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    Immunoglobulins, Normal Human

    BOXED WARNING

    Cardiac disease, coronary artery disease, diabetes mellitus, geriatric, heart failure, hypertriglyceridemia, obesity, thromboembolism

    Thromboembolism is known to be associated with immune globulin therapy, regardless of the route of administration. Thrombosis can occur in patients without any known risk factors; however, patients most at risk include geriatric patients, those with multiple cardiovascular risk factors (e.g., known cardiac disease), impaired cardiac output (heart failure), prolonged immobilization, obesity, diabetes mellitus, use of estrogens, indwelling central venous catheters, acquired or inherited coagulation disorders, and patients with a history of a thrombotic event, vascular disease, atherosclerosis (coronary artery disease), and/or known or suspected hyperviscosity. Assessment of blood viscosity may be warranted for patients at risk for hyperviscosity such as those with cryoglobulins, fasting chylomicronemia, hypertriglyceridemia, or monoclonal gammopathies. For patients at risk of developing thrombosis, use the minimum recommended dose of immune globulin. Ensure patients are not volume depleted prior to the initiation of immune globulin therapy and monitor for signs and symptoms of thrombosis during and after each dose. Encourage patients to report any pain, swelling, discoloration, and/or warmth of the arms or legs, unexplained shortness of breath, chest pain/discomfort, unexplained tachycardia, and numbness or weakness on one side of the body.  [48785]

    DEA CLASS

    Rx

    DESCRIPTION

    Human immune globulin for intramuscular administration
    Used for postexposure prophylaxis of hepatitis A, to prevent or modify measles or varicella after exposure, and to modify rubella after exposure in pregnant women
    Associated with thrombosis

    COMMON BRAND NAMES

    ASCENIV, BIVIGAM, Carimune NF, Flebogamma DIF, Gammagard, Gammagard S/D, Gammaked, Gammaplex, Gamunex-C, Octagam, panzyga, Privigen

    HOW SUPPLIED

    ASCENIV/BIVIGAM/Gamunex-C/Octagam/panzyga/Privigen Intravenous Sol: 5%, 10%
    ASCENIV/Flebogamma DIF/Gammagard/Gammaked/Gammaplex/Octagam Intravenous Inj Sol: 5%, 10%
    Carimune NF/Gammagard S/D Intravenous Inj Pwd F/Sol: 5g, 6g, 10g, 12g
    Cuvitru/Gammagard/Gammaked/Hizentra/Xembify Subcutaneous Inj Sol: 10%, 20%
    Gamunex-C Intravenous Inj Susp: 10%
    Gamunex-C Subcutaneous Inj Susp: 10%
    Gamunex-C Subcutaneous Sol: 10%

    DOSAGE & INDICATIONS

    For hepatitis A prophylaxis.
    For postexposure prophylaxis.
    Intramuscular dosage
    Adults who have not previously received the hepatitis A vaccine and who have been exposed to HAV in the past 2 weeks

    0.1 mL/kg IM as soon as possible after HAV exposure. Hepatitis A vaccine may be an alternative. Use immune globulin for postexposure prophylaxis in immunocompromised patients, chronic liver disease diagnosed patients, and anyone who cannot get the vaccine because of contraindications. Immune globulin is also preferred over hepatitis A vaccine in patients older than 40 years of age; however, vaccine may be used if immune globulin is not available.

    Infants†, Children†, and Adolescents† who have not previously received the hepatitis A vaccine and who have been exposed to HAV in the past 2 weeks

    0.1 mL/kg IM as soon as possible after HAV exposure. Hepatitis A vaccine may be an alternative. Use immune globulin for postexposure prophylaxis in infants, immunocompromised patients, chronic liver disease diagnosed patients, and anyone who cannot get the vaccine because of contraindications.

    For patients traveling to regions that have high or intermediate hepatitis A endemicity.
    Intramuscular dosage
    Adults with anticipated risk of exposure up to 1 month

    0.1 mL/kg IM. Hepatitis A vaccine is preferred to immune globulin for all susceptible persons. Immune globulin may be administered simultaneously with hepatitis A vaccine at a separate anatomical injection site for travel that will begin in 2 weeks or less, in older adults, immunocompromised patients, and patients with chronic liver disease or other chronic medical conditions. If the vaccine is contraindicated or is refused by the patient, administer a single dose of immune globulin prior to travel.

    Infants†, Children†, and Adolescents† with anticipated risk of exposure up to 1 month

    0.1 mL/kg IM. Hepatitis A vaccine is preferred to immune globulin for all susceptible persons. Immune globulin may be administered simultaneously with hepatitis A vaccine at a separate anatomical injection site for travel that will begin in 2 weeks or less, immunocompromised patients, and patients with chronic liver disease or other chronic medical conditions. If the vaccine is contraindicated or is refused by the patient, administer a single dose of immune globulin prior to travel.

    Adults with anticipated risk of exposure up to 2 months

    0.2 mL/kg IM. Hepatitis A vaccine is preferred to immune globulin for all susceptible persons. Immune globulin may be administered simultaneously with hepatitis A vaccine at a separate anatomical injection site for travel that will begin in 2 weeks or less, in older adults, immunocompromised patients, and patients with chronic liver disease or other chronic medical conditions. If the vaccine is contraindicated or is refused by the patient, administer a single dose of immune globulin prior to travel.

    Infants†, Children†, and Adolescents† with anticipated risk of exposure up to 2 months

    0.2 mL/kg IM. Hepatitis A vaccine is preferred to immune globulin for all susceptible persons. Immune globulin may be administered simultaneously with hepatitis A vaccine at a separate anatomical injection site for travel that will begin in 2 weeks or less, immunocompromised patients, and patients with chronic liver disease or other chronic medical conditions. If the vaccine is contraindicated or is refused by the patient, administer a single dose of immune globulin prior to travel.

    Adults with anticipated risk of exposure 2 months or longer

    0.2 mL/kg IM. Repeat dose of 0.2 mL/kg every 2 months. Hepatitis A vaccine is preferred to immune globulin for all susceptible persons. Immune globulin may be administered simultaneously with hepatitis A vaccine at a separate anatomical injection site for travel that will begin in 2 weeks or less, in older adults, immunocompromised patients, and patients with chronic liver disease or other chronic medical conditions. If the vaccine is contraindicated or is refused by the patient, administer a single dose of immune globulin prior to travel.

    Infants†, Children†, and Adolescents† with anticipated risk of exposure 2 months or longer

    0.2 mL/kg IM. Repeat dose of 0.2 mL/kg every 2 months. Hepatitis A vaccine is preferred to immune globulin for all susceptible persons. Immune globulin may be administered simultaneously with hepatitis A vaccine at a separate anatomical injection site for travel that will begin in 2 weeks or less, immunocompromised patients, and patients with chronic liver disease or other chronic medical conditions. If the vaccine is contraindicated or is refused by the patient, administer a single dose of immune globulin prior to travel.

    For measles prophylaxis to prevent or modify measles in an unvaccinated patient who has not previously had measles and who was exposed within the past 6 days.
    NOTE: For most persons 12 months and older who are exposed to measles, use of MMR or measles vaccine within 72 hours of exposure is preferred to using immune globulin (except pregnant women and others for whom the vaccine is contraindicated). Any person exposed to measles who lacks evidence of measles immunity and to whom immune globulin (IG) is administered should subsequently receive MMR vaccine but not earlier than 6 months after IMIG administration or 8 months after IGIV administration (provided the vaccine is not contraindicated).
    In immunocompetent patients.
    Intramuscular dosage
    Adults

    0.5 mL/kg/dose (Max: 15 mL) IM as a single dose for persons exposed to measles within the previous 6 days. The FDA-approved dosage is 0.25 mL/kg IM as a single dose. 

    Children† and Adolescents†

    0.5 mL/kg/dose (Max: 15 mL) IM as a single dose for persons who are not immune and have been exposed to measles within the previous 6 days.

