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- Human Diploid Cell Cultures Rabies Vaccine
- Purified Chick Embryo Cell
Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product
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]
Injectable, Intramuscular [preservative free]:
Imovax Rabies: 2.5 units/mL (1 ea) [contains albumin human, neomycin sulfate]
Suspension Reconstituted, Intramuscular:
RabAvert: 2.5 units (1 ea) [contains albumin human, chicken protein, edetate disodium, gelatin (bovine), neomycin]
RabAvert: 2.5 units (1 ea [DSC]) [contains albumin human, edetate disodium, neomycin, polygeline]
Brand Names: U.S.
- Imovax Rabies
- Vaccine, Inactivated (Viral)
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.
Onset of Action
IM: Rabies antibody: ~7 to 10 days; Peak effect: ~30 to 60 days
Duration of Action
Use: Labeled Indications
Rabies disease prevention: Preexposure and postexposure vaccination against rabies
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, and presence of rabies in the region. Refer to local/state health department and CDC for more information.
The Advisory Committee on Immunization Practices (ACIP) recommends a primary course of prophylactic immunization (preexposure vaccination) for the following (ACIP [Manning 2008]):
• Persons with continuous risk of infection, including rabies research laboratory and biologics production workers
• Persons with frequent risk of infection, including rabies diagnostic laboratory workers, cavers, veterinarians and their staff, and animal control and wildlife workers in areas where rabies is enzootic; persons who frequently handle bats
• Persons with infrequent risk of infection, including veterinarians and animal control staff working with terrestrial animals in areas where rabies infection is rare, veterinary students, and travelers visiting areas where rabies is enzootic and immediate access to medical care and biologicals is limited
The ACIP recommends the use of postexposure vaccination for a particular person be assessed by the severity and likelihood versus the actual risk of acquiring rabies. 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 (ACIP [Manning 2008]; ACIP [Rupprecht 2010]).
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.
Preexposure vaccination: IM: A total of 3 doses, 1 mL each, on days 0, 7, and 21 or 28.
Booster vaccination (for persons with continuous or frequent risk of infection): IM: 1 mL based on antibody titers
Note: Prolonging the interval between doses does not interfere with immunity achieved after the concluding dose of the basic series.
Postexposure vaccination: All postexposure treatment should begin with immediate cleansing of the wound with soap and water
Persons not previously immunized as above:
Immunocompetent: IM: 4 doses (1 mL each) on days 0, 3, 7, 14 (ACIP [Rupprecht 2010]).
Immunocompromised: IM: 5 doses (1 mL each) on days 0, 3, 7, 14, 28 (ACIP [Rupprecht 2010]).
Note: In addition, patients should receive rabies immune globulin with the first dose (day 0).
Persons who have previously received postexposure prophylaxis with rabies vaccine, received a recommended IM pre-exposure series of rabies vaccine or have a previously documented rabies antibody titer considered adequate: IM: Two doses (1 mL each) on days 0 and 3; do not administer rabies immune globulin
Refer to adult dosing.
Preexposure vaccination: Infants, Children, and Adolescents: IM: 1 mL/dose for 3 doses, on days 0, 7, and 21 or 28. Note: Prolonging the interval between doses does not interfere with immunity achieved after the concluding dose of the basic series.
Booster vaccination (for persons with continuous or frequent risk of infection): Infants, Children, and Adolescents: IM: 1 mL/dose based on antibody titers
Postexposure vaccination: Infants, Children, and Adolescents: All postexposure treatment should begin with immediate cleansing of the wound with soap and water (for ~15 minutes); immunization should begin as soon as possible after exposure. On presented dosing, Day 0 is the first day vaccine administered.
Persons not previously immunized: Administer with rabies immune globulin (RIG):
Immunocompetent: 4-dose regimen: IM: 1 mL/dose for 4 doses on days 0, 3, 7, and 14 postexposure (ACIP [Rupprecht 2010])
Immunocompromised: 5-dose regimen: IM: 1 mL/dose for 5 doses on days 0, 3, 7, 14, and 28 postexposure (ACIP [Rupprecht 2010])
Persons who have previously received vaccine (either previous postexposure prophylaxis or preexposure series of vaccination) or have a previously documented rabies antibody titer considered adequate: IM: 1 mL/dose on days 0 and 3 postexposure; do not administer RIG
Reconstitute with provided diluent; gently swirl to dissolve. Use immediately after reconstitution.
Imovax: Suspension will appear pink to red
RabAvert: Suspension will appear clear to slightly opaque to slightly pink
IM: For IM administration only; do not administer intradermally or subcutaneously; administer IM injections in the deltoid muscle. 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 (ACIP [Ezeanolue 2020]). To prevent syncope related injuries, patients should be vaccinated while seated or lying down (ACIP [Ezeanolue 2020]). If purchased under Centers for Disease Control and Prevention contract, 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 (ACIP [Ezeanolue 2020]).
