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Brand and Other Names: HDCV, Imovax Rabies, rabies vaccine human diploid cell culture
Drug Class: Vaccines, Inactivated, Viral; Vaccines, Travel
What is rabies vaccine, and what is it used for?
The rabies vaccine is a viral vaccine administered to prevent or treat rabies, a lethal infectious disease that affects the nervous system.
Rabies virus is transmitted by bites or scratches by infected animals, most commonly dogs, but also by bats, cats, raccoons, foxes and many other wild animals. Rabies vaccine is used as a prophylaxis in people who have a high risk for contracting it, such as veterinarians and lab workers working with live rabies virus.
Protection from preexposure rabies vaccination, with a booster, can last up to 2 years, and one study demonstrated antibody presence even after 5 years. Postexposure vaccination protection may last only up to 6 months. The main purpose of postexposure vaccination is to prevent full-blown rabies infection and in previously unimmunized individuals, it is administered in combination with human rabies immunoglobulin (HRIG), which are lab-grown rabies antibodies.
Rabies vaccine is an inactivated vaccine, which means it is composed of dead, purified virus material. Rabies vaccination introduces harmless virus particles into the body, which do not have the ability to cause disease. The vaccine stimulates the body’s immune system to produce antibodies against the virus, which can kill the rabies virus if there is a future exposure. It takes 7-10 days after immunization for the rabies antibodies to develop.
The rabies virus is cultured in laboratories in a medium such as human diploid cells, purified chick embryo cells or purified vero cells, a cell line isolated from the African green monkey kidney cells. The rabies virus is harvested from these cultures, killed and purified to prepare the rabies vaccine. The rabies vaccine may also contain substances that preserve and stabilize the vaccine, and enhance immune response.
Warnings
- Rabies vaccine should not be administered as preexposure prophylaxis to individuals with known life-threatening hypersensitivity to the rabies vaccine or any of its components, including neomycin.
- Vaccination may not protect 100% of vaccinated individuals.
- Points of note with rabies vaccine administration include:
- The vaccine should not be injected into the gluteal area, because it may result in lower response
- The product is provided in a single dose and should not be used as a multidose vial for intradermal injection
- In both pre-exposure and postexposure immunization, the full 1.0 mL dose should be given intramuscularly
- Once initiated, rabies prophylaxis should not be interrupted or discontinued because of local or mild systemic adverse reactions, which must be managed appropriately. In case of severe reactions, a patient’s risk of developing rabies must be carefully considered before deciding to discontinue vaccination doses.
- When a person with a history of hypersensitivity must be given rabies vaccine, antihistamines may be given to manage it. The person should be carefully monitored and epinephrine and other appropriate agents should be readily available in case of severe allergic reaction (anaphylaxis).
- Rabies vaccine may cause immune reactions such as serum sickness, with symptoms that include nausea, vomiting, joint pain and inflammation, hives and fever.
- Rare cases of neurologic illness resembling Guillain-Barré syndrome have been reported.
- Rabies vaccine produced in human diploid cells contains albumin, a derivative of human blood. It carries a remote risk for transmission of viral diseases and variant Creutzfeldt-Jakob disease (vCJD).
- In individuals undergoing immunosuppressive therapy:
- Corticosteroids or other immunosuppressive drugs can interfere with the development of active immunity and predispose the patient to develop rabies
- Immunosuppressive agents should not be administered during postexposure therapy, unless essential for the treatment of other conditions
- Patients should be tested for rabies antibody to ensure that an adequate response has developed after immunization
- All serious systemic neuroparalytic or anaphylactic reactions to a rabies vaccine should be immediately reported to VAERS at 1-800-822-7967 (http://vaers.hhs.gov) or Sanofi Pasteur Inc., 1-800-VACCINE (1-800-822-2463).
What are the side effects of rabies vaccine?
Common side effects of rabies vaccine include:
- Dizziness
- Headache
- Feeling unwell (malaise)
- Muscle pain (myalgia)
- Nausea
- Abdominal pain
- Injection site reactions including:
- Lymph node swelling (lymphadenopathy)
- Serum sickness
Less common side effects of rabies vaccine include:
- Hypersensitivity reactions including:
- Allergic dermatitis
- Hives (urticaria)
- Pruritus
- Edema
- Anaphylaxis
- Vomiting
- Diarrhea
- Fever
- Chills
- Weakness (asthenia)
- Fatigue
- Joint pain (arthralgia)
- Limb pain
- Edema
- Swelling of injected limb
- Wheezing
- Shortness of breath (dyspnea)
- Hot flash
- Visual disturbance
Rare side effects of rabies vaccine include:
- Abnormal skin sensation (paresthesia)
- Guillain-Barre syndrome
- Brain damage (encephalitis)
- Inflammation of the membrane covering the brain and spinal cord (meningitis)
- Inflammation of the spinal cord (myelitis)
- Multiple sclerosis
- Neurological disease (neuropathy)
- Retrobulbar neuritis, a form of optic nerve inflammation
- Seizure
- Vertigo
- Paralysis
- Cardiovascular toxicity
- Palpitations
This is not a complete list of all side effects or adverse reactions that may occur from the use of this drug.