    Infants†

    0.5 mL/kg/dose (Max: 15 mL) IM as a single dose for all infants exposed to measles within the previous 6 days.

    In patients with an immunodeficiency disorder or receiving immunosuppressant treatment.
    Intramuscular dosage
    Children†

    0.5 mL/kg/dose (Max: 15 mL) IM as a single dose.

    For varicella (chickenpox) infection prophylaxis.
    Intramuscular dosage
    Adults

    0.6 to 1.2 mL/kg IM given as soon as possible after exposure and only if human Varicella-Zoster Immune Globulin is not available.

    For rubella prophylaxis in exposed, susceptible pregnant women who will not consider a therapeutic abortion.
    NOTE: The routine use of IMIG for rubella prophylaxis in early pregnancy is of dubious value and cannot be justified.
    Intramuscular dosage
    Adult pregnant females

    0.55 mL/kg IM.

    MAXIMUM DOSAGE

    Adults

    The maximum dosage is dependent on the indication for therapy.

    Geriatric

    The maximum dosage is dependent on the indication for therapy.

    Adolescents

    Safety and efficacy have not been established, although 0.5 mL/kg IM (Max: 15 mL) has been used off-label for measles prophylaxis.

    Children

    Safety and efficacy have not been established, although 0.5 mL/kg/dose IM (Max: 15 mL) has been used off-label for measles prophylaxis.

    Infants

    Safety and efficacy have not been established, although 0.5 mL/kg/dose IM has been used off-label for measles prophylaxis.

    DOSING CONSIDERATIONS

    Hepatic Impairment

    Specific guidelines for dosage adjustments in hepatic impairment are not available; it appears that no dosage adjustments are needed.

    Renal Impairment

    Specific guidelines for dosage adjustments in renal impairment are not available; it appears that no dosage adjustments are needed.

    ADMINISTRATION

    Injectable Administration

    Administer IMIG intramuscularly only. Do not administer intravenously.
    A separate syringe and needle should be used for each person receiving immune globulin.
    Visually inspect parenteral products for particulate matter and discoloration prior to administration whenever solution and container permit.

    Intramuscular Administration

    Immune Globulin intramuscular injections should be made into the deltoid muscle or into the anterolateral muscles of the thigh. In order to avoid injury to the sciatic nerves, do NOT inject into the central gluteal region; injection into the upper, outer quadrant of the gluteus maximus should be used only if large volumes are administered or when large doses must be divided into multiple IM injections. Dosages greater than 10 mL should be divided and injected into different sites.

    STORAGE

    ASCENIV:
    - Avoid exposure to heat
    - Avoid use of product if it has been frozen
    - Discard product if it contains particulate matter, is cloudy, or discolored
    - Do not freeze
    - Refrigerate (between 36 and 46 degrees F)
    - Refrigerated product should reach room temperature before administration
    BIVIGAM:
    - Avoid exposure to heat
    - Avoid use of product if it has been frozen
    - Discard product if it contains particulate matter, is cloudy, or discolored
    - Discard unused portion. Do not store for later use.
    - Do not dilute the product
    - Do not freeze
    - Refrigerate (between 36 and 46 degrees F)
    - Refrigerated product should reach room temperature before administration
    - Store in a cool, dry place
    - Store in original container
    Carimune NF:
    - Store below 86 degrees F
    Flebogamma:
    - Discard product if it contains particulate matter, is cloudy, or discolored
    - Discard unused portion. Do not store for later use.
    - Do not freeze
    - Store between 36 to 77 degrees F
    Flebogamma DIF :
    - Discard product if it contains particulate matter, is cloudy, or discolored
    - Discard unused portion. Do not store for later use.
    - Do not freeze
    - Protect from light
    - Store between 36 to 77 degrees F
    - Store in carton
    Gammagard:
    - Discard product if it contains particulate matter, is cloudy, or discolored
    - Discard unused portion. Do not store for later use.
    - Do not freeze
    - Product can be stored at room temperature (77 degrees F) for 12 months within the first 24 months from date of manufacture
    - Product cannot be stored at room temperature after 24 months from date of manufacture
    - Protect from freezing
    - See package insert for detailed storage information
    - Store product in refrigerator (36 to 46 degrees F) for up to 36 months from date of manufacture
    Gammagard S/D:
    - Discard unused portion. Do not store for later use.
    - Do not freeze
    - Store reconstituted product in accordance with package insert instructions
    - Store unreconstituted product at or below 77 degrees F
    Gammaked:
    - Discard product if it contains particulate matter, is cloudy, or discolored
    - Discard unused portion. Do not store for later use.
    - Do not freeze
    - May be stored at room temperature not exceeding 77 degrees F for up to 6 months
    - Store between 36 to 46 degrees F
    - Store in the original carton to protect from light
    Gammaplex:
    - Discard product if it contains particulate matter, is cloudy, or discolored
    - Discard unused portion. Do not store for later use.
    - Do not freeze
    - Protect from light
    - Store between 36 to 77 degrees F
    - Store in carton until time of use
    Gamunex:
    - Protect from freezing
    - Refrigerate (between 36 and 46 degrees F)
    - Store below 77 degrees F
    Gamunex-C:
    - Discard product if it contains particulate matter, is cloudy, or discolored
    - Discard unused portion. Do not store for later use.
    - Do not freeze
    - Do not use if product has been frozen
    - May be stored at room temperature not exceeding 77 degrees F for up to 6 months
    - Store in the original carton to protect from light
    - Store product in refrigerator (36 to 46 degrees F) for up to 36 months from date of manufacture
    Iveegam EN:
    - Protect from freezing
    - Refrigerate (between 36 and 46 degrees F)
    Octagam:
    - Discard product if it contains particulate matter, is cloudy, or discolored
    - Do not freeze
    - Do not use if product has been frozen
    - Product can be stored at room temperature (77 degrees F) for 12 months within the first 24 months from date of manufacture
    - Protect from light
    - Store between 36 to 46 degrees F
    panzyga:
    - Discard product if it contains particulate matter, is cloudy, or discolored
    - Discard unused portion. Do not store for later use.
    - Do not freeze
    - Do not use if product has been frozen
    - See package insert for detailed storage information
    - Store in the original carton to protect from light
    Polygam S/D:
    - Protect from freezing
    - Store below 77 degrees F
    Privigen :
    - Discard product if it contains particulate matter, is cloudy, or discolored
    - Discard unused portion. Do not store for later use.
    - Do not freeze
    - Protect from light
    - Store at room temperature (up to 77 degrees F)
    - Store in carton until time of use
    Vigam:
    - Do not freeze
    - May be stored at room temperature not exceeding 77 degrees F for up to 3 months
    - Store between 36 to 46 degrees F
    - Store in original container

    CONTRAINDICATIONS / PRECAUTIONS

    IgA deficiency

    Immune globulin IM (IGIM) is contraindicated for use in patients known to have anaphylactic or severe systemic reactions to human immune globulin preparations. IGIM is also contraindicated for use in patients with IgA deficiency with antibodies against IgA and a history of hypersensitivity; these patients are more likely to have anaphylactic or immune-mediated adverse reactions to pooled immunoglobulin products.

    Intravenous administration

    Immune globulin IM (IGIM) is for intramuscular use only. Do not give IGIM via intravenous administration. Intravenous administration of IGIM significantly increases the risk of developing a severe anaphylactic reaction and should be avoided. Use IGIM cautiously in patients with a history of human immunoglobulin hypersensitivity. Skin testing for hypersensitivity is not recommended. Intradermal injection of concentrated gamma globulin solution causes local inflammation, which may be misinterpreted as an allergic reaction. Although allergic reactions are rare, immediate availability of epinephrine is advised.

