Qualitative And Quantitative Composition
Hepatitis B Immunoglobulin-VF is a sterile, preservative-free solution containing 160 mg/mL human plasma protein of which at least 98% is immunoglobulin , with a hepatitis B antibody titre of not less than 100 IU/mL.The pH value of the ready-to-use solution is 6.6.Hepatitis B Immunoglobulin-VF is manufactured from human plasma collected by Australian Red Cross Lifeblood.Hepatitis B Immunoglobulin-VF contains 22.5 mg/mL glycine.
Other Reported Adverse Events And Conditions
While serious events and chronic illnesses such as chronic fatigue syndrome, multiple sclerosis, Guillain-Barré syndrome, rheumatoid arthritis and sudden infant death syndrome have been alleged or reported following HB vaccination, no evidence of a causal association has been demonstrated in a number of studies.
Guidance On Reporting Adverse Events Following Immunization
Vaccine providers are asked to report, through local public health officials, any serious or unexpected adverse event temporally related to vaccination. An unexpected AEFI is an event that is not listed in available product information but may be due to the immunization, or a change in the frequency of a known AEFI.
Refer to Reporting Adverse Events Following Immunization in Canada and Adverse events following immunization in Part 2 for additional information about AEFI reporting.
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Who Should Get Hepatitis B Immune Globulin
If you have been exposed to hepatitis B virus and have not received the hepatitis B vaccine in the past, you should get 1 dose of HBIg. HBIg works best if given as soon as possible and within 14 days after exposure to the hepatitis B virus.
HBIg is recommended for the following:
- People exposed to blood known or suspected to be infected with hepatitis B virus by:
- being poked with a used injection needle
- being splashed in the mouth, nose or eyes with infected blood
- being bitten by someone with hepatitis B or
- having contact with household articles such as a toothbrush, dental floss, or a razor contaminated with blood from an infected person.
A dose of hepatitis B vaccine may be given at the same time as HBIg. Two more doses of hepatitis B vaccine may be given later to provide full, long-term protection against infection. Speak with your health care provider about when to get these doses. For more information, see HealthLinkBC File #25a Hepatitis B Vaccine.
Common And Local Adverse Events
HB vaccine
HB vaccine is well tolerated. Reactions are generally mild and transient, and include: irritability, headache, fatigue and injection site reactions in 10% or more of recipients.
HAHB vaccine
There is no increase in adverse events when HAHB vaccine is compared with HA vaccine given alone or concomitantly with HB vaccine at a different injection site. When the adult formulation of HAHB vaccine is given to children in the 2 dose schedule, there is no increase in adverse events compared with those occurring after administration of the pediatric formulation of HAHB vaccine.
DTaP-HB-IPV-Hib vaccine
Reactions are usually mild and transient, and include fever, irritability, restlessness and injection site reactions .
HBIg
Headache, diarrhea, fever, urticaria, angioedema and injection site reactions may occur.
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Is Hepatitis B Immune Globulin Safe
Yes. HBIg is prepared from donated human blood that has been tested to ensure its safety. All blood donors are screened for exposure to viruses such as HIV and hepatitis. Each blood donation is also tested for the presence of blood-borne viruses prior to being used to make HBIg. A number of chemical and physical steps are included when preparing HBIg to inactivate and remove viruses and bacteria that can cause disease. The final preparation of HBIg undergoes additional testing to ensure that there are no known infectious viruses present. However, there is an extremely small risk that some blood-borne infections could be passed on through the use of HBIg. Since blood screening and testing began, there have been no reports of blood-borne infections such as HIV, hepatitis B or hepatitis C in people who received HBIg.
What It Is Used For
INDICATIONS AS AT 8 AUGUST 2002 : Hepatitis B Immunoglobulin is indicated for post-exposure prophylaxis in persons who did not receive prior vaccination, or whose prior vaccination regimen is incomplete, or when the hepatitis B antibody level is inadequate . Post-exposure prophylaxis should be considered following percutaneous or permucosal exposure to HBsAg-positive material or suspected HBsAg-positive material, for example, by needle stick, oral ingestion or sexual exposure. Hepatitis B Immunoglobulin is also indicated for prophylaxis in infants born to HBsAg-positive mothers.,Hepatitis B Immunoglobulin-VF is indicated for post-exposure prophylaxis in persons who did not receive prior vaccination, or whose prior vaccination regimen is incomplete, or when the hepatitis B antibody level is inadequate . Post-exposure prophylaxis should be considered following percutaneous or permucosal exposure to HBsAg-positive or suspected HBsAg-positive material, for example, by needle stick, oral ingestion or sexual exposure. Hepatitis B Immunoglobulin-VF is also indicated for prophylaxis in infants born to HBsAg-positive mothers.
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How Is Hepatitis B Immune Globulin Given
Hepatitis B immune globulin is injected into a muscle or into a vein through an infusion pump. A healthcare professional will give you this injection.
