Imovax

— THERAPEUTIC CATEGORIES —
  • Vaccines

Imovax Generic Name & Formulations

General Description

Rabies vaccine 2.5Units/mL; grown in human diploid cell cultures (inactivated whole virus); inj.

How Supplied

Single-dose vial (1mL)—1 (w. syringe and diluent)

How Supplied

Imovax Rabies vaccine is supplied in a tamper evident unit dose box with:

  • One vial of freeze-dried vaccine containing a single dose.

  • One sterile syringe containing diluent. If not already inserted into the syringe, a separate plunger rod is provided. 

  • One sterile disposable needle for reconstitution.

Storage

  • Store in the refrigerator between 2°C and 8°C (35°F to 46°F). Do not freeze.  

Manufacturer

Mechanism of Action

High titer antibody responses to the Imovax Rabies vaccine made in human diploid cells have been demonstrated in trials conducted in England, Germany, France, and Belgium. Post-exposure efficacy of Imovax Rabies vaccine was successfully proven during clinical experience in Iran

Imovax Indications

Indications

Preexposure immunization and postexposure treatment of rabies.

Imovax Dosage and Administration

Adults and Children

Administer IM in the deltoid (for adults and older children) and the anterolateral aspect of the thigh may be preferable (for infants and small children). Preexposure: 3 inj of 1mL IM each on day 0, 7, and either day 21 or 28. Booster doses: 1mL every 2 yrs (see literature). Postexposure treatment: a 5 dose regimen of 1mL IM given on days 0, 3, 7, 14, 28 or 30 (WHO or ACIP recommendations), and 90 (give 1st dose with rabies immune globulin). If previously immunized against rabies, only 2 doses are given, immediately after exposure, and 3 days later (no rabies immune globulin needed).

Adults and Children

Pre-exposure Rabies Prophylaxis Guide

  • Administer IM in the deltoid for adults and older children, and the anterolateral aspect of the thigh may be preferable for infants and small children depending on age and body mass.

  • Primary vaccination

    • Give three 1.0mL doses of Imovax via one IM injection per day on Days 0, 7, and 21 or 28.

  • Booster dose:

    • Give one injection of 1.0mL of Imovax.

    • Check titers periodically to ensure the presence of a primed immune response in persons at higher than normal risk for exposure.

    • For persons who have experienced “immune complex-like” hypersensitivity reactions: do not give further doses of Imovax unless they are exposed to rabies or are truly likely to be apparently and/or unavoidably exposed to rabies and have unsatisfactory antibody titers.

  • For immunosuppressed persons: postpone pre-exposure vaccinations and consider avoiding activities for which rabies pre-exposure prophylaxis is indicated. If unavoidable, immunosuppressed persons who are at risk for rabies should have their viral neutralizing antibody titers checked after completing the pre-exposure series.

Pre-exposure Rabies Prophylaxis Guide

  • Risk category: Continuous. 

    • Nature of risk: Virus present continuously and often in high concentrations. Specific exposures likely to go unrecognized. Bite, nonbite, or aerosol exposure.

    • Typical populations: Rabies research laboratory workers; rabies biologics production workers.

    • Pre-exposure recommendations: Primary course. Serologic testing every 6 months; booster vaccination if antibody titer is below acceptable level (minimum acceptable antibody level is complete virus neutralization at a 1:5 serum dilution by the rapid fluorescent focus inhibition test).

  • Risk category: Frequent.

    • Nature of risk: Exposure usually episodic, with source recognized, but exposure also might be unrecognized. Bite, nonbite, or aerosol exposure.

    • Typical populations: Rabies diagnostic laboratory workers, cavers, veterinarians and staff, and animalcontrol and wildlife workers in areas where rabies is enzootic. All persons who frequently handle bats.

    • Pre-exposure recommendations: Primary course. Serologic testing every 2 years; booster vaccination if antibody titer is below acceptable level (minimum acceptable antibody level is complete virus neutralization at a 1:5 serum dilution by the rapid fluorescent focus inhibition test).

  • Risk category: Infrequent (greater than population at large).

    • Nature of risk: Exposure nearly always episodic with source recognized. Bite or nonbite exposure.

