Imovax

Rabies Vaccines

 
NOTE: According to U.S. federal laws, the health care provider must record in the patient's permanent record the manufacturer, lot number, administration date, and the name and address of the person administering the vaccine.
Inform the patient, parent, guardian, or responsible adult of the benefits and risks of the vaccine. Provide the Vaccine Information Statements from the manufacturer to the patient, parent, or guardian before each immunization. The action is required by the National Childhood Vaccine Injury Act of 1986.
If the rabies vaccine has been previously given, question the patient, parent, or guardian about any symptoms or signs of an adverse reaction.
Complete a Vaccine Adverse Event Reporting System (VAERS) report form if adverse events have been identified. The reporting of events is required by the National Childhood Vaccine Injury Act of 1986. The toll-free number for VAERS is 1-800-822-7967. Also, report an adverse event to the manufacturer of the specific agent administered. Depending on the adverse reaction, a subsequent dose may be contraindicated.
Health care professionals administering vaccines should take appropriate precautions to prevent allergic reactions in vaccine recipients. The health care professional should have immediate availability of epinephrine (1 mg/mL) injection and other agents used in the treatment of severe anaphylaxis in the event of a serious allergic reaction.

Administer only via the intramuscular (IM) route; do not inject intravenously, subcutaneously, or intradermally.
Visually inspect parenteral products for particulate matter and discoloration prior to administration. If either particulate matter or discoloration are present, discard the vaccine vial.
Imovax: The freeze-dried vaccine is creamy white to orange. After reconstitution, it is pink to red.
RabAvert: The freeze-dried vaccine is white. After reconstitution, it is a clear or slightly opaque, colorless suspension.
Do not mix rabies vaccine with any other vaccine or product in the same syringe.

Reconstitution (Imovax)
Inspect syringe and package for leakage, premature plunger activation, or faulty tip seal before use.
Screw the plunger rod into the syringe, if it is provided separately.
Hold the syringe cap in one hand; avoid holding the plunger rod or syringe barrel. Unscrew the syringe tip cap by twisting it counterclockwise.
Attach the reconstitution needle to the syringe by gently twisting the needle clockwise into the syringe until slight resistance is felt.
Reconstitute the freeze-dried vaccine by injecting the diluent from the syringe into the vial. Gently swirl the contents of the vial until completely dissolved; the syringe and reconstitution needle should remain attached.
Prior to withdrawing vial contents and without removing the reconstitution needle from the vial, unscrew the syringe to eliminate negative pressure.
Reattach the syringe to the reconstitution needle which has remained in the vial.
Withdraw the entire contents of the vial into the syringe.
Remove and discard reconstitution needle; attach new needle suitable for intramuscular injection.
Administer reconstituted vaccine immediately.[40848]
 
Reconstitution (RabAvert)
The manufacturer supplies a vial of freeze-dried vaccine, a syringe containing 1 mL of sterile diluent, a long needle for reconstitution, and a shorter needle for administration.
Using aseptic technique, attach the longer of 2 needles provided to the syringe containing the diluent.
Slowly inject the diluent into the vaccine containing vial at a 45 degree angle. Gently mix until the vaccine has completely dissolved.
Withdraw the total amount of the dissolved vaccine back into the syringe and replace the long needle with the shorter needle.
Administer reconstituted vaccine immediately.[40849]
 
Intramuscular (IM) Injection
Before administration, clean skin over the injection site with a suitable cleansing agent.
The preferred administration site for adults and children is the deltoid muscle; infants and younger children should receive the injection into the midlateral muscles of the thigh. Do not inject into the gluteal area.[40848] [40849]

muscle paralysis / Delayed / Incidence not known
Guillain-Barre syndrome / Delayed / Incidence not known
myelitis / Delayed / Incidence not known
angioedema / Rapid / Incidence not known
anaphylactoid reactions / Rapid / Incidence not known
bronchospasm / Rapid / Incidence not known
visual impairment / Early / Incidence not known

