Dosing & Uses
Dosage Forms & Strengths
injection, freeze-dried suspension
- ≥2.5 IU/mL
Rabies Preexposure Immunization
Primary
- 1 mL IM (deltoid region) x3 doses
- Administer on days 0, 7, and 21 or 28
Booster
- 1 mL IM (deltoid region) to maintain a serum titer >1:5 serum dilution by RFFIT
Frequency for testing serum titers
-
Continuous risk
- Test serum for rabies antibodies q6month in persons working with live rabies virus in research laboratories and in vaccine production facilities (continuous risk category)
-
Frequent risk
- Other laboratory workers (eg, those performing rabies diagnostic testing), cavers, veterinarians and staff, animal-control and wildlife officers in areas where rabies is enzootic, and bat handlers regardless of location
- If titer inadequate, administer single booster dose of vaccine
-
Infrequent risk
- Veterinarians, veterinary students, and terrestrial animal-control and wildlife officers, working in areas of low rabies endemicity and certain at-risk international travelers who have completed a full preexposure vaccination series with licensed vaccines and according to schedule do not require routine booster serologic verification of detectable antibody titers or routine preexposure booster doses of vaccine
Rabies Postexposure Immunization
Unimmunized individuals
- 1 mL IM x5 doses
- Administer on days 0, 3, 7, 14, and 28 in conjunction with administration of human rabies immune globulin (HRIG) on day 0
- HRIG: 20 IU/kg; if anatomically feasible, the full dose should be infiltrated around and into the wound(s), and any remaining volume should be administered IM at an anatomical site distant from vaccine administration
Previously immunized individuals
- 1 mL IM x2 doses on days 0 and 3
Additional Information
Current vaccination schedules available at https://www.cdc.gov/vaccines/schedules/hcp/index.html
Dosage Forms & Strengths
injection, freeze-dried suspension
- ≥2.5 IU/mL
Rabies Preexposure Immunization
Vaccination is recommended for children living in or visiting countries where exposure to rabid animals is a constant threat; worldwide statistics indicate children are more at risk than adults
Primary
- 1 mL IM (deltoid region, in small children and infants anterolateral region of thigh) x3 doses
- Administer on days 0, 7, and 21 or 28
Booster
- 1 mL IM (deltoid region) to maintain a serum titer >1:5 serum dilution by RFFIT
Frequency for testing serum titers
-
Continuous risk
- Test serum for rabies antibodies q6month in persons working with live rabies virus in research laboratories and in vaccine production facilities (continuous risk category)
-
Frequent risk
- Other laboratory workers (eg, those performing rabies diagnostic testing), cavers, veterinarians and staff, animal-control and wildlife officers in areas where rabies is enzootic, and bat handlers regardless of location
- If titer inadequate, administer single booster dose of vaccine
-
Infrequent risk
- Veterinarians, veterinary students, and terrestrial animal-control and wildlife officers, working in areas of low rabies endemicity and certain at-risk international travelers who have completed a full preexposure vaccination series with licensed vaccines and according to schedule do not require routine booster serologic verification of detectable antibody titers or routine preexposure booster doses of vaccine
Rabies Postexposure Immunization
Unimmunized individuals
- 1 mL IM x5 doses
- Administer on days 0, 3, 7, 14, and 28 in conjunction with administration of human rabies immune globulin (HRIG) on day 0
- HRIG: 20 IU/kg; if anatomically feasible, the full dose should be infiltrated around and into the wound(s), and any remaining volume should be administered IM at an anatomical site distant from vaccine administration
Previously immunized individuals
- 1 mL IM x2 doses on days 0 and 3
Additional Information
Current vaccination schedules available at https://www.cdc.gov/vaccines/schedules/hcp/index.html
Interactions
Interaction Checker
No Results
Contraindicated
Serious - Use Alternative
Significant - Monitor Closely
Minor
Adverse Effects
Suspected adverse events after administration of any vaccine may be reported to Vaccine Adverse Events Reporting System (VAERS), submit an online report at https://vaers.hhs.gov/reportevent.html or call 1-800-822-7967
>10%
