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Rabies Vaccine

Pronunciation

(RAY beez vak SEEN)

Index Terms

  • HDCV
  • Human Diploid Cell Cultures Rabies Vaccine
  • PCEC
  • Purified Chick Embryo Cell

Dosage Forms

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

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]

Brand Names: U.S.

  • Imovax Rabies
  • RabAvert

Pharmacologic Category

  • Vaccine, Inactivated (Viral)

Pharmacology

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: ~7-10 days; Peak effect: ~30-60 days

Duration of Action

≥1 year

Use: Labeled Indications

Pre-exposure and postexposure vaccination against rabies

The Advisory Committee on Immunization Practices (ACIP) recommends a primary course of prophylactic immunization (pre-exposure vaccination) for the following:

• Persons with continuous risk of infection, including rabies research laboratory and biologics production workers

• Persons with frequent risk of infection in areas where rabies is enzootic, including rabies diagnostic laboratory workers, cavers, veterinarians and their staff, and animal control and wildlife workers; persons who frequently handle bats

• Persons with infrequent risk of infection, including veterinarians and animal control staff 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.

Contraindications

Pre-exposure prophylaxis: Hypersensitivity to rabies vaccine or any component of the formulation

Postexposure prophylaxis: There are no contraindications listed within the FDA-approved manufacturer's labeling.

Dosing: Adult

Pre-exposure vaccination: IM: A total of 3 doses, 1 mL each, on days 0, 7, and 21-28.

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: IM: 5 doses (1 mL each) on days 0, 3, 7, 14, 28. In addition, patients should receive rabies immune globulin with the first dose (day 0). Note: A regimen of 4 doses (1 mL each) on days 0, 3, 7, 14 may be used in persons who are not immunosuppressed (ACIP recommendations, 2010).

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

Booster (for persons with continuous or frequent risk of infection): IM: 1 mL based on antibody titers

Dosing: Geriatric

Refer to adult dosing.

Dosing: Pediatric

Refer to adult dosing.

Dosing: Renal Impairment

No dosage adjustment provided in manufacturer’s labeling.

Dosing: Hepatic Impairment

No dosage adjustment provided in manufacturer’s labeling.

Reconstitution

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

Administration

For IM administration only; this rabies vaccine product must not be administered intradermally; in adults and children, administer IM injections in the deltoid muscle, not the gluteal; for younger children, use the outer aspect of the thigh. 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.

For patients at risk of hemorrhage following intramuscular injection, the ACIP recommends “it 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 (CDC, 2011).

Simultaneous administration of vaccines helps ensure the patients will be fully vaccinated by the appropriate age. Simultaneous administration of vaccines is defined as administering >1 vaccine on the same day at different anatomic sites. The use of licensed combination vaccines is generally preferred over separate injections of the equivalent components. Separate vaccines should not be combined in the same syringe unless indicated by product specific labeling. Separate needles and syringes should be used for each injection. The ACIP prefers each dose of a specific vaccine in a series come from the same manufacturer when possible. Adolescents and adults should be vaccinated while seated or lying down. In general, preterm infants should be vaccinated at the same chronological age as full-term infants (CDC, 2011).

Antipyretics have not been shown to prevent febrile seizures. Antipyretics may be used to treat fever or discomfort following vaccination (CDC, 2011). One study reported that routine prophylactic administration of acetaminophen to prevent fever prior to vaccination decreased the immune response of some vaccines; the clinical significance of this reduction in immune response has not been established (Prymula, 2009).

Storage

Prior to reconstitution, store under refrigeration at 2°C to 8°C (36°F to 46°F); do not freeze. Protect from light.

Drug Interactions

Belimumab: May diminish the therapeutic effect of Vaccines (Inactivated). Management: Patients should receive inactivated vaccines prior to initiation of belimumab therapy whenever possible, due to the risk for an impaired response to the vaccine during belimumab therapy. Consider therapy modification

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. Exceptions: Cytarabine (Liposomal). Consider therapy modification

Adverse Reactions

All serious adverse reactions must be reported to the U.S. Department of Health and Human Services (DHHS) Vaccine Adverse Event Reporting System (VAERS) 1-800-822-7967 or online at https://vaers.hhs.gov/esub/index. In Canada, adverse reactions may be reported to local provincial/territorial health agencies or to the Vaccine Safety Section at Public Health Agency of Canada (1-866-844-0018).

>10%:

Central nervous system: Dizziness, headache, malaise

Gastrointestinal: Abdominal pain, nausea

Local: Erythema, itching, pain, swelling

Neuromuscular & skeletal: Myalgia

Miscellaneous: Lymphadenopathy

Uncommon, frequency not defined, postmarketing, and/or case reports:

Cardiovascular: Circulatory reactions, edema, palpitation

Central nervous system: Chills, fatigue, fever >38°C (100°F), Guillain-Barré syndrome, encephalitis, meningitis, multiple sclerosis, myelitis, neuroparalysis, seizures, vertigo

Dermatologic: Pruritus, urticaria, urticaria pigmentosa

Endocrine & metabolic: Hot flashes

Gastrointestinal: Diarrhea, vomiting

Local: Hematoma, limb swelling (extensive)

Neuromuscular & skeletal: Arthralgia, limb pain, monoarthritis, neuropathy, paralysis (transient), paresthesias (transient), weakness

Ocular: Retrobulbar neuritis, visual disturbances

Respiratory: Bronchospasm, dyspnea, wheezing

Miscellaneous: Allergic reactions, anaphylaxis, hypersensitivity reactions, serum sickness, swollen lymph nodes

Warnings/Precautions

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. 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: An immune complex reaction is possible 2-21 days following booster doses of HDCV. Symptoms may include arthralgia, arthritis, angioedema, fever, generalized urticaria, malaise, nausea, and vomiting.

• Syncope: Syncope has been reported with use of injectable vaccines and may be accompanied by transient visual disturbances, weakness, or tonic-clonic movements. Procedures should be in place to avoid injuries from falling and to restore cerebral perfusion if syncope occurs.

Disease-related concerns:

• Bleeding disorders: Use with caution in patients with a history of bleeding disorders (including thrombocytopenia) and/or patients on anticoagulant therapy; bleeding/hematoma may occur from IM administration.

Special populations:

• Altered immunocompetence: Use with caution in severely immunocompromised patients (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.

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, chicken protein, chlortetracycline, and neomycin.

Other warnings/precautions:

• Appropriate use: Rabies: Rabies vaccine should not be used in persons with a confirmed diagnosis of rabies; use after the onset of symptoms may be detrimental. 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.

• 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 (CDC, 2011).

Monitoring Parameters

Monitor for syncope for 15 minutes following administration. 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):

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 pre-exposure or postexposure prophylaxis series

Monitoring of antibody response to vaccination is not recommended for otherwise healthy persons who complete the pre-exposure or postexposure regimen.

Pregnancy Risk Factor

C

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.

Patient Education

• Discuss specific use of vaccine and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

• Patient may experience injection site pain or irritation, headache, dyspepsia, myalgia, or dizziness. Have patient report immediately to prescriber arthralgia, joint edema, joint rigidity, severe nausea, considerable asthenia, facial paralysis, or difficulty moving (HCAHPS).

• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for healthcare professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience and judgment in diagnosing, treating and advising patients.

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