RABAVERT®

05/22/2024
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Product Information

  • Name: RABAVERT®
  • Type: Rabies Vaccine
  • Form: Lyophilized powder for reconstitution with a diluent
  • Manufacturer: Bavarian Nordic A/S

Indications and Clinical Use

  • Pre-exposure Prophylaxis: For individuals at risk of contact with rabid animals (e.g., certain laboratory workers, veterinarians, animal handlers, travelers to endemic areas).
  • Post-exposure Prophylaxis: For all age groups following exposure to rabies.

Dosage and Administration

  • Pre-exposure Prophylaxis:
    • Primary Vaccination: Three doses (1.0 mL each) intramuscularly on days 0, 7, and 21 or 28.
    • Booster Doses: Administered based on serologic testing or every 2-5 years for continuous high-risk individuals.
  • Post-exposure Prophylaxis:
    • Previously Unvaccinated Individuals: Five doses (1.0 mL each) on days 0, 3, 7, 14, and 28, along with rabies immunoglobulin (RIG) on day 0.
    • Previously Vaccinated Individuals: Two doses (1.0 mL each) on days 0 and 3, without RIG.

Contraindications

  • Hypersensitivity to any component of the vaccine or to a previous dose.
  • Post-exposure prophylaxis should not be delayed or discontinued due to minor illnesses.

Warnings and Precautions

  • General: May not protect all individuals. Post-exposure prophylaxis should be started as soon as possible.
  • Immunocompromised Individuals: May have a reduced immune response.
  • Special Populations:
  • Pregnant Women: Use only if clearly needed.
  • Breastfeeding: Caution is advised.

Adverse Reactions

  • Very Common: Injection site reactions (pain, erythema, swelling), headache, malaise, myalgia, fever.
  • Common: Influenza-like illness, injection site induration, dizziness, rash.
  • Rare: Anaphylaxis, Guillain-Barré syndrome, encephalitis.

Drug Interactions

  • Can be administered with other vaccines, but at different injection sites and using separate syringes.
  • Immunosuppressive agents may interfere with the vaccine's efficacy.

Storage and Stability

  • Store at 2°C to 8°C. Do not freeze. Protect from light. Use immediately after reconstitution.

Clinical Trials and Efficacy

  • Pre-exposure Studies: Demonstrated 100% attainment of protective antibody levels by day 28.
  • Post-exposure Studies: Provided protective antibody levels in almost all subjects by day 14.
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Written By Paul Kim

Medical Director - APN, NSWOC, RNP

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