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Rabies virus vaccine: Drug information

Rabies virus vaccine: Drug information
(For additional information see "Rabies virus vaccine: Patient drug information" and see "Rabies virus vaccine: Pediatric drug information")

For abbreviations, symbols, and age group definitions used in Lexicomp (show table)
Brand Names: US
  • Imovax Rabies;
  • RabAvert
Brand Names: Canada
  • Imovax Rabies
Pharmacologic Category
  • Vaccine;
  • Vaccine, Inactivated (Viral)
Dosing: Adult
Preexposure prophylaxis

Preexposure prophylaxis (Ref): Note: Advisory Committee on Immunization Practices (ACIP) recommendations are based on risk category. The 5 risk categories (level 1: highest risk; level 5: lowest risk) are based on the nature of possible exposure, relevant rabies biogeography, and status of long-term immunogenicity (based on previous rabies vaccination or rabies antibody titers). See ACIP recommendations for details (Ref). Refer to local/state health departments and the CDC for additional guidance.

Primary series: IM: 1 mL/dose for 2 doses administered on days 0 and 7. Note: Recommended for risk categories 1 through 4.

Booster dose: IM: 1 mL/dose if antibody titer is <0.5 units/mL; recommendations vary based on risk category:

Risk category 1: Check antibody titers every 6 months; administer booster dose if needed.

Risk category 2: Check antibody titers every 2 years; administer booster dose if needed.

Risk category 3: Check antibody titers once during the 1 to 3 years after completion of primary series; administer booster dose if needed. Alternatively, may administer a single booster dose no sooner than day 21 and no later than year 3 after 2-dose primary series (with no titer monitoring).

Risk category 4: No booster dose indicated.

Persons who are immunocompromised: Assess antibody titer ≥1 week (preferably 2 to 4 weeks) after administration of primary 2-dose series and every booster vaccination. If 2 booster doses fail to elicit antibody titer ≥0.5 units/mL, contact state or local health department for guidance.

Postexposure prophylaxis

Postexposure prophylaxis (Ref): Note: All postexposure management should begin with immediate cleansing of the wound with soap and water.

Previously vaccinated persons: Note: Previously vaccinated persons are persons who have received an ACIP-recommended preexposure or postexposure vaccination regimen or who have received another vaccine regimen with documentation of rabies antibody titer considered adequate.

IM: 1 mL/dose for 2 doses administered on days 0 and 3.

Unvaccinated persons: Note: Administer the first dose (day 0) in combination with rabies immune globulin.

Immunocompetent: IM: 1 mL/dose for 4 doses administered on days 0, 3, 7, and 14.

Immunocompromised: IM: 1 mL/dose for 5 doses administered on days 0, 3, 7, 14, and 28.

Dosing: Kidney Impairment: Adult

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

Dosing: Hepatic Impairment: Adult

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

Dosing: Older Adult

Refer to adult dosing.

Dosing: Pediatric

(For additional information see "Rabies virus vaccine: Pediatric drug information")

Preexposure prophylaxis

Preexposure prophylaxis:

Note: ACIP recommendations vary based on risk of being exposed to rabies virus. The 5 risk categories (level 1: highest risk to level 5: lowest risk) are based on the nature of possible exposure, relevant rabies biogeography, and status of long-term immunogenicity (based on previous rabies vaccination or rabies antibody titers). See ACIP recommendations for details (Ref). Refer to local/state health departments and the CDC for additional guidance.

Primary series: Infants, Children, and Adolescents: IM: 1 mL/dose for 2 doses administered on days 0 and 7. Note: Recommended for risk categories 1 through 4.

Booster dose: Infants, Children, and Adolescents: IM: 1 mL/dose if antibody titer is <0.5 units/mL; recommendations vary based on risk category:

Risk category 1: Check antibody titers every 6 months; administer booster dose if needed.

Risk category 2: Check antibody titers every 2 years; administer booster dose if needed.

Risk category 3: Check antibody titers once during the 1 to 3 years after completion of primary series; administer booster dose if needed. Alternatively, may administer a single booster dose no sooner than day 21 and no later than year 3 after 2-dose primary series (with no titer monitoring).

Risk category 4: No booster dose indicated.

Persons who are immunocompromised (regardless of risk category): Assess antibody titer ≥1 week (preferably 2 to 4 weeks) after administration of primary 2-dose series and every booster vaccination. If two booster doses fail to elicit antibody titer ≥0.5 units/mL, contact state or local health department for guidance.