lymphadenopathy / Delayed / 15.0
erythema / Early / Incidence not known
neuritis / Delayed / Incidence not known
meningitis / Delayed / Incidence not known
edema / Delayed / Incidence not known
hot flashes / Early / Incidence not known
palpitations / Early / Incidence not known

myalgia / Early / 20.0-53.0
headache / Early / 20.0-52.0
injection site reaction / Rapid / 25.0-45.0
malaise / Early / 15.0-25.0
dizziness / Early / 10.0-15.0
arthralgia / Delayed / 0-6.0
pruritus / Rapid / Incidence not known
chills / Rapid / Incidence not known
rash / Early / Incidence not known
abdominal pain / Early / Incidence not known
paresthesias / Delayed / Incidence not known
asthenia / Delayed / Incidence not known
nausea / Early / Incidence not known
fever / Early / Incidence not known
fatigue / Early / Incidence not known
urticaria / Rapid / Incidence not known
vertigo / Early / Incidence not known
syncope / Early / Incidence not known

Imovax, RabAvert

Rx

Inactivated vaccine containing rabies antigen.
For preexposure and postexposure vaccination against rabies infection in all age groups.
High effectiveness post-exposure when given according to defined treatment protocols along with rabies immune globulin (RIG); pre-exposure vaccination recommended for high-risk groups, such as veterinarians.

Primary series of two 1 mL IM injections administered on days 0 and 7. Persons who have an elevated risk for unrecognized and recognized exposures including unusual or high-risk exposures to live rabies should have their serum antibody titers checked every 6 months and be given a booster dose if titers are less than 0.5 International Units/mL. This includes live rabies virus research laboratory workers, rabies biologics production workers, and those performing testing for rabies in diagnostic laboratories. The FDA-approved regimen is a primary series of three 1 mL IM injections administered on days 0, 7, and 21 or 28.

Primary series of two 1 mL IM injections administered on days 0 and 7. Persons who have an elevated risk for unrecognized and recognized exposures including unusual or high-risk exposures to live rabies should have their serum antibody titers checked every 6 months and be given a booster dose if titers are less than 0.5 International Units/mL. This includes live rabies virus research laboratory workers, rabies biologics production workers, and those performing testing for rabies in diagnostic laboratories. The FDA-approved regimen is a primary series of three 1 mL IM injections administered on days 0, 7, and 21 or 28.

5-dose series of 1 mL IM on days 0, 3, 7, 14, and 28 in conjunction with RIG on day 0. If RIG is not immediately available at the start of therapy, RIG may be given through the seventh treatment day (i.e., 7 days or less after first vaccine dose).

5-dose series of 1 mL IM on days 0, 3, 7, 14, and 28 in conjunction with RIG on day 0. If RIG is not immediately available at the start of therapy, RIG may be given through the seventh treatment day (i.e., 7 days or less after first vaccine dose).

1 mL IM on days 0 and 3; do NOT administer RIG.

1 mL IM on days 0 and 3; do NOT administer RIG.

4-dose series of 1 mL IM on days 0, 3, 7, and 14 in conjunction with RIG on day 0. If RIG is not immediately available at the start of therapy, RIG may be given through the seventh treatment day (i.e., 7 days or less after first vaccine dose). Previous recommendations of the ACIP, as well as the approved product labels, included a 5-dose regimen of 1 mL IM on days 0, 3, 7, 14, and 28.

4-dose series of 1 mL IM on days 0, 3, 7, and 14 in conjunction with RIG on day 0. If RIG is not immediately available at the start of therapy, RIG may be given through the seventh treatment day (i.e., 7 days or less after first vaccine dose). Previous recommendations of the ACIP, as well as the approved product labels, included a 5-dose regimen of 1 mL IM on days 0, 3, 7, 14, and 28.

Limited data are available in neonates. However, the data suggest that if needed for post-exposure prophylaxis in an emergent situation, a 1 mL IM dose, given as the traditional 5-dose series (days 0, 3, 7, 14, and 28) may be effective.

