assist you to [1:<1 Year of Age IV 100 mg/kg (2 mL/kg) administered as a single IV infusion. 1 Prescribing Limits Pediatric Patients Infant Botulism Infants> <1 Year of Age IV Maximum dose 100 mg/kg (2 mL/kg). 1 Special Populations Renal Impairment Do not exceed recommended dosage, concentration, and rate of IV infusion. 1 (See Renal Impairment under Cautions.) Cautions for BabyBIG Contraindications History of severe reaction to any immune globulin preparation. 1 Selective IgA deficiency. 1 (See IgA Deficiency under Cautions.) Warnings/Precautions Sensitivity Reactions Hypersensitivity Reactions Mild, transient, erythematous rash on face or trunk reported in 9 14% of infants receiving BIG-IV in clinical studies. 1 4 Acute or severe systemic allergic reactions (e.g., anaphylaxis, angioedema) not reported in clinical studies, but such reactions are possible. 1 Anaphylaxis can occur in patients with no known sensitivity to immune globulin preparations. 1 Reactions may also be related to rate of infusion. 1 (See Administration Precautions under Cautions.) Epinephrine should be available to treat acute allergic symptoms. 1 If anaphylaxis or hypotension occurs, immediately discontinue BIG-IV infusion and initiate appropriate treatment (e.g., epinephrine) as indicated. 1 IgA Deficiency Individuals with IgA deficiency may develop antibodies to IgA; anaphylaxis could occur following administration of BIG-IV or other blood products containing IgA. 1 BIG-IV contains trace amounts of IgA. 1 Renal Effects Renal dysfunction, acute renal failure, osmotic nephrosis, and death reported in patients receiving IGIV. 1 Increases in BUN and S cr have been observed as soon as 1 2 days following IGIV treatment. 1 Available data indicate that IGIV preparations stabilized with sucrose and administered at daily dosages ≥400 mg/kg are associated with a greater risk of developing IGIV-associated renal dysfunction. 1 BIG-IV contains 5% sucrose as a stabilizer. 1 Administer BIG-IV at the minimum concentration available and minimum IV infusion rate practicable, especially in patients predisposed to acute renal failure (e.g., those with any degree of preexisting renal insufficiency, diabetes mellitus, volume depletion, sepsis, paraproteinemia, receiving nephrotoxic drugs). 1 Prior to administration, ensure that patient is adequately hydrated and assess renal function (e.g., BUN or S cr ). 1 Monitor renal function and urine output periodically, particularly in patients at risk of acute renal failure. 1 (See Renal Impairment under Cautions.) Administration Precautions Adverse effects that appear to be related to infusion rate (e.g., chills, muscle cramps, back pain, fever, nausea, vomiting, wheezing) reported with immune globulin preparations, including BIG-IV. 1 Do not exceed recommended infusion rate. 1 (See Dosage and Administration: Administration.) If relatively minor adverse effect (e.g., flushing) occurs, immediately decrease infusion rate or temporarily discontinue infusion. 1 If anaphylaxis or substantial decrease in BP occurs, discontinue infusion and initiate appropriate therapy (e.g., epinephrine). 1 (See Sensitivity Reactions under Cautions.) Risk of Transmissible Infectious Agents in Plasma-derived Preparations Because BIG-IV is prepared from pooled human plasma, it is a potential vehicle for transmission of human viruses and theoretically may carry a risk of transmitting the causative agent of Creutzfeldt-Jakob disease (CJD). 1 Although donors are screened for certain viruses (e.g., HIV, HBV, HCV) and BIG-IV undergoes certain procedures (cold ethanol fractionation, nanofiltration, solvent/detergent viral inactivation) that reduce viral infectious potential, some unrecognized blood-borne infectious agents may not be inactivated and a risk for transmission of infectious agents still remains. 1 Administer only when a benefit is expected. 1 Aseptic Meningitis Syndrome Aseptic meningitis syndrome reported rarely in patients receiving IGIV; 1 occurs more frequently in patients receiving high total doses of IGIV (e.g., 2 g/kg). 