Postexposure prophylaxis

Postexposure prophylaxis:

Note: All postexposure management should begin with immediate cleansing of the wound with soap and water (for ~15 minutes); immunization should begin as soon as possible after exposure (Ref).

Previously vaccinated persons: Note: Previously vaccinated persons are individuals who have previously received an ACIP-recommended preexposure or postexposure vaccination regimen or who have received another vaccine regimen with documentation of adequate rabies antibody titer.

Infants, Children, and Adolescents: IM: 1 mL/dose for 2 doses administered on days 0 and 3 (Ref).

Unvaccinated persons: Note: Administer the first dose (day 0) in combination with rabies immune globulin (Ref).

Infants, Children, and Adolescents:

Immunocompetent: IM: 1 mL/dose for 4 doses administered on days 0, 3, 7, and 14 (Ref).

Immunocompromised: IM: 1 mL/dose for 5 doses administered on days 0, 3, 7, 14, and 28 (Ref).

Dosing: Kidney Impairment: Pediatric

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

Dosing: Hepatic Impairment: Pediatric

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

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.

>10%:

Central nervous system: Dizziness, headache, malaise

Dermatologic: Injection site pruritus

Gastrointestinal: Abdominal pain, nausea

Hematologic & oncologic: Lymphadenopathy

Local: Erythema at injection site, pain at injection site, swelling at injection site

Neuromuscular & skeletal: Myalgia

Frequency not defined:

Cardiovascular: Cardiovascular toxicity, edema, palpitations, swelling of injected limb (extensive)

Central nervous system: Chills, encephalitis, fatigue, Guillain-Barre syndrome, meningitis, neuropathy, paralysis (may be transient; includes neuroparalysis), paresthesia (transient), retrobulbar neuritis, seizure, vertigo

Dermatologic: Pruritus, urticaria (including urticaria pigmentosa)

Endocrine & metabolic: Hot flash

Gastrointestinal: Diarrhea, vomiting

Hematologic & oncologic: Adenopathy

Hypersensitivity: Anaphylaxis, hypersensitivity reaction, serum sickness

Local: Hematoma at injection site

Neuromuscular & skeletal: Arthralgia, arthritis (one joint), limb pain, multiple sclerosis, myelitis, weakness

Ophthalmic: Visual disturbance

Respiratory: Bronchospasm, dyspnea, wheezing

Miscellaneous: Fever >38°C (100°F)

Contraindications

Preexposure prophylaxis: Life-threatening hypersensitivity to rabies vaccine or any component of the formulation

Postexposure prophylaxis: There are no contraindications listed in the manufacturer's labeling.

Warnings/Precautions

Concerns related to adverse effects:

• Anaphylactoid/hypersensitivity reactions: Once postexposure prophylaxis has begun, administration should generally not be interrupted or discontinued due to local or mild systemic adverse events; anti-inflammatory, antihistamine, and antipyretic agents are typically sufficient to manage local or mild systemic reactions. Continuation of vaccination following severe systemic reactions should consider the person's risk of developing rabies. Report serious reactions to the state health department or the manufacturer/distributor.

• Immune complex-like reactions (serum sickness): An immune complex reaction is possible ~2 to 21 days following booster doses of HDCV (Imovax). Symptoms may include arthralgia, arthritis, angioedema, fever, generalized urticaria, malaise, nausea, and vomiting.

• Neurologic reactions: Rare cases of Guillain-Barre syndrome (transient neuroparalytic illnesses that resolves without sequelae in 12 weeks, potentially fatal encephalitis, meningitis, transient paralysis, myelitis, retrobulbar neuritis, and multiple sclerosis) have been reported.

• Shoulder injury related to vaccine administration: Vaccine administration that is too high on the upper arm may cause shoulder injury (eg, shoulder bursitis, tendinopathy) resulting in shoulder pain and reduced range of motion following injection. Use proper injection technique for vaccines administered in the deltoid muscle (eg, injecting in the central, thickest part of the muscle) to reduce the risk of shoulder injury related to vaccine administration (Cross 2016; Foster 2013).