Call your doctor for medical advice about serious side effects or adverse reactions. You may also report side effects or health problems to the FDA at 1-800-FDA-1088.
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What are the dosages of rabies vaccine?
Injection, Freeze-Dried Suspension
- 2.5 IU/mL
Adult and pediatric:
Rabies Preexposure Immunization
Vaccination is recommended for children living in or visiting countries where exposure to rabid animals is a constant threat; worldwide statistics indicate children are more at risk than adults
Primary
- 1 mL intramuscular (IM) in the deltoid region (in small children and infants, anterolateral region of thigh) x 3 doses
- Administer on days 0, 7, and 21 or 28
Booster
- 1 mL IM (deltoid region) to maintain a serum titer greater than 1:5 serum dilution by RFFIT
Frequency for testing serum titers
Continuous risk
- Test serum for rabies antibodies every 6 months in persons working with live rabies virus in research laboratories and in vaccine production facilities (continuous risk category)
Frequent risk
- Other laboratory workers (e.g., those performing rabies diagnostic testing), cavers, veterinarians and staff, animal-control and wildlife officers in areas where rabies is enzootic, and bat handlers regardless of location
- If titer inadequate, administer single booster dose of vaccine
Infrequent risk
- Veterinarians, veterinary students, and terrestrial animal-control and wildlife officers, working in areas of low rabies endemicity and certain at-risk international travelers who have completed a full preexposure vaccination series with licensed vaccines and according to schedule do not require routine booster serologic verification of detectable antibody titers or routine preexposure booster doses of vaccine
Rabies Postexposure Immunization
Unimmunized individuals
- 1 mL IM x 5 doses
- Administer on days 0, 3, 7, 14, and 28 in conjunction with administration of human rabies immune globulin (HRIG) on day 0
- HRIG: 20 IU/kg; if anatomically feasible, the full dose should be infiltrated around and into the wound(s), and any remaining volume should be administered IM at an anatomical site distant from vaccine administration
Previously immunized individuals
- 1 mL IM x 2 doses on days 0 and 3
What drugs interact with rabies vaccine?
Inform your doctor of all medications you are currently taking, who can advise you on any possible drug interactions. Never begin taking, suddenly discontinue, or change the dosage of any medication without your doctor’s recommendation.
- Severe interactions of rabies vaccine include:
- Rabies Vaccine has serious interactions with at least 36 different drugs.
- Moderate interactions of rabies vaccine include:
- certolizumab pegol
- cyclosporine
- ibrutinib
- ifosfamide
- lomustine
- mechlorethamine
- melphalan
- mercaptopurine
- methotrexate
- onasemnogene abeparvovec
- oxaliplatin
- ponesimod
- procarbazine
- rabies immune globulin, human (RIG)
- rituximab
- rituximab-hyaluronidase
- tralokinumab
- ustekinumab
- voclosporin
- Mild interactions of rabies vaccine include:
- chloroquine
- ozanimod
The drug interactions listed above are not all of the possible interactions or adverse effects. For more information on drug interactions, visit the RxList Drug Interaction Checker.
It is important to always tell your doctor, pharmacist, or health care provider of all prescription and over-the-counter medications you use, as well as the dosage for each, and keep a list of the information. Check with your doctor or health care provider if you have any questions about the medication.
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Pregnancy and breastfeeding
Preexposure
- There have been no animal reproduction studies and it is not known if rabies vaccine can affect reproductive capacity or cause fetal harm if administered during pregnancy. Administer to pregnant women only if benefits outweigh risks, however, if there is a substantial risk for rabies exposure, rabies vaccine may be administered to pregnant women as preexposure prophylaxis.
Postexposure
- Rabies is a deadly disease and because of the potential consequences of inadequately treated rabies exposure and limited data indicate that fetal abnormalities have not been associated with rabies vaccination, pregnant women should be administered rabies vaccine postexposure.
- It is not known whether rabies vaccine is present in human milk, however, many drugs are excreted in human milk, and rabies vaccine must be administered with caution in nursing mothers.
What else should I know about rabies vaccine?
- Rabies is a lethal disease and vaccine is recommended for everyone who has a potential risk for contracting it.
- Consult with your healthcare provider for rabies vaccination if:
- You are bitten or scratched by a rabid wild or pet animal, or a pet animal whose rabies vaccination status is unknown
- You have reason to believe an open wound or mucous membrane has come into contact with the saliva of a rabid animal or an animal whose immunization status is unknown
- Rabies vaccine is recommended before travel to places where exposure to rabid animals is a threat. Children are more at risk than adults.
- Current vaccination schedules available at https://www.cdc.gov/vaccines/schedules/hcp/index.html