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PRIVIGEN
Bleeding 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

e-Prescribe this drug via Surescripts

Therapeutic Use:

Indications for PRIVIGEN:

Chronic immune thrombocytopenic purpura (ITP).

Adults and Children's Dose:

<15yrs: not recommended. ≥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).

Pharmacological Class:

Immune globulin.

Contraindications:

IgA-deficiency with IgA antibodies. Hyperprolinemia.

Warnings/Precautions:

Correct volume depletion; assess renal function, BUN, serum creatinine, urine output before and during therapy; discontinue if renal function deteriorates. Diabetes, obese, hypovolemia: increased risk of renal dysfunction. History of atherosclerosis, multiple CV risk factors, advanced age, impaired cardiac output, coagulation disorders, prolonged immobilization, hyperviscosity: increased risk of thrombotic events; consider baseline assessment of blood viscosity for those at risk of hyperviscosity. Monitor for aseptic meningitis, hemolysis, delayed hemolytic anemia, transfusion-related acute lung injury (eg, respiratory distress, pulmonary edema, hypoxemia). Antibody formation. Risk of transmission of viral diseases. Have epinephrine inj available. Elderly. Pregnancy (Cat.C). Nursing mothers.

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, pain, nausea, vomiting, fatigue, chills, joint swelling/effusion, pyrexia, urticaria, anemia, hyperthermia; hyperproteinemia, increased serum viscosity, hyponatremia; rare: aseptic meningitis syndrome (esp. high dose of 2g/kg), hemolysis, TRALI, thrombosis.

Generic Availability:

NO

How Supplied:

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

Indications for PRIVIGEN:

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

Adults and Children's Dose:

<3yrs: not recommended. ≥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.

Pharmacological Class:

Immune globulin.

Contraindications:

IgA-deficiency with IgA antibodies. Hyperprolinemia.

Warnings/Precautions:

Correct volume depletion; assess renal function, BUN, serum creatinine, urine output before and during therapy; discontinue if renal function deteriorates. Diabetes, obese, hypovolemia: increased risk of renal dysfunction. History of atherosclerosis, multiple CV risk factors, advanced age, impaired cardiac output, coagulation disorders, prolonged immobilization, hyperviscosity: increased risk of thrombotic events; consider baseline assessment of blood viscosity for those at risk of hyperviscosity. Monitor for aseptic meningitis, hemolysis, delayed hemolytic anemia, transfusion-related acute lung injury (eg, respiratory distress, pulmonary edema, hypoxemia). Antibody formation. Risk of transmission of viral diseases. Have epinephrine inj available. Elderly. Pregnancy (Cat.C). Nursing mothers.

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, pain, nausea, vomiting, fatigue, chills, joint swelling/effusion, pyrexia, urticaria, anemia, hyperthermia; hyperproteinemia, increased serum viscosity, hyponatremia; rare: aseptic meningitis syndrome (esp. high dose of 2g/kg), hemolysis, TRALI, thrombosis.

Generic Availability:

NO

How Supplied:

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