• Syncope: Syncope has been reported with use of injectable vaccines and may result in serious secondary injury (eg, skull fracture, cerebral hemorrhage); typically reported in adolescents and young adults and within 15 minutes after vaccination. Procedures should be in place to avoid injuries from falling and to restore cerebral perfusion if syncope occurs (ACIP [Kroger 2023]).

Disease-related concerns:

• Bleeding disorders: Use with caution in patients with a history of bleeding disorders (including thrombocytopenia); bleeding/hematoma may occur from IM administration; if the patient receives antihemophilia or other similar therapy, IM injection can be scheduled shortly after such therapy is administered (ACIP [Kroger 2023]).

Special populations:

• Altered immunocompetence: Postpone vaccination during periods of severe immunosuppression (eg, patients receiving chemo/radiation therapy [including high-dose corticosteroids]) if appropriate; response to vaccination may be reduced. Withhold nonessential immunosuppressive agents during postexposure prophylaxis; if possible, postpone pre-exposure prophylaxis until the immunocompromising condition is resolved. If a person remains immunocompromised and requires preexposure prophylaxis (PrEP) vaccination, administer the rabies vaccine and check antibody titers ≥1 week (preferable 2 to 4 weeks) after 2-dose PrEP series and any booster doses; booster dose(s) may be needed for suboptimal antibody titer. Participation in high-risk activities should be deferred until adequate antibody titers are confirmed (CDC/ACIP [Rao 2022]).

• Pediatric: Apnea has occurred following intramuscular vaccine administration in premature infants; consider clinical status implications. In general, preterm infants should be vaccinated at the same chronological age as full-term infants (ACIP [Kroger 2023]).

Concurrent drug therapy issues:

• Anticoagulant therapy: Use with caution in patients receiving anticoagulant therapy; bleeding/hematoma may occur from IM administration (ACIP [Kroger 2023]).

• Vaccines: In order to maximize vaccination rates, the ACIP recommends simultaneous administration (ie, >1 vaccine on the same day at different anatomic sites) of all age-appropriate vaccines (live or non-live) for which a person is eligible at a single visit, unless contraindications exist. The ACIP prefers each dose of a specific vaccine in a series come from the same manufacturer when possible (ACIP [Kroger 2023]).

Dosage form specific issues:

• Albumin: Products may contain albumin and therefore carry a remote risk of transmitting Creutzfeldt-Jakob or other viral diseases.

• Imovax Rabies: Contains neomycin.

• RabAvert: Contains amphotericin B, bovine gelatin, egg and chicken protein, chlortetracycline, and neomycin.

Other warnings/precautions:

• Antipyretics: Antipyretics have not been shown to prevent febrile seizures; antipyretics may be used to treat fever or discomfort following vaccination (ACIP [Kroger 2023]). One study reported that routine prophylactic administration of acetaminophen prior to vaccination to prevent fever decreased the immune response of some vaccines; the clinical significance of this reduction in immune response has not been established (Prymula 2009).

• Appropriate use: Rabies vaccine should not be used in persons with a confirmed diagnosis of rabies; use after the onset of symptoms may be detrimental (ACIP [Manning 2008]). Postexposure vaccination may begin regardless of the length of time from documented or likely exposure, as long as clinical signs of rabies are not present; however, it is ideal to start the treatment as soon as possible.

• Effective immunity: Vaccination may not result in effective immunity in all patients. Response depends upon multiple factors (eg, type of vaccine, age of patient) and may be improved by administering the vaccine at the recommended dose, route, and interval (ACIP [Kroger 2023]).

Dosage Forms Considerations

Imovax Rabies is grown in human diploid cell culture.

RabAvert is grown in purified chick embryo cell culture (PCEC).

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product

Suspension Reconstituted, Intramuscular:

Imovax Rabies: 2.5 units/mL (1 ea) [contains albumin human, neomycin sulfate]

Imovax Rabies: 2.5 units/mL (1 ea) [contains albumin human, neomycin sulfate, phenol]

RabAvert: 2.5 units (1 ea) [contains albumin human, chicken protein, edetate (edta) disodium, gelatin (bovine), neomycin]

RabAvert: 2.5 units (1 ea) [contains albumin human, chicken protein, edetate (edta) sodium (tetrasodium), gelatin (bovine), neomycin]

RabAvert: 2.5 units (1 ea [DSC]) [contains albumin human, edetate (edta) disodium, neomycin, polygeline]

Suspension Reconstituted, Intramuscular [preservative free]:

