Medicine overview
Indications of IMMUNOHBs
IMMUNOHBs is a passive immunizing agent used for post-exposure prophylaxis against hepatitis B virus (HBV) infection. Its established and guideline-supported uses include:
- Perinatal exposure: Infants born to hepatitis B surface antigen (HBsAg)-positive mothers, given together with hepatitis B vaccine to prevent mother-to-child transmission (established/guideline-recommended).
- Acute percutaneous or mucosal exposure: Needlestick injuries, other percutaneous exposure, or mucosal (eye, mouth) exposure to HBsAg-positive blood or body fluids in unvaccinated or inadequately vaccinated individuals (established, given with hepatitis B vaccine series).
- Sexual exposure: Sexual contact with a person known to have acute or chronic hepatitis B infection, in individuals who are unvaccinated (established/guideline-supported).
- Prevention of HBV recurrence after liver transplantation: Used (often long-term, in combination with antiviral therapy) in patients undergoing liver transplantation for HBV-related liver disease, to prevent graft reinfection (established for this specific indication with certain formulations).
IMMUNOHBs provides passive, immediate but temporary protection; it does not treat an already-established hepatitis B infection and is not a substitute for hepatitis B vaccination, which should be given concurrently (at a separate site) whenever indicated for long-term active immunity.
Composition
Hepatitis b immune globulin is a sterile, purified solution prepared from human plasma that has been screened and processed to contain a high titer of antibody (immunoglobulin G, IgG) specifically directed against hepatitis B surface antigen (anti-HBs). It also contains the range of other antibodies normally present in pooled human plasma. Formulations are available for intramuscular (IM) or intravenous (IV) use depending on the product and indication.
Description
IMMUNOHBs is a human plasma-derived immunoglobulin preparation used to provide rapid, passive (temporary) immunity against hepatitis B virus. It is manufactured from the plasma of donors with high levels of antibody to hepatitis B surface antigen, and the plasma undergoes screening and viral-inactivation steps as part of manufacture. It is administered by injection under medical supervision, typically as a single dose or short course for post-exposure prophylaxis, or as part of a longer prophylactic regimen after liver transplantation.
Therapeutic Class
IMMUNOHBs belongs to the therapeutic class of specific human immunoglobulins (passive immunizing agents / hyperimmune globulins), used for post-exposure prophylaxis against hepatitis B virus infection.
Pharmacology
Mechanism
Hepatitis b immune globulin works by passive immunization: it directly supplies pre-formed antibody (anti-HBs) against the hepatitis B surface antigen, neutralizing circulating hepatitis B virus and reducing the likelihood that the virus can establish infection in the recipient's hepatocytes. Because the antibody is administered ready-made rather than produced by the recipient's own immune system, protection is immediate but temporary, lasting only as long as the passively transferred antibody persists (generally a few weeks to a few months).
Onset and duration
Protective antibody levels are achieved within hours of administration. Because Hepatitis b immune globulin does not stimulate the recipient's own long-term immune memory, hepatitis B vaccine is given concurrently (at a different injection site) in most indications to provide durable active immunity.
Dosage & Administration of IMMUNOHBs
General principles
IMMUNOHBs must be administered by, or under the direct supervision of, a qualified healthcare professional in a clinical setting, by intramuscular or intravenous injection depending on the specific product and indication. It should be given as soon as possible after exposure, since efficacy declines with delay.
| Indication | Typical Dosing | Timing |
|---|---|---|
| Perinatal exposure (infant of HBsAg-positive mother) | Approximately 0.5 mL (per product labeling) intramuscularly, together with the first dose of hepatitis B vaccine at a separate injection site | Within 12 hours of birth |
| Percutaneous/mucosal exposure (e.g. needlestick) | Approximately 0.06 mL/kg body weight intramuscularly (per product labeling), with hepatitis B vaccine series if not previously vaccinated | As soon as possible, preferably within 24 hours and generally not later than 7 days after exposure |
| Sexual exposure to an infected partner | Approximately 0.06 mL/kg body weight intramuscularly (per product labeling) | Within 14 days of the most recent sexual contact |
| Prevention of HBV recurrence after liver transplantation | Product-specific intravenous dosing (often weight- or titer-based), used as part of a defined perioperative and long-term regimen with antiviral therapy | Perioperatively, then at intervals per transplant protocol |
Exact volume/dose depends on the specific licensed product; the prescribing healthcare professional determines the precise dose and schedule.