Prior to reconstitution, store under refrigeration at 2°C to 8°C (36°F to 46°F); do not freeze. RabAvert should be protected from light.
Chloroquine: May diminish the therapeutic effect of Rabies Vaccine. Monitor therapy
Fingolimod: May diminish the therapeutic effect of Vaccines (Inactivated). 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. Consider therapy modification
Immunosuppressants: May diminish the therapeutic effect of Vaccines (Inactivated). Management: Vaccine efficacy may be reduced. Complete all age-appropriate vaccinations at least 2 weeks prior to starting an immunosuppressant. If vaccinated during immunosuppressant therapy, revaccinate at least 3 months after immunosuppressant discontinuation. 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. Consider therapy modification
Siponimod: May diminish the therapeutic effect of Vaccines (Inactivated). Management: Avoid administration of vaccines (inactivated) during treatment with siponimod and for 1 month after discontinuation due to potential decreased vaccine efficacy. Consider therapy modification
Venetoclax: May diminish the therapeutic effect of Vaccines (Inactivated). Monitor therapy
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)
Concerns related to adverse effects:
• Anaphylactoid/hypersensitivity reactions: Immediate treatment (including epinephrine 1 mg/mL) for anaphylactoid and/or hypersensitivity reactions should be available during vaccine use (ACIP [Ezeanolue 2020]). Once postexposure prophylaxis has begun, administration should generally not be interrupted or discontinued due to local or mild adverse events. Continuation of vaccination following severe systemic reactions should consider the persons 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 to 2 to 21 days following booster doses of HDCV. 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, tendinitis) 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 [Ezeanolue 2020]).
• 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 [Ezeanolue 2020]).
• Altered immunocompetence: Consider deferring immunization during periods of severe immunosuppression (eg, patients receiving chemo/radiation therapy [including high-dose corticosteroids]); may have a reduced response to vaccination. Withhold nonessential immunosuppressive agents during postexposure prophylaxis; if possible postpone pre-exposure prophylaxis until the immunocompromising condition is resolved. Persons with altered immunocompetence should receive the five-dose postexposure vaccine regimen. In general, household and close contacts of persons with altered immunocompetence may receive all age appropriate vaccines (ACIP [Ezeanolue 2020]; IDSA [Rubin 2014]).
• 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 [Ezeanolue 2020]).
Concurrent drug therapy issues:
• Anticoagulant therapy: Use with caution in patients receiving anticoagulant therapy; bleeding/hematoma may occur from IM administration (ACIP [Ezeanolue 2020]).
• 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 inactivated) for which a person is eligible at a single clinic visit, unless contraindications exist. The ACIP prefers each dose of a specific vaccine in a series come from the same manufacturer when possible (ACIP [Ezeanolue 2020]).
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.
• Antipyretics: Antipyretics have not been shown to prevent febrile seizures; antipyretics may be used to treat fever or discomfort following vaccination (ACIP [Ezeanolue 2020]). 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. Vaccines may not be effective if administered during periods of altered immune competence (ACIP [Ezeanolue 2020]).
Monitor for anaphylaxis and syncope for 15 minutes following administration (ACIP [Ezeanolue 2020]). If seizure-like activity associated with syncope occurs, maintain patient in supine or Trendelenburg position to reestablish adequate cerebral perfusion.
Antibody response to vaccination is not recommended for otherwise healthy persons who complete the pre-exposure or postexposure regimen. Serologic testing to determine if the antibody titer is at an acceptable level is required for the following persons (booster vaccination recommended if titer is below the acceptable level) (ACIP [Manning 2008]):
Persons with continuous risk of infection: Serologic testing every 6 months
Persons with frequent risk of infection: Serologic testing every 2 years
Persons who are immunocompromised: Serologic testing after completion of preexposure or postexposure prophylaxis series
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. Inactivated vaccines have not been shown to cause increased risks to the fetus (ACIP [Ezeanolue 2020]).
What is this drug used for?
• It is used to prevent rabies.
All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:
• Injection site pain, redness, or swelling
• Flu-like symptoms
• Joint pain
• Muscle pain
WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:
• Severe dizziness
• Passing out
• Burning or numbness feeling
• Abnormal movements
• Meningitis like headache with fever, stiff neck, nausea, confusion, or sensitivity to light
• Vision changes
• Swollen glands
• Severe loss of strength and energy
• Facial paralysis
• Muscle weakness
• Trouble moving
• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, 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 limited summary of general information about the medicine's uses from the patient education leaflet and is not intended to be comprehensive. This limited summary does NOT include all information available about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not intended to provide medical advice, diagnosis or treatment and does not replace information you receive from the healthcare provider. For a more detailed summary of information about the risks and benefits of using this medicine, please speak with your healthcare provider and review the entire patient education leaflet.
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