Immune globulin: Drug information

Copyright 1978-2013 Lexicomp, Inc. All rights reserved. (For additional information see "Immune globulin: Patient drug information" and see "Immune globulin: Pediatric drug information") For abbreviations and symbols that may be used in Lexicomp (show table)

Adverse Reactions Significant

Frequency not always defined. Cardiovascular: Chest tightness (7%), hypertension (5%), angioedema, edema, flushing of the face, hypotension, palpitation, tachycardia Central nervous system: Headache (16% to 48%), fever (6%), chills (3%), dizziness (1%), malaise (1%), anxiety, aseptic meningitis syndrome, drowsiness, fatigue, irritability, lethargy, lightheadedness, migraine, pain Dermatologic: Bruising, contact dermatitis, eczema, erythema, hyperhidrosis, petechiae, pruritus, purpura, rash, urticaria Endocrine & metabolic: Hyperglycemia (neuromuscular disease: 1%) Gastrointestinal: Nausea (3% to 18%), anorexia (neuromuscular disease: 1%), abdominal cramps, abdominal pain, diarrhea, discomfort, dyspepsia, gastroenteritis, sore throat, toothache, vomiting Hematologic: Anemia, autoimmune hemolytic anemia, hematocrit decreased, hematoma, hemolysis (mild), hemorrhage, thrombocytopenia Hepatic: Bilirubin increased, LDH increased, liver function test increased Local: Muscle stiffness at I.M. site; pain, swelling, redness or irritation at the infusion site Neuromuscular & skeletal: Muscle spasm (MMN 7%), weakness (1%; MMN: 7%), arthralgia (1%), back or hip pain, leg cramps, muscle cramps, myalgia, neck pain, rigors Ocular: Conjunctivitis Otic: Ear pain Renal: Acute renal failure, acute tubular necrosis, anuria, BUN increased, creatinine increased, oliguria, proximal tubular nephropathy, osmotic nephrosis Respiratory: Oropharyngeal pain (7%), asthma aggravated, bronchitis, cough, dyspnea, epistaxis, nasal congestion, pharyngeal pain, pharyngitis, rhinitis, rhinorrhea, sinus headache, sinusitis, upper respiratory infection, wheezing Miscellaneous: Anaphylaxis, diaphoresis, flu-like syndrome, hypersensitivity reactions, infusion reaction, thermal burn <1% (Limited to important or life-threatening): Apnea, ARDS, autoimmune pure red cell aplasia (PRCA) exacerbation, bronchopneumonia, bullous dermatitis, cardiac arrest, coma, Coombs' test positive, cyanosis, epidermolysis, erythema multiforme, heart failure, hepatic dysfunction, hypoxemia, leukopenia, loss of consciousness, MI, pancytopenia, phlebitis, pulmonary edema, pulmonary embolism, seizures, Stevens-Johnson syndrome, stroke, thromboembolism, transfusion-related acute lung injury (TRALI), vascular collapse

Contraindications
Hypersensitivity to immune globulin or any component of the formulation; selective IgA deficiency; hyperprolinemia (Hizentra, Privigen); severe thrombocytopenia or coagulation disorders; severe thrombocytopenia or coagulation disorders where IM injections are contraindicated

