Immune Globulin

Class: Serums
VA Class: IM500
CAS Number: 9007-83-4
Brands: Carimune, Flebogamma, Flebogamma DIF, Gammagard, GamaSTAN, Gammaplex, Gamunex, Hizentra, Octagam, Privigen, Vivaglobin

• Acute Renal Dysfunction and Failure


• 
  

  IGIV has been reported to be associated with renal dysfunction, acute renal failure, osmotic nephrosis, and death.^{125 151 249 263 264 265 266 282 292 308} (See Renal Effects under Cautions.)

  
  


• 
  

  Renal dysfunction and acute renal failure reported more commonly in patients receiving IGIV preparations that contain sucrose.^{125 151 263 264 265 266 282 292 308}

  
  


• 
  

  Patients predisposed or at increased risk of acute renal failure include those with any degree of preexisting renal insufficiency, diabetes mellitus, volume depletion, sepsis, or paraproteinemia; those receiving concomitant nephrotoxic drugs; and/or those >65 years of age.^{125 151 249 263 264 265 266 282 308}

  
  


• 
  

  Administer IGIV at the minimum concentration available and at the minimum practicable infusion rate, especially in patients at risk for renal dysfunction or acute renal failure.^{125 151 249 263 264 265 266 282 292 308}

  
  

Introduction

Immune globulin IM (IGIM), immune globulin IV (IGIV), and immune globulin subcutaneous; sterile, nonpyrogenic solutions of globulins containing many antibodies normally present in adult human blood.^{154 263 264 266 273 282 292 294 308}

Uses for Immune Globulin

Hepatitis A Virus (HAV) Infection (Preexposure Prophylaxis)

IGIM is used to provide passive immunity to HAV infection for preexposure prophylaxis in certain susceptible individuals who are at risk of exposure to the virus.^{154 186 187 286}

Preexposure passive immunization with IGIM is recommended if hepatitis A vaccine cannot be used because it is contraindicated or unavailable and short-term protection against HAV is needed.^{186 187 191 192 193 206 286} In addition, for optimal protection, use of IGIM for passive immunization may be considered in conjunction with active immunization with hepatitis A vaccine in certain individuals.^{206 286}

Travelers to areas with intermediate or high levels of endemic HAV are at risk of exposure to the disease.^{186 206 286} Risk of acquiring HAV while traveling varies with living conditions, length of stay, and incidence of HAV infection in the area visited.²⁰⁶ Consider that many cases of HAV occur in travelers to developing countries with standard tourist itineraries, accommodations, and food consumption behaviors.²⁰⁶ CDC website () has information regarding which countries have high or intermediate levels of HAV endemicity.²⁰⁶

USPHS Advisory Committee on Immunization Practices (ACIP), CDC, WHO, and others recommend preexposure vaccination against HAV for all susceptible individuals traveling to areas with intermediate or high levels of endemic HAV.^{186 189 193 206 286 291} Although active immunization with hepatitis A vaccine is preferred since it provides long-term protection, if the vaccine is contraindicated or cannot be used (e.g., in children <1 year of age, individuals hypersensitive to vaccine components) or the traveler chooses not to receive the vaccine, passive immunization with IGIM is recommended.^{186 231 206 286 291}

For optimal protection in travelers at greatest risk for HAV (older adults or individuals with altered immunocompetence, chronic liver disease, or other chronic medical condition) who plan to depart in <2 weeks, the ACIP and CDC recommend that a single dose of IGIM be given concomitantly with the initial dose of hepatitis A vaccine (at a different site).^{206 286}

A single 0.02-mL/kg dose of IGIM confers short-term protection (up to 3 months) against HAV and a single 0.06-mL/kg dose confers longer-term protection (3–5 months).^{186 206 286 291}

Hepatitis A Virus (HAV) Infection (Postexposure Prophylaxis)

IGIM is used for postexposure prophylaxis of HAV in susceptible individuals with recent (within 2 weeks) exposure to the virus.^{154 186 187 286}

The choice of active immunization with hepatitis A vaccine and/or passive immunization with IGIM should take into account the magnitude of risk associated with the exposure and characteristics of the patient that may be associated with more severe manifestations of HAV (e.g., older age, chronic liver disease).^{107 186 187 286}