1 Not reported in clinical trials of BIG-IV. 1 Symptoms include severe headache, nuchal rigidity, drowsiness, fever, photophobia, painful eye movements, nausea, and vomiting; usually evident within several hours to 2 days after administration of IGIV. 1 Perform complete neurologic examination in patients exhibiting such symptoms to rule out other causes of meningitis. 1 CSF analysis frequently reveals pleocytosis (up to several thousand cells per mm 3 ), predominantly from the granulocytic series, and protein concentrations up to several hundred mg/dL. 1 Syndrome generally resolved within several days without sequelae following IGIV discontinuance. 1 Hyperproteinemia, Hyponatremia, and Increased Serum Viscosity Hyperproteinemia, hyponatremia, and increased serum viscosity reported in patients receiving IGIV; 1 not reported to date with BIG-IV. 1 If hyponatremia occurs, it is critical to distinguish true hyponatremia from pseudohyponatremia caused by decreased calculated serum osmolality or elevated osmolar gap. 1 Treatment aimed at decreasing serum free water in patients with pseudohyponatremia may lead to volume depletion, a further increase in serum viscosity, and increased risk of thromboembolic events. 1 Thrombotic Events Thrombotic events reported in patients receiving IGIV; 1 not reported to date with BIG-IV. 1 Patients at risk of thrombotic events include those with history of atherosclerosis, multiple cardiovascular risk factors, advanced age, impaired cardiac output, coagulation disorders, prolonged periods of immobilization, and/or known or suspected hyperviscosity. 1 Consider baseline assessment of blood viscosity in patients at risk for hyperviscosity (e.g., those with cryoglobulins, fasting chylomicronemia/markedly high triacylglycerols [triglycerides], monoclonal gammopathies). 1 In patients judged to be at risk of developing thrombotic events, administer BIG-IV at slowest infusion rate considered practicable. 1 Hemolysis and Hemolytic Anemia Immune globulin preparations may contain blood group antibodies that can act as hemolysins and induce in vivo coating of RBCs with immunoglobulin, causing a positive direct antiglobulin reaction and, rarely, hemolysis. 1 Hemolytic anemia also can develop subsequent to immune globulin therapy due to enhanced RBC sequestration. 1 Monitor for clinical signs and symptoms of hemolysis and, if necessary, perform appropriate confirmatory laboratory testing. 1 Transfusion-related Acute Lung Injury Transfusion-related acute lung injury (TRALI; noncardiogenic pulmonary edema) reported in patients receiving IGIV; 1 not reported to date with BIG-IV. 1 Typically occurs within 1 6 hours after IGIV infusion and is characterized by severe respiratory distress, pulmonary edema, hypoxemia, normal left ventricular function, and fever. 1 Monitor for adverse pulmonary reactions. 1 If TRALI is suspected, perform appropriate tests to determine whether antineutrophil antibodies are present in the product or patient serum. 1 Manage using oxygen therapy with adequate ventilatory support. 1 Improper Storage and Handling Improper storage or handling of immune globulins may affect efficacy. 6 Do not administer BIG-IV that has been mishandled or has not been stored at the recommended temperature. 6 (See Storage under Stability.) Inspect all immune globulins upon delivery and monitor during storage to ensure that the appropriate temperature is maintained. 6 If there are concerns about mishandling, contact the manufacturer or state or local health departments for guidance on whether BIG-IV is usable. 6 Specific Populations Pregnancy Safety and efficacy not evaluated in adults, including pregnant women. 1 Pediatric Use Safety and efficacy established only in children> <1 year of age. 1 Safety and efficacy not evaluated in older pediatric patients. 1 Geriatric Use Safety and efficacy not evaluated in adults, including geriatric adults. 1 Renal Impairment Use with caution in patients with preexisting renal impairment and in patients judged to be at increased risk of developing renal impairment (e.g., those with diabetes mellitus, volume depletion, paraproteinemia, sepsis, receiving nephrotoxic drugs). 