For prevention after exposure to contaminated blood: Hepatitis B immune globulin is usually given as soon as possible after exposure to an infected person, preferably within 7 days. A booster medication is then given 24 hours later. Your doctor may also recommend that you receive a hepatitis B vaccine when you start treatment with hepatitis B immune globulin.
For liver transplant: Hepatitis B immune globulin is given as part of the transplant procedure, and then for several weeks or months afterward. The medication is usually given to transplant patients every day for 7 days, then every 2 weeks for the next 11 weeks, followed by monthly injections from then on.
For prevention after sexual contact with an infected person: Hepatitis B immune globulin is given as a single dose within 14 days after the last contact. You should also receive a hepatitis B vaccine if you will continue to have contact with the infected person.
For prevention in people sharing the home of an infected person: hepatitis B immune globulin should be given to infants younger than 12 months old, caregivers who may come into contact with the infected person’s blood, and people who share razors, toothbrushes, or other personal items with the infected person. Household members may also need to receive hepatitis B vaccine.
Measuring Antibody And Hbsag Levels After Vaccine And Immunoglobulin Administration
Measuring antibody and HBsAg levels after vaccine and immunoglobulin administration
Measure levels of hepatitis B surface antigen and anti-HBs in infants born to mothers with chronic hepatitis B 312 months after completing the infant vaccine course.
Do not test the infant before 9 months of age, to avoid detecting anti-HBs from the HBIG given at birth.
The infant is protected against hepatitis B if:22
- anti-HBs levels are adequate and
- HBsAg is negative
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Who Should Not Get Hepatitis B Immune Globulin
Speak with your health care provider if you have:
- had a life-threatening reaction to a previous dose of any immune globulin or any of its components
- a condition called isolated immunoglobulin A deficiency
- a history of thrombosis or risk factors for thrombosis or
- been immunized against measles, mumps, rubella or chickenpox within the past 14 days.
There is no need to delay getting immunized because of a cold or other mild illness. However, if you have concerns speak with your health care provider.
What Is Hepatitis B
Hepatitis B is a virus that attacks the liver. It can cause serious disease including permanent liver damage, also known as cirrhosis. Hepatitis B is also one of the main causes of liver cancer, which can be fatal. Hepatitis B virus is spread from one infected person to another by contact with blood or body fluids. After the virus enters your body, it usually takes 2 to 3 months to develop symptoms or signs of illness.
Symptoms of hepatitis B may include fatigue, fever, nausea and vomiting, loss of appetite, abdominal pain, dark urine, pale stools and jaundice . Many people who get hepatitis B show no symptoms and may not know they have the disease. Whether there are signs of illness or not, you can pass the virus on to others.
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Botulism Antitoxin And Botulism Immunoglobulin
Botulism antitoxin or botulism immunoglobulin is used therapeutically in people with established or suspected botulism as well as prophylactically in asymptomatic people strongly suspected of having eaten food contaminated with the botulism toxin. Health Canada’s Botulism-Guide for Health Care Professionals provides information about botulism including clinical specimen collection and submission. Botulism antitoxin and botulism immunoglobulin are not authorized for sale in Canada and are currently only available through the SAP. Only the following four products can be accessed through the SAP:
BabyBIG® is a human-derived botulism antitoxin indicated in the treatment of infant botulism for infants up to one year of age. The manufacturers of BabyBIG® do not permit pre-orders of this product and it can only be obtained by directly contacting the SAP. For additional information on BabyBIG®, health care providers can contact the California Department of Public Health, Infant Botulism Treatment and Prevention Program at 510-231-7600.
Hepatitis B Immune Globulin And Postexposure Prophylaxis
HBIG is prepared from plasma containing high concentrations of anti-HBs. HBIG provides short-term protection from infection. Currently, HBIG administered in conjunction with HepB is recommended for: infants born to HBsAg-positive mothers unvaccinated sexual contacts of a person known to be or at high risk of being HBsAg-positive and unvaccinated persons with a percutaneous exposure from someone who is known to be or at high risk of being HBsAg-positive. Administration of HBIG alone is the primary means of protection after exposure to HBV in known non-responders to vaccination.109 HBIG also is used in patients with HBV-related chronic liver disease who have undergone liver transplantation to reduce the incidence of recurrent HBV infection.179 HepB at birth, with or without HBIG, eliminates any theoretical risk of virus transmission through breastfeeding.180182
Melissa G. Collier, Sarah Schillie, in, 2018
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Human Immunoglobulin Administration And Storage
Large volumes of immunoglobulin for IM injection should be divided and injected at two or more sites. Currently available human Ig preparations, with the exception of IVIg, VarIg, CMVIg, VIG, and BIG-IG, must not be given IV because of the risk of rare anaphylactic reactions.
Human Ig preparations should be stored at +2°C to +8°C. Do not freeze.
What May Interact With This Medicine
Do not take this medicine with any of the following medications:
- live virus vaccines
This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.
