HEPATITIS - Hepatitis is a liver disease, initially resulting in possible inflammation of the liver, and
frequently leading to more serious conditions including cirrhosis and liver cancer. In the United States
there are approximately 300,000 new cases of Hepatitis B Virus (HBV), the most prevalent form of
Hepatitis, every year.
Health care workers are 20 times more likely to contract Hepatitis B than the normal population. It is
estimated that there are as many as 18,000 new cases of HBV each year among healthcare workers,
resulting in 200-300 deaths. While there is no cure for Hepatitis B, a vaccine does exist that can prevent
infection.
In healthcare settings HBV is most often transmitted through breaks in the skin or mucous membranes.
This usually occurs through needlesticks, human bites, or having infectious material (such as blood or
other body fluids) get into existing cuts or abrasions.
The symptoms of HBV infection are very much like a mild "flu." Initially, there is a sense of fatigue,
possible stomach pain, loss of appetite, and even nausea. As the disease continues to develop, jaundice
(a distinct yellowing of the skin) and a darkened urine will often occur. However, people who are infected
with HBV will often show no symptoms for some time.
After exposure it can take 2 - 6 months for Hepatitis B to develop. This is extremely important, since
vaccinations begun immediately after exposure to the virus can often prevent infection.
Additional Information on Hepatitis
The Disease
Hepatitis means inflammation of the liver. Several hepatitis viruses are known to cause a systemic
infection resulting in major pathologic changes in the liver (e. g., A,B,C,D). Most people with Hepatitis B
recover completely, but 6-10% of adults who are infected today in the U. S. will become chronic carriers.
CDC estimates that there are approximately 0.75 to 1.0 million chronic carriers of Hepatitis B Virus in the
U. S. today. Many of these chronic carriers have no symptoms and appear wall, yet can transmit the
virus to others. Those patients who become chronic carriers are at risk of developing primary
hepatocellular carcinoma. Among other factors, infection with Hepatitis B may be the single most
important factor for the development of the carcinoma.
Hepatitis B Virus can be transmitted by contact with body fluids including blood (including contaminated
needles), semen, tears, saliva, urine, breast milk, and vaginal secretions. Health workers are at high risk
of acquiring Hepatitis B because of frequent contact with blood or potentially contaminated body fluids
and, therefore, vaccination is recommended to prevent illness.
The Vaccine
'Energix-B' (Hepatitis B Vaccine [Recombinant]) is a noninfectious Recombinant DNA Hepatitis B Vaccine.
Clinical studies have shown that after three doses
85-97% of healthy adults have been seroprotected.
Persons with immune system abnormalities, such as dialysis patients, have less response to the vaccine,
but over 67% of those receiving it do develop antibodies. If you have immune deficiency problems, you
should obtain written release from your physician.
Dosing Schedules & Administration
'Energix-B' should be administered by IM injection. The injection should be given in the deltoid region.
'Energix-B' should not be given in the gluteal region; such injections may result in sub optimal response.
The usual immunization regimen consists of three (3) doses of vaccine administered initially at 1 and 6
months after initial dose.
Adverse Reactions
'Energix-B' (Hepatitis B Vaccine [Recombinant]) is generally well tolerated. During clinical studies
involving over 10,000 individuals distributed over all age groups, no serious adverse reactions attributable
to vaccine administration were reported. As with any vaccine, however, it is possible that expanded
commercial use of the vaccine could reveal rare adverse reactions not observed in clinical studies. The
most frequently reported adverse reactions (1-10%) include injection-site soreness, induration, erythema,
swelling, fever, headache, and dizziness. Other more serious adverse reactions have occurred
infrequently. If you have any questions about Hepatitis B or about 'Energix-B', please ask.
Contra-indications
Hypersensitivity to yeast or any other component of the vaccine is a contra-indication for use of the
vaccine.
Warnings
Patients experiencing hypersensitivity after and 'Energix-B' injection should not receive further injections
of 'Energix-B' (see contra-indications).
Pregnancy
Pregnancy Category C: Animal reproductions studies have not been conducted with 'Energix-B'. It is also
not known whether 'Energix-B' can cause fetal harm when administered to a pregnant woman or can
affect reproduction capacity. 'Energix-B' should be given to a pregnant woman only if clearly needed.
Nursing Mothers
It is not known whether 'Energix-B' is excreted in human milk. Because many drugs are excreted in
human milk, caution should be exercised when 'Energix-B' is administered to a nursing mother.