    Viral infection

    As with other products derived from or purified with human blood components, the possibility of transmitting a bacterial or viral infection, including hepatitis, or Creutzfeldt-Jakob disease (CJD) exists in patients receiving immune globulin IM (IGIM). Screening plasma donors for prior exposure to certain viruses, testing for the presence of viruses, and inactivating and/or reducing viruses has reduced the risk of transmission of infectious agents; however, none of the processes are completely effective. There is also the possibility that unknown infectious agents are present in the pooled product. To date, no cases of viral transmission have been identified for products manufactured with the same core manufacturing process as IGIM. All infections thought to have been transmitted by IGIM should be reported to the manufacturer.

    Vaccination

    The immune globulins present in immune globulin IM (IGIM) products may interfere with live virus vaccination, such as measles, mumps, polio, rubella, and varicella, immunization. Defer live vaccine administration for up to 6 months after IGIM administration.

    Cardiac disease, coronary artery disease, diabetes mellitus, geriatric, heart failure, hypertriglyceridemia, obesity, thromboembolism

    Thromboembolism is known to be associated with immune globulin therapy, regardless of the route of administration. Thrombosis can occur in patients without any known risk factors; however, patients most at risk include geriatric patients, those with multiple cardiovascular risk factors (e.g., known cardiac disease), impaired cardiac output (heart failure), prolonged immobilization, obesity, diabetes mellitus, use of estrogens, indwelling central venous catheters, acquired or inherited coagulation disorders, and patients with a history of a thrombotic event, vascular disease, atherosclerosis (coronary artery disease), and/or known or suspected hyperviscosity. Assessment of blood viscosity may be warranted for patients at risk for hyperviscosity such as those with cryoglobulins, fasting chylomicronemia, hypertriglyceridemia, or monoclonal gammopathies. For patients at risk of developing thrombosis, use the minimum recommended dose of immune globulin. Ensure patients are not volume depleted prior to the initiation of immune globulin therapy and monitor for signs and symptoms of thrombosis during and after each dose. Encourage patients to report any pain, swelling, discoloration, and/or warmth of the arms or legs, unexplained shortness of breath, chest pain/discomfort, unexplained tachycardia, and numbness or weakness on one side of the body.  [48785]

    Pregnancy

    There are no data with immune globulin IM (IGIM) use during pregnancy to inform a drug-associated risk. It is not known whether IGIM can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Animal studies have not been conducted with IGIM.[48785] According to the Advisory Committee on Immunization Practices (ACIP), fetal adverse events have not occurred after administration of immune globulin preparations to pregnant women.[43236]

    Breast-feeding

    There are no data available regarding the presence of immune globulin in human milk, the effect on the breast-fed infant, or the effect on milk production.[48785] Case reports of 2 nursing mothers receiving intravenous immune globulin therapy suggest transfer of IgG and IgM into the colostrum and breast milk.[48199] Consider the developmental and health benefits of breast-feeding along with the mother's clinical need for immune globulin and any potential adverse effects on the breast-fed infant from immune globulin or the underlying maternal condition.[48785]

    ADVERSE REACTIONS

    Severe

    anaphylactoid reactions / Rapid / Incidence not known
    thrombosis / Delayed / Incidence not known
    thromboembolism / Delayed / Incidence not known

    Moderate

    dyspnea / Early / Incidence not known

    Mild

    fatigue / Early / Incidence not known
    injection site reaction / Rapid / Incidence not known
    nausea / Early / Incidence not known
    headache / Early / Incidence not known
    fever / Early / Incidence not known
    flushing / Rapid / Incidence not known
    rash / Early / Incidence not known
    infection / Delayed / Incidence not known

