rabies vaccine (HDCV, Imovax, rabies vaccine human diploid cell culture)

Dosing and uses of HDCV, Imovax (rabies vaccine)

• Adult
• Pediatric

 

Adult dosage forms and strengths

lyophilized powder for reconstitution

• 2.5 International Unit/1mL

 

Pre-exposure

Primary

• 1 mL IM (deltoid region) 3x
• one injection on each of days 0, 7, and 21 or 28

Booster

• 1 mL IM (deltoid region) to maintain a serum titer >1:5 serum dilution by RFFIT
• Test serum for rabies antibodies q6month

 

Post-exposure

CDC recommendations: 1 mL IM (in deltoid region) x4

One injection each on days 0, 3, 7, and 14 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

Immunosuppressed patients: Administer 1 mL IM x5 doses on days 0, 3, 7, 14, and 28 with HRIg

 

Postexposure (Previously Immunized)

1 mL IM (deltoid region) x2

One injection each on days 0 and 3

 

Administration

Using the longer of the 2 needles supplied, transfer the entire contents of diluent vial into vaccine viaL

Mix gently to avoid foaming

The white, freeze-dried vaccine dissolves to give a clear or slightly opaque suspension

Withdraw total amount of dissolved vaccine into the syringe and replace long needle with smaller needle for IM injection

 

Additional Information

Up-to-date vaccination schedules available at www.cdc.gov/nip/publications

 

Pediatric dosage forms and strengths

lyophilized powder for reconstitution

• 2.5 International Unit/1mL

 

Pre-exposure

1 mL IM (deltoid region, in small children and infants anterolateral region of thigh) 3x, one injection on each of days 0, 7, and 21 or 28

 

Postexposure

CDC recommendations: 1 mL IM (in deltoid or gluteal muscle, in small children and infants anterolateral region of thigh) on days 0, 3, 7, and 14 postexposure with 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

Immunosuppressed patients: Administer 1 mL IM x5 doses on days 0, 3, 7, 14, and 28 with HRIg

 

Postexposure (Previously Immunized)

If previously immunized, give 2 doses (1 mL each) on days 0 and 3 postexposure without HRIg

 

HDCV, Imovax (rabies vaccine) adverse (side) effects

Suspected adverse events after administration of any vaccine may be reported to Vaccine Adverse Events Reporting System (VAERS), 1-800-822-7967

 

>10%

Injection site pain, soreness, swelling, erythema, itching, burning (30-74%)

N/V (5-40%)

Abd pain (5-40%)

Diarrhea (5-40%)

Headache (5-40%)

Fatigue (5-40%)

Localized enlarged lymph nodes sore throat (5-40%)

Low grade fever (5-40%)

Chills (5-40%)

Muscle ache (5-40%)

Dizziness (5-40%)

Malaise (5-40%)

 

Postmarketing Reports

Guillain-Barre synd (rare)

Anaphylaxis (rare )

Encephalitis (very rare )

Meningitis (very rare )

Retrobulbar neuritis

 

Warnings

Contraindications

Documented hypersensitivity to neomycin

 

Pregnancy and lactation

Pregnancy category: C

Lactation: if exposure to rabies suspected, nursing a baby is not a priority as far as immunization is concerned

 

Pregnancy categories

A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA: Information not available.

 

Pharmacology of HDCV, Imovax (rabies vaccine)

Onset (antibodies): 7-10 d

Duration (antibodies): >1 yr

Peak Plasma Time (antibodies): 30-60 d

These products convey active immunity via stimulation of production of endogenously produced antibodies

The onset of protection from disease is relatively slow, but duration is long lasting (years)

 

Mechanism of action

Inactivated virus stimulates active immunity to rabies