RECOMBIVAX HB®

Indications and Clinical Use:
RECOMBIVAX HB® is a hepatitis B vaccine indicated for immunization against infection caused by all known subtypes of hepatitis B virus (HBV). It is recommended for people of all ages, especially those at increased risk of infection, such as healthcare personnel, individuals with chronic liver disease, and those exposed to HBV through sexual contact or drug use. Universal immunization before adolescence is advised in areas with low prevalence like Canada.

Dosage and Administration:

• Three-Dose Regimen: Administered intramuscularly at 0, 1, and 6 months.
  • Infants and children (0-10 years): 5 μg per dose.
  • Adolescents (11-19 years): 5 μg per dose.
  • Adults (20+ years): 10 μg per dose.
  • Adult dialysis patients: 40 μg per dose.
• Two-Dose Regimen for Adolescents (11-15 years): Administered at 0 and 4-6 months with a 10 μg dose.
• Infants Born to HBsAg-Positive Mothers: Administer 5 μg dose within one week after birth, followed by additional doses at 1 and 6 months. Concurrent administration of 0.5 mL hepatitis B immune globulin (HBIG) at birth is recommended.

Contraindications:

• Hypersensitivity to any component of the vaccine.
• Severe allergic reactions (e.g., anaphylaxis) to previous doses of RECOMBIVAX HB® or its components.

Warnings and Precautions:

• Immediate availability of epinephrine is necessary to manage potential anaphylactic reactions.
• Patients with severe cardiopulmonary conditions or ongoing severe infections should delay vaccination unless the risk of hepatitis B outweighs these concerns.
• Caution is advised for individuals with compromised immune systems or those on immunosuppressive therapy as they may require larger doses and respond less effectively.

Adverse Reactions:

• Common local reactions include pain, soreness, and redness at the injection site.
• Systemic reactions may include fatigue, headache, fever, nausea, diarrhea, and malaise.
• Rare but serious reactions include hypersensitivity reactions, Guillain-Barré syndrome, multiple sclerosis exacerbations, and other neurological events.

Drug Interactions:

• RECOMBIVAX HB® can be administered concurrently with other vaccines using separate injection sites and syringes. Studies indicate no impairment of immune response when co-administered with vaccines like DTaP-IPV-Hib or M-M-R® II.

Storage and Stability:

• Store at 2°C - 8°C. Do not freeze as freezing destroys the potency.
• Use within the expiration date indicated.

Dosage Forms, Composition, and Packaging:

• Available in pediatric, adult, and adult dialysis presentations.
• Pediatric: Single-dose vial containing 5 μg HBsAg/0.5 mL.
• Adult: Single-dose vial containing 10 μg HBsAg/1.0 mL or multi-dose vial with 30 μg HBsAg/3.0 mL (contains thimerosal).
• Adult Dialysis: Single-dose vial containing 40 μg HBsAg/1.0 mL.

Scientific Information:

• Clinical trials have shown high efficacy, with over 90% of healthy individuals achieving protective antibody levels.
• Long-term studies suggest lasting protection, with boosters not routinely recommended for immunocompetent individuals.

Consumer Information:

• The vaccine helps prevent hepatitis B, which is a serious liver infection.
• Adverse effects are generally mild but can include injection site reactions and systemic symptoms.
• Storage, administration guidelines, and special considerations for pregnant or nursing women are provided.