1 Do not exceed recommended dosage, concentration, and IV infusion rate in patients with or at increased risk for renal impairment. 1 (See Dosage and Administration.) Common Adverse Effects Erythematous rash. 1 Interactions for BabyBIG Live Vaccines Antibodies present in immune globulin preparations may interfere with immune responses to some live virus vaccines, including measles, mumps, and rubella virus vaccine live (MMR), varicella virus vaccine live, and fixed combination of MMR and varicella vaccine (MMRV); 1 6 no evidence that immune globulin preparations interfere with immune responses to rotavirus vaccine live oral, influenza virus vaccine live intranasal, yellow fever virus vaccine live, typhoid vaccine live oral, or zoster vaccine live. 6 (See Specific Drugs under Interactions.) Inactivated Vaccines and Toxoids Immune globulin preparations are not expected to have a clinically important effect on immune responses to inactivated vaccines or toxoids; therefore, inactivated vaccines, recombinant vaccines, polysaccharide vaccines, and toxoids may be administered simultaneously (using different syringes and different injection sites) or at any interval before or after BIG-IV. 6 Specific Drugs Drug Interaction Comments Measles, mumps, rubella, and varicella virus vaccines Antibodies in immune globulin preparations can interfere with immune response to measles and rubella antigens contained in MMR or MMRV; 1 6 effect on immune response to mumps or varicella antigens unknown, but an effect is possible 6 Duration of interference depends on amount of antigen-specific antibody in the immune globulin preparation 6 MMR, MMRV, or varicella vaccine should not be administered simultaneously with BIG-IV; defer for at least 3 5 months after BIG-IV 1 6 9 Revaccination with MMR, MMRV, or varicella vaccine may be necessary if vaccine was given> <3 5 months after BIG-IV 1 6 Revaccination with MMR, MMRV, or varicella vaccine is necessary if BIG-IV was administered> <14 days after vaccine dose, unless serologic testing is feasible and indicates there was an adequate response to the vaccine 6 Rotavirus vaccine No evidence that immune globulin preparations interfere with immune response to rotavirus vaccine 6 Rotavirus vaccine generally can be administered simultaneously with or at any interval before or after immune globulin preparations 6 Because intestinal motility usually profoundly slower in patients with infant botulism than healthy infants, some clinicians recommend rotavirus vaccine be deferred until 5 months after BIG-IV 9 Yellow fever vaccine No evidence that immune globulin preparations interfere with immune response to yellow fever vaccine 6 Yellow fever vaccine may be given simultaneously (at a different site) or at any interval before or after immune globulin preparations 6 BabyBIG Pharmacokinetics Absorption Bioavailability Pharmacokinetics not fully elucidated. 1 Elimination Half-life Approximately 28 days in infants. 1 4 Stability Storage Parenteral Powder for IV Infusion 2 8°C. 1 Following reconstitution, initiate IV infusion within 2 hours and complete infusion within 4 hours; 1 do not store reconstituted solution. 1 Actions BIG-IV is prepared from pooled plasma of adults who were immunized with pentavalent botulinum toxoid and selected for their high titers of neutralizing antibody against botulinum toxin types A and B. 1 Each mL of reconstituted BIG-IV contains approximately 40 60 mg of immunoglobulin, primarily IgG with trace amounts of IgA and IgM, and 10 mg of albumin human, 50 mg of sucrose, and approximately 20 x 10 -3 mEq of sodium. 1 Reconstituted BIG-IV contains antibody titers against botulinum toxin types A and B that are at least 15 and 2 international units (IUs, units), respectively; 1 by definition, 1 unit neutralizes 10,000 intraperitoneal mouse LD 50 of these botulinum toxins. 1 Titers of antibody against botulinum toxins C, D, and E in BIG-IV not determined. 1 Following IV administration, specific antibodies contained in BIG-IV bind to and neutralize circulating botulinum toxin types A and B. 1 In infants> <1 year of age, administration of a single dose is expected to provide protective levels of antibodies sufficient to neutralize circulating levels of botulinum toxins A and B. 1 4 9 If administered promptly after clinical diagnosis of infant botulism, can reduce duration of hospitalization and duration of supportive care measures (i.e., mechanical ventilation, tube feedings). 