Imovax Rabies: 2.5 units/mL (1 ea [DSC], 1 mL [DSC]) [contains albumin human, neomycin sulfate]

Generic Equivalent Available: US

No

Pricing: US

Suspension (reconstituted) (Imovax Rabies Intramuscular)

2.5 units/mL (per each): $520.57

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Dosage Forms: Canada

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

Suspension Reconstituted, Intramuscular:

Imovax Rabies: 2.5 units/mL (1 ea)

Administration: Adult

IM: Administer IM into the deltoid muscle. Use proper injection technique in the deltoid muscle (eg, injecting in the central, thickest part of the muscle) to reduce the risk of shoulder injury related to vaccine administration (Ref). Avoid administration into the gluteal area; may result in lower response. Postexposure prophylaxis should begin with immediate cleansing of wounds with soap and water; if available, a virucidal agent (eg, povidone-iodine solution) should be used to irrigate the wounds. Do not mix rabies vaccine and human rabies immune globulin in the same syringe, and do not administer in the same anatomical site. Do not mix with other vaccines or injections; separate needles and syringes should be used for each injection. To prevent syncope-related injuries, patients should be vaccinated while seated or lying down (Ref). US law requires that the date of administration, the vaccine manufacturer, lot number of vaccine, Vaccine Information Statement (VIS) edition date and date it was provided, and the administering person's name, title, and address be recorded.

For patients at risk of hemorrhage following intramuscular injection, the vaccine should be administered intramuscularly if, in the opinion of the physician familiar with the patient's bleeding risk, the vaccine can be administered by this route with reasonable safety. If the patient receives antihemophilia or other similar therapy, intramuscular vaccination can be scheduled shortly after such therapy is administered. A fine needle (23-gauge or smaller) can be used for the vaccination and firm pressure applied to the site (without rubbing) for at least 2 minutes. The patient should be instructed concerning the risk of hematoma from the injection. Patients on anticoagulant therapy should be considered to have the same bleeding risks and treated as those with clotting factor disorders (Ref).

Administration: Pediatric

IM: Reconstitute immediately before administration. Administer IM into the anterolateral thigh for neonates, infants, and small children as appropriate and into the deltoid muscle for children and adolescents (Ref). Use proper injection technique in the deltoid muscle (eg, injecting in the central, thickest part of the muscle) to reduce the risk of shoulder injury related to vaccine administration (Ref). Do not administer to the gluteal region; may decrease efficacy. Do not mix rabies vaccine and human rabies immune globulin in the same syringe, and do not administer in the same anatomical site. Do not mix with other vaccines or injections; separate needles and syringes should be used for each injection. To prevent syncope-related injuries, adolescents should be vaccinated while seated or lying down (Ref). US law requires that the date of administration, the vaccine manufacturer, lot number of vaccine, Vaccine Information Statement (VIS) edition date and date it was provided, and the administering person's name, title, and address be recorded.

For patients at risk of hemorrhage following IM injection, the vaccine should be administered IM if, in the opinion of the physician familiar with the patient's bleeding risk, the vaccine can be administered by this route with reasonable safety. If the patient receives antihemophilia or other similar therapy, IM vaccination can be scheduled shortly after such therapy is administered. A fine needle (23-gauge or smaller) should be used for the vaccination and firm pressure applied to the site (without rubbing) for at least 2 minutes. The patient should be instructed concerning the risk of hematoma from the injection. Patients on anticoagulant therapy should be considered to have the same bleeding risks and treated as those with clotting factor disorders (Ref).

Medication Guide and/or Vaccine Information Statement (VIS)

In the United States, the appropriate Centers for Disease Control and Prevention (CDC)-approved Vaccine Information Statement (VIS) should be provided to the patient/caregiver before administering each dose of this vaccine. If purchased under CDC contract, the VIS must be provided and the VIS edition date and date it was provided to the patient/caregiver should be recorded. VIS is available at http://www.cdc.gov/vaccines/hcp/vis/vis-statements/rabies.html.

Use: Labeled Indications

Rabies disease prevention: Preexposure and postexposure vaccination against rabies.