    DRUG INTERACTIONS

    Acetaminophen; Aspirin, ASA; Caffeine: (Moderate) Immune Globulin (IG) products have been reported to be associated with renal dysfunction, acute renal failure, osmotic nephrosis, and death. Patients predisposed to acute renal failure include patients receiving known nephrotoxic drugs like nonsteroidal anti-inflammatory drugs (NSAIDs) and salicylates. Coadminister IG products at the minimum concentration available and the minimum rate of infusion practicable. Also, closely monitor renal function.
    Acetaminophen; Aspirin: (Moderate) Immune Globulin (IG) products have been reported to be associated with renal dysfunction, acute renal failure, osmotic nephrosis, and death. Patients predisposed to acute renal failure include patients receiving known nephrotoxic drugs like nonsteroidal anti-inflammatory drugs (NSAIDs) and salicylates. Coadminister IG products at the minimum concentration available and the minimum rate of infusion practicable. Also, closely monitor renal function.
    Acetaminophen; Aspirin; Diphenhydramine: (Moderate) Immune Globulin (IG) products have been reported to be associated with renal dysfunction, acute renal failure, osmotic nephrosis, and death. Patients predisposed to acute renal failure include patients receiving known nephrotoxic drugs like nonsteroidal anti-inflammatory drugs (NSAIDs) and salicylates. Coadminister IG products at the minimum concentration available and the minimum rate of infusion practicable. Also, closely monitor renal function.
    Acetaminophen; Ibuprofen: (Moderate) Immune Globulin (IG) products have been reported to be associated with renal dysfunction, acute renal failure, osmotic nephrosis, and death. Patients predisposed to acute renal failure include patients receiving known nephrotoxic drugs like nonsteroidal anti-inflammatory drugs (NSAIDs) and salicylates. Coadminister IG products at the minimum concentration available and the minimum rate of infusion practicable. Also, closely monitor renal function.
    Acyclovir: (Moderate) Immune Globulin (IG) products have been reported to be associated with renal dysfunction, acute renal failure, osmotic nephrosis, and death. Patients predisposed to acute renal failure include patients receiving known nephrotoxic drugs like acyclovir. Administer IG products at the minimum concentration available and the minimum rate of infusion practicable. Also, closely monitor renal function. Periodic monitoring of renal function tests and urine output is particularly important in patients judged to have a potential risk for developing acute renal failure.
    Adefovir: (Moderate) Immune Globulin (IG) products have been reported to be associated with renal dysfunction, acute renal failure, osmotic nephrosis, and death. Patients predisposed to acute renal failure include patients receiving known nephrotoxic drugs like adefovir. Coadminister IG products at the minimum concentration available and the minimum rate of infusion practicable. Also, closely monitor renal function.
    Amikacin: (Moderate) Immune globulin (IG) products have been reported to be associated with renal dysfunction, acute renal failure, osmotic nephrosis, and death. Patients predisposed to acute renal failure include patients receiving known nephrotoxic drugs like aminoglycosides. Coadminister IG products at the minimum concentration available and the minimum rate of infusion practicable. Closely monitor renal function.
    Aminoglycosides: (Moderate) Immune globulin (IG) products have been reported to be associated with renal dysfunction, acute renal failure, osmotic nephrosis, and death. Patients predisposed to acute renal failure include patients receiving known nephrotoxic drugs like aminoglycosides. Coadminister IG products at the minimum concentration available and the minimum rate of infusion practicable. Closely monitor renal function.
    Amlodipine; Celecoxib: (Moderate) Immune Globulin (IG) products have been reported to be associated with renal dysfunction, acute renal failure, osmotic nephrosis, and death. Patients predisposed to acute renal failure include patients receiving known nephrotoxic drugs like nonsteroidal anti-inflammatory drugs (NSAIDs) and salicylates. Coadminister IG products at the minimum concentration available and the minimum rate of infusion practicable. Also, closely monitor renal function.
    Amphotericin B lipid complex (ABLC): (Moderate) Immune Globulin (IG) products have been reported to be associated with renal dysfunction, acute renal failure, osmotic nephrosis, and death. Patients predisposed to acute renal failure include patients receiving known nephrotoxic drugs like amphotericin B. Coadminister IG products at the minimum concentration available and the minimum rate of infusion practicable. Also, closely monitor renal function.
    Amphotericin B liposomal (LAmB): (Moderate) Immune Globulin (IG) products have been reported to be associated with renal dysfunction, acute renal failure, osmotic nephrosis, and death. Patients predisposed to acute renal failure include patients receiving known nephrotoxic drugs like amphotericin B. Coadminister IG products at the minimum concentration available and the minimum rate of infusion practicable. Also, closely monitor renal function.
    Amphotericin B: (Moderate) Immune Globulin (IG) products have been reported to be associated with renal dysfunction, acute renal failure, osmotic nephrosis, and death. Patients predisposed to acute renal failure include patients receiving known nephrotoxic drugs like amphotericin B. Coadminister IG products at the minimum concentration available and the minimum rate of infusion practicable. Also, closely monitor renal function.
    Aspirin, ASA: (Moderate) Immune Globulin (IG) products have been reported to be associated with renal dysfunction, acute renal failure, osmotic nephrosis, and death. Patients predisposed to acute renal failure include patients receiving known nephrotoxic drugs like nonsteroidal anti-inflammatory drugs (NSAIDs) and salicylates. Coadminister IG products at the minimum concentration available and the minimum rate of infusion practicable. Also, closely monitor renal function.
    Aspirin, ASA; Butalbital; Caffeine: (Moderate) Immune Globulin (IG) products have been reported to be associated with renal dysfunction, acute renal failure, osmotic nephrosis, and death. Patients predisposed to acute renal failure include patients receiving known nephrotoxic drugs like nonsteroidal anti-inflammatory drugs (NSAIDs) and salicylates. Coadminister IG products at the minimum concentration available and the minimum rate of infusion practicable. Also, closely monitor renal function.
    Aspirin, ASA; Caffeine: (Moderate) Immune Globulin (IG) products have been reported to be associated with renal dysfunction, acute renal failure, osmotic nephrosis, and death. Patients predisposed to acute renal failure include patients receiving known nephrotoxic drugs like nonsteroidal anti-inflammatory drugs (NSAIDs) and salicylates. Coadminister IG products at the minimum concentration available and the minimum rate of infusion practicable. Also, closely monitor renal function.
    Aspirin, ASA; Caffeine; Orphenadrine: (Moderate) Immune Globulin (IG) products have been reported to be associated with renal dysfunction, acute renal failure, osmotic nephrosis, and death. Patients predisposed to acute renal failure include patients receiving known nephrotoxic drugs like nonsteroidal anti-inflammatory drugs (NSAIDs) and salicylates. Coadminister IG products at the minimum concentration available and the minimum rate of infusion practicable. Also, closely monitor renal function.
    Aspirin, ASA; Carisoprodol: (Moderate) Immune Globulin (IG) products have been reported to be associated with renal dysfunction, acute renal failure, osmotic nephrosis, and death. Patients predisposed to acute renal failure include patients receiving known nephrotoxic drugs like nonsteroidal anti-inflammatory drugs (NSAIDs) and salicylates. Coadminister IG products at the minimum concentration available and the minimum rate of infusion practicable. Also, closely monitor renal function.
    Aspirin, ASA; Carisoprodol; Codeine: (Moderate) Immune Globulin (IG) products have been reported to be associated with renal dysfunction, acute renal failure, osmotic nephrosis, and death. Patients predisposed to acute renal failure include patients receiving known nephrotoxic drugs like nonsteroidal anti-inflammatory drugs (NSAIDs) and salicylates. Coadminister IG products at the minimum concentration available and the minimum rate of infusion practicable. Also, closely monitor renal function.
    Aspirin, ASA; Citric Acid; Sodium Bicarbonate: (Moderate) Immune Globulin (IG) products have been reported to be associated with renal dysfunction, acute renal failure, osmotic nephrosis, and death. Patients predisposed to acute renal failure include patients receiving known nephrotoxic drugs like nonsteroidal anti-inflammatory drugs (NSAIDs) and salicylates. Coadminister IG products at the minimum concentration available and the minimum rate of infusion practicable. Also, closely monitor renal function.
    Aspirin, ASA; Dipyridamole: (Moderate) Immune Globulin (IG) products have been reported to be associated with renal dysfunction, acute renal failure, osmotic nephrosis, and death. Patients predisposed to acute renal failure include patients receiving known nephrotoxic drugs like nonsteroidal anti-inflammatory drugs (NSAIDs) and salicylates. Coadminister IG products at the minimum concentration available and the minimum rate of infusion practicable. Also, closely monitor renal function.
    Aspirin, ASA; Omeprazole: (Moderate) Immune Globulin (IG) products have been reported to be associated with renal dysfunction, acute renal failure, osmotic nephrosis, and death. Patients predisposed to acute renal failure include patients receiving known nephrotoxic drugs like nonsteroidal anti-inflammatory drugs (NSAIDs) and salicylates. Coadminister IG products at the minimum concentration available and the minimum rate of infusion practicable. Also, closely monitor renal function.
    Aspirin, ASA; Oxycodone: (Moderate) Immune Globulin (IG) products have been reported to be associated with renal dysfunction, acute renal failure, osmotic nephrosis, and death. Patients predisposed to acute renal failure include patients receiving known nephrotoxic drugs like nonsteroidal anti-inflammatory drugs (NSAIDs) and salicylates. Coadminister IG products at the minimum concentration available and the minimum rate of infusion practicable. Also, closely monitor renal function.
    Aspirin, ASA; Pravastatin: (Moderate) Immune Globulin (IG) products have been reported to be associated with renal dysfunction, acute renal failure, osmotic nephrosis, and death. Patients predisposed to acute renal failure include patients receiving known nephrotoxic drugs like nonsteroidal anti-inflammatory drugs (NSAIDs) and salicylates. Coadminister IG products at the minimum concentration available and the minimum rate of infusion practicable. Also, closely monitor renal function.
    Atropine; Benzoic Acid; Hyoscyamine; Methenamine; Methylene Blue; Phenyl Salicylate: (Moderate) Immune Globulin (IG) products have been reported to be associated with renal dysfunction, acute renal failure, osmotic nephrosis, and death. Patients predisposed to acute renal failure include patients receiving known nephrotoxic drugs like nonsteroidal anti-inflammatory drugs (NSAIDs) and salicylates. Coadminister IG products at the minimum concentration available and the minimum rate of infusion practicable. Also, closely monitor renal function.
