Dosage Forms
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Solution, Injection:
Imogam Rabies-HT: 300 units/2 mL (2 mL); 1500 units/10 mL (10 mL)
Solution, Injection [preservative free]:
HyperRAB: 300 units/mL (1 mL); 1500 units/5 mL (5 mL)
HyperRAB S/D: 300 units/2 mL (2 mL); 1500 units/10 mL (10 mL)
Kedrab: 300 units/2 mL (2 mL); 1500 units/10 mL (10 mL) [latex free, pyrogen free]
Pharmacology
Mechanism of Action
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.
Use: Labeled Indications
Rabies, postexposure prophylaxis: Component of postexposure prophylaxis for patients with suspected rabies exposure. Provides passive immunity until active immunity with rabies vaccine is established. Not for use in patients with a history of complete vaccination (preexposure or postexposure prophylaxis) and documentation of antibody response, as these patients require only the vaccination. 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 (may interfere with active immunity of vaccine).
HyperRAB, HyperRAB S/D; 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.
Dosage and Administration
Dosing: Adult
Note: Potency varies among currently available products; use caution to ensure correct dose is administered.
Rabies, postexposure prophylaxis: Local wound infiltration/IM: 20 units/kg in a single dose, rabies immune globulin (human) (HRIG) 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. HRIG should be administered as soon as possible after exposure, preferably at time of first rabies vaccine dose. If rabies vaccine was initiated without HRIG, HRIG may be administered through the seventh day after the administration of the first dose of the vaccine (day 0). Administration of HRIG 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 complete rabies vaccination (preexposure or postexposure prophylaxis) and documentation of antibody response.
Dosing: Geriatric
Refer to adult dosing.
Dosing: Pediatric
Note: Not recommended for use in persons with a history of vaccination (preexposure or postexposure) and documentation of antibody response.
Postexposure prophylaxis: Infants, Children, and Adolescents: Local wound infiltration/IM: 20 units/kg single dose administered as soon as possible after exposure and as part of a rabies vaccine regimen; do not exceed recommended dose since passive antibody can interfere with response to rabies vaccine. If anatomically feasible, the full rabies immune globulin (RIG) dose should be infiltrated around and into the wound(s); any 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 first vaccine dose. Administration of RIG is not recommended after the seventh day postvaccine since an antibody response to the vaccine is expected during this time period.
Administration
IM: Postexposure wound infiltration: If anatomically feasible, the full rabies immune globulin (human) (HRIG) 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, unless gluteal region is exposure site. Do not administer IV. Do not administer rabies vaccine in the same syringe or at the same administration site as HRIG. 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 additional volume is needed to infiltrate the wound(s), may dilute with an equal volume of D5W (HyperRAB) or NS (Kedrab, Imogam) (CDC 2014); HyperRAB should not be diluted with NS.
If IM administration is contraindicated (eg, patients with uncorrectable bleeding disorders), Kedrab may be administered SubQ; however, no clinical efficacy data are available to support administration SubQ.
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. Extended storage information at room temperature for other products may be available; contact product manufacturer to obtain current recommendations.
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. Exceptions: Adenovirus (Types 4, 7) Vaccine; Cholera Vaccine; Influenza Virus Vaccine (Live/Attenuated); Poliovirus Vaccine (Live/Bivalent/Oral); Poliovirus Vaccine (Live/Trivalent/Oral); Rotavirus Vaccine; Yellow Fever Vaccine; Zoster Vaccine (Live/Attenuated). 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 (8% 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: Diarrhea (8%), flatulence (8%), nausea (4%), abdominal pain (1% to 4%)
Genitourinary: Leukocyturia (3% to 5%), hematuria (2% to 4%)
Hematologic & oncologic: Bruise (1% to 3%)
Local: Injection site nodule (8%)
Neuromuscular & skeletal: Myalgia (7% to 9%), arthralgia (≤6%)
Respiratory: Upper respiratory tract infection (9% to 10%), nasal congestion (8%), oropharyngeal pain (8%)
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)
<1%, postmarketing, and/or case reports: Hypersensitivity reaction, hypoesthesia, limb pain
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 (defer live vaccines ≥4 months after HyperRAB); measles vaccine should be given ≥4 months after Kedrab.
Pregnancy
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
What is this drug used for?
- It is used to prevent rabies.
Frequently reported side effects of this drug
- Headache
- Abdominal pain
- Passing gas
- Stuffy nose
- Sore throat
- Muscle pain
- Joint pain
- Common cold symptoms
- Dizziness
- Injection site pain or irritation
Other side effects of this drug: Talk with your doctor right away if you have any of these signs of:
- Parvovirus B19 or hepatitis A infection
- Severe loss of strength and energy
- Diarrhea
- Dark urine
- Blood clots like 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; chest pain; shortness of breath; fast heartbeat; or coughing up blood.
- Signs of a significant reaction like 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. Talk to your doctor if you have questions.
Consumer Information Use and Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.