Advisory Committee on Immunization Practices (ACIP) recommendations:

Preexposure prophylaxis (PrEP) : Vaccination recommendations are based on a person's level of risk for being exposed to rabies virus. The 5 risk categories (level 1: highest risk; level 5: lowest risk) are based on the nature of possible exposure, relevant rabies biogeography, and status of long-term immunogenicity (based on previous rabies vaccination or rabies antibody titers). See ACIP recommendations for details (CDC/ACIP [Rao 2022]). Refer to local/state health departments and the CDC for additional guidance.

Postexposure prophylaxis (PEP): Recommendations for use of PEP for a given scenario are based on risk-benefit assessment, including assessment of the risk of actually acquiring rabies versus the risk of providing PEP (ie, likelihood and severity of possible adverse effects). Consideration should include the type of exposure, epidemiology of rabies in the area, species of the animal, circumstances of the incident, and the availability of the exposing animal for observation or rabies testing. Postexposure vaccination is used in both previously vaccinated and previously unvaccinated individuals, though number of doses may vary. Refer to local/state health departments for additional guidance, particularly in nonroutine scenarios (CDC/ACIP [Manning 2008]; CDC/ACIP [Rao 2022]; CDC/ACIP [Rupprecht 2010]).

Metabolism/Transport Effects

None known.

Drug Interactions

Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.

Acetaminophen: May diminish the therapeutic effect of Vaccines. Management: Consider avoiding routine prophylactic use of acetaminophen before or during vaccine administration when possible. Acetaminophen is still recommended to treat fevers and/or pain that occurs after vaccination. Risk D: Consider therapy modification

Aminoquinolines (Antimalarial): May diminish the therapeutic effect of Rabies Vaccine. Management: If coadministration is unavoidable during rabies post-exposure vaccination, give a 5th dose of the rabies vaccine. If coadministration is unavoidable during rabies pre-exposure vaccination, ensure antibody titers are greater than or equal to 0.5 IU/mL. Risk D: Consider therapy modification

Anti-CD20 B-Cell Depleting Therapies: May diminish the therapeutic effect of Rabies Vaccine. Management: Complete rabies vaccination at least 2 weeks before initiation of immunosuppressant therapy if possible. If combined, check for rabies antibody titers, and if vaccination is for post exposure prophylaxis, administer a 5th dose of the vaccine. Risk D: Consider therapy modification

Cladribine: May diminish the therapeutic effect of Vaccines (Inactivated/Non-Replicating). Management: Give inactivated vaccines at least 2 weeks prior to initiation of cladribine when possible. Patients vaccinated less than 14 days before initiating or during cladribine should be revaccinated at least 3 months after therapy is complete. Risk D: Consider therapy modification

Corticosteroids (Systemic): May diminish the therapeutic effect of Rabies Vaccine. Management: Complete rabies vaccination at least 2 weeks before initiation of immunosuppressant therapy if possible. If combined, check for rabies antibody titers, and if vaccination is for post exposure prophylaxis, administer a 5th dose of the vaccine. Risk D: Consider therapy modification

Elivaldogene Autotemcel: May enhance the adverse/toxic effect of Vaccines. Specifically, there may be a greater risk for contracting an infection from any live vaccine. Elivaldogene Autotemcel may diminish the therapeutic effect of Vaccines. Management: Administration of vaccines is not recommended in the 6 weeks before myeloablative conditioning, and until hematologic recovery after elivaldogene autotemcel treatment. Risk X: Avoid combination

Fingolimod: May diminish the therapeutic effect of Vaccines (Inactivated/Non-Replicating). Management: Vaccine efficacy may be reduced. Complete all age-appropriate vaccinations at least 2 weeks prior to starting fingolimod. If vaccinated during fingolimod therapy, revaccinate 2 to 3 months after fingolimod discontinuation. Risk D: Consider therapy modification

Immunosuppressants (Cytotoxic Chemotherapy): May diminish the therapeutic effect of Rabies Vaccine. Management: Complete rabies vaccination at least 2 weeks before initiation of immunosuppressant therapy if possible. If combined, check for rabies antibody titers, and if vaccination is for post exposure prophylaxis, administer a 5th dose of the vaccine. Risk D: Consider therapy modification

Immunosuppressants (Miscellaneous Oncologic Agents): May diminish the therapeutic effect of Rabies Vaccine. Management: Complete rabies vaccination at least 2 weeks before initiation of immunosuppressant therapy if possible. If combined, check for rabies antibody titers, and if vaccination is for post exposure prophylaxis, administer a 5th dose of the vaccine. Risk D: Consider therapy modification