    Bacitracin: (Moderate) Immune Globulin (IG) products have been reported to be associated with renal dysfunction, acute renal failure, osmotic nephrosis, and death. Patients predisposed to acute renal failure include patients receiving known nephrotoxic drugs like bacitracin. Coadminister IG products at the minimum concentration available and the minimum rate of infusion practicable. Also, closely monitor renal function.
    Benzoic Acid; Hyoscyamine; Methenamine; Methylene Blue; Phenyl Salicylate: (Moderate) Immune Globulin (IG) products have been reported to be associated with renal dysfunction, acute renal failure, osmotic nephrosis, and death. Patients predisposed to acute renal failure include patients receiving known nephrotoxic drugs like nonsteroidal anti-inflammatory drugs (NSAIDs) and salicylates. Coadminister IG products at the minimum concentration available and the minimum rate of infusion practicable. Also, closely monitor renal function.
    Bismuth Subsalicylate: (Moderate) Immune Globulin (IG) products have been reported to be associated with renal dysfunction, acute renal failure, osmotic nephrosis, and death. Patients predisposed to acute renal failure include patients receiving known nephrotoxic drugs like nonsteroidal anti-inflammatory drugs (NSAIDs) and salicylates. Coadminister IG products at the minimum concentration available and the minimum rate of infusion practicable. Also, closely monitor renal function.
    Bismuth Subsalicylate; Metronidazole; Tetracycline: (Moderate) Immune Globulin (IG) products have been reported to be associated with renal dysfunction, acute renal failure, osmotic nephrosis, and death. Patients predisposed to acute renal failure include patients receiving known nephrotoxic drugs like nonsteroidal anti-inflammatory drugs (NSAIDs) and salicylates. Coadminister IG products at the minimum concentration available and the minimum rate of infusion practicable. Also, closely monitor renal function.
    Bupivacaine; Meloxicam: (Moderate) Immune Globulin (IG) products have been reported to be associated with renal dysfunction, acute renal failure, osmotic nephrosis, and death. Patients predisposed to acute renal failure include patients receiving known nephrotoxic drugs like nonsteroidal anti-inflammatory drugs (NSAIDs) and salicylates. Coadminister IG products at the minimum concentration available and the minimum rate of infusion practicable. Also, closely monitor renal function.
    Butalbital; Aspirin; Caffeine; Codeine: (Moderate) Immune Globulin (IG) products have been reported to be associated with renal dysfunction, acute renal failure, osmotic nephrosis, and death. Patients predisposed to acute renal failure include patients receiving known nephrotoxic drugs like nonsteroidal anti-inflammatory drugs (NSAIDs) and salicylates. Coadminister IG products at the minimum concentration available and the minimum rate of infusion practicable. Also, closely monitor renal function.
    Capreomycin: (Moderate) Immune Globulin (IG) products have been reported to be associated with renal dysfunction, acute renal failure, osmotic nephrosis, and death. Patients predisposed to acute renal failure include patients receiving known nephrotoxic drugs like capreomycin. Coadminister IG products at the minimum concentration available and the minimum rate of infusion practicable. Also, closely monitor renal function.
    Celecoxib: (Moderate) Immune Globulin (IG) products have been reported to be associated with renal dysfunction, acute renal failure, osmotic nephrosis, and death. Patients predisposed to acute renal failure include patients receiving known nephrotoxic drugs like nonsteroidal anti-inflammatory drugs (NSAIDs) and salicylates. Coadminister IG products at the minimum concentration available and the minimum rate of infusion practicable. Also, closely monitor renal function.
    Celecoxib; Tramadol: (Moderate) Immune Globulin (IG) products have been reported to be associated with renal dysfunction, acute renal failure, osmotic nephrosis, and death. Patients predisposed to acute renal failure include patients receiving known nephrotoxic drugs like nonsteroidal anti-inflammatory drugs (NSAIDs) and salicylates. Coadminister IG products at the minimum concentration available and the minimum rate of infusion practicable. Also, closely monitor renal function.
    Chlorpheniramine; Ibuprofen; Pseudoephedrine: (Moderate) Immune Globulin (IG) products have been reported to be associated with renal dysfunction, acute renal failure, osmotic nephrosis, and death. Patients predisposed to acute renal failure include patients receiving known nephrotoxic drugs like nonsteroidal anti-inflammatory drugs (NSAIDs) and salicylates. Coadminister IG products at the minimum concentration available and the minimum rate of infusion practicable. Also, closely monitor renal function.
    Choline Salicylate; Magnesium Salicylate: (Moderate) Immune Globulin (IG) products have been reported to be associated with renal dysfunction, acute renal failure, osmotic nephrosis, and death. Patients predisposed to acute renal failure include patients receiving known nephrotoxic drugs like nonsteroidal anti-inflammatory drugs (NSAIDs) and salicylates. Coadminister IG products at the minimum concentration available and the minimum rate of infusion practicable. Also, closely monitor renal function.
    Cidofovir: (Moderate) Immune Globulin (IG) products have been reported to be associated with renal dysfunction, acute renal failure, osmotic nephrosis, and death. Patients predisposed to acute renal failure include patients receiving known nephrotoxic drugs like cidofovir. Coadminister IG products at the minimum concentration available and the minimum rate of infusion practicable. Also, closely monitor renal function.
    Cisplatin: (Moderate) Closely monitor renal function if concomitant use with cisplatin and immune globulin products (IVIG) are necessary. Coadminister IG products at the minimum concentration available and the minimum rate of infusion practicable. Cisplatin can cause nephrotoxicity, which may be exacerbated with the use of additional nephrotoxins. IVIG has been reported to be associated with renal dysfunction, acute renal failure, osmotic nephrosis, and death.
    Colistimethate, Colistin, Polymyxin E: (Moderate) Use caution with concomitant Immune Globulin (IG) products and colistimethate sodium. IG products have been reported to be associated with renal dysfunction, acute renal failure, osmotic nephrosis, and death. Patients predisposed to acute renal failure include patients receiving known nephrotoxic drugs. Coadminister IG products at the minimum concentration available and the minimum rate of infusion practicable. Closely monitor renal function.
    Colistin: (Moderate) Use caution with concomitant Immune Globulin (IG) products and colistimethate sodium. IG products have been reported to be associated with renal dysfunction, acute renal failure, osmotic nephrosis, and death. Patients predisposed to acute renal failure include patients receiving known nephrotoxic drugs. Coadminister IG products at the minimum concentration available and the minimum rate of infusion practicable. Closely monitor renal function.
    Cyclosporine: (Moderate) Immune Globulin (IG) products have been reported to be associated with renal dysfunction, acute renal failure, osmotic nephrosis, and death. Patients predisposed to acute renal failure include patients receiving known nephrotoxic drugs like cyclosporine. Coadminister IG products at the minimum concentration available and the minimum rate of infusion practicable. Also, closely monitor renal function.
    Diclofenac: (Moderate) Immune Globulin (IG) products have been reported to be associated with renal dysfunction, acute renal failure, osmotic nephrosis, and death. Patients predisposed to acute renal failure include patients receiving known nephrotoxic drugs like nonsteroidal anti-inflammatory drugs (NSAIDs) and salicylates. Coadminister IG products at the minimum concentration available and the minimum rate of infusion practicable. Also, closely monitor renal function.
    Diclofenac; Misoprostol: (Moderate) Immune Globulin (IG) products have been reported to be associated with renal dysfunction, acute renal failure, osmotic nephrosis, and death. Patients predisposed to acute renal failure include patients receiving known nephrotoxic drugs like nonsteroidal anti-inflammatory drugs (NSAIDs) and salicylates. Coadminister IG products at the minimum concentration available and the minimum rate of infusion practicable. Also, closely monitor renal function.
    Diflunisal: (Moderate) Immune Globulin (IG) products have been reported to be associated with renal dysfunction, acute renal failure, osmotic nephrosis, and death. Patients predisposed to acute renal failure include patients receiving known nephrotoxic drugs like nonsteroidal anti-inflammatory drugs (NSAIDs) and salicylates. Coadminister IG products at the minimum concentration available and the minimum rate of infusion practicable. Also, closely monitor renal function.
    Diphenhydramine; Ibuprofen: (Moderate) Immune Globulin (IG) products have been reported to be associated with renal dysfunction, acute renal failure, osmotic nephrosis, and death. Patients predisposed to acute renal failure include patients receiving known nephrotoxic drugs like nonsteroidal anti-inflammatory drugs (NSAIDs) and salicylates. Coadminister IG products at the minimum concentration available and the minimum rate of infusion practicable. Also, closely monitor renal function.
    Diphenhydramine; Naproxen: (Moderate) Immune Globulin (IG) products have been reported to be associated with renal dysfunction, acute renal failure, osmotic nephrosis, and death. Patients predisposed to acute renal failure include patients receiving known nephrotoxic drugs like nonsteroidal anti-inflammatory drugs (NSAIDs) and salicylates. Coadminister IG products at the minimum concentration available and the minimum rate of infusion practicable. Also, closely monitor renal function.
    Efgartigimod Alfa: (Moderate) Monitor for reduced efficacy of immune globulin during coadministration with efgartigimod. Concomitant use of efgartigimod with medications that bind to the human neonatal Fc receptor (FcRn), such as immune globulin, may reduce immune globulin exposure and efficacy. Consider efgartigimod discontinuation and the use of alternative therapies if long-term therapy with immune globulin is needed.
    Etodolac: (Moderate) Immune Globulin (IG) products have been reported to be associated with renal dysfunction, acute renal failure, osmotic nephrosis, and death. Patients predisposed to acute renal failure include patients receiving known nephrotoxic drugs like nonsteroidal anti-inflammatory drugs (NSAIDs) and salicylates. Coadminister IG products at the minimum concentration available and the minimum rate of infusion practicable. Also, closely monitor renal function.
    Fenoprofen: (Moderate) Immune Globulin (IG) products have been reported to be associated with renal dysfunction, acute renal failure, osmotic nephrosis, and death. Patients predisposed to acute renal failure include patients receiving known nephrotoxic drugs like nonsteroidal anti-inflammatory drugs (NSAIDs) and salicylates. Coadminister IG products at the minimum concentration available and the minimum rate of infusion practicable. Also, closely monitor renal function.
    Flurbiprofen: (Moderate) Immune Globulin (IG) products have been reported to be associated with renal dysfunction, acute renal failure, osmotic nephrosis, and death. Patients predisposed to acute renal failure include patients receiving known nephrotoxic drugs like nonsteroidal anti-inflammatory drugs (NSAIDs) and salicylates. Coadminister IG products at the minimum concentration available and the minimum rate of infusion practicable. Also, closely monitor renal function.
