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Rabies Immune Globulin (Human)

Pronunciation

(RAY beez i MYUN GLOB yoo lin, HYU man)

Index Terms

  • HRIG
  • RIG

Dosage Forms

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Injectable, Intramuscular:

Imogam Rabies-HT: 150 units/mL (2 mL, 10 mL)

Injectable, Intramuscular [preservative free]:

HyperRAB S/D: 150 units/mL (2 mL, 10 mL)

Solution, Intramuscular [preservative free]:

Kedrab: 150 units/mL (2 mL, 10 mL) [latex free, pyrogen free]

Brand Names: U.S.

  • HyperRAB S/D
  • Imogam Rabies-HT
  • Kedrab

Pharmacologic Category

  • Blood Product Derivative
  • Immune Globulin

Pharmacology

Rabies immune globulin is a solution of globulins dried from the plasma or serum of selected adult human donors who have been immunized with rabies vaccine and have developed high titers of rabies antibody. It generally contains 10% to 18% of protein of which not less than 80% is monomeric immunoglobulin G.

Use: Labeled Indications

Rabies exposure: Part of postexposure prophylaxis of persons with suspected rabies exposure. Provides passive immunity until active immunity with rabies vaccine is established. Not for use in persons with a history of vaccination (preexposure or postexposure prophylaxis) and documentation of antibody response. Each exposure to possible rabies infection should be individually evaluated.

Factors to consider include: species of biting animal, circumstances of biting incident (provoked vs unprovoked bite), type of exposure to rabies infection (bite vs nonbite), vaccination status of biting animal, presence of rabies in the region. See product information for additional details.

Contraindications

Imogam Rabies-HT: Should not be administered in repeated doses once vaccine treatment has been initiated.

HyperRAB SD; Kedrab: There are no contraindications listed in the manufacturer's labeling.

Documentation of allergenic cross-reactivity for immune globulins is limited. However, because of similarities in chemical structure and/or pharmacologic actions, the possibility of cross-sensitivity cannot be ruled out with certainty.

Dosing: Adult

Postexposure prophylaxis: Local wound infiltration/IM: 20 units/kg in a single dose, RIG should always be administered as part of rabies vaccine regimen. If anatomically feasible, the full rabies immune globulin dose should be infiltrated around and into the wound(s); remaining volume should be administered IM at a site distant from the vaccine administration site. If rabies vaccine was initiated without rabies immune globulin, rabies immune globulin may be administered through the seventh day after the administration of the first dose of the vaccine (day 0). Administration of RIG is not recommended after the seventh day post vaccine since an antibody response to the vaccine is expected during this time period.

Note: Not recommended for use in persons with a history of rabies vaccination (preexposure or postexposure prophylaxis) and documentation of antibody response.

Dosing: Geriatric

Refer to adult dosing.

Dosing: Pediatric

Refer to adult dosing.

Dosing: Renal Impairment

There are no dosage adjustments provided in the manufacturer’s labeling.

Dosing: Hepatic Impairment

There are no dosage adjustments provided in the manufacturer’s labeling.

Administration

IM: Postexposure wound infiltration: If anatomically feasible, the full rabies immune globulin dose should be infiltrated around and into the wound(s); remaining volume should be administered IM in the deltoid muscle of the upper arm or lateral thigh muscle. Per the manufacturer, the gluteal area should be avoided to reduce the risk of sciatic nerve damage or unpredictable absorbance. Do not administer IV. Do not administer rabies vaccine in the same syringe or at the same administration site as RIG. If the wound is small or on a finger, then a small dose (eg, 0.5 mL or more) may be injected around the wound. For extensive wounds, do not exceed the calculated dose. If the calculated dose is inadequate to infiltrate all wounds, then dilute RIG with normal saline (CDC 2014).

If IM administration is contraindicated (eg, patients with uncorrectable bleeding disorders), Kedrab may be administered subcutaneously; however, no clinical efficacy data are available to support administration subcutaneously.

Storage

Store between 2°C to 8°C (36°F to 46°F); do not freeze. Discard unused portion immediately and any product exposed to freezing. Kedrab may be stored at room temperature (≤25°C [≤77°F]) for up to 1 month; do not return to refrigeration. HyperRAB S/D may be exposed to room temperature for a cumulative 7 days (Cohen 2007).