Although IGIM is 80–90% effective if administered within 2 weeks of exposure^{186 286} and was traditionally the recommended regimen for HAV postexposure prophylaxis,^{186 187 286} there is some evidence that monovalent hepatitis A vaccine administered within 2 weeks of exposure may be as effective as IGIM in preventing symptomatic HAV infection in susceptible contacts 2–40 years of age.^{187 286 287} The vaccine also offers certain advantages over IGIM (e.g., induces active immunity and longer protection, more readily available, easier to administer, greater patient acceptance).^{286 287}

For HAV postexposure prophylaxis in healthy individuals 12 months to 40 years of age, ACIP and AAP prefer use of monovalent hepatitis A vaccine.^{187 286} In adults >40 years of age, IGIM is preferred since data are not available to date regarding efficacy of the vaccine for postexposure prophylaxis in this age group and these individuals are at risk for more severe manifestations of HAV; the vaccine can be used if IGIM cannot be obtained.^{187 286} Use IGIM for HAV postexposure prophylaxis in children <12 months of age, immunocompromised individuals, individuals with chronic liver disease, and whenever the vaccine is contraindicated.^{187 286}

In individuals in whom IGIM is preferred for HAV postexposure prophylaxis, administer a dose of hepatitis A vaccine simultaneously (using different syringes and different injection sites) if the vaccine is indicated for other reasons (e.g., catch-up vaccination, preexposure vaccination in high-risk groups) and is not contraindicated.^{187 286} If a dose of hepatitis A vaccine is used (with or without IGIM) for HAV postexposure prophylaxis, administer an additional (booster) dose of the vaccine according to the usually recommended schedule to ensure long-term protection.^{186 187 286}

If HAV postexposure prophylaxis is indicated, administer as soon as possible (within 2 weeks of exposure).^{186 187 286} Data not available regarding efficacy of HAV postexposure prophylaxis administered >2 weeks after exposure.²⁸⁶ Routine serologic screening of contacts for markers of HAV infection prior to administration of HAV postexposure prophylaxis is not recommended since this would delay prophylaxis.^{186 187}

HAV postexposure prophylaxis is indicated in all previously unvaccinated individuals who have had household or sexual (heterosexual or homosexual) contact (within the past 2 weeks) with an individual with serologically confirmed HAV.²⁸⁶ Also consider HAV postexposure prophylaxis for individuals exposed (within the past 2 weeks) through other types of ongoing, close personal contact (e.g., regular babysitting).²⁸⁶

Contacts who have shared illicit drugs (within the past 2 weeks) with an individual with serologically confirmed HAV should receive HAV postexposure prophylaxis.²⁸⁶

Administer HAV postexposure prophylaxis to all previously unvaccinated staff and attendees of child-care centers or homes if ≥1 case of HAV is recognized in children or employees or if HAV is recognized in ≥2 households of center attendees (within the past 2 weeks).²⁸⁶ In centers that do not provide care to children who wear diapers, HAV postexposure prophylaxis is indicated only in classroom contacts of the index patient.²⁸⁶ If an outbreak occurs (i.e., HAV in ≥3 families), also consider HAV postexposure prophylaxis for members of households that have diapered children attending the center.²⁸⁶

If HAV is diagnosed in a food handler, ACIP recommends HAV postexposure prophylaxis (within 2 weeks) for other food handlers at the same establishment.²⁸⁶ Because common-source transmission to patrons is unlikely, HAV postexposure prophylaxis is not usually indicated for patrons, but may be considered if the food handler directly handled uncooked or cooked food and had diarrhea or poor hygienic practices and if patrons can be identified and given prophylaxis within 2 weeks after exposure.^{186 286} Settings where repeated HAV exposure might have occurred (e.g., institutional cafeterias) warrant stronger consideration of postexposure prophylaxis for patrons.^{186 286}

HAV postexposure prophylaxis is not usually indicated after a common-source HAV outbreak if cases have begun to occur because the 2-week period when such prophylaxis is known to be effective will have been exceeded.²⁸⁶

