Bleeding disorders:
Indications for: PRIVIGEN
Chronic immune thrombocytopenic purpura (ITP).
Clinical Trials:
Prospective, open-label, single-arm, multicenter study.
Efficacy, safety, and tolerability of Privigen was evaluated in 57 patients with chronic ITP and a platelet count of 20 x 109/L or less.
Patients received a 2g/kg dosage of Privigen administered as 1g/kg (10mL/kg) intravenous infusion daily for 2 consecutive days, and were observed for 29 days.
Primary endpoint: response rate defined as the percentage of patients with an increase in platelet counts to at least 50 x 109/L within 7 days after the first infusion (responders).
Of the 57 patients in the efficacy analysis, 46 (80.7%) responded to Privigen with a rise in platelet counts to at least 50 x 109/L within 7 days after the first infusion.
Adults and Children:
<15yrs: not established. ≥15yrs: Give by IV infusion at an initial rate of 0.5mg/kg/min, if tolerated may increase to 4mg/kg/min. Renal dysfunction, thrombosis risk: give at the minimum infusion rate practicable. Usual dose: 1g/kg once daily for 2 consecutive days for a total dose of 2g/kg. Increased risk of thrombosis, hemolysis, acute renal injury, or volume overload: consider carefully the relative risks and benefits before prescribing high dose regimen (2g/kg).
PRIVIGEN Contraindications:
IgA-deficiency with antibodies against IgA and history of hypersensitivity. Privigen contains trace amounts of IgA (≤25mcg/mL). Hyperprolinemia (contains the stabilizer L-proline). Previous severe reaction to human immune globulin.
Boxed Warning:
Thrombosis. Renal dysfunction. Acute renal failure.
PRIVIGEN Warnings/Precautions:
Advanced age, prolonged immobilization, hypercoagulable conditions, history of venous or arterial thrombosis, use of estrogens, indwelling central vascular catheters, hyperviscosity, cardiovascular risk factors: increased risk of thrombosis. Monitor for signs/symptoms of thrombosis and assess blood viscosity in patients at risk for hyperviscosity. Pre-existing renal insufficiency, diabetes, >65yrs, obese, hypovolemia: 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, hemolysis, delayed hemolytic anemia, transfusion-related acute lung injury (eg, respiratory distress, pulmonary edema, hypoxemia). History of hypertension. Monitor BP before, during and after infusions. Antibody formation. Risk of transmission of viral diseases. Have epinephrine inj available. Elderly. Pregnancy. Nursing mothers.
PRIVIGEN Classification:
Immune globulin.
PRIVIGEN Interactions:
Concomitant nephrotoxic drugs: increased risk of renal toxicity. May affect response to live virus vaccines. May interfere with serological test interpretation.
Adverse Reactions:
Headache, fatigue, nausea, chills, vomiting, pain (back, pharyngolaryngeal, extremity), elevated body temperature, abdominal pain, diarrhea, cough, stomach discomfort, chest pain, joint swelling/effusion, influenza-like illness, urticaria, dizziness, hemolysis, anemia, asthenia, hypertension, leukopenia, rash; hypersensitivity, hyperproteinemia, increased serum viscosity, hyponatremia; rare: aseptic meningitis syndrome (esp. high dose of 2g/kg), TRALI, thrombosis.
Generic Drug Availability:
NO
How Supplied:
Single-use vial (50mL, 100mL, 200mL, 400mL)—1
Miscellaneous immune disorders:
Indications for: PRIVIGEN
Chronic inflammatory demyelinating polyneuropathy (CIDP) to improve neuromuscular disability and impairment.
Limitations of Use:
Not studied for maintenance therapy longer than 6 months. Individualize the duration of any treatment beyond 6 months based on patient's response and demonstrated need for continued therapy.
Clinical Trials:
PRIMA trial
- Prospective, open-label, single-arm, multicenter clinical study.
- 28 patients with CIDP (13 IGIV-pretreated and 15 IGIV-untreated) received a Privigen loading dose of 2g/kg followed by Privigen maintenance doses of 1g/kg for up to 21 weeks with a 3 week follow up.
- Primary endpoint: responder rate of Privigen vs historical control in the adjusted 10-point Inflammatory Neuropathy Cause and Treatment (INCAT) score.
- Responder rate was defined as the proportion of subjects who demonstrated clinically meaningful improvement (at least 1 point decrease on adjusted INCAT score) between baseline and week 25, with a pre-specified threshold of 35% in the lower limit of the 2-sided 95% Wilson-Score CI.
- Overall percentage of responders was 61% (95% CI, 42.4-76.4).
- Response rates were 47% in IGIV-untreated and 77% in IGIV-pretreated patient subgroups.
- Overall median time to first adjusted INCAT response was 7.5 weeks.
PATH trial
- Same Privigen dosing regimen as in the PRIMA study.
- 207 IGIV-pretreated patients who had relapsed following withdrawal of IGIV prior to being administered Privigen.
- Response rate was 73%.
- Among the 151 patients in the PATH study who had deteriorated by 1 or more points in adjusted INCAT score following withdrawal of IGIV, 137 patients (90.7%) responded during the Privigen “restabilization” period with an increase of 1 or more adjusted INCAT score points.
- Median time to first adjusted INCAT response was 3.7 weeks.
Adult Dosage:
≥18yrs: Give by IV infusion at an initial rate of 0.5mg/kg/min, if tolerated may increase to 8mg/kg/min. Renal dysfunction, thrombosis risk, or volume overload: give at the minimum infusion rate practicable. Loading dose: 2g/kg in divided doses over 2–5 consecutive days. Maintenance: 1g/kg as a single infusion given in one day or divided into two infusions on 2 consecutive days, every 3 weeks.
Children Dosage:
<18yrs: not established.
