Bleeding disorders:
Indications for: GAMMAKED
Idiopathic thrombocytopenic purpura (ITP), to raise platelet counts to prevent bleeding or to allow surgery.
Adults and Children:
See full labeling. Individualize. Give as IV infusion only. 2g/kg, divided in 2 doses of 1g/kg given on 2 consecutive days (may withhold 2nd dose if adequate platelet increase at 24hrs) or into 5 doses of 0.4g/kg given on 5 consecutive days. Initial infusion rate: 1mg/kg/min; may gradually increase to max 8mg/kg/min if tolerated. Expanded fluid volume or fluid volume concern: 1g/kg regimen not recommended. Risk for renal dysfunction/failure or thrombosis: give at the minimum infusion rate practicable.
GAMMAKED Contraindications:
IgA deficiency with antibodies against IgA and history of hypersensitivity. Previous severe reaction to human immune globulin.
Boxed Warning:
Thrombosis. Renal dysfunction. Acute renal failure.
GAMMAKED 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 for thrombosis. Monitor for signs/symptoms of thrombosis and assess blood viscosity in patients at risk for hyperviscosity. Ensure adequate hydration. Have epinephrine inj available. Pre-existing renal insufficiency, diabetes, >65yrs, concomitant nephrotoxic drugs, hypovolemia, sepsis, paraproteinemia: increased risk for renal dysfunction or 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, and delayed hemolytic anemia (esp. with pre-existing anemia and/or cardiovascular or pulmonary compromise; consider appropriate hemoglobin or hematocrit testing). Monitor for pulmonary dysfunction; perform test for anti-neutrophil antibodies if transfusion-related acute lung injury (TRALI) suspected. Contains human plasma; monitor for possible infection transmission (eg, viruses, Creutzfeldt-Jakob disease agent). Elderly. Pregnancy. Nursing mothers.
GAMMAKED Classification:
Immune globulin.
GAMMAKED Interactions:
Concomitant nephrotoxic drugs: increased risk of renal toxicity. Avoid mixing with other IGIVs. Avoid coadministration of heparin through single lumen delivery device. May interfere with response to live viral vaccines (eg, measles, mumps, rubella, varicella). May cause false (+) direct or indirect Coombs' test.
Adverse Reactions:
Headache, ecchymosis, vomiting, fever, nausea, rash, abdominal pain, back pain, dyspepsia; renal dysfunction (may be fatal), hyperproteinemia, hyperviscosity, hyponatremia, hypersensitivity reaction (discontinue if occurs); rare: hemolytic anemia, aseptic meningitis syndrome (esp. high dose of 2g/kg and/or rapid infusion), TRALI, thrombosis.
Generic Drug Availability:
NO
How Supplied:
Single-use vial (10mL, 25mL, 50mL, 100mL, 200mL)—1
Primary immune deficiency:
Indications for: GAMMAKED
Primary humoral immunodeficiency (eg, common variable immunodeficiency, X-linked or congenital agammaglobulinemia, Wiskott-Aldrich syndrome, severe combined immunodeficiencies). To improve neuromuscular disability and impairment in adults with chronic inflammatory demyelinating polyneuropathy (CIDP), and as maintenance therapy to prevent relapse.
Adults and Children:
See full labeling. Individualize. Primary immunodeficiency (PI): <2yrs: not established. ≥2yrs: IV infusion: 300–600mg/kg every 3–4 weeks. Initial infusion rate: 1mg/kg/min; may gradually increase to max 8mg/kg/min if tolerated. Risk of measles exposure with routine dose of <400mg/kg every 3–4 weeks: give at least 400mg/kg dose just prior to expected exposure; if exposed, give 400mg/kg dose as soon as possible. SC infusion: give by using an infusion pump into abdomen, thigh, upper arm, and/or lateral hip areas. May use up to 6 (children) or 8 (adults) infusion sites (at least 2 inches apart) simultaneously. Obtain serum IgG trough level to guide subsequent dose adjustments. Start 1 week after last IGIV infusion. Initial weekly dose: 1.37 x previous IGIV dose (in grams)/number of weeks between IGIV doses. Infusion rate: adults: 20mL/hr/site; children/adolescents (if <25kg): 10mL/hr/site; (if ≥25kg): initially 15mL/hr/site, then increase up to 20mL/hr/site. Dose adjustments: see full labeling. CIDP: children: not established. Give as IV infusion only. Adults: initially 2g/kg loading dose divided over 2–4 consecutive days. May be administered as a maintenance infusion: 1g/kg given over 1 day or divided in 2 doses of 0.5g/kg given on 2 consecutive days, every 3 weeks. Initial infusion rate: 2mg/kg/min; may increase to max 8mg/kg/min if tolerated. For PI (IV regimen), CIDP: if risk for renal dysfunction/failure or thrombosis, give at the minimum infusion rate practicable.
GAMMAKED Contraindications:
IgA deficiency with antibodies against IgA and history of hypersensitivity. Previous severe reaction to human immune globulin.
Boxed Warning:
Thrombosis. Renal dysfunction. Acute renal failure.
GAMMAKED 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 for thrombosis. Monitor for signs/symptoms of thrombosis and assess blood viscosity in patients at risk for hyperviscosity. Ensure adequate hydration. Have epinephrine inj available. Pre-existing renal insufficiency, diabetes, >65yrs, concomitant nephrotoxic drugs, hypovolemia, sepsis, paraproteinemia: increased risk for renal dysfunction or 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, and delayed hemolytic anemia (esp. with pre-existing anemia and/or cardiovascular or pulmonary compromise; consider appropriate hemoglobin or hematocrit testing). Monitor for pulmonary dysfunction; perform test for anti-neutrophil antibodies if transfusion-related acute lung injury (TRALI) suspected. Contains human plasma; monitor for possible infection transmission (eg, viruses, Creutzfeldt-Jakob disease agent). Elderly. Pregnancy. Nursing mothers.
GAMMAKED Classification:
Immune globulin.
GAMMAKED Interactions:
Concomitant nephrotoxic drugs: increased risk of renal toxicity. Avoid mixing with other IGIVs. Avoid coadministration of heparin through single lumen delivery device. May interfere with response to live viral vaccines (eg, measles, mumps, rubella, varicella). May cause false (+) direct or indirect Coombs' test.
Adverse Reactions:
IV: increased cough, rhinitis, pharyngitis, headache, asthma, nausea, fever, diarrhea, sinusitis, hypertension, chills, rash, arthralgia, asthenia. SC: also infusion site reactions, fatigue, upper respiratory tract infection, arthralgia, bronchitis, depression, allergic dermatitis, erythema, migraine, myalgia, viral infection, pyrexia. Both: renal dysfunction (may be fatal), hyperproteinemia, hyperviscosity, hyponatremia, hypersensitivity reaction (discontinue if occurs); rare: hemolytic anemia, aseptic meningitis syndrome (esp. high dose of 2g/kg and/or rapid infusion), TRALI, thrombosis.
Generic Drug Availability:
NO
How Supplied:
Single-use vial (10mL, 25mL, 50mL, 100mL, 200mL)—1