Warnings/Precautions
Boxed warnings: Renal impairment: See Concerns related to adverse effects below. Concerns related to adverse effects: Anaphylaxis/hypersensitivity reactions: Hypersensitivity and anaphylactic reactions can occur; a severe fall in blood pressure may rarely occur with anaphylactic reaction; immediate treatment (including epinephrine 1:1000) should be available. Aseptic meningitis: Aseptic meningitis syndrome (AMS) has been reported with immune globulin administration (rare); may occur with high doses (1 -2 g/kg [product-dependent]) and/or rapid infusion. Syndrome usually appears within several hours to 2 days following treatment; usually resolves within several days after product is discontinued. Patients with a migraine history may be at higher risk for AMS. Hematoma: Increased risk of hematoma formation when administered subcutaneously for the treatment of ITP. Hemolysis: Intravenous immune globulin has been associated with antiglobulin hemolysis; monitor for signs of hemolytic anemia. Risk factors associated with hemolysis include high doses (2 g/kg) given either as a single administration or divided over several days, and non-O blood type. Hyperproteinemia: Hyperproteinemia, increased serum viscosity, and hyponatremia may occur; distinguish hyponatremia from pseudohyponatremia to prevent volume depletion, a further increase in serum viscosity and a higher risk of thrombotic events. Infusion reactions: Patients should be monitored for adverse events during and after the infusion. Stop administration with signs of infusion reaction (fever, chills, nausea, vomiting, and rarely shock). Risk may be increased with initial treatment, when switching brands of immune globulin, and with treatment interruptions of >8 weeks. Pulmonary edema: Monitor for transfusion-related acute lung injury (TRALI); noncardiogenic pulmonary edema has been reported with intravenous immune globulin use. TRALI is characterized by severe respiratory distress, pulmonary edema, hypoxemia, and fever in the presence of normal left ventricular function. Usually occurs within 1-6 hours after infusion. Renal impairment: [U.S. Boxed Warning]: I.V. administration only: Acute renal dysfunction (increased serum creatinine, oliguria, acute renal failure, osmotic nephrosis) can rarely occur; usually within 7 days of use (more likely with products stabilized with sucrose). Use with caution in the elderly, patients with renal disease, diabetes mellitus, volume depletion, sepsis, paraproteinemia, and nephrotoxic medications due to risk of renal dysfunction. In patients at risk of renal dysfunction, the rate of infusion and concentration of solution should be minimized. Discontinue if renal function deteriorates. Thrombotic events: Thrombotic events have been reported with administration of intravenous immune globulin and subcutaneous immune globulin; use with caution in patients with a history of atherosclerosis or cardiovascular and/or thrombotic risk factors or patients with known/suspected

hyperviscosity. Consider a baseline assessment of blood viscosity in patients at risk for hyperviscosity. Disease-related concerns: Fluid overload: High-dose regimens (1 g/kg for 1-2 days) are not recommended for individuals with fluid overload or where fluid volume may be of concern. Hypovolemia: Patients should not be volume depleted prior to initiation of therapy. IgA deficiency: Increased risk of hypersensitivity, especially in patients with anti-IgA antibodies. ITP, chronic: Consider risk versus benefit for high-dose regimen in patients with increased risk of thrombosis, hemolysis, acute kidney injury, or volume overload. Special populations: Elderly: Use with caution in the elderly; may be at increased risk for renal dysfunction. Dosage form specific issues: Human plasma: Product of human plasma; may potentially contain infectious agents which could transmit disease. Screening of donors, as well as testing and/or inactivation or removal of certain viruses, reduces the risk. Infections thought to be transmitted by this product should be reported to the manufacturer. Latex: Packaging of some products may contain natural latex/natural rubber. L-proline: Hizentra and Privigen contain the stabilizer L-proline and are contraindicated in patients with hyperprolinemia. Maltose: Some products may contain maltose, which may result in falsely-elevated blood glucose readings. Maltose-containing products are contraindicated with patients with corn allergy. Polysorbate 80: Some products may contain polysorbate 80. Skin testing: Skin testing should not be performed with GamaSTAN S/D as local irritation can occur and be misinterpreted as a positive reaction. Sodium: Some product may contain sodium. Sorbitol: Some products may contain sorbitol; do not use in patients with fructose intolerance. Subcutaneous administration: Some clinicians may administer intravenous immune globulin products as a subcutaneous infusion based on patient tolerability and clinical judgment. SubQ infusion should begin 1 week after the last I.V. dose; dose should be individualized based on clinical response and serum IgG trough concentrations. Consider premedicating with acetaminophen and diphenhydramine. Sucrose: Some products may contain sucrose. Other warnings/precautions: Administration: Patients should be adequately hydrated prior to intravenous therapy. Vaccinations: Response to live vaccinations may be impaire d