Primary series of two 1 mL IM injections administered on days 0 and 7. Persons wo have an elevated risk for unrecognized and recognized exposures should have their serum checked for antibody titer every 2 years and be given a booster dose if titers are less than 0.5 International Units/mL. This incudes persons who frequently handle bats, have contact with bats, enter high-density bat environments, or perform animal necropsies. The FDA-approved regimen is a primary series of three 1 mL IM injections administered on days 0, 7, and 21 or 28.

Primary series of two 1 mL IM injections administered on days 0 and 7. Persons wo have an elevated risk for unrecognized and recognized exposures should have their serum checked for antibody titer every 2 years and be given a booster dose if titers are less than 0.5 International Units/mL. This incudes persons who frequently handle bats, have contact with bats, enter high-density bat environments, or perform animal necropsies. The FDA-approved regimen is a primary series of three 1 mL IM injections administered on days 0, 7, and 21 or 28.

Primary series of two 1 mL IM injections administered on days 0 and 7. Persons who have an elevated risk for recognized exposures and have sustained risk (more than 3 years after primary vaccination) should have their serum antibody titers checked once during years 1 to 3 after primary series (no sooner than day 21 and no later than 3 years after primary series) and be given a booster dose if titers are less than 0.5 International Units/mL. This includes veterinarians, technicians, animal control officers, students/trainees, persons who handle wildlife reservoir species, spelunkers, and selected high-risk travelers. The FDA-approved regimen is a primary series of three 1 mL IM injections administered on days 0, 7, and 21 or 28.

Primary series of two 1 mL IM injections administered on days 0 and 7. Persons who have an elevated risk for recognized exposures and have sustained risk (more than 3 years after primary vaccination) should have their serum antibody titers checked once during years 1 to 3 after primary series (no sooner than day 21 and no later than 3 years after primary series) and be given a booster dose if titers are less than 0.5 International Units/mL. This includes veterinarians, technicians, animal control officers, students/trainees, persons who handle wildlife reservoir species, spelunkers, and selected high-risk travelers. The FDA-approved regimen is a primary series of three 1 mL IM injections administered on days 0, 7, and 21 or 28.

Primary series of two 1 mL IM injections administered on days 0 and 7. Persons who are at short-term elevated risk for recognized exposures do not require antibody titer testing or booster dosing. This includes veterinarians, technicians, animal control officers, students/trainees, and persons who handle wildlife reservoir species with 3 years or fewer hands on animal care as well as spelunkers and selected travelers with no expected high risk travel 3 years after primary preexposure vaccination. The FDA-approved regimen is a primary series of three 1 mL IM injections administered on days 0, 7, and 21 or 28.

Primary series of two 1 mL IM injections administered on days 0 and 7. Persons who are at short-term elevated risk for recognized exposures do not require antibody titer testing or booster dosing. This includes veterinarians, technicians, animal control officers, students/trainees, and persons who handle wildlife reservoir species with 3 years or fewer hands on animal care as well as spelunkers and selected travelers with no expected high risk travel 3 years after primary preexposure vaccination. The FDA-approved regimen is a primary series of three 1 mL IM injections administered on days 0, 7, and 21 or 28.

No dosage adjustments are needed.

No dosage adjustments are needed.

