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PRIVIGEN
Bleeding disorders
Miscellaneous immune disorders
Primary immune deficiency
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Drug Name:

PRIVIGEN Rx

Generic Name and Formulations:
Immune globulin (human) 0.1g/mL; soln for IV infusion; contains L-proline; sucrose-, preservative-, and latex-free.

Company:
CSL Behring, LLC

Therapeutic Use:

Indications for PRIVIGEN:

Chronic immune thrombocytopenic purpura (ITP).

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).

Contraindications:

IgA-deficiency with antibodies against IgA and history of hypersensitivity. Hyperprolinemia. Previous severe reaction to human immune globulin.

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.

Interactions:

Concomitant nephrotoxic drugs: increased risk of renal toxicity. May affect response to live virus vaccines. May interfere with serological test interpretation.

Pharmacological Class:

Immune globulin.

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 Availability:

NO

How Supplied:

Single-use vial (50mL, 100mL, 200mL, 400mL)—1

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.

Adult:

≥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:

<18yrs: not established.

Contraindications:

IgA-deficiency with antibodies against IgA and history of hypersensitivity. Hyperprolinemia. Previous severe reaction to human immune globulin.

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.

Interactions:

Concomitant nephrotoxic drugs: increased risk of renal toxicity. May affect response to live virus vaccines. May interfere with serological test interpretation.

Pharmacological Class:

Immune globulin.

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 Availability:

NO

How Supplied:

Single-use vial (50mL, 100mL, 200mL, 400mL)—1

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).

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.

Contraindications:

IgA-deficiency with antibodies against IgA and history of hypersensitivity. Hyperprolinemia. Previous severe reaction to human immune globulin.

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.

Interactions:

Concomitant nephrotoxic drugs: increased risk of renal toxicity. May affect response to live virus vaccines. May interfere with serological test interpretation.

Pharmacological Class:

Immune globulin.

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 Availability:

NO

How Supplied:

Single-use vial (50mL, 100mL, 200mL, 400mL)—1

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