Immunosuppressants (Therapeutic Immunosuppressant Agents): May diminish the therapeutic effect of Rabies Vaccine. Management: Complete rabies vaccination at least 2 weeks before initiation of immunosuppressant therapy if possible. If combined, check for rabies antibody titers, and if vaccination is for post exposure prophylaxis, administer a 5th dose of the vaccine. Risk D: Consider therapy modification

Methotrexate: May diminish the therapeutic effect of Rabies Vaccine. Management: Complete rabies vaccination at least 2 weeks before initiation of immunosuppressant therapy if possible. If combined, check for rabies antibody titers, and if vaccination is for post exposure prophylaxis, administer a 5th dose of the vaccine. Risk D: Consider therapy modification

Propacetamol: May diminish the therapeutic effect of Vaccines. Management: Consider avoiding routine prophylactic use of propacetamol before or during vaccine administration when possible. Propacetamol is still recommended to treat fevers and/or pain that occurs after vaccination. Risk D: Consider therapy modification

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. Risk D: Consider therapy modification

Siponimod: May diminish the therapeutic effect of Vaccines (Inactivated/Non-Replicating). Management: Avoid administration of vaccines (inactivated) during treatment with siponimod and for 1 month after discontinuation due to potential decreased vaccine efficacy. Risk D: Consider therapy modification

Teplizumab: May diminish the therapeutic effect of Rabies Vaccine. Management: Complete rabies vaccination at least 2 weeks before initiation of immunosuppressant therapy if possible. If combined, check for rabies antibody titers, and if vaccination is for post exposure prophylaxis, administer a 5th dose of the vaccine. Risk D: Consider therapy modification

Pregnancy Considerations

Animal reproduction studies have not been conducted. Pregnancy is not a contraindication to postexposure prophylaxis. Pre-exposure prophylaxis during pregnancy may also be considered if risk of rabies is great. Non-live vaccines have not been shown to cause increased risks to the fetus (ACIP [Kroger 2023]).

Breastfeeding Considerations

It is not known if rabies vaccine is present in breast milk; the manufacturer recommends that caution be exercised when administering rabies vaccine to breastfeeding women. Non-live vaccines have not been shown to affect the safety of the breastfed infant or mother. Breastfeeding infants should be vaccinated according to the recommended schedules (ACIP [Kroger 2023]).

Monitoring Parameters

Monitor for hypersensitivity and syncope for 15 minutes following administration (ACIP [Kroger 2023]). If seizure-like activity associated with syncope occurs, maintain patient in supine or Trendelenburg position to reestablish adequate cerebral perfusion.

Evaluation of antibody response to vaccination is not recommended for otherwise healthy persons who complete the preexposure or postexposure regimen. Serologic testing to determine if the rabies antibody titer is at an acceptable level is recommended as part of preexposure prophylaxis for persons in the following risk categories as defined by the CDC (see CDC guidelines for details). Booster vaccination may be recommended if titer is below the acceptable level of <0.5 units/mL (CDC/ACIP [Rao 2022]):

Risk category 1: Check antibody titers every 6 months.

Risk category 2: Check antibody titers every 2 years.

Risk category 3: Check antibody titers 1 to 3 years after completion of primary series. Alternatively, may administer a single booster dose between 3 weeks and 3 years following the first vaccine dose in the 2-dose series (with no titer monitoring).

Risk categories 4 and 5: No antibody titer monitoring recommended.

Persons who are immunocompromised: Assess antibody titer ≥1 week (preferably 2 to 4 weeks) after administration of primary series and every booster vaccination. If 2 booster doses fail to elicit antibody titer ≥0.5 units/mL, contact state or local health department.

Reference Range

Adequate adaptive immune response: Rabies antibody titers of ≥0.5 international units/mL (CDC/ACIP [Rao 2022]) or complete virus neutralization at a 1:5 serum dilution by the rapid fluorescent focus inhibition test (RFFIT) (ACIP [Manning 2008]).

Mechanism of Action

Rabies vaccine is an inactivated virus vaccine which promotes immunity by inducing an active immune response. The production of specific antibodies requires about 7-10 days to develop. Rabies immune globulin or antirabies serum, equine (ARS) is given in conjunction with rabies vaccine to provide immune protection until an antibody response can occur.