Adalimumab: (Major) If administered concurrently, adalimumab can impair the immunologic response to the rabies vaccine, thereby, decreasing its protective effect. If possible, administration of immunosuppressive mediations, such as adalimumab, should be avoided during use of the rabies vaccine for postexposure prophylaxis. When immunosuppressive therapies must be administered to persons also receiving the rabies vaccine for postexposure prophylaxis, a serum rabies antibody titer should be obtained on day 14 (day of the 4th vaccination) to ensure an acceptable antibody response has been induced.
Antimalarials: (Major) If administered concurrently, antimalarials can impair the immunologic response to the rabies vaccine, thereby, decreasing its protective effect. If possible, administration of antimalarials should be avoided during use of the rabies vaccine for postexposure prophylaxis. When antimalarials must be administered to persons also receiving the rabies vaccine for postexposure prophylaxis, a serum rabies antibody titer should be obtained on day 14 (day of the 4th vaccination) to ensure an acceptable antibody response has been induced.
Artemether; Lumefantrine: (Major) If administered concurrently, antimalarials can impair the immunologic response to the rabies vaccine, thereby, decreasing its protective effect. If possible, administration of antimalarials should be avoided during use of the rabies vaccine for postexposure prophylaxis. When antimalarials must be administered to persons also receiving the rabies vaccine for postexposure prophylaxis, a serum rabies antibody titer should be obtained on day 14 (day of the 4th vaccination) to ensure an acceptable antibody response has been induced.
Atovaquone: (Major) If administered concurrently, antimalarials can impair the immunologic response to the rabies vaccine, thereby, decreasing its protective effect. If possible, administration of antimalarials should be avoided during use of the rabies vaccine for postexposure prophylaxis. When antimalarials must be administered to persons also receiving the rabies vaccine for postexposure prophylaxis, a serum rabies antibody titer should be obtained on day 14 (day of the 4th vaccination) to ensure an acceptable antibody response has been induced.
Atovaquone; Proguanil: (Major) If administered concurrently, antimalarials can impair the immunologic response to the rabies vaccine, thereby, decreasing its protective effect. If possible, administration of antimalarials should be avoided during use of the rabies vaccine for postexposure prophylaxis. When antimalarials must be administered to persons also receiving the rabies vaccine for postexposure prophylaxis, a serum rabies antibody titer should be obtained on day 14 (day of the 4th vaccination) to ensure an acceptable antibody response has been induced.
Chloroquine: (Major) If administered concurrently, antimalarials can impair the immunologic response to the rabies vaccine, thereby, decreasing its protective effect. If possible, administration of antimalarials should be avoided during use of the rabies vaccine for postexposure prophylaxis. When antimalarials must be administered to persons also receiving the rabies vaccine for postexposure prophylaxis, a serum rabies antibody titer should be obtained on day 14 (day of the 4th vaccination) to ensure an acceptable antibody response has been induced.
Deucravacitinib: (Moderate) Patients receiving immunosuppressant medications may have a diminished vaccine response. When feasible, administer indicated vaccines at least two weeks prior to initiating immunosuppressant medications. If vaccine administration is necessary, consider revaccination following restoration of immune competence. Counsel patients receiving immunosuppressant medications about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure after receiving the vaccine.
Elivaldogene Autotemcel: (Moderate) Patients receiving immunosuppressant medications may have a diminished response to non-live vaccines. When feasible, administer indicated vaccines at least six weeks prior to initiating immunosuppressant medications. If vaccine administration is necessary, consider revaccination following restoration of immune competence. Counsel patients receiving immunosuppressant medications about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure after receiving the vaccine.
Etanercept: (Major) Etanercept has not been found to act as a general immunosuppressant; however, the patient's underlying disease state may result in the immunosuppression of the patient, thereby, impairing the immunologic response to the rabies vaccine. If possible, administration of etanercept should be avoided during use of the rabies vaccine for postexposure prophylaxis. When etanercept must be administered to persons also receiving the rabies vaccine for postexposure prophylaxis, a serum rabies antibody titer should be obtained on day 14 (day of the 4th vaccination) to ensure an acceptable antibody response has been induced.
Hydroxychloroquine: (Major) If administered concurrently, antimalarials can impair the immunologic response to the rabies vaccine, thereby, decreasing its protective effect. If possible, administration of antimalarials should be avoided during use of the rabies vaccine for postexposure prophylaxis. When antimalarials must be administered to persons also receiving the rabies vaccine for postexposure prophylaxis, a serum rabies antibody titer should be obtained on day 14 (day of the 4th vaccination) to ensure an acceptable antibody response has been induced.
Mefloquine: (Major) If administered concurrently, antimalarials can impair the immunologic response to the rabies vaccine, thereby, decreasing its protective effect. If possible, administration of antimalarials should be avoided during use of the rabies vaccine for postexposure prophylaxis. When antimalarials must be administered to persons also receiving the rabies vaccine for postexposure prophylaxis, a serum rabies antibody titer should be obtained on day 14 (day of the 4th vaccination) to ensure an acceptable antibody response has been induced.