    Foscarnet: (Moderate) Immune Globulin (IG) products have been reported to be associated with renal dysfunction, acute renal failure, osmotic nephrosis, and death. Patients predisposed to acute renal failure include patients receiving known nephrotoxic drugs like foscarnet. Coadminister IG products at the minimum concentration available and the minimum rate of infusion practicable. Also, closely monitor renal function.
    Ganciclovir: (Moderate) Immune Globulin (IG) products have been reported to be associated with renal dysfunction, acute renal failure, osmotic nephrosis, and death. Patients predisposed to acute renal failure include patients receiving known nephrotoxic drugs like ganciclovir. Coadminister IG products at the minimum concentration available and the minimum rate of infusion practicable. Also, closely monitor renal function.
    Gentamicin: (Moderate) Immune globulin (IG) products have been reported to be associated with renal dysfunction, acute renal failure, osmotic nephrosis, and death. Patients predisposed to acute renal failure include patients receiving known nephrotoxic drugs like aminoglycosides. Coadminister IG products at the minimum concentration available and the minimum rate of infusion practicable. Closely monitor renal function.
    Hydrocodone; Ibuprofen: (Moderate) Immune Globulin (IG) products have been reported to be associated with renal dysfunction, acute renal failure, osmotic nephrosis, and death. Patients predisposed to acute renal failure include patients receiving known nephrotoxic drugs like nonsteroidal anti-inflammatory drugs (NSAIDs) and salicylates. Coadminister IG products at the minimum concentration available and the minimum rate of infusion practicable. Also, closely monitor renal function.
    Hyoscyamine; Methenamine; Methylene Blue; Phenyl Salicylate; Sodium Biphosphate: (Moderate) Immune Globulin (IG) products have been reported to be associated with renal dysfunction, acute renal failure, osmotic nephrosis, and death. Patients predisposed to acute renal failure include patients receiving known nephrotoxic drugs like nonsteroidal anti-inflammatory drugs (NSAIDs) and salicylates. Coadminister IG products at the minimum concentration available and the minimum rate of infusion practicable. Also, closely monitor renal function.
    Ibuprofen: (Moderate) Immune Globulin (IG) products have been reported to be associated with renal dysfunction, acute renal failure, osmotic nephrosis, and death. Patients predisposed to acute renal failure include patients receiving known nephrotoxic drugs like nonsteroidal anti-inflammatory drugs (NSAIDs) and salicylates. Coadminister IG products at the minimum concentration available and the minimum rate of infusion practicable. Also, closely monitor renal function.
    Ibuprofen; Famotidine: (Moderate) Immune Globulin (IG) products have been reported to be associated with renal dysfunction, acute renal failure, osmotic nephrosis, and death. Patients predisposed to acute renal failure include patients receiving known nephrotoxic drugs like nonsteroidal anti-inflammatory drugs (NSAIDs) and salicylates. Coadminister IG products at the minimum concentration available and the minimum rate of infusion practicable. Also, closely monitor renal function.
    Ibuprofen; Oxycodone: (Moderate) Immune Globulin (IG) products have been reported to be associated with renal dysfunction, acute renal failure, osmotic nephrosis, and death. Patients predisposed to acute renal failure include patients receiving known nephrotoxic drugs like nonsteroidal anti-inflammatory drugs (NSAIDs) and salicylates. Coadminister IG products at the minimum concentration available and the minimum rate of infusion practicable. Also, closely monitor renal function.
    Ibuprofen; Pseudoephedrine: (Moderate) Immune Globulin (IG) products have been reported to be associated with renal dysfunction, acute renal failure, osmotic nephrosis, and death. Patients predisposed to acute renal failure include patients receiving known nephrotoxic drugs like nonsteroidal anti-inflammatory drugs (NSAIDs) and salicylates. Coadminister IG products at the minimum concentration available and the minimum rate of infusion practicable. Also, closely monitor renal function.
    Indomethacin: (Moderate) Immune Globulin (IG) products have been reported to be associated with renal dysfunction, acute renal failure, osmotic nephrosis, and death. Patients predisposed to acute renal failure include patients receiving known nephrotoxic drugs like nonsteroidal anti-inflammatory drugs (NSAIDs) and salicylates. Coadminister IG products at the minimum concentration available and the minimum rate of infusion practicable. Also, closely monitor renal function.
    Ketoprofen: (Moderate) Immune Globulin (IG) products have been reported to be associated with renal dysfunction, acute renal failure, osmotic nephrosis, and death. Patients predisposed to acute renal failure include patients receiving known nephrotoxic drugs like nonsteroidal anti-inflammatory drugs (NSAIDs) and salicylates. Coadminister IG products at the minimum concentration available and the minimum rate of infusion practicable. Also, closely monitor renal function.
    Ketorolac: (Moderate) Immune Globulin (IG) products have been reported to be associated with renal dysfunction, acute renal failure, osmotic nephrosis, and death. Patients predisposed to acute renal failure include patients receiving known nephrotoxic drugs like nonsteroidal anti-inflammatory drugs (NSAIDs) and salicylates. Coadminister IG products at the minimum concentration available and the minimum rate of infusion practicable. Also, closely monitor renal function.
    Lansoprazole; Naproxen: (Moderate) Immune Globulin (IG) products have been reported to be associated with renal dysfunction, acute renal failure, osmotic nephrosis, and death. Patients predisposed to acute renal failure include patients receiving known nephrotoxic drugs like nonsteroidal anti-inflammatory drugs (NSAIDs) and salicylates. Coadminister IG products at the minimum concentration available and the minimum rate of infusion practicable. Also, closely monitor renal function.
    Magnesium Salicylate: (Moderate) Immune Globulin (IG) products have been reported to be associated with renal dysfunction, acute renal failure, osmotic nephrosis, and death. Patients predisposed to acute renal failure include patients receiving known nephrotoxic drugs like nonsteroidal anti-inflammatory drugs (NSAIDs) and salicylates. Coadminister IG products at the minimum concentration available and the minimum rate of infusion practicable. Also, closely monitor renal function.
    Measles Virus; Mumps Virus; Rubella Virus; Varicella Virus Vaccine, Live: (Major) Do not give immune globulin including varicella zoster immune globulin concurrently with the varicella-zoster virus vaccine, live. Because of the potential inhibition of the immune response to vaccination by passively transferred antibodies, it is advisable not to give varicella-zoster virus vaccine, live to any patient who has received blood (except washed red blood cells), plasma transfusions, or immunoglobulins within the previous 5 months. There should be an interval of at least 5 months following administration of immune globulin, including varicella-zoster immune globulin, VZIG, before varicella vaccination. After varicella vaccination, the CDC recommends that immune globulin products should not be given for 3 weeks, unless the benefit outweighs the risk; the manufacturer recommends waiting 2 months before administering immunoglobulins. In the case that IgG products are administered within 3 weeks of vaccination, the vaccinee should be either revaccinated at 5 months or tested for immunity and revaccinated if seronegative. Consult current CDC guidelines for recommendations. (Major) Rubella virus vaccine or Measles/mumps/rubella vaccines, MMR should not be given for at least 3 months following administration of blood, plasma, and/or immunoglobulins because antibodies in these products can neutralize the vaccine.
    Measles/Mumps/Rubella Vaccines, MMR: (Major) Rubella virus vaccine or Measles/mumps/rubella vaccines, MMR should not be given for at least 3 months following administration of blood, plasma, and/or immunoglobulins because antibodies in these products can neutralize the vaccine.
    Meclofenamate Sodium: (Moderate) Immune Globulin (IG) products have been reported to be associated with renal dysfunction, acute renal failure, osmotic nephrosis, and death. Patients predisposed to acute renal failure include patients receiving known nephrotoxic drugs like nonsteroidal anti-inflammatory drugs (NSAIDs) and salicylates. Coadminister IG products at the minimum concentration available and the minimum rate of infusion practicable. Also, closely monitor renal function.
    Mefenamic Acid: (Moderate) Immune Globulin (IG) products have been reported to be associated with renal dysfunction, acute renal failure, osmotic nephrosis, and death. Patients predisposed to acute renal failure include patients receiving known nephrotoxic drugs like nonsteroidal anti-inflammatory drugs (NSAIDs) and salicylates. Coadminister IG products at the minimum concentration available and the minimum rate of infusion practicable. Also, closely monitor renal function.
    Meloxicam: (Moderate) Immune Globulin (IG) products have been reported to be associated with renal dysfunction, acute renal failure, osmotic nephrosis, and death. Patients predisposed to acute renal failure include patients receiving known nephrotoxic drugs like nonsteroidal anti-inflammatory drugs (NSAIDs) and salicylates. Coadminister IG products at the minimum concentration available and the minimum rate of infusion practicable. Also, closely monitor renal function.
    Nabumetone: (Moderate) Immune Globulin (IG) products have been reported to be associated with renal dysfunction, acute renal failure, osmotic nephrosis, and death. Patients predisposed to acute renal failure include patients receiving known nephrotoxic drugs like nonsteroidal anti-inflammatory drugs (NSAIDs) and salicylates. Coadminister IG products at the minimum concentration available and the minimum rate of infusion practicable. Also, closely monitor renal function.
    Naproxen: (Moderate) Immune Globulin (IG) products have been reported to be associated with renal dysfunction, acute renal failure, osmotic nephrosis, and death. Patients predisposed to acute renal failure include patients receiving known nephrotoxic drugs like nonsteroidal anti-inflammatory drugs (NSAIDs) and salicylates. Coadminister IG products at the minimum concentration available and the minimum rate of infusion practicable. Also, closely monitor renal function.
    Naproxen; Esomeprazole: (Moderate) Immune Globulin (IG) products have been reported to be associated with renal dysfunction, acute renal failure, osmotic nephrosis, and death. Patients predisposed to acute renal failure include patients receiving known nephrotoxic drugs like nonsteroidal anti-inflammatory drugs (NSAIDs) and salicylates. Coadminister IG products at the minimum concentration available and the minimum rate of infusion practicable. Also, closely monitor renal function.
    Naproxen; Pseudoephedrine: (Moderate) Immune Globulin (IG) products have been reported to be associated with renal dysfunction, acute renal failure, osmotic nephrosis, and death. Patients predisposed to acute renal failure include patients receiving known nephrotoxic drugs like nonsteroidal anti-inflammatory drugs (NSAIDs) and salicylates. Coadminister IG products at the minimum concentration available and the minimum rate of infusion practicable. Also, closely monitor renal function.