When an individual with HAV is admitted to a hospital, health-care personnel do not need to receive routine HAV postexposure prophylaxis; careful hygienic practices should be emphasized in such situations.^{107 182 186 187 286}

If an epidemiologic investigation indicates that HAV transmission has occurred among students in a school or among hospital patients and/or hospital staff, ACIP recommends HAV postexposure prophylaxis in individuals who have close contact with index patients.²⁸⁶

Routine HAV postexposure prophylaxis is not indicated when a single HAV case occurs in an elementary or secondary school or an office or other work setting and the source case is outside the school or work setting.²⁸⁶

Hepatitis B Virus (HBV) Infection

IGIM is not effective for postexposure prophylaxis of HBV infection since concentrations of anti-HBs in IGIM are too low.¹⁸⁷

Hepatitis B immune globulin (HBIG) is the only immune globulin recommended by ACIP and AAP for passive immunization for postexposure prophylaxis of HBV.^{100 126 182 187}

Hepatitis C Virus (HCV) Infection

IGIM has been used in attempt to prevent HCV† infection or other parenterally transmitted non-A, non-B hepatitis†.^{107 182}

ACIP and AAP state that available data indicate that immune globulin is not effective for, and not recommended for, postexposure prophylaxis of HCV, including following occupational exposures to HCV.^{107 187 246} Manage occupational exposures through early identification of the disease in exposed individuals and appropriate antiviral therapy if indicated.¹⁰⁰

ACIP states that immune globulin is not recommended for postexposure prophylaxis in infants born to HCV-positive women.²⁴⁶

Hepatitis E Virus (HEV) Infection

No evidence that IGIM is effective for postexposure prophylaxis of HEV infection.^{182 230} Travelers who received IGIM for protection against HAV should not assume that they are protected against HEV.^{182 230} Consult CDC website () for information regarding where HEV is endemic.²⁰⁶

Measles

IGIM is used to prevent or modify symptoms of measles (rubeola) in susceptible individuals exposed to the disease <6 days previously.^{154 187 206}

Postexposure vaccination (i.e., within 72 hours of exposure) generally is preferred to postexposure prophylaxis with IGIM for most susceptible individuals ≥12 months of age who are exposed to measles in most settings (e.g., day-care facilities, schools, colleges, health-care facilities), and is acceptable for susceptible individuals ≥6 months of age who are household contacts of measles patients.¹³³ ACIP and AAP recommend that susceptible individuals receive vaccination against measles within 72 hours after exposure, unless the vaccine is contraindicated.^{101 133 187} If measles is not recognized within this time frame, postexposure prophylaxis with IGIM is recommended (if administered within 6 days of exposure), especially for susceptible household contacts for whom the risk of measles complications is high (e.g., contacts ≤12 months of age, pregnant women, immunocompromised individuals).^{133 187}

If measles is diagnosed in a mother, unvaccinated children of all ages in the household who lack evidence of measles immunity should receive IGIM.¹³³

Postexposure prophylaxis with IGIM is not indicated for household contacts who have received a dose of vaccine containing measles virus vaccine live on or after 12 months of age, unless they are immunocompromised.^{133 187}

When postexposure prophylaxis is indicated in a pregnant woman with documented measles exposure, administer IGIM within 6 days of exposure.^{187 206}

Passive immunity to measles following IGIM administration is temporary (unless modified or typical measles occurs); 5–6 months after IGIM administration, initiate immunization with vaccine containing measles virus vaccine live in individuals ≥12 months of age who have no contraindications to the vaccine.^{133 206} Do not administer the vaccine and IGIM concurrently.^{133 206} (See Specific Drugs and Laboratory Tests under Interactions.)