Ocrelizumab: (Moderate) Administer all non-live vaccines at least 2 weeks before ocrelizumab initiation, whenever possible. Ocrelizumab may interfere with the effectiveness of non-live virus vaccines. Attenuated antibody responses to tetanus toxoid-containing vaccine, pneumococcal polysaccharide and pneumococcal conjugate vaccines, and seasonal influenza vaccine were observed in patients exposed to ocrelizumab at the time of vaccination during an open-label study. Infants born to mothers exposed to ocrelizumab during pregnancy may receive non-live vaccines as indicated before B-cell recovery; however, consider assessing the immune response to the vaccine. ACIP recommends that patients receiving any vaccination during immunosuppressive therapy or in the 2 weeks prior to starting therapy should be considered unimmunized and should be revaccinated a minimum of 3 months after discontinuation of therapy. Passive immunoprophylaxis with immune globulins may be indicated for immunocompromised persons instead of, or in addition to, vaccination.
Ofatumumab: (Major) Administer all needed non-live vaccines according to immunization guidelines at least 2 weeks before initiation of ofatumumab. Ofatumumab may interfere with the effectiveness of inactivated vaccines due to its actions, which cause B-cell depletion.
Primaquine: (Major) If administered concurrently, antimalarials can impair the immunologic response to the rabies vaccine, thereby, decreasing its protective effect. If possible, administration of antimalarials should be avoided during use of the rabies vaccine for postexposure prophylaxis. When antimalarials must be administered to persons also receiving the rabies vaccine for postexposure prophylaxis, a serum rabies antibody titer should be obtained on day 14 (day of the 4th vaccination) to ensure an acceptable antibody response has been induced.
Pyrimethamine: (Major) If administered concurrently, antimalarials can impair the immunologic response to the rabies vaccine, thereby, decreasing its protective effect. If possible, administration of antimalarials should be avoided during use of the rabies vaccine for postexposure prophylaxis. When antimalarials must be administered to persons also receiving the rabies vaccine for postexposure prophylaxis, a serum rabies antibody titer should be obtained on day 14 (day of the 4th vaccination) to ensure an acceptable antibody response has been induced.
Quinine: (Major) If administered concurrently, antimalarials can impair the immunologic response to the rabies vaccine, thereby, decreasing its protective effect. If possible, administration of antimalarials should be avoided during use of the rabies vaccine for postexposure prophylaxis. When antimalarials must be administered to persons also receiving the rabies vaccine for postexposure prophylaxis, a serum rabies antibody titer should be obtained on day 14 (day of the 4th vaccination) to ensure an acceptable antibody response has been induced.
Rabies Immune Globulin, human RIG: (Minor) The rabies immune globulin, human RIG may be administered concurrently with, and up to 8 days after the rabies vaccine. The RIG and the rabies vaccine must be administered via separate syringes and at different anatomical site. Avoid administering RIG if more than 7 days have elapsed since administration of the rabies vaccine as this may impair rabies vaccine-induced active immunity. Additionally, RIG doses greater than the recommended 20 International Units/kg and repeat RIG doses should also be avoided as these too may partially suppress active production of antibodies by the rabies vaccine.
Satralizumab: (Major) Administer all non-live vaccines according to immunization guidelines at least 2 weeks before initiation of satralizumab.
Siponimod: (Moderate) Administer all non-live vaccines at least 2 weeks before siponimod initiation, whenever possible. Vaccines may be less effective if given during siponimod treatment. Patients should be considered unimmunized if vaccinated within a 14-day period before starting immunosuppresive therapy or during immunosuppressive therapy, and should they be revaccinated at least 3 months after therapy is discontinued if immune competence is restored.
Sulfadiazine: (Major) If administered concurrently, antimalarials can impair the immunologic response to the rabies vaccine, thereby, decreasing its protective effect. If possible, administration of antimalarials should be avoided during use of the rabies vaccine for postexposure prophylaxis. When antimalarials must be administered to persons also receiving the rabies vaccine for postexposure prophylaxis, a serum rabies antibody titer should be obtained on day 14 (day of the 4th vaccination) to ensure an acceptable antibody response has been induced.
Tafenoquine: (Major) If administered concurrently, antimalarials can impair the immunologic response to the rabies vaccine, thereby, decreasing its protective effect. If possible, administration of antimalarials should be avoided during use of the rabies vaccine for postexposure prophylaxis. When antimalarials must be administered to persons also receiving the rabies vaccine for postexposure prophylaxis, a serum rabies antibody titer should be obtained on day 14 (day of the 4th vaccination) to ensure an acceptable antibody response has been induced.
Ublituximab: (Moderate) Patients receiving immunosuppressant medications may have a diminished response to non-live vaccines. When feasible, administer indicated vaccines at least two weeks prior to initiating immunosuppressant medications. If vaccine administration is necessary, consider revaccination following restoration of immune competence. Counsel patients receiving immunosuppressant medications about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure after receiving the vaccine.