Injection site reactions (eg, pain, erythema, swelling or itching) (25%)
Headache (20%)
Nausea (20%)
Abdominal pain (20%)
Muscle aches (20%)
Dizziness (20%)
1-10%
Serum sickness (7%)
Postmarketing Reports
Blood and lymphatic system disorders: Lymphadenopathy
Immune system disorders: Anaphylactic reaction, serum sickness type reaction, dermatitis allergic, pruritus (itching), edema
Nervous system disorders: Paresthesia, neuropathy, convulsion, encephalitis, Guillain-Barré-like syndrome
Gastrointestinal disorders: Vomiting, diarrhea
Musculoskeletal and connective tissue disorders: Arthralgia
General disorders and administration site conditions: Asthenia, malaise, fever and chills (shivering), injection site hematoma
Respiratory, thoracic, and mediastinal disorders: Wheezing, dyspnea
Warnings
Contraindications
Preexposure prophylaxis
- Known life-threatening hypersensitivity to vaccine, neomycin, or any component of a vaccine
Postexposure prophylaxis
- None
Cautions
When dose must be administered to person with history of hypersensitivity, antihistamines may be given; have epinephrine (1:1000) and other appropriate agents readily available to counteract anaphylactic reactions while carefully monitoring after immunization
Serum sickness type reactions reported in persons receiving booster doses for preexposure prophylaxis; characterized by onset ~2-21 days post-booster, presents with a generalized urticaria, and may also include arthralgia, arthritis, angioedema, nausea, vomiting, fever, and malaise
Rare cases of neurologic illness resembling Guillain-Barré-like syndrome have occurred
Product contains albumin; remote risk for transmission of viral diseases and variant Creutzfeldt-Jakob disease (vCJD)
Immunosuppressive illnesses can interfere with vaccine efficacy
Drug interaction overview
-
Immunosuppressive drugs
- Corticosteroids or other immunosuppressive can interfere with the development of active immunity and predispose the patient to developing rabies
- Do not administer immunosuppressive agents during postexposure therapy, unless essential for the treatment of other conditions
- When rabies postexposure prophylaxis is administered to persons receiving steroids or other immunosuppressive therapy, test for rabies antibody to ensure that an adequate response has developed
Pregnancy & Lactation
Pregnancy
Preexposure
- Animal reproduction studies have not been conducted
- It is also not known whether rabies vaccine can cause fetal harm when administered to pregnant women or can affect reproductive capacity
- Administer to pregnant women only if potential benefits outweigh potential risks
- If there is substantial risk of exposure to rabies, preexposure prophylaxis may also be indicated during pregnancy
Postexposure
- Because of the potential consequences of inadequately treated rabies exposure and limited data that indicate that fetal abnormalities have not been associated with rabies vaccination, pregnancy is not considered a contraindication to postexposure prophylaxis
Lactation
Unknown if excreted in human milk; exercise caution
Pregnancy Categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk. C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done. D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk. X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist. NA: Information not available.Pharmacology
Mechanism of Action
Inactivated virus vaccine provides immunity to rabies by eliciting an active immune response
Pharmacokinetics
Onset (antibodies): 7-10 days
Duration (antibodies): >1 year
Peak Plasma Time (antibodies): 30-60 days
Administration
IM Preparation
Using the longer of the 2 needles supplied, transfer the entire contents of provided diluent into vaccine vial to reconstitute the freeze-dried vaccine
Mix gently to avoid foaming
The creamy white to orange freeze-dried vaccine dissolves to a pink-to-red suspension
Withdraw total amount of dissolved vaccine into the syringe and replace long needle with smaller needle for IM injection
IM Administration
Adults and older children: Inject IM in deltoid muscle
Infants and small children: Inject IM in anterolateral aspect of the thigh
Do not inject in gluteal area; may result in lower neutralizing antibody titers
Storage
Refrigerate at 2-8ºC (35-46ºF)
Do not freeze
Images
Patient Handout
Formulary
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