Do not use IGIM to control measles outbreaks.^{101 133}

IGIM is used following measles exposure in children and young adults with symptomatic HIV infection and immunosuppression associated with AIDS or other clinical manifestations of HIV infection, regardless of vaccination status;^{132 133 187} however, IGIM may not be necessary if the patient has been receiving IGIV (100–400 mg/kg) at regular intervals and received the last dose within 2–3 weeks of exposure to measles.^{133 150 187}

IGIM (given within 6 days of exposure) can be used to prevent or modify measles infection in asymptomatic HIV-infected children.¹⁵⁰ In addition, administer IGIM to measles-susceptible household contacts of asymptomatic HIV-infected children, particularly contacts <1 year of age and pregnant women.^{150 187}

Consider preexposure prophylaxis with immune globulin in susceptible individuals with severe immunosuppression (e.g., HIV-infected individuals) who are planning travel to measles-endemic areas; vaccines containing measles virus vaccine live are not recommended for severely immunocompromised individuals.²⁹³

Mumps

IGIM is not effective for and should not be used for postexposure prophylaxis of mumps infection.^{133 154 187}

Poliomyelitis

IGIM should not be used for postexposure prophylaxis of poliomyelitis.¹⁵⁴

Rubella

Although some studies suggest that use of IGIM in susceptible women exposed to rubella during the first trimester of pregnancy† may lessen the likelihood of infection and adverse fetal effects, ACIP states that use of IGIM after exposure to rubella will not prevent infection or viremia but may modify or suppress symptoms and can create an unwarranted sense of security.^{131 133}

ACIP and AAP state that IGIM should not be used routinely for postexposure prophylaxis of rubella in early pregnancy or any other circumstance.^{131 133 187} The only instance in which IGIM might be considered for postexposure prophylaxis of rubella is in a susceptible pregnant woman who is exposed to a confirmed case of rubella early in the pregnancy and who will not consider terminating the pregnancy under any circumstances.^{131 133 187} Administration within 72 hours of exposure might reduce, but will not eliminate, risk for rubella.^{131 133}

Varicella

ACIP, AAP, and others state that varicella-zoster immune globulin (VZIG) is the preferred immune globulin for postexposure prophylaxis of varicella in individuals who do not have evidence of immunity (i.e., without a history of varicella or varicella vaccination) and are at high risk for severe disease and complications (e.g., HIV-infected individuals).^{187 215 269 272 293}

IGIV is recommended as an alternative to VZIG for postexposure prophylaxis of varicella† in susceptible individuals when VZIG is unavailable (e.g., cannot be obtained within 96 hours of exposure).^{187 215 268 269 272} ACIP and others state that IGIV may be used (if VZIG is unavailable) in immunocompromised patients (including HIV-infected patients),^{215 269} neonates whose mothers develop signs and symptoms of varicella around the time of delivery (within 5 days before to 2 days after delivery),²⁶⁹ premature infants exposed during the neonatal period whose mothers do not have evidence of varicella immunity,²⁶⁹ or premature infants exposed during the neonatal period who were born at <28 weeks’ gestation or with a birthweight of ≤1 kg (regardless of maternal history of varicella).²⁶⁹

ACIP, AAP, CDC, National Institutes of Health (NIH), and other experts state that HIV-infected children, adolescents, or adults who are receiving IGIV replacement therapy (≥400 mg/kg given at regular intervals) and received a dose of IGIV within 3 weeks prior to exposure should be protected and should not require postexposure prophylaxis with VZIG.^{134 187 215 269 293}

IGIV may prolong the incubation period; therefore, closely observe the patient for signs or symptoms of varicella for 28 days following exposure.²⁶⁹

IGIM has been used as an alternative to VZIG for postexposure prophylaxis of varicella in susceptible individuals,¹⁵⁴ but IGIV (not IGIM) is recommended when VZIG is unavailable.^{187 215 268 269 272}

If the exposed patient does not develop varicella, administer varicella virus vaccine live at a later date, unless contraindicated.²⁶⁹ (See Specific Drugs and Laboratory Tests under Interactions.)