Imovax/RabAvert/Rabies Vaccine/Rabies Vaccine (Avian) Intramuscular Inj Pwd F/Susp: 2.5IU, 2.5U

1 ml/dose IM.

1 ml/dose IM.

1 ml/dose IM.

1 ml/dose IM.

1 ml/dose IM.

Limited data in newborns; 1 ml/dose IM.

The rabies vaccine is manufactured from inactivated strains of the rabies virus. Each dose (1 ml) of the vaccines marketed in the US, ImoVax and RabAvert, contains at least 2.5 international units of rabies antigen. When administered intramuscularly, the rabies antigen induces production of specific neutralizing antibodies against the rabies virus, thereby providing active immunity. The active antibody response requires approximately 7 to 10 days to develop, and detectable rabies virus neutralizing antibodies generally persist for several years. Due to the delay in development of antibodies, post-exposure prophylaxis must include administration of Rabies Immune Globulin (see separate monograph).

The rabies vaccine is administered intramuscularly. Pre-exposure vaccination does not ensure immunity.
 
The Centers for Disease Control and Prevention (CDC) defines the minimum antibody titer acceptable for seroconversion as a 1:5 dilution (complete inhibition) by rapid fluorescent focus inhibition test (RFFIT); The World Heath Organization (WHO) recommends a titer of at least 0.5 international units/ml. Immunization with the rabies vaccine has been shown to achieve titers above these minimum concentrations within 14 days of initiating the postexposure prophylaxis series in all age groups. In US clinical trials, administering the rabies vaccine for preexposure prophylaxis has resulted in seroconversion (>= 0.5 international units/ml) in all patients by the end of the 28 day vaccination series. The duration of protection is undefined; therefore, persons with continued exposure to rabies should obtain serum titers every 6 months to 2 years (depending on exposure risk) to ensure acceptable antibody concentrations (see Indications).

There are no adequate, well controlled studies in pregnant humans; animal reproduction studies have not been conducted. It is not known if administration of the vaccine can cause fetal harm or affect the reproductive system. Rabies vaccine should be used during pregnancy only if the potential benefit to the mother justifies the potential risk to the fetus. Because of the potential consequences of inadequately treated rabies exposure, pregnancy is not considered a contraindication to postexposure prophylaxis. If the risk of exposure to rabies is substantial, preexposure prophylaxis might be indicated during pregnancy.

It is not known whether rabies vaccine is excreted in human breast milk; however, because of the potential consequences of inadequately treated rabies exposure, the manufacturer does not consider breast-feeding to be a contraindication for postexposure prophylaxis. Additionally, if the risk of exposure to rabies is substantial, preexposure vaccination might also be indicated during nursing. According to the Advisory Committee on Immunization Practices (ACIP), inactivated virus vaccines pose no risk to mothers or their infants. Consider the benefits of breast-feeding, the risk of potential infant drug exposure, and the risk of an untreated or inadequately treated condition. If a breast-feeding infant experiences an adverse effect related to a maternally administered drug, health care providers are encouraged to report the adverse effect to the FDA.