After being exposed to hepatitis b positive blood products, semen, saliva, or children born to HBsAg-positive moms, a person develops passive immunity thanks to hepatitis B immune globulin (HepaGam B).

Hepatitis B immune globulin (HepaGam B) Uses:

Hepatitis B virus recurrence prevention in liver transplant recipients with HBsAg positivity via:

• sexual exposure to HBsAg-positive persons
• Blood
• Exposures through parenteral nutrition
• Direct contact through the mucus membrane
• Oral intake
• Exposure of children born to HBsAg-positive moms during pregnancy

• Exposure to acute HBV infections in the home

• Hepatitis B virus recurrence prevention in liver transplant recipients with HBsAg positivity

• The Advisory Committee on Immunization Practices (ACIP) additionally advises management to adhere to:

  • When the source's HBsAg status is unknown, a health care provider (HCP) should administer postexposure prophylaxis.

  • Neonates whose mothers' HBsAg lab tests are unavailable and who may have had HBV infection while pregnant according to other evidence

  • Postexposure prophylaxis for someone who hasn't had all of their shots.

Note:

• Hepatitis B immune globulin therapy for active acute or chronic hepatitis B infection is not advised.

Dose in Adults

Postexposure prophylaxis:

• Intramuscularly (IM): 0.06 mL per kg within 24 hours of a needlestick, ocular, or mucosal exposure, or within 14 days of a sexual encounter.
• After 28 to 30 days of exposure, give the vaccine again to non-responders or those who opted out.

Postexposure management of health care personnel:

• Give two doses of HBIG separated by a month if the source patient has HBsAg or is unknown.
• If the HCP has prior proof of receiving at least three doses of the hepatitis B vaccine and postvaccination anti-HBs at or below 10 micrograms per millilitre, HBIG is not required, regardless of the patient's HBsAg status.
• The use of HBIG is not necessary if anti-HBs is greater than 10 milliunits/mL.
• One dosage of HBIG should be given if the source patient has HBsAg positivity or if the anti-HBs level is less than 10 microunits/mL.
• One dose of HBIG should be administered if the HCP is unvaccinated or just partially immunised, and if the source patient is HBsAg positive or if their status is unclear. If the source patient's HBsAg test is negative, HBIG is not necessary.
• Additionally, HBIG is not necessary if the donor patient tests negative for HBsAg if anti-HBs is 10 milliunits/mL.
• If the HCP has gotten three doses of the hepatitis B vaccine but it is unclear how their anti-HBs response has changed since vaccination, test for anti-HBs.
• It is not necessary to administer HBIG if the source patient is HBsAg negative and the HCP has received six doses of the hepatitis B vaccine but is listed as a nonresponder to the vaccine.

Postexposure management in nonoccupational settings: IM:

• Even though HBIG therapy is not required in cases where exposure was to an HBsAg-unknown source, the hepatitis B immunisation should be finished.
• If the exposed person is already receiving the hepatitis B vaccine series and the exposure originated from an HBsAg-positive source, administer one dose of HBIG and complete the series.
• Even though HBIG therapy is not required if exposure originated from an HBsAg-unknown source, the hepatitis B vaccine series should be completed.
• If the exposed person provides documentation of having had three doses of the hepatitis B vaccine in the past, treatment with HBIG is not required.
• If the exposed person is unvaccinated and the exposure came from an HBsAg-positive source, administer one dose of HBIG and the hepatitis B vaccine as soon as you can (ideally within 24 hours of exposure [seven days for percutaneous exposure or 14 days for sexual exposure]), and complete the immunisation series.

Hepatitis B immune globulin (HepaGam B) for the prevention of hepatitis B virus recurrence after liver transplantation (HepaGam B):

• IV: 20,000 units/dose according to the following schedule:
  • Week 1 postop:
    • One dose (20,000 units) daily for 1 week (days 1 to 7)
  • Anhepatic phase (Initial dose):
    • One dose (20,000 units) given with the liver transplant
  • Month 4 onward:
    • One dose (20,000 units) once monthly starting on month 4

• Weeks 2 to 12 postop:
  • One dose (20,000 units) every 2 weeks starting day 14

• Dose adjustment:

  • Adjust the dosage to reach anti-HBs levels of 500 units/L during the first week after transplantation.

  • Give patients who are getting plasmapheresis, have abdominal fluid drainage that is larger than 500 mL, or are undergoing surgery 10,000 units/dose six hours apart until target anti-HBs levels are reached.

Dose in Children's

Note:

• Without compromising the active immune response, HBIG can be given for exposure prophylaxis concurrently (but at a separate location) or up to one month following hepatitis B immunisation.

Hepatitis B immune globulin (HepaGam B) dose for perinatal prophylaxis after exposure:

• Infants born to HBsAg-positive mothers:

  • Inject 0.5 mL intramuscularly (IM) as a repetition of the birth dose if the hepatitis B vaccination series is delayed for up to three months (hepatitis B vaccine should also be given at the same time/different site).

Postexposure prophylaxis:

• Infants less than 12 months:

  • IM: 0.5 mL as soon as practical after exposure (for example, if the mother or main caretaker has an acute HBV infection); start the hepatitis B vaccination series.

• Children ≥12 months and Adolescents:

  • When practical after exposure, IM: 0.06 mL/kg (ie, within 24 hours of needlestick, ocular, or mucosal exposure or within 14 days of sexual exposure)

  • Repeat 28–30 days after the exposure

Pregnancy Risk Factor C

• Studies on animal reproduction have not been conducted.
• Females who are pregnant are advised against using HBIG. If necessary, HBIG can be administered as postexposure prophylaxis.
• It was also investigated whether HBIG could reduce hepatitis B transmission from the mother to the foetus during pregnancy.