Primary Immunodeficiency Diseases

Immune globulins (IGIM, IGIV, immune globulin subcutaneous) are used as replacement therapy to promote passive immunity in patients with primary humoral immunodeficiency diseases.^{125 263 264 265 266 273 274 275 276 280 292 294 308}

IGIV and immune globulin subcutaneous are used in patients with IgG and other antibody-deficiency diseases, including congenital agammaglobulinemia (e.g., X-linked agammaglobulinemia), common variable immunodeficiency, Wiskott-Aldrich syndrome, and severe combined immunodeficiency syndromes.^{125 151 263 264 265 266 282 292 294 308}

Prophylactic IGIM therapy, especially against infections caused by encapsulated bacteria, is often effective in Bruton-type, sex-linked congenital agammaglobulinemia, agammaglobulinemia associated with thymoma, and acquired agammaglobulinemia.¹⁵⁴ IGIM may not prevent chronic infections of the external secretory tissues (e.g., respiratory and GI tracts).¹⁵⁴

IGIV (not IGIM) may be preferred in patients who require an immediate or large increase in intravascular immunoglobulin concentrations, in patients with small muscle mass, and in patients with bleeding tendencies in whom IM injections are contraindicated.^{125 264 280 282}

Self-administration of immune globulin subcutaneous (at home) may result in improved quality of life and treatment satisfaction compared with use of IGIV (administered in the hospital or clinician’s office).^{275 276}

IGIM, IGIV, and immune globulin subcutaneous should not be used in individuals with selective IgA deficiency^{151 154 266 280 282} and should not be used in IgA-deficient individuals^{125 151 154 263 264 265 266 273 280 282 292 294 308} with antibodies against IgA.^{125 263 264 265 273 292 294 308} (See Contraindications under Cautions and see IgA Deficiency under Cautions.)

Idiopathic Thrombocytopenic Purpura (ITP)

IGIV (i.e., Carimune NF, Gammagard S/D, Gamunex 10%, Privigen 10%) is used for the treatment of acute or chronic (e.g., >6 months duration) ITP (also known as immune thrombocytopenic purpura).^{125 138 139 151 265 292}

In patients in whom an IGIV response is obtained, the rise in platelet count is generally rapid (within 1–5 days) and transient (usually lasting from several days to 2–4 weeks)^{125 130 139 151} but rarely may last 4–12 months or longer.^{125 130 138}

Chronic Inflammatory Demyelinating Polyneuropathy

IGIV (i.e., Gamunex 10%) is used for the treatment of chronic inflammatory demyelinating polyneuropathy (CIDP) to improve neuromuscular disability and impairment and for maintenance therapy to prevent relapse.²⁶⁵

Some clinicians consider IGIV the preferred treatment for CIDP, especially in children, patients with poor venous access that precludes use of plasma exchange, and in those susceptible to complications of long-term corticosteroid therapy.^{305 306}

Kawasaki Disease

IGIV (i.e., Gammagard S/D) is used in conjunction with aspirin therapy for initial treatment of the acute phase of Kawasaki disease.^{103 104 105 128 151 155 156 157 163 187 237 238 240 241 299 300}

Concomitant use of IGIV and high-dose aspirin therapy initiated within 10 days of the onset of fever is more effective than aspirin alone in preventing or reducing the occurrence of coronary artery abnormalities associated with Kawasaki disease and may result in more rapid resolution of fever and other manifestations of acute inflammation.^{104 128 151 187 280 299}

AAP, AHA, and American College of Chest Physicians (ACCP) state that combined therapy with IGIV and aspirin should be administered as soon as possible after Kawasaki disease is diagnosed or strongly suspected (optimally within 7–10 days of disease onset).^{187 299 300} In those with a delayed diagnosis (i.e., >10 days after disease onset), AAP and AHA suggest that combined therapy with IGIV and aspirin should be initiated if the patient has unexplained persistent fever or aneurysms and manifestations of ongoing systemic inflammation (elevated erythrocyte sedimentation rate [ESR] or C-reactive protein [CRP]) or evolving CAD.^{187 237 238 299}

Approximately ≥10% of patients with Kawasaki disease fail to respond to initial treatment with IGIV and aspirin therapy and have persistent fever or recurrent fever after an initial afebrile period.^{187 299} Retreatment with IGIV (within 24–48 hours of persistent or recrudescent fever) and continued aspirin therapy usually is recommended for these patients.^{187 237 299}