1 4 10 11 More effective when administered during first 72 hours of hospitalization than when given 4 7 days after admission. 3 4 Advice to Patients Advise patient s parent or legal guardian of the risks and benefits of BIG-IV. 1 Discuss the possibility of adverse reactions, including hypersensitivity reactions (e.g., anaphylaxis), renal failure, aseptic meningitis syndrome, hemolysis, thrombosis, and TRALI. 1 (See Cautions.) Advise patient s parent or guardian that BIG-IV is prepared from pooled human plasma. 1 Although improved donor screening and viral-inactivating and purification procedures used in manufacture of plasma-derived preparations have reduced the risk of pathogen transmission, BIG-IV is a potential vehicle for transmission of infectious agents. 1 Importance of reporting any concerning adverse effects. 1 Advise patient s parent or guardian that BIG-IV may interfere with the immune response to certain live virus vaccines (e.g., MMR, varicella vaccines); importance of informing clinicians administering vaccines about recent use of BIG-IV. 1 6 (See Interactions.) Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, as well as any concomitant illnesses. 1 Importance of informing patient s parent or legal guardian of other important precautionary information. 1 (See Cautions.) Preparations Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details. Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations. Botulism Immune Globulin IV (Human) Routes Dosage Forms Strengths Brand Names Manufacturer Parenteral For injection, for IV infusion 100 20 mg (of immunoglobulin) BabyBIG (nanofiltered, solvent/detergent treated) California Department of Public Health AHFS DI Essentials. Copyright 2017, Selected Revisions September 1, 2012. American Society of Health-System Pharmacists, Inc., 4500 East-West Highway, Suite 900, Bethesda, Maryland 20814. References 1. California Department of Public Health. BabyBIG (botulism immune globulin intravenous [human]) prescribing information. Richmond, CA; 2012 Jan. 2. Food and Drug Administration. FDA Application: Search Orphan Drug Designations and Approvals. Rockville, MD. From FDA website. Accessed 2012 Mar 12. 3. Long SS. Infant botulism and treatment with BIG-IV (BabyBIG). Pediatr Infect Dis J . 2007; 26:261-2. [PubMed 17484226] 4. Arnon SS, Schechter R, Maslanka SE et al. Human botulism immune globulin for the treatment of infant botulism. N Engl J Med . 2006; 354:462-71. [PubMed 16452558] 5. Arnon SS. Creation and development of the public service orphan drug Human Botulism Immune Globulin. Pediatrics . 2007; 119:785-9. [PubMed 17403850] 6. National Center for Immunization and Respiratory Diseases. General recommendations on immunization -- recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR Recomm Rep . 2011; 60:1-64. 7. American Academy of Pediatrics. Red Book: 2009 Report of the Committee on Infectious Diseases. 28th ed. Elk Grove Village, IL: American Academy of Pediatrics; 2009. 8. California Department of Public Health Services, Richmond CA: Personal Communication. 9. Infant Botulism Treatment and Prevention Program. Division of Communicable Disease Control, California Department of Health Services. From IBTPP website. Accessed 2012 Mar 26. 10. Underwood K, Rubin S, Deakers T et al. Infant botulism: a 30-year experience spanning the introduction of botulism immune globulin intravenous in the intensive care unit at Childrens Hospital Los Angeles. Pediatrics . 2007; 120:e1380-5. [PubMed 18055655] 11. Chalk C, Benstead TJ, Keezer M. Medical treatment for botulism. Cochrane Database Syst Rev . 2011; :CD008123. [PubMed 21412916] 12. Arnon SS. Infant botulism. In: Feigin RD, Cherry JD, Demmler-Harrison GJ et al. Feigin: Feigin and Cherry s Textbook of Pediatric Infectious Diseases, 6th ed. Philadelphia, PA: Saunders Elsevier; 2009. 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