    • Typical populations: Veterinarians and animal-control staff working with terrestrial animals in areas where rabies is uncommon to rare. Veterinary students. Travelers visiting areas where rabies is enzootic and immediate access to appropriate medical care including biologics is limited.

    • Pre-exposure recommendations: Primary course. No serologic testing or booster vaccination.

  • Risk category: Rare (population at large).

    • Nature of risk: Exposure always episodic with source recognized. Bite or nonbite exposure.

    • Typical populations: US population at large, including persons in areas where rabies is epizootic.

    • Pre-exposure recommendations: No vaccination necessary.

 

Post-exposure Treatment

Post-exposure dosage for previously unimmunized persons

  • Administer IM in the deltoid for adults and older children, and the anterolateral aspect of the thigh may be preferable for infants and small children depending on age and body mass.

  • Give five IM doses of 1.0mL each of Imovax on Day 0 (immediately after exposure) and one dose at 3, 7, 14, and 28 days later.

    • Administer rabies immune globulin (RIG) 20 IU/kg on Day 0 in conjunction with the first vaccine dose. If possible, administer the full dose of RIG to infiltrate the wound(s); if not possible, administer the remaining dose via IM at a different site from the site used to administer the vaccine.

Post-exposure dosage for previously immunized persons

  • Administer IM in the deltoid for adults and older children, and the anterolateral aspect of the thigh may be preferable for infants and small children depending on age and body mass.

  • For an immunized person who previously was vaccinated using the recommended pre-exposure regimen or a prior post-exposure regimen with a cell culture vaccine or who had previously demonstrated rabies antibody is exposed to rabies: 

    • Give two IM doses of 1.0mL each of Imovax on Day 0 (immediately after exposure) and one dose 3 days later.

    • Do not administer RIG to these patients.

  • If the immune status of a previously vaccinated persons who did not receive the recommended HDCV regimen is not known, may need to administer the full primary post-exposure antirabies treatment (RIG plus 5 doses of HDCV).

    • If antibody levels of greater than 1:5 dilution by a RFFIT can be reported in a serum sample collected before vaccine is given, discontinue treatment after at least 2 doses of HDCV.

Local Treatment of Wounds

  • Thoroughly wash and flush all bite wounds and scratches immediately or as early as possible for about 15 minutes (if possible) with soap or a cleansing agent and copious amounts of water. If available, apply an iodine-containing, or similarly viricidal, topical preparation to the wound.

  • Give as indicated tetanus prophylaxis and measures to control bacterial infection.

Specific Treatment

  • Post-exposure antirabies vaccination should always include both passive antibody and vaccine, with the exception of persons who have every previously received complete vaccination regimens (pre-exposure or post-exposure) with a cell culture vaccine or persons who have been vaccinated with other types of vaccines and have previously had a documented rabies virus neutralizing antibody titer. Only administer the vaccine for post-exposure for a person previously vaccinated.

  • The combination of RIG and vaccine is recommended for both bite and nonbite exposures reported by persons who have never been previously vaccinated for rabies, regardless of the interval between exposure and initiation of prophylaxis.

  • If post-exposure prophylaxis has been initiated and appropriate laboratory diagnostic testing (ie, the direct fluorescent antibody test) indicates that the exposing animal was not rabid, post-exposure prophylaxis can be discontinued.

Treatment Outside the United States

  • If post-exposure is begun outside the United States with locally produced biologics, it may be desirable to provide additional treatment when the patient reaches the US. State or local health departments should be contacted for specific advice in such cases.

Post-exposure Treatments Guide

  • Animal type: Dogs, cats, and ferrets.

    • Evaluation and disposition of animal: Healthy and available for 10 days observation. Rabid or suspected rabid. Unknown (eg, escaped).

    • Post-exposure prophylaxis recommendations: Persons should not begin prophylaxis unless animal develops clinical signs of rabies. Immediately begin prophylaxis. Consult public health officials.

  • Animal type: Skunks, raccoons, foxes, and most other carnivores. Bats.

    • Evaluation and disposition of animal: Regard as rabid unless animal proven negative by laboratory tests.

    • Post-exposure prophylaxis recommendations: Consider immediate prophylaxis.

