Hepatitis B Vaccine (rDNA) BP

Introduction: Hepatitis B Vaccine (rDNA) BP is a noninfectious recombinant DNA Hepatitis B vaccine. It is a sterile suspension of purified surface antigen of hepatitis B virus obtained by culturing genetically engineered yeast cells (Saccharomyces cerevisiae cells), which carry the gene that codes for the HBsAg.

How it works: Hepatitis B vaccines are used for active immunisation against hepatitis B infection. Two types of vaccine have been available each containing hepatitis B surface antigen (HBsAg) adsorbed onto aluminium hydroxide or a similar adsorbent.

Important Information: For intramuscular injection only. Usual immunization regimen: 3 doses (0, 1 and 6 months) or Accelerated schedule: 4 doses (0, 1, 2 and 12 months).

• Active immunization against Hepatitis B virus infection

Vaccines, Anti-sera & Immunoglobulin

Recombinant DNA Vaccine

Hepatitis B Vaccine is a noninfectious recombinant DNA Hepatitis B vaccine. It is a sterile suspension of purified surface antigen of hepatitis B virus obtained by culturing genetically engineered yeast cells (Saccharomyces cerevisiae cells), which carry the gene that codes for the HBsAg. The HBsAg protein expressed in Saccharomyces cerevisiae cells is purified by several physicochemical steps and formulated as a suspension of the antigen adsorbed on aluminium hydroxide.

Hepatitis B Vaccine introduces HBsAg antigen which induces antibody production and provides protection against Hepatitis B virus infection.

Adult & Child Dose:

• Neonates-19 years: 0.5 ml (10 mcg antigen)
• 19 years and older: 1 ml (20 mcg antigen)

Usual schedule (0, 1, 6 months):

• 1st dose: at elected date
• 2nd dose: 1 month after first dose
• 3rd dose: 6 months after first dose

Accelerated schedule (0, 1, 2, 12 months):

• 1st dose: at elected date
• 2nd dose: 1 month after first dose
• 3rd dose: 2 months after first dose
• 4th dose: 12 months after first dose

HBsAg-positive mother's neonate: 4 doses of 10 mcg (birth, 1, 2 and 12 months)

Renal insufficiency (haemodialysis): 4 doses of 40 mcg

* Use as directed by the registered physician

Intramuscular (IM) injection only - in the deltoid muscle for older children and adolescents; anterolateral thigh for neonates/infants/small children. Do not give IV or intradermally.

If you miss a dose, take the next dose according to the schedule. Consult your doctor.

Common Side Effects (>10%):

• Pain (10-29%)
• Pruritus (10-29%)
• Erythema (10-29%)
• Burning (10-29%)
• Nodules (10-29%)
• Fatigue (15%)
• Headache (15%)
• Fever (15%)

1-10%: Lightheadedness, Flushing, Insomnia, Irritability, Arthralgia, Constipation

Precautions:

• Alcohol or disinfectant used for skin cleansing should be allowed to evaporate before vaccination (to prevent inactivation of live vaccines)
• Shake well before use
• Inspect visually prior to administration

Contraindications:

• Previous confirmed anaphylactic reaction to a previous dose of a vaccine containing the same antigens
• Hypersensitivity
• Hypersensitivity to yeast
• Severe immunodeficiency

Drug Interactions:

• Reduced response to vaccination when used concurrently with immunosuppressants such as corticosteroids or antineoplastics

Food Interactions: No interaction found/established.

Use in Pregnancy: Adequate human data on use during pregnancy is not available. Use only when clearly needed and when possible advantages outweigh possible risks.

Use in Lactation: Adequate data on administration to breastfeeding women is not available. Use when needed and possible advantages outweigh possible risks.

Pediatric Use: Dosage available from neonates to 19 years.

Geriatric Use: Use as per doctor's advice for elderly patients.

Renal Impairment: Renal insufficiency (including haemodialysis) patients require 4 doses of 40 mcg.

Hepatic Impairment: No known restrictions.

Overdose: Limited information available on overdose. Employ usual supportive measures.

Storage: Store at 2°C-8°C. Do not freeze. Protect from light.

Hepatitis B Vaccine (rDNA) BP