Pharmacokinetics (Adult Data Unless Noted)

Onset of action: IM: Rabies antibody: ~7 to 10 days

Peak effect: ~30 to 60 days

Duration: ≥1 year

Brand Names: International
International Brand Names by Country
For country code abbreviations (show table)

  • (AE) United Arab Emirates: Verorab;
  • (AR) Argentina: Verorab;
  • (AT) Austria: Lyssavac | Rabipur;
  • (AU) Australia: Verorab;
  • (BD) Bangladesh: Rabipur | Rabivax;
  • (BE) Belgium: Rabipur;
  • (BG) Bulgaria: Verorab;
  • (BO) Bolivia, Plurinational State of: Verorab;
  • (BR) Brazil: Vacina raiva (inativada) | Vacina ravia | Verorab;
  • (CH) Switzerland: Merieux | Rabipur;
  • (CI) Côte d'Ivoire: Indirab | Rabivax s;
  • (CL) Chile: Rabipur | Verorab;
  • (CN) China: Rabies vaccine (vero cell) for human use | Rabipur | Wu Sheng Xin Ning | Yi sheng bao er;
  • (CO) Colombia: Rabipur | Verorab;
  • (CZ) Czech Republic: Rabipur | Verorab;
  • (DE) Germany: Rabies | Rabipur | Tollwud-impfstoff;
  • (DO) Dominican Republic: Verorab;
  • (EC) Ecuador: Verorab;
  • (EE) Estonia: Verorab;
  • (EG) Egypt: Rabipur;
  • (ES) Spain: Rabipur;
  • (ET) Ethiopia: Rabivax s;
  • (FR) France: Rabipur | Vaccin rabique pasteur | Verorab;
  • (GB) United Kingdom: Merieux rabies | Rabipur | Verorab;
  • (HK) Hong Kong: Verorab;
  • (HR) Croatia: Rabipur;
  • (HU) Hungary: Rabipur | Verorab;
  • (ID) Indonesia: Imovax rabies vero | Rabipur | Vaccine Rabies(Human);
  • (IE) Ireland: Rabies vaccine pmm;
  • (IN) India: Abhayrab pf | Berab | Chirorab | Indirab | Rabipur | Rabivax | Rabivax s | Sure rab | Thrabis | Verorab | Verovax-r | Worab | Zoonovac v | Zuvirab;
  • (IT) Italy: Rabipur;
  • (JO) Jordan: Verorab;
  • (JP) Japan: Rabipur;
  • (KE) Kenya: Abhayrab | Indirab | Rabipur | Speeda | Vaxirab n | Verorab;
  • (LB) Lebanon: Verorab;
  • (LT) Lithuania: Verorab;
  • (LU) Luxembourg: Rabipur;
  • (LV) Latvia: Verorab;
  • (MX) Mexico: Rabipur | Verorab;
  • (MY) Malaysia: Verorab;
  • (NL) Netherlands: Rabies vaccin | Rabiesvaccin | Rabipur;
  • (NO) Norway: Verorab;
  • (NZ) New Zealand: Rabipur | Verorab;
  • (PE) Peru: Rabipur | Rabivax s | Verorab;
  • (PH) Philippines: Abhayrab | Imovax rabies vero | Indirab | Rabiesvax fd | Rabipur | Rabivax s | Speeda | Vaxirab n | Verorab;
  • (PK) Pakistan: Abhayrab | Imovax rabies vero | Rabipur | Vaccin antirabies;
  • (PL) Poland: Rabipur | Verorab;
  • (PR) Puerto Rico: Rabavert;
  • (PT) Portugal: Rabipur;
  • (PY) Paraguay: Verorab;
  • (QA) Qatar: Rabivax-S | SII Rabivax;
  • (RO) Romania: Verorab;
  • (RU) Russian Federation: Cocav | Cultural concentrated purified inactivated dried antirabies vaccine | Rabipur | Rabivac vnukovo 32;
  • (SA) Saudi Arabia: Verorab;
  • (SE) Sweden: Rabipur;
  • (SK) Slovakia: Rabipur | Verorab;
  • (SV) El Salvador: Verorab;
  • (TH) Thailand: Inactivated rabies | Rabipur(pcec) | Speeda | Trcs speeda | Trcs-verorab | Verorab;
  • (TN) Tunisia: Rabipur | Rabivax s | Verorab;
  • (TR) Turkey: Abhayrab | Indirab;
  • (TW) Taiwan: Rabipur | Verorab;
  • (UA) Ukraine: Indirab | Rabipur | Rabivax s;
  • (UG) Uganda: Abhayrab | Rabivax s | Vaxirab n;
  • (UY) Uruguay: Verorab;
  • (VE) Venezuela, Bolivarian Republic of: Verorab;
  • (ZA) South Africa: Verorab;
  • (ZM) Zambia: Abhayrab;
