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HepaGam B
Overview
What is HepaGam B?
HepaGam B, Hepatitis B Immune Globulin Intravenous (Human), is a solvent/detergent-treated sterile solution of purified gamma globulin containing anti-HBs. It is prepared from plasma donated by healthy, screened donors with high titers of anti-HBs that is purified by an anion-exchange column chromatography manufacturing method. HepaGam B is formulated as a 5% (50 milligrams per milliliter) protein solution with 10% maltose and 0.03% polysorbate 80 at pH 5.6. It is available in 1 milliliter and 5 milliliters single dose vials. The product appears as a clear to opalescent liquid. HepaGam B does not contain mercury. It contains no preservatives. This product is intended for single use. HepaGam B may be administered intravenously or intramuscularly dependent upon indication [see ]. The source plasma used in the manufacture of this product was tested by FDA licensed Nucleic Acid testing (NAT) for HIV-1, HBV and HCV and found to be negative. Plasma also has been tested by in-process NAT for hepatitis A virus (HAV) and parvovirus B19 (B19) via minipool testing and the limit for B19 in the manufacturing pool is set not to exceed 10 IU of B19 DNA per milliliter.
The manufacturing process contains two steps implemented specifically for virus clearance. The solvent and detergent step (using tri-n-butyl phosphate and Triton X-100) is effective in the inactivation of enveloped viruses, such as hepatitis B, hepatitis C and HIV. Virus filtration, using a Planova 20N virus filter, is effective for the removal of viruses based on their size, including some non-enveloped viruses. These two viral clearance steps are designed to increase product safety by reducing the risk of transmission of enveloped and non-enveloped viruses. In addition to these two specific steps, the process step of anion-exchange chromatography was identified as contributing to the overall viral clearance capacity for small non-enveloped viruses.
The inactivation and reduction of known enveloped and non–enveloped model viruses were validated in laboratory studies as summarized in . The viruses employed for spiking studies were selected to represent those viruses that are potential contaminants in the product, and to represent a wide range of physiochemical properties in order to challenge the manufacturing process’s ability for viral clearance in general.
The product potency is expressed in international units (IU) by comparison to the World Health Organization (WHO) standard Hepatitis B Immune Globulin. Each vial contains greater than 312 IU per milliliter. The measured potency of each lot is stamped on the vial label [].
What does HepaGam B look like?
What are the available doses of HepaGam B?
1.0 milliliter sterile solution; single use vial (> 312 IU per milliliter). ()
5.0 milliliters sterile solution; single use vial (> 312 IU per milliliter). ()
The measured potency of each lot is stamped on the vial label.
What should I talk to my health care provider before I take HepaGam B?
How should I use HepaGam B?
HepaGam B [Hepatitis B immune globulin intravenous (Human)] is an intravenous immune globulin indicated for the following:
Administer the first dose of HepaGam B during the grafting of the transplanted liver (the anhepatic phase) with subsequent dosing as recommended in .
Calculate the dosing from the measured potency of the particular lot of HepaGam B as stamped on the vial label.
Administer by intravenous infusion ().
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 transplantation. Patients who have surgical bleeding or abdominal fluid drainage (> 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.
What interacts with HepaGam B?
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What are the warnings of HepaGam B?
Sorry No Records found
What are the precautions of HepaGam B?
Sorry No Records found
What are the side effects of HepaGam B?
Sorry No records found
What should I look out for while using HepaGam B?
History of anaphylactic or severe systemic reactions to human globulins ()
IgA deficient individuals may have the potential to develop IgA antibodies and have an anaphylactoid reaction. ()
IM injections may be contraindicated in patients with coagulation disorders. ()
What might happen if I take too much HepaGam B?
Consequences of an overdose are not known. For intramuscular administration of HepaGam B, the only manifestations of overdose would be pain and tenderness at the injection site.
How should I store and handle HepaGam B?
Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from light.Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.PHARMACIST:Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from light.Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.PHARMACIST:Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from light.Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.PHARMACIST:Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from light.Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.PHARMACIST:NDC 70504-0052-2; a carton containing a 1.0 milliliter single dose vial (>312 IU per milliliter; measured potency of each lot is stamped on the vial label) and a package insert.NDC 70504-0051-2; a carton containing a 5.0 milliliter single dose vial (>312 IU per millileter; measure potency of each lot is stamped on the vial label) and a package insert.Store at 36 to 46 °F (2 to 8 °C). Do not freeze. Do not use after expiration date. Use within 6 hours after the vial has been entered.NDC 70504-0052-2; a carton containing a 1.0 milliliter single dose vial (>312 IU per milliliter; measured potency of each lot is stamped on the vial label) and a package insert.NDC 70504-0051-2; a carton containing a 5.0 milliliter single dose vial (>312 IU per millileter; measure potency of each lot is stamped on the vial label) and a package insert.Store at 36 to 46 °F (2 to 8 °C). Do not freeze. Do not use after expiration date. Use within 6 hours after the vial has been entered.NDC 70504-0052-2; a carton containing a 1.0 milliliter single dose vial (>312 IU per milliliter; measured potency of each lot is stamped on the vial label) and a package insert.NDC 70504-0051-2; a carton containing a 5.0 milliliter single dose vial (>312 IU per millileter; measure potency of each lot is stamped on the vial label) and a package insert.Store at 36 to 46 °F (2 to 8 °C). Do not freeze. Do not use after expiration date. Use within 6 hours after the vial has been entered.
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
HepaGam B provides passive immunization for individuals exposed to the hepatitis B virus, by binding to the surface antigen and reducing the rate of hepatitis B infection.
Non-Clinical Toxicology
History of anaphylactic or severe systemic reactions to human globulins ()IgA deficient individuals may have the potential to develop IgA antibodies and have an anaphylactoid reaction. ()
IM injections may be contraindicated in patients with coagulation disorders. ()
Many drugs affect thyroid hormone pharmacokinetics and metabolism (e.g., absorption, synthesis, secretion, catabolism, protein binding, and target tissue response) and may alter the therapeutic response to Levothyroxine Sodium Tablets, USP. In addition, thyroid hormones and thyroid status have varied effects on the pharmacokinetics and action of other drugs. A listing of drug-thyroidal axis interactions is contained in Table 2.
The list of drug-thyroidal axis interactions in Table 2 may not be comprehensive due to the introduction of new drugs that interact with the thyroidal axis or the discovery of previously unknown interactions. The prescriber should be aware of this fact and should consult appropriate reference sources (e.g., package inserts of newly approved drugs, medical literature) for additional information if a drug-drug interaction with levothyroxine is suspected.
Severe hypersensitivity reactions may occur with HepaGam B. HepaGam B should be administered in a setting with appropriate equipment, medication and personnel trained in the management of hypersensitivity, anaphylaxis and shock. In case of hypersensitivity, discontinue HepaGam B infusion immediately and begin appropriate emergency treatment. Medications such as epinephrine and antihistamines should be available for immediate treatment of acute hypersensitivity reactions.
HepaGam B contains trace amounts of IgA (<40 micrograms per milliliter). Patients with known antibodies to IgA may have a greater risk of severe hypersensitivity and anaphylactic reactions. HepaGam B is contraindicated in IgA deficient patients with antibodies against IgA and history of hypersensitivity reaction. (see [])
The only adverse reactions observed in clinical trial subjects were hypotension and nausea (2% of clinical trial subjects).
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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