hepatitis b vaccine (Recombivax HB)

Hepatitis B vaccines (Recombivax HB, Engerix-B) are used to prevent hepatitis B infection, a serious liver infection caused by the hepatitis B virus (HBV).

Hepatitis B is easily spread through contact with blood or other fluids of an infected person. People may also become infected from touching or coming into contact with a contaminated object. The hepatitis B virus can live on surfaces for up to 7 days. Some ways that people may become infected include:

• Transmission during birth from an infected mother to her newborn
• Contact with blood or other body fluids though breaks in the skin such as bites, cuts, or sores
• Contact with objects that have blood or body fluids on them such as razors or toothbrushes that may themselves come into contact with other person's blood
• Having unprotected sex with an infected person
• Sharing needles used to inject illicit drugs
• Getting stuck with a previously used needle that is contaminated

Hepatitis B can cause an acute (short term) illness, with symptoms that include:

• Loss of appetite
• Tiredness
• Diarrhea
• Vomiting
• Jaundice (yellowing of the skin or eyes)
• Pain in muscles, joints, and stomach
• Additionally, some patients may develop a long term (chronic) infection which can lead to:
• Liver damage
• Liver cancer
• Death

Getting vaccinated against the hepatitis B virus is the best way to prevent these problems. Hepatitis B vaccines are made from noninfectious parts of HBV using recombinant DNA technology. The vaccines are sterile preparations for intramuscular injection and contain purified inactive proteins from the surface of HBV. The proteins can activate the immune system but cannot give rise to a replicating virus. Viral proteins used in HBV vaccines are manufactured in yeast cells (S. cerevisiae) using recombinant technology. Hepatitis B vaccines work by stimulating the immune system to attack the viral proteins. When a hepatitis B vaccine is administered, the body's immune system recognizes the viral proteins in the vaccine as foreign, and develops antibodies against them, thus providing immunity from future infections. In the event of HBV exposure following vaccination, the body will already be primed to fight the infection.

The FDA approved the first HBV vaccine in 1983.

What brand names are available for hepatitis b vaccine-injection?

Recombivax HB, Engerix-B

Is hepatitis b vaccine-injection available as a generic drug?

No

Do I need a prescription for hepatitis b vaccine-injection?

No

Hepatitis B vaccine is used to prevent hepatitis B, a serious infection that affects the liver.

Most children are given their first shot at birth, followed by a 2nd shot at 1-2 months of age, and a 3rd shot at 6-18 months of age. Also, anyone who is 18 years of age or younger and hasn't received the vaccine should be vaccinated.

Additionally, all unvaccinated adults at risk for hepatitis B infection should be vaccinated. This includes:

• Partners or people infected with hepatitis B
• Men who have sex with men
• People who inject street drugs
• People with more than one sex partner
• People with chronic liver or kidney disease
• People under the age of 60 who have type 1 or 2 diabetes
• People with jobs that expose them to human blood or other body fluids
• People who live with a family member infected with hepatitis B
• Kidney dialysis patients
• People who travel to countries where hepatitis B is common
• People with HIV infection
• People who live or work in institution for the developmentally disabled
• Anyone else who wishes to be protected from the hepatitis B infection

Common side effects of HBV vaccines include:

• Irritability
• Fever
• Diarrhea
• Fatigue/weakness
• Reduced appetite
• Cold symptoms

Other reported side effects include:

• Headache
• Injections site reactions
• Low blood pressure
• Flushing
• Back pain
• Muscle pain
• Joint pain
• Rash
• Difficulty sleeping
• Dizziness
• Ringing in the ears
• Seizures
• Hair loss
• Constipation
• Taste changes

• Dosing for children and adolescents is 3 doses of 0.5 mL given on 0, 1, and 6 month schedule.
• The dose for adults is 3 doses of 1 ml given on 0, 1, and 6 month schedule.

Patients with a weak immune system may not fully benefit from the hepatitis B vaccine.

• Some medications may decrease the effectiveness of the hepatitis B vaccine. Examples include fingolimod (Gilenya), belimumab (Benlysta), anakinra (Kineret), adalimumab (Humira), infliximab (Remicade), antineoplastic agents (anti-cancer medications), and other immunosuppressives.
• Cancer patient's receiving treatment with anti-cancer medications and those taking immunosuppressant medications should ask their doctor or pharmacist if the hepatitis B vaccine is right for them.

• There are no adequate or well-controlled trials of hepatitis B vaccine use in pregnant women. Therefore, hepatitis B vaccine should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
• It is not known if the hepatitis B vaccine is excreted into human milk after administration to the mother. The manufacturer recommends caution when given to nursing mothers.

What preparations of hepatitis b vaccine-injection are available?

• Suspension for injection in single does vials and syringes: Recombivax 0.5 ml (5 mcg), 1 ml (10 mcg); Engerix-B 0.5 ml (10 mcg), 1 ml (20 mcg).

How should I keep hepatitis b vaccine-injection stored?

Hepatitis B vaccine should be stored in the refrigerator, between 2 C to 8 C (36 F to 46 F).