    Nonsteroidal antiinflammatory drugs: (Moderate) Immune Globulin (IG) products have been reported to be associated with renal dysfunction, acute renal failure, osmotic nephrosis, and death. Patients predisposed to acute renal failure include patients receiving known nephrotoxic drugs like nonsteroidal anti-inflammatory drugs (NSAIDs) and salicylates. Coadminister IG products at the minimum concentration available and the minimum rate of infusion practicable. Also, closely monitor renal function.
    Oxaprozin: (Moderate) Immune Globulin (IG) products have been reported to be associated with renal dysfunction, acute renal failure, osmotic nephrosis, and death. Patients predisposed to acute renal failure include patients receiving known nephrotoxic drugs like nonsteroidal anti-inflammatory drugs (NSAIDs) and salicylates. Coadminister IG products at the minimum concentration available and the minimum rate of infusion practicable. Also, closely monitor renal function.
    Pamidronate: (Moderate) Immune Globulin (IG) products have been reported to be associated with renal dysfunction, acute renal failure, osmotic nephrosis, and death. Patients predisposed to acute renal failure include patients receiving known nephrotoxic drugs like pamidronate. Coadminister IG products at the minimum concentration available and the minimum rate of infusion practicable. Also, closely monitor renal function.
    Paromomycin: (Moderate) Immune globulin (IG) products have been reported to be associated with renal dysfunction, acute renal failure, osmotic nephrosis, and death. Patients predisposed to acute renal failure include patients receiving known nephrotoxic drugs like aminoglycosides. Coadminister IG products at the minimum concentration available and the minimum rate of infusion practicable. Closely monitor renal function.
    Pentamidine: (Moderate) Immune Globulin (IG) products have been reported to be associated with renal dysfunction, acute renal failure, osmotic nephrosis, and death. Patients predisposed to acute renal failure include patients receiving known nephrotoxic drugs like pentamidine. Coadminister IG products at the minimum concentration available and the minimum rate of infusion practicable. Also, closely monitor renal function.
    Piroxicam: (Moderate) Immune Globulin (IG) products have been reported to be associated with renal dysfunction, acute renal failure, osmotic nephrosis, and death. Patients predisposed to acute renal failure include patients receiving known nephrotoxic drugs like nonsteroidal anti-inflammatory drugs (NSAIDs) and salicylates. Coadminister IG products at the minimum concentration available and the minimum rate of infusion practicable. Also, closely monitor renal function.
    Plazomicin: (Moderate) Immune globulin (IG) products have been reported to be associated with renal dysfunction, acute renal failure, osmotic nephrosis, and death. Patients predisposed to acute renal failure include patients receiving known nephrotoxic drugs like aminoglycosides. Coadminister IG products at the minimum concentration available and the minimum rate of infusion practicable. Closely monitor renal function.
    Polymyxin B: (Moderate) Immune Globulin (IG) products have been reported to be associated with renal dysfunction, acute renal failure, osmotic nephrosis, and death. Patients predisposed to acute renal failure include patients receiving known nephrotoxic drugs like polymyxin B. Coadminister IG products at the minimum concentration available and the minimum rate of infusion practicable. Also, closely monitor renal function.
    Ravulizumab: (Major) Administer a supplemental dose of ravulizumab and monitor for reduced efficacy of ravulizumab during concurrent use with immune globulin. Consult the manufacturer's recommendations for the supplemental dosage. Concomitant use of immune gloublin with ravulizumab may reduce ravulizumab exposure and efficacy.
    Rotavirus Vaccine: (Major) Efficacy of live attenuated virus vaccines such as Rotavirus may be impaired by immune globulin administration; revaccination may be necessary. As the passive transfer of antibodies may impair the efficacy of live attenuated virus vaccines, defer vaccination with live virus vaccines until approximately 3 months after immune globulin administration. Inform the immunizing physician of recent therapy with immune globulin so that appropriate measures can be taken.
    Rubella Virus Vaccine Live: (Major) Rubella virus vaccine or Measles/mumps/rubella vaccines, MMR should not be given for at least 3 months following administration of blood, plasma, and/or immunoglobulins because antibodies in these products can neutralize the vaccine.
    Salsalate: (Moderate) Immune Globulin (IG) products have been reported to be associated with renal dysfunction, acute renal failure, osmotic nephrosis, and death. Patients predisposed to acute renal failure include patients receiving known nephrotoxic drugs like nonsteroidal anti-inflammatory drugs (NSAIDs) and salicylates. Coadminister IG products at the minimum concentration available and the minimum rate of infusion practicable. Also, closely monitor renal function.
    Streptomycin: (Moderate) Immune globulin (IG) products have been reported to be associated with renal dysfunction, acute renal failure, osmotic nephrosis, and death. Patients predisposed to acute renal failure include patients receiving known nephrotoxic drugs like aminoglycosides. Coadminister IG products at the minimum concentration available and the minimum rate of infusion practicable. Closely monitor renal function.
    Streptozocin: (Moderate) Immune Globulin (IG) products have been reported to be associated with renal dysfunction, acute renal failure, osmotic nephrosis, and death. Patients predisposed to acute renal failure include patients receiving known nephrotoxic drugs like streptozocin. Coadminister IG products at the minimum concentration available and the minimum rate of infusion practicable. Also, closely monitor renal function.
    Sulindac: (Moderate) Immune Globulin (IG) products have been reported to be associated with renal dysfunction, acute renal failure, osmotic nephrosis, and death. Patients predisposed to acute renal failure include patients receiving known nephrotoxic drugs like nonsteroidal anti-inflammatory drugs (NSAIDs) and salicylates. Coadminister IG products at the minimum concentration available and the minimum rate of infusion practicable. Also, closely monitor renal function.
    Sumatriptan; Naproxen: (Moderate) Immune Globulin (IG) products have been reported to be associated with renal dysfunction, acute renal failure, osmotic nephrosis, and death. Patients predisposed to acute renal failure include patients receiving known nephrotoxic drugs like nonsteroidal anti-inflammatory drugs (NSAIDs) and salicylates. Coadminister IG products at the minimum concentration available and the minimum rate of infusion practicable. Also, closely monitor renal function.
    Tacrolimus: (Moderate) Immune Globulin (IG) products have been reported to be associated with renal dysfunction, acute renal failure, osmotic nephrosis, and death. Patients predisposed to acute renal failure include patients receiving known nephrotoxic drugs like tacrolimus. Coadminister IG products at the minimum concentration available and the minimum rate of infusion practicable. Also, closely monitor renal function.
    Tobramycin: (Moderate) Immune globulin (IG) products have been reported to be associated with renal dysfunction, acute renal failure, osmotic nephrosis, and death. Patients predisposed to acute renal failure include patients receiving known nephrotoxic drugs like aminoglycosides. Coadminister IG products at the minimum concentration available and the minimum rate of infusion practicable. Closely monitor renal function.
    Tolmetin: (Moderate) Immune Globulin (IG) products have been reported to be associated with renal dysfunction, acute renal failure, osmotic nephrosis, and death. Patients predisposed to acute renal failure include patients receiving known nephrotoxic drugs like nonsteroidal anti-inflammatory drugs (NSAIDs) and salicylates. Coadminister IG products at the minimum concentration available and the minimum rate of infusion practicable. Also, closely monitor renal function.
    Valacyclovir: (Moderate) Immune Globulin (IG) products have been reported to be associated with renal dysfunction, acute renal failure, osmotic nephrosis, and death. Patients predisposed to acute renal failure include patients receiving known nephrotoxic drugs like valacyclovir. Coadminister IG products at the minimum concentration available and the minimum rate of infusion practicable. Also, closely monitor renal function.
    Valdecoxib: (Moderate) Immune Globulin (IG) products have been reported to be associated with renal dysfunction, acute renal failure, osmotic nephrosis, and death. Patients predisposed to acute renal failure include patients receiving known nephrotoxic drugs like nonsteroidal anti-inflammatory drugs (NSAIDs) and salicylates. Coadminister IG products at the minimum concentration available and the minimum rate of infusion practicable. Also, closely monitor renal function.
    Valganciclovir: (Moderate) Immune Globulin (IG) products have been reported to be associated with renal dysfunction, acute renal failure, osmotic nephrosis, and death. Patients predisposed to acute renal failure include patients receiving known nephrotoxic drugs like valganciclovir. Coadminister IG products at the minimum concentration available and the minimum rate of infusion practicable. Also, closely monitor renal function.
    Vancomycin: (Moderate) Immune Globulin (IG) products have been reported to be associated with renal dysfunction, acute renal failure, osmotic nephrosis, and death. Patients predisposed to acute renal failure include patients receiving known nephrotoxic drugs like vancomycin. Coadminister IG products at the minimum concentration available and the minimum rate of infusion practicable. Also, closely monitor renal function.
    Varicella-Zoster Virus Vaccine, Live: (Major) Do not give immune globulin including varicella zoster immune globulin concurrently with the varicella-zoster virus vaccine, live. Because of the potential inhibition of the immune response to vaccination by passively transferred antibodies, it is advisable not to give varicella-zoster virus vaccine, live to any patient who has received blood (except washed red blood cells), plasma transfusions, or immunoglobulins within the previous 5 months. There should be an interval of at least 5 months following administration of immune globulin, including varicella-zoster immune globulin, VZIG, before varicella vaccination. After varicella vaccination, the CDC recommends that immune globulin products should not be given for 3 weeks, unless the benefit outweighs the risk; the manufacturer recommends waiting 2 months before administering immunoglobulins. In the case that IgG products are administered within 3 weeks of vaccination, the vaccinee should be either revaccinated at 5 months or tested for immunity and revaccinated if seronegative. Consult current CDC guidelines for recommendations.
    Zoledronic Acid: (Moderate) Immune Globulin (IG) products have been reported to be associated with renal dysfunction, acute renal failure, osmotic nephrosis, and death. Patients predisposed to acute renal failure include patients receiving known nephrotoxic drugs like zoledronic acid. Coadminister IG products at the minimum concentration available and the minimum rate of infusion practicable. Also, closely monitor renal function.

    PREGNANCY AND LACTATION

    Pregnancy

    There are no data with immune globulin IM (IGIM) use during pregnancy to inform a drug-associated risk. It is not known whether IGIM can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Animal studies have not been conducted with IGIM.[48785] According to the Advisory Committee on Immunization Practices (ACIP), fetal adverse events have not occurred after administration of immune globulin preparations to pregnant women.[43236]

    There are no data available regarding the presence of immune globulin in human milk, the effect on the breast-fed infant, or the effect on milk production.[48785] Case reports of 2 nursing mothers receiving intravenous immune globulin therapy suggest transfer of IgG and IgM into the colostrum and breast milk.[48199] Consider the developmental and health benefits of breast-feeding along with the mother's clinical need for immune globulin and any potential adverse effects on the breast-fed infant from immune globulin or the underlying maternal condition.[48785]

    MECHANISM OF ACTION

    The pooled, heterogenous IgG present in IGIM provides a variety of antibodies that activate both humoral and cell-mediated immunity by allosterically interacting with many toxins, bacteria, and viruses. Studies reveal that these antibodies are capable of opsonization and complement activation as well as stimulation of cell-mediated immunity. The passive immunity imparted by IGIM is capable of attenuating or preventing infectious diseases or deleterious reactions to these microbes or toxins.

    PHARMACOKINETICS

    Immune globulin IM, IMIG, IGIM is administered intramuscularly. The half-life of IGIM is about 23 days.

    Intramuscular Route

    Absorption of immune globulin IM (IGIM) after IM injection is slow, with peak concentrations occurring in approximately 2 days.