Drug Interactions

Rabies Vaccine: Rabies Immune Globulin (Human) may diminish the therapeutic effect of Rabies Vaccine. Management: Do not administer additional or repeated doses of rabies immune globulin once rabies vaccine has been administered. The rabies immune globulin should also not be administered in the same site as the vaccine. Consider therapy modification

Vaccines (Live): Rabies Immune Globulin (Human) may diminish the therapeutic effect of Vaccines (Live). Management: Avoid administering the measles vaccine within 4 months after administration of rabies immune globulin. Avoid administering other live vaccines within 3 months after administration of rabies immune globulin. Consider therapy modification

Test Interactions

False-positive serologic tests due to transient rise of passively transferred antibodies; passive transmission of antibodies to erythrocyte antigens may interfere with serologic test for red cell antibodies (ie, antiglobulin test [Coombs’ test])

Adverse Reactions

>10%:

Central nervous system: Headache (13% to 15%)

Local: Pain at injection site (31% to 33%)

1% to 10%:

Central nervous system: Fatigue (2% to 6%), dizziness (1% to 6%)

Dermatologic: Sunburn (≤3%)

Gastrointestinal: Nausea (4%), abdominal pain (1% to 4%)

Genitourinary: Leukocyturia (3% to 5%), hematuria (2% to 4%)

Hematologic & oncologic: Bruise (1% to 3%)

Neuromuscular & skeletal: Myalgia (7% to 9%)

Respiratory: Upper respiratory tract infection (9% to 10%), arthralgia (≤6%)

Frequency not defined.

Central nervous system: Malaise

Dermatologic: Skin rash

Genitourinary: Nephrotic syndrome

Hypersensitivity: Anaphylaxis, angioedema

Local: Local soreness/soreness at injection site, tenderness at injection site

Neuromuscular & skeletal: Stiffness (at injection site)

Miscellaneous: Fever (mild)

Warnings/Precautions

Concerns related to adverse effects:

• Anaphylaxis/hypersensitivity reactions: Hypersensitivity and anaphylactic reactions can occur; discontinue immediately and institute supportive emergency measures if hypersensitivity or anaphylaxis occurs. Use with caution in patients with isolated immunoglobulin A deficiency or a history of systemic hypersensitivity to human immunoglobulins.

• Hemolysis: May occur; risk is increased in patients with non-O blood group types, underlying associated inflammatory conditions, and those receiving high cumulative doses of immune globulins over several days. Monitor patients for signs and symptoms of hemolysis (eg, fever, chills, dark urine).

• Thrombosis: Use with caution in patients at increased risk of thrombosis (eg, acquired or hereditary hypercoagulable states, prolonged immobilization, indwelling vascular catheters, advanced age, estrogen use, history of thrombosis, cardiovascular risk factors, hyperviscosity syndromes). Monitor these patients for at least 24 hours after administration; consider measuring a baseline blood viscosity in patients at risk for hyperviscosity.

Disease-related concerns:

• Bleeding disorders: Use with caution in patients with a history of bleeding disorders (including thrombocytopenia) and/or patients on anticoagulant therapy; bleeding/hematoma may occur from IM administration.

Dosage form specific issues:

• Human plasma: Product of human plasma; may potentially contain infectious agents which could transmit disease. Screening of donors, as well as testing and/or inactivation or removal of certain viruses, reduces the risk. Infections thought to be transmitted by this product should be reported to the manufacturer.

Other warnings/precautions:

• Administration: Not for intravenous administration.

• Administration: Administration is a medical urgency (not emergency); however, do not delay decision to treat.

• Appropriate use: A single dose is recommended; repeating the dose may interfere with maximum active immunity expected from the vaccine. Repeated doses of Imogam Rabies-HT after vaccine treatment has been initiated are contraindicated.

• Immunizations: Antibodies may interfere with the immune response to live vaccines. Live vaccines should be given ≥3 months after rabies immune globulin; measles vaccine should be given ≥4 months after Kedrab.

Pregnancy Risk Factor

C

Pregnancy Considerations

Animal reproduction studies have not been conducted. Pregnancy is not a contraindication to postexposure prophylaxis. Pre-exposure prophylaxis may be indicated during pregnancy if the risk for exposure to rabies is significant (CDC 2011).

Patient Education

• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

• Patient may experience headache, muscle pain, joint pain, common cold symptoms, dizziness, or injection site pain. Have patient report immediately to prescriber signs of infection, severe loss of strength and energy, diarrhea, dark urine, signs of blood clots (numbness or weakness on one side of the body; pain, redness, tenderness, warmth, or swelling in the arms or legs; change in color of an arm or leg; angina; shortness of breath; tachycardia; or coughing up blood) (HCAHPS).

• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for health care professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience, and judgment in diagnosing, treating, and advising patients.

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