IMMUNE GLOBULIN INTRAMUSCULAR [IGIM, GAMMA GLOBULIN, IMMUNE SERUM GLOBULIN (ISG)]

(im'mune glob'u-lin)

BayGam
IMMUNE GLOBULIN INTRAVENOUS (IGIV)
Flebogamma, Gammagard, Gammar-P IV, Gamunex, IGIV, Iveegam, Octagam, Sandoglobulin
Classifications: biologic response modifier; immunoglobulin;
Therapeutic: immunoglobulin
Pregnancy Category: C

Availability

IGIM: 2 mL, 10 mL vials

IGIV: 5%, 10% solution; 50 mg/mL powder for injection

Action

Sterile concentrated solution containing globulin (primarily IgG) prepared from large pools of normal human plasma of either venous or placental origin and processed by a special fractionating technique.

Therapeutic Effect

Like hepatitis B immune globulin (H-BIG), contains antibodies specific to hepatitis B surface antigen but in lower concentrations. Therefore, not considered treatment of first choice for postexposure prophylaxis against hepatitis B but usually an acceptable alternative when H-BIG is not available.

Uses

IGIM: In susceptible persons to provide passive immunity or to modify severity of certain infectious diseases [e.g., rubeola (measles), rubella (German measles), varicella-zoster (chickenpox), type A (infectious) hepatitis], and as replacement therapy in congenital agammaglobulinemia or IgG deficiency diseases. May be used as an alternative to H-BIG to provide passive immunity in hepatitis B infection. Also for postexposure prophylaxis of hepatitis non-A, non-B, and nonspecific hepatitis. IGIV: Principally as maintenance therapy in patients unable to manufacture sufficient quantities of IgG antibodies, in patients requiring an immediate increase in immunoglobulin levels, and when IM injections are contraindicated as in patients with bleeding disorders or who have small muscle mass. Also in chronic autoimmune thrombocytopenia and idiopathic thrombocytopenic purpura (ITP). Treatment of primary immunodeficiency disorders associated with defects in humoral immunity.

Unlabeled Uses

Kawasaki syndrome, chronic lymphocytic leukemia, AIDS, premature and low-birth-weight neonates, autoimmune neutropenia, or hemolytic anemia.

Contraindications

History of anaphylaxis or severe reaction to human immune serum globulin (IG) or to any ingredient in the formulation such as thimerosal (mercury derivative) preservative in IM formulations and maltose (stabilizing agent) in IV formulations; persons with clinical hepatitis A; IGIV for patients with class-specific anti-IgA deficiencies; IGIM in severe thrombocytopenia or other bleeding disorders; intramuscular injection, pregnancy (category C).

Cautious Use

Dehydration, diabetes mellitus, children, older adults, hypovolemia, IgA deficiency, infection; renal disease, renal failure, renal impairment; sepsis; sucrose hypersensitivity; vaccination, viral infection; lactation.

Route & Dosage

Hepatitis A Exposure
Adult/Child: IM 0.02 mL/kg as soon as possible after exposure; if period of exposure will be ≥3 mo, give 0.05–0.06 mL/kg once q4–6mo

Hepatitis B Exposure
Adult/Child: IM 0.02–0.06 mL/kg as soon as possible after exposure if H-BIG is unavailable

Rubella Exposure
Adult: IM 20 mL as single dose in susceptible pregnant women

Rubeola Exposure
Adult/Child: IM 0.25 mL/kg within 6 d of exposure

Varicella-Zoster Exposure
Adult/Child: IM 0.6–1.2 mL/kg promptly

Immunoglobulin Deficiency

*Dosages may vary between brands

Adult/Child: IV 200–400 mg/kg monthly IM 1.2 mL/kg followed by 0.6 mL/kg q2–4wk

Idiopathic Thrombocytopenia Purpura
Adult/Child: IV 400 mg/kg/d for 5 consecutive days or 1 g/kg x 1–2 d

Obesity
Dose based on IBW or adjusted IBW.

Administration

Note: In hepatitis A (infectious hepatitis), immune globulin is most effective when given before or as soon as possible after exposure but not more than 2 wk after (incubation period for hepatitis A is 15–50 d). Do not give immune globulin to those presenting clinical manifestations of hepatitis A. For hepatitis B (serum hepatitis), give immune globulin within 24 h and not more than 7 d after exposure. IGIM and IGIV formulations are NOT interchangeable.

Intramuscular

Give adults and older children injections into deltoid or anterolateral aspect of thigh; neonates and small children, into anterolateral aspect of thigh.
Avoid gluteal injections; however, when large volumes of immune globulin are prescribed or when large doses must be divided into several injections, the upper outer quadrant of the gluteus has been used in adults.

Intravenous

PREPARE: IV Infusion: Refer to manufacturer's directions for information on reconstitution and dilution of the specific product.

ADMINISTER: IV Infusion: Flow rates vary with product being infused. Refer to manufacturer's directions for the specific product.

INCOMPATIBILITIES Manufacturer recommends not mixing other drugs with immunoglobulin.

Store as directed by manufacturer for specific product. Avoid freezing. Do not use if turbidity has occurred or if product has been frozen.
Do not mix with other drugs.
Discard partially used vial.

Adverse Effects (≥1%)

Body as a Whole: Pain, tenderness, muscle stiffness at IM site; local inflammatory reaction, erythema, urticaria, angioedema, headache, malaise, fever, arthralgia, nephrotic syndrome, hypersensitivity (fever, chills, anaphylactic shock), infusion reactions (nausea, flushing, chills, headache, chest tightness, wheezing, skeletal pain, back pain, abdominal cramps, anaphylaxis), renal dysfunction, renal failure.

Interactions

Drug: May interfere with antibody response to live virus vaccines (measles/mumps/rubella); give vaccines 14 d before or 3 mo after immune globulins.

Pharmacokinetics

Peak: 2 d. Distribution: Rapidly and evenly distributed to intravascular and extravascular fluid compartments. Half-Life: 21–23 d.

Nursing Implications

Assessment & Drug Effects

Make sure emergency drugs and appropriate emergency facilities are immediately available for treatment of anaphylaxis or sensitization.
Note: Hypersensitivity reactions (see Appendix F) are most likely in patients receiving large IM doses, repeated injections, or rapid IV infusion.
Monitor vital signs and infusion rate closely when patient is receiving IGIV.
Note: IGIV has a mild diuretic effect in some patients due to presence of maltose.

Patient & Family Education

Report immediately S&S of hypersensitivity (see Appendix F).
Report immediately infusion symptoms of nausea, chills, headache, and chest tightness; these are indications to slow rate of infusion.
Note: Passive immunity to measles (rubeola) lasts about 3–4 wk after immune globulin. In general, children ≤15 mo need active immunization with measles virus vaccine 3 mo after IGIM.

Common adverse effects in italic, life-threatening effects underlined; generic names in bold; classifications in SMALL CAPS; Canadian drug name; Prototype drug

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