Hepatitis B immune globulin use during breastfeeding:

• Infants born to HBsAg-positive moms who get postexposure prophylaxis or to mothers who are HBsAg-negative may be able to breastfeed.
• It is unknown if immune globulin from these preparations is present in breast milk.
• Immune globulins produced naturally are found in breast milk.
• The use of HBIG is not recommended for females who are nursing.
• The manufacturer advises women who are nursing to exercise cautious

Dose in Kidney Disease:

No dosage adjustment in the manufacturer's labelling

Dose in Liver Disease:

No dosage adjustment in the manufacturer's labelling 

reported together with postexposure prevention. In patients with liver transplants, tremor and hypotension were two side effects associated with a single infusion during the first week of therapy and did not recur with repeated infusions.

Common Side Effects

• Dermatologic:

  • Erythema

• Central nervous system:

  • Headache

Less Common Side Effects:

• Cardiovascular:

  • Hypotension

• Dermatologic:

  • Ecchymoses

• Central nervous system:

  • Malaise

• Gastrointestinal:

  • Nausea
  • Vomiting

• Hepatic:

  • Increased Liver Enzymes
  • Increased Serum Alkaline Phosphatase

• Neuromuscular & Skeletal:

  • Myalgia
  • Joint Stiffness

• Hematologic & Oncologic:

  • Change In WBC Count

• Local:

  • Pain At Injection Site

• Renal:

  • Increased Serum Creatinine

Contraindications to Hepatitis B immune globulin (HepaGam B):

• HyperHEPB S/D:
  • There are no warnings on the packaging from the manufacturer.
• Nabi-HB
  • severe systemic or anaphylactic responses to human globulin products
• HepaGam B
  • IgA deficiency can cause anaphylactic or severe systemic responses to human globulin products.
  • Thrombocytopenia severe and other coagulation issues that would rule out intramuscular injections (administer only if the benefit is greater than the risk).

Warnings and precautions

• Anaphylaxis/ Hypersensitivity reactions:
  • There is a chance of hypersensitivity and anaphylactic responses.
  • There should be immediate medical care accessible, including epinephrine 1 mg/mL.
  • Patients who have a history of systemic immunoglobulin hypersensitivity or an isolated immunoglobulin A deficiency should proceed with caution.
• Infusion reactions
  • During and following infusions, keep an eye on the patients for any negative responses.
  • If you are administering IV, do not go beyond the suggested IV infusion rates. Your chance of having a negative response may rise as a result.
• Thrombotic events
  • Thrombotic events have been linked to intravenous immunoglobulin administration.
  • Blood viscosity should be evaluated in patients who are at high risk of hyperviscosity.
  • Use caution while treating individuals who have a history of atherosclerosis, cardiovascular disease, thrombosis, reduced cardiac output, coagulation problems, or who have suspected or confirmed hyperviscosity.
• Bleeding disorders:
  • Patients with thrombocytopenia or coagulation issues should exercise caution.
  • IM injections might not be advised.

Hepatitis B immune globulin: Drug Interaction

Monitoring parameters:

• Liver transplant:
  • Serum HBsAg;
  • Liver function studies;
  • infusion-related side effects

How to administer?

The hepatitis B vaccine may be administered concurrently, but at a different site, or up to one month beforehand.

IM: Post-exposure prophylaxis:

• To avoid injection-related harm, only administer an intramuscular injection to the upper arm's deltoid muscle and the anterolateral side of the upper thigh.
• Patients with thrombocytopenia or bleeding issues should use with caution.

IV administration:

• HepaGam B:
  • Transplant of the liver: Give at a rate of 2 mL/min.
  • If the patient has pain or undesirable effects from the infusion, reduce the infusion to 1 mL/minute.
  • The potency listed on each individual vial determines the actual infusion volume.
• Nabi-HB:
  • Despite not being FDA-approved for this use, Nabi-HB has been administered intravenously to patients undergoing liver transplants who had hepatitis B.

Mechanism of action:

• Hepatitis b immune globulin (HBIG), a non-pyrogenic sterile solution, contains immunoglobulin G (IgG) specific to the hepatitis b surface antigen (HBsAg). Immune globulin and HBIG contain different amounts of anti-HBs.
• The plasma used to create HBIG has been pre-selected for high titer Anti-HBs. Immune globulin does not operate in this way.

Absorption after IM administration:

• Slow

Duration:

• Postexposure prophylaxis: 3 to 6 months

Time to peak serum concentration after IM administration:

• 2 to 10 days

Half-life:

• 17 to 25 days

International Brand Names of Hepatitis B Immunoglobulin:

• HepaGam B
• HyperHEP B S/D
• Nabi-HB
• Fovepta
• Hebagam IM
• Hep-B Gammagee
• Bayhep
• Euvax-B
• Neohepatect
• NEOHepatect
• Hepabig
• Hepatitis B Immunoglobulin-VF
• HyperHEP B
• Hepacaf
• Hepatect CP
• Hepagam B
• Hepatect
• Igantibe
• IMMUNOHBs
• HepBQuin
• Hepuman Berna
• IVheBex
• Niuliva
• VENBIG
• Zutectra

Hepatitis B immune globulin Brand Names in Pakistan: