HepaGam B

HEPAGAM B- human hepatitis b virus immune globulin injection
Saol Therapeutics Inc.

1 INDICATIONS AND USAGE

HepaGam B [Hepatitis B immune globulin intravenous (Human)] is an intravenous or intramuscular immune globulin indicated for the following:

1.1 Prevention of Hepatitis B recurrence following liver transplant in HBsAg-positive liver transplant patients

1.2 Post-exposure prophylaxis

including

  • acute exposure to HBsAg-positive blood, plasma, or serum (parenteral exposure, direct mucus membrane contact, oral ingestion, etc.),
  • perinatal exposure of infants born to HBsAg-positive mothers,
  • sexual exposure to HBsAg-positive persons, and
  • household exposure to persons with acute HBV infection.

2 DOSAGE AND ADMINISTRATION

2.1 Prevention of Hepatitis B recurrence following liver transplantation

Administer the first dose of HepaGam B during the grafting of the transplanted liver (the anhepatic phase) with subsequent dosing as recommended in Table 1.

Calculate the dosing from the measured potency of the particular lot of HepaGam B as stamped on the vial label.

Administer by intravenous infusion (Table 2).

Table 1 — HepaGam B Dosing Regimen for HBV-Related Liver Transplant Patients

* Each dose should contain 20,000 international units calculated from the measured potency as stamped on the vial label [see Dosage Forms and Strengths (3) ].

Anhepatic Phase Week 1 Post-Operative Weeks 2-12 Post-Operative Month 4 onwards
First dose Daily from Day 1-7 Every two weeks from Day 14 Monthly
Table 2 – HepaGam B Intravenous Infusion Rate
Route of Administration Dosage Infusion Rate
Intravenous 20,000 international units per dose 2 milliliters per minute. Decrease to 1 milliliter per minute or slower if the patient develops discomfort or infusion-related adverse reactions.

HepaGam B dose adjustments may be required in patients who fail to reach anti-HBs levels of 500 international units per liter within the first week post-liver transplantation1. Patients who have surgical bleeding or abdominal fluid drainage (greater than 500 milliliters) or patients who undergo plasmapheresis are particularly susceptible to extensive loss of circulated anti-HBs. In these cases, the dosing regimen should be increased to a half-dose (10,000 international units calculated from the measured potency as stamped on the vial label) intravenously every 6 hours until the target anti-HBs is reached.

2.2 Postexposure Prophylaxis

Administer HepaGam B intramuscularly as recommended in Table 3.

Table 3 – HepaGam B Dosing Regimen for Postexposure Prophylaxis (Intramuscular)
Indication Dosage Instructions
Acute Exposure to Blood Containing HBsAg 0.06 milliliter per kilogram Administer HepaGam B as soon as possible after exposure. The value after seven days following exposure is unclear2, 3.For persons who refuse Hepatitis B vaccine or who are known non-responders to vaccine, give a second dose of HepaGam B one month after the first dose2.
Perinatal exposure of Infants Born to HBsAg-positive mothers 0.5 milliliter Administer after physiologic stabilization of the infant and preferably within twelve hours of birth. Administer concurrently with Hepatitis B vaccine.
Sexual Exposure to HBsAg-Positive Persons 0.06 milliliter per kilogram Administer HepaGam B and Hepatitis B Vaccine series within 14 days of sexual contact or if sexual contact with the infected person will continue.
Household Exposure to Person with Acute HBV Infection 0.5 milliliter For infants less than twelve months of age administered concurrently with Hepatitis B Vaccine. Prophylaxis of other household contacts of persons with acute HBV infection is not indicated unless there is an identifiable blood exposure to the index patient, such as by sharing toothbrushes or razors. Treat such exposures like sexual exposures.

HepaGam B may be administered at the same time (but at a different site), or up to one month preceding Hepatitis B vaccination without impairing the active immune response to Hepatitis B vaccine2,3.

2.3 Preparation

  • Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Do not use if turbid.
  • Do not shake vials during preparation to avoid foaming.
  • The HepaGam B vial is for single use only. HepaGam B contains no preservatives.
  • Promptly use any vial of HepaGam B that has been entered. Do not reuse or save for future use.
  • For intravenous administration, administer HepaGam B through a separate intravenous line using an infusion pump.
  • Use normal saline as the diluent if dilution of HepaGam B is preferred prior to intravenous administration. [see Clinical Trials in Liver Transplant Patients (14.1)]
  • Do not use dextrose (5%) in water (D5W).
  • Use a separate vial, sterile syringe, and needle for each individual patient, to prevent transmission of infectious agents from one person to another.

3 DOSAGE FORMS AND STRENGTHS

  • HepaGam B is a sterile solution of purified gamma globulin (5% or 50 milligrams per milliliter) that contains greater than 312 international units per milliliter of anti-HBs.
  • The measured potency of each lot is stamped on the vial label.
  • To ensure that the label claim of greater than 312 international units per milliliter is maintained over the product shelf life, a higher potency of 550 international units per milliliter is targeted at the time of manufacture.
    • This higher target potency is a manufacturing requirement to account for variability in the potency assay and changes in potency over time.
    • The potency assay has a relative standard deviation (RSD) of approximately 10%.
    • The actual potency test result may vary from approximately 400 to 700 international units per milliliter (3x RSD) based on statistical assessment of manufactured lots with a target potency of 550 international units per milliliter.
  • Calculate the dosing for the prevention of hepatitis B recurrence following liver transplantation from the measured potency of the particular lot of HepaGam B as stamped on the vial label.

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