Coronary artery abnormalities develop in 15–25% of children with Kawasaki disease if they are not treated within 10 days of fever onset;^{187 299 300} 2–4% of patients develop coronary artery abnormalities despite prompt treatment with IGIV and aspirin.¹⁸⁷ Long-term management of those who develop coronary abnormalities depends on the severity of coronary involvement and may include low-dose aspirin (with or without clopidogrel or dipyridamole), anticoagulant therapy with warfarin or low molecular weight heparin, or a combination of antiplatelet and anticoagulant therapy (usually low-dose aspirin and warfarin).^{187 299 300} Consult specialized references for additional information on long-term management of Kawasaki disease in individuals with coronary abnormalities.^{299 300}

B-cell Chronic Lymphocytic Leukemia (CLL)

IGIV (i.e., Gammagard S/D) is used for prevention of bacterial infections in patients with hypogammaglobulinemia and/or recurrent bacterial infections associated with B-cell CLL.^{151 153 155 156 157}

Prevention of Serious Bacterial Infections in HIV-infected Individuals

IGIV has been used in children with symptomatic HIV infection† who are immunosuppressed in association with AIDS or AIDS-related complex (ARC) in an attempt to control or prevent infections and improve immunologic parameters.^{130 139 155 156 157 173 174 175 176 177 178 179 180 181 184 215 216}

IGIV also has been used in HIV-infected adults†.^{130 155 156 157}

IGIV reduces the incidence of recurrent bacterial infections and sepsis, including upper respiratory tract infections, in adults and children with symptomatic HIV infection.^{155 156 157 175 176 177 178 216}

The ACIP, AAP, CDC, NIH, HIV Medicine Association of the IDSA, Pediatric Infectious Diseases Society, and other experts state that HIV-infected infants and children with hypogammaglobulinemia (IgG <400 mg/dL) should receive IGIV (400 mg/kg once every 2–4 weeks) to prevent serious bacterial infections.²¹⁵ These experts state that use of IGIV is no longer recommended for routine primary prevention of serious bacterial infections in HIV-infected infants and children; IGIV should only be used for prevention of serious bacterial infections if hypogammaglobulinemia is present or functional antibody deficiency is demonstrated by either poor specific antibody titers or recurrent bacterial infections.²¹⁵

Bone Marrow Transplantation (BMT)

IGIV has been used in adults and children undergoing BMT† to decrease the risk of infections (e.g., septicemia), interstitial pneumonia of infectious or idiopathic etiologies, and acute graft-versus-host disease (GVHD).^{221 223 224 225 306}

Effect of IGIV on the incidence of cytomegalovirus (CMV) infection, other infections, or GVHD in patients undergoing allogeneic BMT is unclear.^{221 222 223 224 225 304 306} IGIV prophylaxis in BMT patients does not appear to affect survival or risk of cancer relapse, and the long-term effects of such therapy remain to be determined.²²¹

Although efficacy and safety in BMT patients have not been established, some clinicians suggest that IGIV be used for prophylaxis in all allogeneic BMT patients, especially CMV-positive patients or those who have received a transplant from a CMV-positive donor.²²²

Some clinicians suggest that, although there is a perceived benefit of IGIV prophylaxis in infants with severe combined immunodeficiency or other primary immunodeficiency diseases undergoing BMT, the effect of IGIV in these children is difficult to study since they generally are receiving IGIV for replacement therapy.³⁰⁶ These clinicians also state that use of IGIV appears to offer little benefit in patients with malignancies undergoing HLA-identical sibling BMT and that additional study is needed to determine whether the drug is beneficial in those undergoing HLA-matched unrelated BMT or cord blood transplants.³⁰⁶

Hematopoietic Stem Cell Transplant (HSCT) Recipients

CDC, IDSA, and ASBMT state that, although routine use of IGIV for prophylaxis is not recommended for autologous HSCT recipients, some clinicians recommend use of IGIV to prevent bacterial infections (e.g., Streptococcus pneumoniae sinopulmonary infections) in adult, adolescent, or pediatric allogeneic HSCT recipients† who experience severe hypogammaglobulinemia (IgG <400 mg/dL) within the first 100 days after transplant.²⁶²

Routine administration of IGIV in HSCT recipients >90 days after HSCT is not recommended in the absence of severe hypogammaglobulinemia.²⁶²