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What Side Effects May I Notice From Receiving This Medicine
Side effects that you should report to your doctor or health care professional as soon as possible:
- allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue
- breathing problems
- chest pain or tightness
Side effects that usually do not require medical attention :
- headache
- nausea
- pain and tenderness at site where injected
This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
How Should I Use This Medicine
This medicine is for injection into a muscle. HepaGam B may also be infused in a vein. It is given by a health care professional in a hospital or clinic setting.
Talk to your pediatrician regarding the use of this medicine in children. While this drug may be prescribed for children as young as newborn for selected conditions, precautions do apply.
Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.
NOTE: This medicine is only for you. Do not share this medicine with others.
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Persons New To Canada
Health care providers who see persons newly arrived in Canada should review the immunization status and update immunization for these individuals, as necessary. In many countries outside of Canada, HB vaccine is in limited use.
All persons from a country that is endemic for HB should be assessed and vaccinated against HB if not immune and not infected. Individuals born in developing countries are more likely to be carriers of HB, necessitating vaccination of their sexual and household contacts based on review of their serologic test results. HB vaccine is recommended for all household contacts whose families have immigrated to Canada from areas in which there is a high prevalence of HB and who may be exposed to HB carriers through their extended families or when visiting their country of origin.
Children adopted from countries in which there is a high prevalence of HB infection should be screened for HBsAg and, if positive, household or close contacts in the adopting family should be immunized before adoption or as soon as possible thereafter. Adults going to pick-up children from these countries should be vaccinated before departure. Refer to Immunization of Persons New to Canada in Part 3 for additional information.
Household Exposure To Persons With Acute Hbv Infection
Since infants have close contact with primary care-givers and they have a higher risk of becoming HBV carriers after acute HBV infection, prophylaxis of an infant less than 12 months of age with Hepatitis B Immune Globulin and hepatitis B vaccine is indicated if the mother or primary care-giver has acute HBV infection.
Administration of Hepatitis B Immune Globulin either preceding or concomitant with the commencement of active immunization with Hepatitis B Vaccine provides for more rapid achievement of protective levels of hepatitis B antibody, than when the vaccine alone is administered. Rapid achievement of protective levels of antibody to hepatitis B virus may be desirable in certain clinical situations, as in cases of accidental inoculations with contaminated medical instruments. Administration of Hepatitis B Immune Globulin either 1 month preceding or at the time of commencement of a program of active vaccination with Hepatitis B Vaccine has been shown not to interfere with the active immune response to the vaccine.
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Hepatitis B Vaccine: Canadian Immunization Guide
For health professionals
Last partial content update : May 2022
The footnotes in and the accompanying text description for the figure have been revised to align with the corresponding figure in Protocole d’immunisation du Québec, 5e édition from which it was adapted.
Last complete chapter revision :
Acute Exposure To Blood Containing Hbsag
After either parenteral exposure, e.g., by accidental needlestick or direct mucous membrane contact , or oral ingestion involving HBsAg-positive materials such as blood, plasma or serum. For inadvertent percutaneous exposure, a regimen of two doses of Hepatitis B Immune Globulin , one given after exposure and one a month later, is about 75% effective in preventing hepatitis B in this setting.
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What Hepatitis B Immunoglobulin
Hepatitis B Immunoglobulin-VF is manufactured from human plasma collected by Australian Red Cross Lifeblood. Hepatitis B Immunoglobulin-VF contains protein substances called antibodies which can prevent infection from developing in a person who has been exposed to the hepatitis B virus. Hepatitis B Immunoglobulin-VF is used to prevent hepatitis B infection in a person who comes into contact with blood or other material suspected of being infected with hepatitis B, for example, by accidental needle stick injury or sexual exposure. It is also given to babies born to mothers with hepatitis B infection.
Ask your doctor if you have any questions about why Hepatitis B Immunoglobulin-VF has been prescribed for you. Your doctor will have assessed the risks and benefits associated with the use of this medicine for you.
Important: How To Use This Information
This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.
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Perinatal Exposure Of Infants Born To Hbsag
Infants born to HBsAg-positive mothers are at risk of being infected with hepatitis B virus and becoming chronic carriers. This risk is especially great if the mother is HBeAg-positive. For an infant with perinatal exposure to an HBsAg-positive and HBeAg-positive mother, a regimen combining one dose of Hepatitis B Immune Globulin at birth with the hepatitis B vaccine series started soon after birth is 85%95% effective in preventing development of the HBV carrier state. Regimens involving either multiple doses of Hepatitis B Immune Globulin alone or the vaccine series alone have 70%90% efficacy, while a single dose of Hepatitis B Immune Globulin alone has only 50% efficacy.
Concurrent Administration Of Vaccines
HB-containing vaccines may be administered concomitantly with other vaccines or with HBIg. Different injection sites and separate needles and syringes must be used for concurrent parenteral injections.
Refer to Timing of Vaccine Administration in Part 1 for additional information about concurrent administration of vaccines.
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