Hepatitis B Vaccine

Hepatitis B Vaccine is indicated for prevention of infection caused by all known subtypes of hepatitis B virus. Recombivax HB is approved for use in individuals of all ages.

• Hepatitis B Vaccine is available under the following different brand names: Energix B, and Recombivax HB.

Dosages of Hepatitis B Vaccine:

Intramuscular suspension (adult formulation)

• 10 mcg/ml (Recombivax HB)
• 20 mcg/ml (Engerix B)
• 40 mcg/ml (Recombivax HB [dialysis formulation])

Intramuscular suspension (pediatric/adolescent formulation)

• 5 mcg/0.5 ml (Recombivax HB)
• 10 mcg/0.5 mg (Engerix B)

Dosage Considerations – Should be Given as Follows:

Hepatitis B Vaccination

Adult Dosage:

• Engerix B: 1 mL (20 mcg) intramuscularly at 0, 1, and 6 months
• Recombivax HB: 1 mL (10 mcg) intramuscularly at 0, 1, and 6 months

• Adults receiving dialysis or other immunocompromising conditions
• Recombivax HB (40 mcg/mL): 40 mcg intramuscularly at 0, 1, and 6 months, OR
• Engerix-B (20 mcg/mL): 40 mcg intramuscularly at 0, 1, and 6 months

Routine vaccination

• First dose: Administer the first dose to all newborns before hospital discharge
• Infants born to HBsAg-positive mothers: 0.5 mL intramuscularly within 12 hours of birth PLUS hepatitis B immune globulin (HBIG); test for HBsAg and antibody to HBsAg (anti-HBs) 1-2 months after completion of hepatitis B vaccination series, at age 9 through 18 months
• Mother's HBsAg status unknown: 0.5 mL intramuscularly within 12 hours of birth PLUS give HBIG if newborn weight under 2 kg; determine mother's HBsAg status as soon as possible and, if she is HBsAg-positive, also administer HBIG for infants weighing 2 kg or more (no later than age 1 week)
• Second dose: Administered at age 1-2 months Monovalent Hepatitis B vaccine should be used for doses administered before age 6 weeks
• Infants who did not receive a birth dose should receive 3 doses of a Hepatitis B-containing vaccine on a schedule of 0, 1 to 2 months, and 6 months starting as soon as feasible
• The minimum interval between dose 1 and dose 2 is 4 weeks, and between dose 2 and 3 is 8 weeks
• The Final (3rd or 4th) dose in the Hepatitis B vaccine series should be administered no earlier than age 24 weeks, and at least 16 weeks after the first dose
• A total of 4 doses of Hepatitis B vaccine is recommended when a combination vaccine containing Hepatitis B is administered after the birth dose

Catch-up vaccination

• Unvaccinated children should complete a 3-dose series
• Children aged 11-15 years: 2-dose series (doses separated by at least 4 months) of adult formulation Recombivax HB is licensed for use in children aged 11 through 15 years

Dosing Considerations

• Routine immunization against hepatitis B; also protects against hepatitis D which always occurs in the presence of hepatitis B
• Targeted groups that should receive Hepatitis B vaccination series include:
  • Sexually active persons who are not in a long-term, mutually monogamous relationship persons seeking evaluation or treatment for a sexually transmitted disease (STD); current or recent injection-drug users; and men who have sex with men
  • Healthcare personnel and public-safety workers who are potentially exposed to blood or other infectious body fluids
  • Persons with diabetes
  • Persons with end-stage renal disease, including patients receiving hemodialysis; persons with HIV infection; and persons with chronic liver disease
  • Household contacts and sex partners of hepatitis B surface antigen-positive persons; clients and staff members of institutions for persons with developmental disabilities; and international travelers to countries with a high or intermediate prevalence of chronic HBV infection
  • All adults in the following settings: STD treatment facilities; HIV testing and treatment facilities; facilities providing drug-abuse treatment and prevention services; health-care settings targeting services to injection-drug users or men who have sex with men; correctional facilities; end-stage renal disease programs and facilities for chronic hemodialysis patients; and institutions and nonresidential daycare facilities for persons with developmental disabilities