  • (ZW) Zimbabwe: Abhayrab | Verorab
  1. “A New Rabies Vaccine,” Med Lett Drugs Ther, 1998, 40(1029):64-5. [PubMed 9653425]
  2. Cross GB, Moghaddas J, Buttery J, Ayoub S, Korman TM. Don't aim too high: avoiding shoulder injury related to vaccine administration. Aust Fam Physician. 2016;45(5):303‐306. [PubMed 27166466]
  3. Foster SL, Davis MV. Vaccine administration: preventing serious shoulder injuries. J Am Pharm Assoc (2003). 2013;53(1):102‐103. doi:10.1331/JAPhA.2013.13503 [PubMed 23636163]
  4. Imovax (rabies vaccine) [prescribing information]. Swiftwater, PA: Sanofi Pasteur Inc; December 2019.
  5. Kroger A, Bahta L, Hunter P. General best practice guidelines for immunization: best practices guidance of the Advisory Committee on Immunization Practices (ACIP). https://www.cdc.gov/vaccines/hcp/acip-recs/general-recs/downloads/general-recs.pdf. Accessed September 28, 2022.
  6. Kroger A, Bahta L, Long S, Sanchez P. General best practice guidelines for immunization. Best practices guidance of the Advisory Committee on Immunization Practices (ACIP). https://www.cdc.gov/vaccines/hcp/acip-recs/general-recs/downloads/general-recs.pdf. Updated 2023. Accessed April 20, 2023.
  7. Lang J and Plotkin SA, “Rabies Risk and Immunoprophylaxis in Children,” Adv Pediatr Infect Dis, 1997, 13:219-55. [PubMed 9544314]
  8. Manning, SE, Rupprecht CE, Fishbein D, et al. Human Rabies Prevention - United States, 2008 Recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR Recomm Rep. 2008;57(RR-3):1-28. [PubMed 18496505]
  9. Prymula R, Siegrist CA, Chlibek R, et al. Effect of prophylactic paracetamol administration at time of vaccination on febrile reactions and antibody responses in children: two open-label, randomised controlled trials. Lancet. 2009;374(9698):1339-1350. [PubMed 19837254]
  10. RabAvert (rabies vaccine) [prescribing information]. Morrisville, NC: Bavarian Nordic Inc; January 2021.
  11. Rao AK, Briggs D, Moore SM, et al. Use of a modified preexposure prophylaxis vaccination schedule to prevent human rabies: recommendations of the Advisory Committee on Immunization Practices - United States, 2022. MMWR Morb Mortal Wkly Rep. 2022;71(18):619-627. doi:10.15585/mmwr.mm7118a2 [PubMed 35511716]
  12. Refer to manufacturer's labeling.
  13. Rubin LG, Levin MJ, Ljungman P, et al; Infectious Diseases Society of America. 2013 IDSA clinical practice guideline for vaccination of the immunocompromised host. Clin Infect Dis. 2014;58(3):e44-100. [PubMed 24311479]
  14. Rupprecht CE, Briggs D, Brown CM, et al. Use of a reduced (4-Dose) vaccine schedule for postexposure prophylaxis to prevent human rabies: recommendations of the Advisory Committee on Immunization Practices. MMWR Recomm Rep. 2010;59(RR-2):1-9. [PubMed 20300058]
  15. Strady A, Lang J, Lienard M, et al, “Antibody Persistence Following Pre-exposure Regimens of Cell-Culture Rabies Vaccines: 10-Year Follow-up and Proposal for a New Booster Policy,” J Infect Dis, 1998, 177(5):1290-5. [PubMed 9593014]
  16. World Health Organization. WHO Guide for Rabies Pre and Post Exposure Prophylaxis in Humans. Updated 2014. http://www.who.int/rabies/PEP_Prophylaxis_guideline_15_12_2014.pdf?ua=1
Topic 9850 Version 257.0

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