DrugindexOnline^{2nd edition}

Pronouncation: (RAY-beez vaccine)
Class: Vaccine, viral

Trade Names:
Imovax Rabies Vaccine (Human Diploid Cell)
- Powder for injection Freeze-dried suspension of Wistar rabies virus strain PM-1503-3M grown in human diploid cell cultures (inactivated whole virus). Contains 2.5 IU or more rabies antigen/mL.

Trade Names:
Imovax Rabies I.D. Vaccine (Human Diploid Cell)
- Powder for injection Freeze-dried suspension of Wistar rabies virus strain PM-1503-3M grown in human diploid cell cultures. Contains 0.25 IU rabies antigen/0.1 mL intradermal use. (For pre-exposure use only via intradermal route)

Trade Names:
RabAvert
- Powder for injection Freeze-Dried fixed-virus strain Flury LEP grown in cultures of chicken fibroblasts. Contains 2.5 IU or more rabies antigen/mL IM dose.

Trade Names:
Rabies Vaccine (Adsorbed)
- Injection Challenge Virus Standard (CVS) Kissling/MDPH strain

Mechanism of Action

Pharmacology

Induces neutralizing antibodies and cellular immunity.

Indications and Usage

Induction of active immunity against rabies virus either before or after viral exposure.

Contraindications

May theoretically be contraindicated in people who have had life-threatening allergic reactions to rabies vaccine or any of its components. Pre-exposure treatment: developing febrile illness.

Dosage and Administration

Preexposure Prophylaxis
Adults & Children

IM 1 mL or Intradermal 0.1 mL ( Imovax ID only) on days 0, 7, and 21 or 28.

Postexposure Prophylaxis
Adults & Children

Following RIG administration, IM 1 mL on days 0, 3, 7, 14, and 28. Patients who previously received preexposure prophylaxis: IM 1 mL on only days 0 and 3. Do not give RIG.

General Advice

• Reconstitute vaccine with 1 mL of diluent using a needle longer than the intradermal needle used for administration. Stir contents until dissolved and withdraw amount needed. Remove reconstitution needle and replace with smaller needle for administration.
• For postexposure vaccination, do not administer intradermally; administer IM in deltoid area in older children and adults and in vastis lateralis in young children. Never administer rabies vaccine in gluteal area; this may result in inadequate immune response.
• May administer pre-exposure prophylaxis vaccine intradermally. Intradermal injections in lateral aspect of upper arm are less likely to cause adverse reactions than intradermal injections in forearm.
• Follow careful recordkeeping when administering vaccine: note manufacturer, lot number, expiration date of vaccine, date of administration, and signature of person administering vaccine.
• Report severe reaction to FDA through local/state health departments; note reaction on patient chart.

Storage/Stability

Store under refrigeration (36° to 46°F); do not freeze.

Drug Interactions

Chloroquine

Long-term therapy with chloroquine may suppress immune response to intradermal rabies vaccine. Complete pre-exposure rabies vaccination 1 to 2 mo before starting chloroquine administration.

Immunosuppressant drugs (including high-dose corticosteroids)

May result in insufficient response to immunization. If possible, do not give immunosuppressive agents during postexposure therapy.

Laboratory Test Interactions

None well documented.

Adverse Reactions

CNS

Headache; dizziness.

GI

Nausea; abdominal pain.

Local

Swelling; erythema; pruritus; local pain; discomfort.

Miscellaneous

Muscle aches; slight fever; fatigue; serum-sickness-like reactions with intradermal booster doses.

Precautions

Pregnancy

Category C . Vaccinate if risk of disease outweighs risk to patients.

Lactation

Unknown.

Hypersensitivity

In people who experience immune-complex-like (or serum-sickness-like) hypersensitivity reactions during pre-exposure prophylaxis, do not give further doses of rabies vaccine unless they are exposed to rabies or they are likely to be unapparently or unavoidably exposed to rabies virus and have unsatisfactory antibody titers.

Intradermal route

Indicated only for preexposure immunization.

Pre-exposure immunization

Those at high risk of exposure to the rabies virus require preexposure immunization: veterinarians, certain laboratory workers, animal handlers, forest rangers, spelunkers, and people staying longer than 1 mo in other countries where rabies is constant threat (eg, India).

Postexposure prophylaxis

If bite from animal is unprovoked, animal is not apprehended and rabies is present in that species in area, administer RIG and rabies vaccine. Consider vaccine recipients adequately immunized if they previously completed preexposure or postexposure prophylaxis with either current rabies vaccine (but not Wyvac brand from Wyeth) or have documented adequate antibody response.

Radiation therapy

People undergoing radiation therapy may experience insufficient response to immunization and remain susceptible.

Travelers

Travelers to endemic areas may receive vaccine by intradermal route if 3-dose series can be completed 30 days or more before departure; otherwise give vaccine IM.

Patient Information

• Advise patient at risk for ongoing rabies exposure to receive rabies booster every 2 yr or more often (per serology q 6 mo) if very high risk (eg, veterinarians).
• Advise patient to seek immediate medical attention should future rabies exposure occur. Emphasize danger of wound infection and need to evaluate rabies antibody response.
• Teach patient/family wound care and signs of infection (eg, fever, wound drainage, increased pain at wound) prior to discharge.
• Advise patient that aspirin/antihistamines can be taken to treat mild local or systemic reactions.
• Encourage medical follow-up within 7 to 10 days after discharge for wound evaluation.
• Advise female patients to contact health care provider if pregnant, planning on becoming pregnant, or breastfeeding.