Administration of IMMUNOHBs
IMMUNOHBs is given by intramuscular injection (usually into the deltoid or anterolateral thigh, particularly in infants) for most post-exposure prophylaxis indications, or by intravenous infusion for certain products used in the liver transplantation setting. When given with hepatitis B vaccine, the two products are administered at different anatomical sites using separate syringes. It should never be mixed with other medicines in the same syringe.
Interaction of IMMUNOHBs
Live vaccines: IMMUNOHBs may interfere with the immune response to live attenuated virus vaccines (e.g., measles, mumps, rubella, varicella). If a live vaccine is needed, it should generally be delayed for approximately 3 months (or as locally recommended) after administration of IMMUNOHBs, unless there are compelling reasons to give it sooner.
Other immunoglobulin products: Concurrent use with other immunoglobulin preparations should be coordinated by the treating physician to avoid additive effects or dosing confusion.
Hepatitis B vaccine: Not a true drug interaction; the two are intentionally co-administered at separate sites for combined passive-active immunization and do not interfere with each other's efficacy when given correctly.
Contraindications
Hepatitis b immune globulin is contraindicated in patients with:
- A history of anaphylactic or severe systemic (hypersensitivity) reaction to human immunoglobulin preparations or any component of the specific product.
- Known selective IgA deficiency with documented antibodies against IgA, due to the risk of severe hypersensitivity or anaphylactic reactions.
Side Effects of IMMUNOHBs
Most reactions to IMMUNOHBs are mild and local. Reported side effects include:
- Injection-site pain, tenderness, redness, or swelling
- Low-grade fever, chills
- Headache, malaise, myalgia (muscle aches)
- Nausea
- Rarely, hypersensitivity reactions ranging from mild urticaria to (very rarely) anaphylaxis
As with all plasma-derived products, there is a theoretical risk of transmission of infectious agents, although this risk is minimized by donor screening and viral-inactivation steps used during manufacture. Any signs of a severe allergic reaction require immediate medical attention.
Pregnancy & Lactation
IMMUNOHBs has not been formally studied in controlled trials in pregnant women; however, as a passive immunizing agent containing antibodies rather than a live organism or a small-molecule drug, it is generally considered acceptable for use during pregnancy when clearly indicated for post-exposure prophylaxis against hepatitis B (e.g., after a significant exposure), since the benefit of preventing maternal and neonatal HBV infection is considered to outweigh potential risk. It should be used only if clearly needed and the potential benefit justifies the potential risk to the fetus; use only under medical supervision. Data on excretion into breast milk are limited; it is generally considered compatible with breastfeeding when indicated, but a physician should be consulted before use during lactation.
Precautions & Warnings
IMMUNOHBs should be administered only by, or under the supervision of, a qualified healthcare professional in a setting equipped to manage acute hypersensitivity or anaphylactic reactions, since such reactions can rarely occur (see Contraindications). It should be given as soon as possible after a qualifying exposure, as effectiveness diminishes the longer treatment is delayed (generally most effective within 24 hours to 7 days of exposure, depending on the type of exposure). IMMUNOHBs does not treat established hepatitis B infection and should not be relied upon as a substitute for hepatitis B vaccination, which provides durable long-term protection. As with all plasma-derived products, there is a theoretical, minimized risk of transmission of infectious agents. Caution is warranted in patients with a history of severe systemic reactions to other immunoglobulin products.
Overdose Effects of IMMUNOHBs
Overdose with IMMUNOHBs is unlikely in a clinical administration setting, as dosing is weight-based and given by a healthcare professional. Administration of doses larger than recommended could theoretically increase the risk of local or systemic hypersensitivity reactions. If an inadvertent overdose is suspected or if any signs of a severe reaction (e.g., difficulty breathing, swelling of the face/throat, severe rash, dizziness) occur, seek immediate medical attention or contact emergency services/poison control without delay.
Storage Conditions
Store in a refrigerator at 2°C to 8°C (36°F to 46°F). Do not freeze. Protect from light. Keep out of reach of children. Do not use if the solution is turbid or contains particulate matter.
Use In Special Populations
Pediatric use
IMMUNOHBs is well established for use in infants, including newborns born to HBsAg-positive mothers, where it is given at a weight-appropriate/standard neonatal dose together with hepatitis B vaccine within 12 hours of birth. See Pediatric Uses for details.
Renal/hepatic impairment
No specific dose adjustment is well established for renal or hepatic impairment; use in patients undergoing liver transplantation for HBV-related liver disease is itself a labeled indication for certain intravenous formulations, under specialist supervision.