Infections in Low-birthweight Neonates

IGIV has been used for prophylaxis and treatment of infections in certain high-risk, preterm, low-birthweight neonates†.^{130 137 155 156 157 166 167 168 169 170 171 172 214} However, until further data are available, do not use IGIV routinely for prophylaxis or treatment of nosocomial infections in preterm, low-birthweight infants.^{155 167 170 171 172 187 214}

Toxic Shock Syndrome

Some clinicians suggest that IGIV may be considered as an adjunct in the treatment of staphylococcal or streptococcal toxic shock syndrome† or necrotizing fasciitis† in severely ill patients.^{187 201 306}

Although efficacy and safety have not been established, AAP suggests that IGIV may be considered in the management of severe staphylococcal or streptococcal toxic shock syndrome† when the infection is refractory to several hours of aggressive therapy, an undrainable focus is present, or the patient has persistent oliguria with pulmonary edema.¹⁸⁷

Tetanus

IGIV has been recommended as an alternative for the treatment of tetanus† when tetanus immune globulin (TIG) is unavailable; TIG is the immune globulin of choice.¹⁸⁷

IGIV has been recommended as an alternative for postexposure prophylaxis of tetanus† in individuals with tetanus-prone wounds when TIG is unavailable; TIG is the immune globulin of choice.¹⁸⁷

Other Bacterial or Viral Infections

IGIV has been used alone or in conjunction with appropriate anti-infective therapy to prevent or modify acute bacterial or viral infections (e.g., CMV infections) in patients with iatrogenically induced or disease-associated immunosuppression† (e.g., patients undergoing major surgery [e.g., cardiac transplants]; patients with hematologic malignancies, extensive burns, or collagen-vascular diseases).^{130 136 141 155 156 157}

Autoimmune Neutropenia and Autoimmune Hemolytic Anemia

IGIV has been used with some success in a limited number of adults and children for the treatment of autoimmune neutropenia†.^{130 138 140 156 157 164} May be beneficial in some patients,^{304 306} but unclear whether IGIV offers any advantage over corticosteroid therapy.³⁰⁶

IGIV has been used with variable results in patients with autoimmune hemolytic anemia†.^{130 140 142 143 157} Some clinicians state IGIV should be used in the management of autoimmune hemolytic anemia only in those who fail to respond to other treatment options.³⁰⁶

Systemic Lupus Erythematosus

IGIV has been used with some success in the treatment of systemic lupus erythematosus† (SLE);^{218 301 304 305 306} efficacy and safety not definitely established and additional study is needed.^{305 306} Some clinicians suggest use of IGIV can be considered in patients with severe active SLE when other drugs have been ineffective or not tolerated;²¹⁸ other clinicians recommend caution.³⁰⁶

Neurologic and Neuromuscular Disorders

IGIV has been used in the treatment of Guillain-Barré syndrome† (GBS).^{165 219 301 304 305 306 310 312 317 318} Although safety and efficacy have not been established, IGIV initiated within 2 weeks of symptom onset appears to be as effective as plasma exchange^{218 301 305 306 310 312 317} and is recommended by some clinicians as a treatment of choice for GBS in adults or children,^{218 301 305 306 310 312 318} especially if disease is severe.^{301 312} Additional study needed to determine whether IGIV is beneficial in patients with mild GBS or Miller Fischer syndrome.^{310 312 317}

IGIV has been used in the management of multifocal motor neuropathy† (MMN) and may provide benefits (e.g., improved muscle strength) in some patients.^{301 304 305 306 310 311 312 313 314 315 316} Although efficacy and safety have not been established, some clinicians recommend IGIV as a treatment of choice for MMN^{301 305 306 310 311} when severe disability warrants treatment.³¹¹

IGIV has been used in the management of multiple sclerosis† (MS) and has provided benefits (e.g., reduced exacerbations, reduced disability scores) in some patients with relapsing-remitting MS.^{301 305 306 310 318} Although some clinicians suggest that IGIV can be considered as a potentially effective second- or third-line treatment in patients with relapsing-remitting MS,^{306 310} others state that additional study is needed to further evaluate potential benefits and role of the drug in this disease.