kg or 2 g/kg according to their respective dose arm for 7 maintenance infusions at 3-week intervals during the 24-week dose-evaluation phase; those in the 0.5g/kg and 1g/kg arms had the option of rescue treatment with 2 consecutive infusions of 2g/kg at 3-week intervals if criteria were met.
The primary efficacy outcome was based on the proportion of responders, defined as a patient with a decrease of at least 1 point in the adjusted 10-point Inflammatory Neuropathy Cause and Treatment (INCAT) disability score.
Results showed that almost 80% (55/69) of patients in the 1g/kg arm responded to treatment. Findings also showed a dose-dependent response based on the proportion of responders in the 2g/kg dose arm in the adjusted INCAT disability score (91.7%; 33/36), and the proportion of responders in the 1 g/kg and 2 g/kg dose arms in the grip strength (65.2% and 83.3%, respectively), inflammatory Rasch-built Overall Disability Scale (55.1% and 72.2%, respectively) and Medical Research Council sum score (72.5% and 86.1%, respectively).
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).
Clinical Trials:
Treatment of Primary Humoral Immunodeficiency (PI)
The approval was based on data from a prospective, open-label, single-arm, multicenter study that evaluated Panzyga in 51 children and adults with PI. Patients received Panzyga at a dose between 200 to 800 mg/kg body weigh every 3 or 4 weeks. In the study, patients received Panzyga for a mean of 360 days. The primary endpoint was the number of episodes of serious bacterial infections per patient per year.
Results showed that the observed rate was 0.08 serious bacterial infections per patient per year (4 infections over 50.2 patient-years). There was 1 adult patients hospitalized due to an infection for 4 days (overall rate of days in hospital per person-year: 0.080. The mean resolution time was 14 days for serious bacterial infections and 18 days for other infections.
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
