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GAMMAPLEX 5%
Bleeding disorders
Primary immune deficiency
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Drug Name:

GAMMAPLEX 5% Rx

Generic Name and Formulations:
Immune globulin (human) 5g/100mL, 10g/200mL, 20g/400mL; liq for IV infusion; sucrose-, maltose-, preservative- and latex-free.

Company:
BPL Inc.

Therapeutic Use:

Indications for GAMMAPLEX 5%:

Chronic immune thrombocytopenic purpura (ITP).

Adult:

Individualize. 1g/kg (20mL/kg) given on 2 consecutive days by IV infusion at a rate of 0.5mg/kg/min for 15mins, if tolerated may increase at 15min intervals up to max 4mg/kg/min. Risk of thrombosis, volume overload, renal dysfunction or acute renal failure: give at the minimum practicable infusion rate. See full labeling.

Children:

Not recommended.

Contraindications:

Previous severe reaction to human immune globulin. Hereditary intolerance to fructose. Infants and neonates without established sucrose or fructose tolerance. IgA deficiency with antibodies against IgA.

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. Ensure adequate hydration. Pre-existing renal insufficiency, diabetes, >65yrs, overweight, hypovolemia, sepsis, paraproteinemia: increased risk of renal dysfunction or acute renal failure. Correct volume depletion prior to initiation. Assess renal function, BUN, serum creatinine, urine output before and during therapy; discontinue if renal function deteriorates. Discontinue if hypersensitivity reactions occur; have epinephrine available. Monitor for aseptic meningitis; consider a thorough neurological examination. Monitor for hemolysis and hemolytic anemia; consider measuring baseline hemoglobin or hematocrit and approx. 36–96hrs post-infusion in high risk patients. Monitor for pulmonary adverse reactions; perform test for anti-neutrophil antibodies if transfusion-related acute lung injury (TRALI) is suspected. Volume overload. Risk of transmission of infectious agents. Elderly. Pregnancy. Nursing mothers.

Interactions:

May interfere with immune response to live virus vaccines. Concomitant nephrotoxic drugs: increased risk of acute renal failure. May cause false (+) serological test results or (+) direct or indirect antiglobulin (Coombs’) test.

Pharmacological Class:

Immune globulin.

Adverse Reactions:

Headache, pyrexia, nasal congestion/edema, fatigue, nausea, hypertension, rash, hypotension, infusion site reaction, vomiting, myalgia, chills, tachycardia, chest pain/discomfort, pain, dizziness, malaise, dysuria, dry skin; thrombosis, aseptic meningitis syndrome (esp. with high doses or rapid infusion), hemolysis, hemolytic anemia, TRALI. Also ITP: pruritus, dehydration, arthralgia.

Generic Availability:

NO

How Supplied:

Single-use bottle—1

Indications for GAMMAPLEX 5%:

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

Adults and Children:

<2yrs: not established. Individualize. ≥2yrs: 300–800mg/kg by IV infusion every 3–4 weeks at a rate of 0.5mg/kg/min for 15mins, if tolerated may increase at 15 min intervals up to max 4mg/kg/min. Risk of thrombosis, volume overload, renal dysfunction or acute renal failure: give at the minimum practicable infusion rate. See full labeling.

Contraindications:

Previous severe reaction to human immune globulin. Hereditary intolerance to fructose. Infants and neonates without established sucrose or fructose tolerance. IgA deficiency with antibodies against IgA.

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. Ensure adequate hydration. Pre-existing renal insufficiency, diabetes, >65yrs, overweight, hypovolemia, sepsis, paraproteinemia: increased risk of renal dysfunction or acute renal failure. Correct volume depletion prior to initiation. Assess renal function, BUN, serum creatinine, urine output before and during therapy; discontinue if renal function deteriorates. Discontinue if hypersensitivity reactions occur; have epinephrine available. Monitor for aseptic meningitis; consider a thorough neurological examination. Monitor for hemolysis and hemolytic anemia; consider measuring baseline hemoglobin or hematocrit and approx. 36–96hrs post-infusion in high risk patients. Monitor for pulmonary adverse reactions; perform test for anti-neutrophil antibodies if transfusion-related acute lung injury (TRALI) is suspected. Volume overload. Risk of transmission of infectious agents. Elderly. Pregnancy. Nursing mothers.

Interactions:

May interfere with immune response to live virus vaccines. Concomitant nephrotoxic drugs: increased risk of acute renal failure. May cause false (+) serological test results or (+) direct or indirect antiglobulin (Coombs’) test.

Pharmacological Class:

Immune globulin.

Adverse Reactions:

Headache, pyrexia, nasal congestion/edema, fatigue, nausea, hypertension, rash, hypotension, infusion site reaction, vomiting, myalgia, chills, tachycardia, chest pain/discomfort, pain, dizziness, malaise, dysuria, dry skin; thrombosis, aseptic meningitis syndrome (esp. with high doses or rapid infusion), hemolysis, hemolytic anemia, TRALI. Also ITP: pruritus, dehydration, arthralgia.

Generic Availability:

NO

How Supplied:

Single-use bottle—1

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