  • Animal type: Livestock, small rodents (rabbits and hares), large rodents (woodchucks and beavers), and other mammals.

    • Evaluation and disposition of animal: Consider individually.

    • Post-exposure prophylaxis recommendations: Consult public health officials. Bites from squirrels, hamsters, guinea pigs, gerbils, chipmunks, rats, mice, other small rodents, rabbits, and hares almost never require anti-rabies post-exposure prophylaxis.

Imovax Contraindications

Not Applicable

Imovax Boxed Warnings

Not Applicable

Imovax Warnings/Precautions

Warnings/Precautions

Postpone preexposure immunization during acute febrile illness or infection. Immunocompromised: may get suboptimal response (monitor titers). Have epinephrine inj (1:1000) available. Pregnancy. Nursing mothers.

Warnings/Precautions

  • Do not inject into the gluteal area as administration into this area may lead to lower neutralizing antibody titers.

  • Inject the full dose of 1.0mL intramuscularly for both pre-exposure and post-exposure immunization.

  • Serum sickness type reactions may occur in persons receiving booster doses for pre-exposure prophylaxis. Onset of reactions occur approximately 2 to 21 days post-booster. Reactions present with a generalized urticaria, and may also include arthralgia, arthritis, angioedema, nausea, vomiting, fever, and malaise.

  • Rare cases of neurologic illness resembling Guillain-Barre syndrome, transient neuroparalytic illness, and a focal subacute CNS disorder temporarily associated with HDCV have been reported.

  • Rare risk for transmission of viral diseases and variant Creutzfeldt-Jakob disease (vCJD) because this product contains albumin. No cases of transmission of viral diseases have been identified.

  • Report all serious systemic neuroparalytic or anaphylactic reactions to a rabies vaccine to VAERS at 1-800-822-7967 or Sanofi Pasteur Inc., 1-800-VACCINE.

  • Imovax may not protect 100% of vaccinated individuals.

  • Have epinephrine (1:1000) and other appropriate agents readily available to counteract anaphylactic reactions, and carefully monitor patients after vaccination.

Pregnancy Considerations

Pre-exposure

  • It is not known whether Imovax can cause fetal harm in pregnant women or can affect reproductive capacity.

  • Only administer to a pregnant woman if potential benefits outweigh potential risks.

Post-exposure

  • Pregnancy is not considered a contraindication for post-exposure prophylaxis.

Nursing Mother Considerations

  • It is not known whether Imovax is excreted in human milk.

  • Use caution when administering Imovax to a nursing woman.

Imovax Pharmacokinetics

See Literature

Imovax Interactions

Interactions

Immunosuppressants: may get suboptimal response.

Imovax Adverse Reactions

Adverse Reactions

Local reactions (pain, erythema, swelling), systemic reactions (nausea, headache, muscle aches, abdominal pain).

Imovax Clinical Trials

Clinical Trials

Pre-exposure immunization

  • Imovax demonstrated high antibody responses in human diploid cells in clinical trials conducted in England, Germany, France, and Belgium. Seroconversion was often obtained after one dose. After 2 doses (1 month apart), 100% of recipients developed specific antibody, and the geometric mean titer of the group was approximately 10 international units.

  • In the US, Imovax Rabies vaccine resulted in geometric mean titers (GMT) of 12.9 IU/mL at Day 49 and 5.1 IU/mL at Day 90 when 3 IM doses were given during the course of 1 month. The range of antibody responses was 2.8 to 55.0 IU/mL at Day 49 and 1.8 to 12.4 IU at Day 90. 

Post-exposure immunization

  • The post-exposure efficacy of Imovax Rabies vaccine was based on clinical experience in Iran in which six 1.0mL doses were given on days 0, 3, 7, 14, 30, and 90, in conjunction with antirabies serum. There were 45 individuals severely bitten by rabid dogs and wolves who received Imovax within hours of and up to 14 days after the bites. All individuals were fully protected against rabies. 

  • In studies conducted by the US CDC, 1 dose of Rabies Immune Globulin (RIG) and 5 doses of HDCV elicited an excellent antibody response in all 511 recipients who were bitten by proven rabid animals and so treated, none developed rabies.

Imovax Note

Not Applicable

Imovax Patient Counseling

See Literature