IgA-deficient patients
Patients with selective IgA deficiency who have developed antibodies to IgA are at increased risk of severe hypersensitivity reactions and should not receive IMMUNOHBs (see Contraindications).
Elderly
No specific dose adjustment is established for elderly patients; dosing follows the same indication-based schedule as in adults.
Duration Of Treatment
For most post-exposure prophylaxis indications, IMMUNOHBs is given as a single dose (or occasionally repeated per protocol for ongoing/repeated exposure risk, such as in some perinatal or sexual exposure situations), followed by completion of the hepatitis B vaccine series for durable protection. For prevention of HBV recurrence after liver transplantation, treatment duration is longer, following a defined perioperative and maintenance regimen determined by the transplant team, often for months or with tapering under specialist guidance.
Drug Classes
Hepatitis b immune globulin is classified as a specific (hyperimmune) human immunoglobulin used for passive immunization against hepatitis B virus.
Mode Of Action
Hepatitis b immune globulin acts by providing pre-formed, high-titer antibody against hepatitis B surface antigen (anti-HBs), which binds and neutralizes hepatitis B virus particles, reducing viral entry into hepatocytes and lowering the likelihood of establishing infection following exposure. This confers immediate but temporary (passive) protection, in contrast to the durable active immunity produced by hepatitis B vaccination.
Pediatric Uses
IMMUNOHBs is an established part of neonatal hepatitis B prevention. Infants born to HBsAg-positive mothers should receive IMMUNOHBs along with the first dose of hepatitis B vaccine, administered at separate injection sites, within 12 hours of birth, to prevent perinatal transmission. It may also be used in infants and children who experience percutaneous, mucosal, or other significant exposure to HBV, following the same weight-based dosing principles used in adults. Safety and efficacy in this age group for these specific, guideline-directed indications are well established; use outside these established indications should be guided by a pediatrician or specialist.
Frequently Asked Questions
Q: What is IMMUNOHBs 180 IU/ml Injection used for?
A: IMMUNOHBs 180 IU/ml Injection is used to provide immediate, temporary protection against hepatitis B virus infection after a known or suspected exposure, such as a needlestick injury, sexual contact with an infected person, or birth to a mother who is hepatitis B surface antigen positive. It is also used to help prevent hepatitis B recurrence after liver transplantation in appropriate patients.
Q: How soon after exposure should IMMUNOHBs 180 IU/ml Injection be given?
A: IMMUNOHBs 180 IU/ml Injection should be given as soon as possible after exposure, ideally within 24 hours and generally no later than 7 days for most percutaneous/mucosal exposures, within 12 hours of birth for newborns of HBsAg-positive mothers, and within 14 days for sexual exposure. Effectiveness decreases the longer treatment is delayed.
Q: Does IMMUNOHBs 180 IU/ml Injection treat hepatitis B infection?
A: No. IMMUNOHBs 180 IU/ml Injection does not treat an already-established hepatitis B infection. It only helps prevent infection from developing after a recent exposure, by supplying ready-made antibodies. Established infection requires different, specific management under a physician's care.
Q: Who should not receive IMMUNOHBs 180 IU/ml Injection?
A: IMMUNOHBs 180 IU/ml Injection should not be given to anyone with a history of anaphylactic or severe systemic reaction to human immunoglobulin products, or to people with selective IgA deficiency who have developed antibodies against IgA, because of the risk of severe allergic reactions. Always inform your doctor of any prior reactions to immunoglobulin injections.
Q: Is IMMUNOHBs 180 IU/ml Injection safe during pregnancy?
A: IMMUNOHBs 180 IU/ml Injection is generally considered acceptable for use during pregnancy when clearly indicated for post-exposure prophylaxis, since the benefit of preventing hepatitis B infection typically outweighs potential risk. It should still be used only if clearly needed and under a physician's guidance.
Q: What are the common side effects of IMMUNOHBs 180 IU/ml Injection?
A: Common side effects of IMMUNOHBs 180 IU/ml Injection include pain, redness, or swelling at the injection site, mild fever, headache, and muscle aches. Serious allergic reactions are rare but require immediate medical attention if they occur.
Disclaimer
The information provided is accurate to the best of our knowledge, but it does not replace professional medical advice. We cannot guarantee its completeness or accuracy, and the absence of specific information about a drug should not be taken as an endorsement. We are not responsible for any consequences arising from this information, so please consult a healthcare professional for any concerns or questions.