Administration

Adult:

• Administer intramuscularly in the deltoid muscle
• Do not give IV/intradermal

Pediatric:

• Administer in deltoid muscle for older children and adolescents; anterolateral thigh preferred for neonates/infants/small children
• Do not give intravenously/intradermal

Additional Information

• Up-to-date vaccination schedules are available at http://www.cdc.gov/vaccines/schedules/hcp/index.html

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

Side effects of Hepatitis B Vaccine include:

• pain
• severe itching
• reddening of the skin
• weakness
• feeling unwell (malaise)
• nausea
• vomiting
• abdominal pain/cramps
• difficult or labored breathing
• diminished appetite
• stuffy nose
• influenza
• cough
• sweating
• achiness
• sensation of warmth
• lightheadedness
• chills
• flushing
• diarrhea
• sore throat
• upper respiratory infection
• burning
• nodules
• headache
• fever
• spinning sensation (vertigo)
• numbness or tingling
• skin swelling
• hives
• muscle pain
• back pain
• neck pain
• shoulder pain
• stiff neck
• earache
• inability to sleep (insomnia)
• irritability
• joint pain
• constipation
• Lupus-like syndrome (rash, joint pain, and fatigue)
• Systemic Lupus Erythematosus (autoimmune disease)
• polyarthritis nodules
• enlargement of lymph nodes
• fast heart rate
• fainting
• inflammation of the cornea
• inflammation of the optic nerve
• ringing in the ears (tinnitus)
• pink eye (conjunctivitis)
• visual disturbance
• inflammation of the eye
• agitation
• sleepiness
• increased erythrocyte sedimentation rate (ESR)
• deficiency of platelets in the blood
• Steven-Johnson syndrome
• hair loss
• red or brown round spots on the skin
• eczema
• Guillain-Barre syndrome
• multiple sclerosis
• inflammation of the spinal cord
• febrile seizure
• damage to nerves in hands or feet
• Bell's palsy
• herpes zoster
• migraine
• muscle weakness
• reduced sense of touch or sensation
• inflammation of the brain (encephalitis)
• hypersensitivity
• acute allergic reaction (anaphylactic reaction)
• sudden difficulty breathing
• skin eruptions
• discoloration of the skin due to bruising
• inflammation of blood vessels
• low blood pressure (hypotension)
• pain when urinating

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

This document does not contain all possible side effects and others may occur. Check with your physician for additional information about side effects.

If your doctor has directed you to use this medication, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Severe Interactions of Hepatitis B Vaccine include:
  • belimumab
• Hepatitis B Vaccine has serious interactions with at least 37 different drugs.
• Moderate Interactions of Hepatitis B Vaccine include:
  • daclizumab
  • hydroxyurea
  • mercaptopurine
  • methotrexate
• Mild Interactions of Hepatitis B Vaccine include:
  • chloroquine

This information does not contain all possible interactions or adverse effects. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share this information with your doctor and pharmacist. Check with your health care professional or doctor for additional medical advice, or if you have health questions, concerns, or for more information about this medicine.

Warnings

This medication contains the hepatitis b vaccine. Do not take Engerix B or Recombivax HB if you are allergic to the hepatitis b vaccine or any ingredients contained in this drug.

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center immediately.

Contraindications

• Hypersensitivity to yeast

Effects of Drug Abuse

• No information available

Short-Term Effects

• See "What Are Side Effects Associated with Using Hepatitis B Vaccine?"

Long-Term Effects

• See "What Are Side Effects Associated with Using Hepatitis B Vaccine?"

Cautions

• Not protective against hepatitis A, C, or E
• Gluteal muscle injection is not recommended
• Heptavax B (plasma-derived) is no longer used in the US

Pregnancy and Lactation

• Use the hepatitis B vaccine during pregnancy with caution if the benefits outweigh the risks. Animal studies show risk and human studies are not available, or neither animal nor human studies were done.
• It is not known if the hepatitis B vaccine is excreted in breast milk. Consult your doctor before breastfeeding.