PRIVIGEN Contraindications:
IgA-deficiency with antibodies against IgA and history of hypersensitivity. Privigen contains trace amounts of IgA (≤25mcg/mL). Hyperprolinemia (contains the stabilizer L-proline). Previous severe reaction to human immune globulin.
Boxed Warning:
Thrombosis. Renal dysfunction. Acute renal failure.
PRIVIGEN Warnings/Precautions:
Advanced age, prolonged immobilization, hypercoagulable conditions, history of venous or arterial thrombosis, use of estrogens, indwelling central vascular catheters, hyperviscosity, cardiovascular risk factors: increased risk of thrombosis. Monitor for signs/symptoms of thrombosis and assess blood viscosity in patients at risk for hyperviscosity. Pre-existing renal insufficiency, diabetes, >65yrs, obese, hypovolemia: 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, hemolysis, delayed hemolytic anemia, transfusion-related acute lung injury (eg, respiratory distress, pulmonary edema, hypoxemia). History of hypertension. Monitor BP before, during and after infusions. Antibody formation. Risk of transmission of viral diseases. Have epinephrine inj available. Elderly. Pregnancy. Nursing mothers.
PRIVIGEN Classification:
Immune globulin.
PRIVIGEN Interactions:
Concomitant nephrotoxic drugs: increased risk of renal toxicity. May affect response to live virus vaccines. May interfere with serological test interpretation.
Adverse Reactions:
Headache, fatigue, nausea, chills, vomiting, pain (back, pharyngolaryngeal, extremity), elevated body temperature, abdominal pain, diarrhea, cough, stomach discomfort, chest pain, joint swelling/effusion, influenza-like illness, urticaria, dizziness, hemolysis, anemia, asthenia, hypertension, leukopenia, rash; hypersensitivity, hyperproteinemia, increased serum viscosity, hyponatremia; rare: aseptic meningitis syndrome (esp. high dose of 2g/kg), TRALI, thrombosis.
Generic Drug Availability:
NO
How Supplied:
Single-use vial (50mL, 100mL, 200mL, 400mL)—1
Primary immune deficiency:
Indications for: PRIVIGEN
As replacement therapy for primary humoral immunodeficiency (eg, congenital agammaglobulinemia, X-linked agammaglobulinemia, common variable immunodeficiency, Wiskott-Aldrich syndrome, severe combined immunodeficiencies).
Clinical Trials:
Prospective, open-label, single-arm, multicenter study.
Efficacy, safety, and pharmacokinetics of Privigen was evaluated in adult and pediatric patients with PI, who were treated for 12 months at a 3-week or 4-week dosing interval.
Efficacy analysis included 80 patients, 16 (20%) on the 3-week dosing interval (median dose was 428.3mg/kg per infusion) and 64 (80%) on the 4-week dosing interval (median dose was 440.6mg/kg per infusion).
Primary endpoint: annual rate of acute serious bacterial infections (aSBI), defined as pneumonia, bacteremia/septicemia, osteomyelitis/septic arthritis, bacterial meningitis, and visceral abscess, per patient per year.
During the 12-month study period, the aSBI rate was 0.08 (with an upper 1-sided 99% CI of 0.203), which met the predefined success rate of less than 1 aSBI per patient per year.
The rate of other infections was 3.55 infections per patient per year.
Adults and Children:
<3yrs: not established. ≥3yrs: Give by IV infusion at an initial rate of 0.5mg/kg/min, if tolerated may increase to 8mg/kg/min. Renal dysfunction, thrombosis risk: give at the minimum infusion rate practicable. Usual dose: 200–800mg/kg every 3–4 weeks. Adjust subsequent dose based on serum IgG trough levels and clinical response.
PRIVIGEN Contraindications:
IgA-deficiency with antibodies against IgA and history of hypersensitivity. Privigen contains trace amounts of IgA (≤25mcg/mL). Hyperprolinemia (contains the stabilizer L-proline). Previous severe reaction to human immune globulin.
Boxed Warning:
Thrombosis. Renal dysfunction. Acute renal failure.
PRIVIGEN Warnings/Precautions:
Advanced age, prolonged immobilization, hypercoagulable conditions, history of venous or arterial thrombosis, use of estrogens, indwelling central vascular catheters, hyperviscosity, cardiovascular risk factors: increased risk of thrombosis. Monitor for signs/symptoms of thrombosis and assess blood viscosity in patients at risk for hyperviscosity. Pre-existing renal insufficiency, diabetes, >65yrs, obese, hypovolemia: 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, hemolysis, delayed hemolytic anemia, transfusion-related acute lung injury (eg, respiratory distress, pulmonary edema, hypoxemia). History of hypertension. Monitor BP before, during and after infusions. Antibody formation. Risk of transmission of viral diseases. Have epinephrine inj available. Elderly. Pregnancy. Nursing mothers.
PRIVIGEN Classification:
Immune globulin.
PRIVIGEN Interactions:
Concomitant nephrotoxic drugs: increased risk of renal toxicity. May affect response to live virus vaccines. May interfere with serological test interpretation.
Adverse Reactions:
Headache, fatigue, nausea, chills, vomiting, pain (back, pharyngolaryngeal, extremity), elevated body temperature, abdominal pain, diarrhea, cough, stomach discomfort, chest pain, joint swelling/effusion, influenza-like illness, urticaria, dizziness, hemolysis, anemia, asthenia, hypertension, leukopenia, rash; hypersensitivity, hyperproteinemia, increased serum viscosity, hyponatremia; rare: aseptic meningitis syndrome (esp. high dose of 2g/kg), TRALI, thrombosis.
Generic Drug Availability:
NO
How Supplied:
Single-use vial (50mL, 100mL, 200mL, 400mL)—1
