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Nabi-HB®
Hepatitis B Immune Globulin (Human)
Solvent/Detergent Treated and Filtered
Hepatitis B Immune Globulin (Human), Nabi-HB (hepatitis b vaccine recombinant) , is a sterile solution of immunoglobulin (5 ± 1% protein) containing antibodies to hepatitis B surface antigen (anti-HBs). It is prepared from plasma donated by individuals with high titers of anti-HBs. The plasma is processed using a modified Cohn 6 / Oncley 9 cold-alcohol fractionation process1,2 with two added viral reduction steps described below. Nabi-HB (hepatitis b vaccine recombinant) is formulated in 0.075 M sodium chloride, 0.15 M glycine, and 0.01% polysorbate 80, at pH 6.2. The product is supplied as a nonturbid sterile liquid in single dose vials and appears as clear to opalescent. It contains no preservative and is intended for single use by the intramuscular route only.
The manufacturing steps for Nabi-HB (hepatitis b vaccine recombinant) are designed to reduce the risk of transmission of viral disease. The solvent/detergent treatment step, using tri-n-butyl phosphate and Triton® X-100, is effective in inactivating known enveloped viruses such as hepatitis B virus (HBV), hepatitis C virus (HCV), and human immunodeficiency virus (HIV)3. Virus filtration, using a Planova® 35 nm Virus Filter, is effective in reducing some known enveloped and non-enveloped viruses4. The inactivation and reduction of known enveloped and non-enveloped model viruses were validated in laboratory studies as summarized in the following table:
Table 1 : Log Reduction of Test Viruses5
| Test Virus | |||||
| HIV | BVD | PRV | EMC | PPV | |
| Model Virus: | HIV | HCV | HBV | Hepatitis A | PVB19 |
| Envelope/Genome: | yes/RNA | yes/RNA | yes/DNA | no/RNA | no/DNA |
| Manufacturing Step | |||||
| Precipitation of Cohn Fraction III | > 5.9 | 3.6 | 3.7 | 4.4 | 3.9 |
| Cuno Filtration | NT | NT | NT | > 6.6 | 5.4 |
| Solvent/Detergent | > 4.2 | > 6.9 | > 6.4 | NT | NT |
| Nanofiltration | > 7.4 | > 6.9 | > 5.7 | 3.0 | 0.7 * |
| Cumulative | > 17.5 | > 17.4 | > 15.8 | > 14.0 | 9.3 |
| BVD = Bovine Viral Diarrhea Virus EMC = Encephalomyocarditis Virus HIV = Human Immunodeficiency Virus PVB19 = Parvovirus B19 PPV = Porcine Parvovirus PRV = Pseudorabies Virus NT = not tested * Value not included in cumulative clearance |
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Product potency is expressed in international units (IU) by comparison to the World Health Organization (WHO) standard. Each milliliter (mL) of product contains greater than 312 IU anti-HBs. The potency of each milliliter of Nabi-HB (hepatitis b vaccine recombinant) exceeds the potency of anti-HBs in a U.S. reference hepatitis B immune globulin (FDA). The U.S. reference has been tested by Nabi® Biopharmaceuticals against the WHO standard and found to be equal to 208 IU/mL.
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have any of these serious side effects:
Read All Potential Side Effects and See Pictures of Nabi-HB »
Before receiving hepatitis B immune globulin, tell your doctor or pharmacist if you are allergic to it; or had a previous reaction to other immune globulins; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
Before using this medication, tell your doctor or pharmacist your medical history, especially of: bleeding/blood clotting problems, a certain immune system problem (immunoglobulin A deficiency).
This drug may make you dizzy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.
This medication is made from human blood. Even though...
REFERENCES
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have any of these serious side effects:
Read All Potential Side Effects and See Pictures of Nabi-HB »
Before receiving hepatitis B immune globulin, tell your doctor or pharmacist if you are allergic to it; or had a previous reaction to other immune globulins; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
Before using this medication, tell your doctor or pharmacist your medical history, especially of: bleeding/blood clotting problems, a certain immune system problem (immunoglobulin A deficiency).
This drug may make you dizzy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.
This medication is made from human blood. Even though...
1. Cohn E.J., Strong W.L., Mulford D.J., Ashworth J.N., Melin M., Taylor H.L. Preparation and Properties of Serum and Plasma Proteins IV. A system for the separation into fractions of the protein and lipoprotein components of biological tissues and fluids. J Am Chem Soc 1946, 68: 459-475.
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have any of these serious side effects:
Read All Potential Side Effects and See Pictures of Nabi-HB »
Before receiving hepatitis B immune globulin, tell your doctor or pharmacist if you are allergic to it; or had a previous reaction to other immune globulins; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
Before using this medication, tell your doctor or pharmacist your medical history, especially of: bleeding/blood clotting problems, a certain immune system problem (immunoglobulin A deficiency).
This drug may make you dizzy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.
This medication is made from human blood. Even though...
2. Oncley J.L, Melin M, Richert D.A, Cameron J. W, Gross P.M. The separation of antibodies, isoagglutinins, prothrombin, plasminogen and b1-lipoproteins into sub-fractions of human plasma. J Am Chem Soc 1949, 71:541-550.
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have any of these serious side effects:
Read All Potential Side Effects and See Pictures of Nabi-HB »
Before receiving hepatitis B immune globulin, tell your doctor or pharmacist if you are allergic to it; or had a previous reaction to other immune globulins; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
Before using this medication, tell your doctor or pharmacist your medical history, especially of: bleeding/blood clotting problems, a certain immune system problem (immunoglobulin A deficiency).
This drug may make you dizzy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.
This medication is made from human blood. Even though...
3. Horowitz B: Investigations into the application of tri(n-butyl)phosphate/detergent mixtures to blood derivatives. Morgenthaler J (ed): Virus Inactivation in Plasma Products, Curr Stud Hematol Blood Transfus 1989; 56:83-96.
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have any of these serious side effects:
Read All Potential Side Effects and See Pictures of Nabi-HB »
Before receiving hepatitis B immune globulin, tell your doctor or pharmacist if you are allergic to it; or had a previous reaction to other immune globulins; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
Before using this medication, tell your doctor or pharmacist your medical history, especially of: bleeding/blood clotting problems, a certain immune system problem (immunoglobulin A deficiency).
This drug may make you dizzy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.
This medication is made from human blood. Even though...
4. Burnouf T: Value of virus filtration as method for improving the safety of plasma products. Vox Sang 1996; 70:235-236.
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have any of these serious side effects:
Read All Potential Side Effects and See Pictures of Nabi-HB »
Before receiving hepatitis B immune globulin, tell your doctor or pharmacist if you are allergic to it; or had a previous reaction to other immune globulins; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
Before using this medication, tell your doctor or pharmacist your medical history, especially of: bleeding/blood clotting problems, a certain immune system problem (immunoglobulin A deficiency).
This drug may make you dizzy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.
This medication is made from human blood. Even though...
5. Unpublished data on file, Viral Validation Study Reports, Nabi® Biopharmaceuticals.
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have any of these serious side effects:
Read All Potential Side Effects and See Pictures of Nabi-HB »
Before receiving hepatitis B immune globulin, tell your doctor or pharmacist if you are allergic to it; or had a previous reaction to other immune globulins; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
Before using this medication, tell your doctor or pharmacist your medical history, especially of: bleeding/blood clotting problems, a certain immune system problem (immunoglobulin A deficiency).
This drug may make you dizzy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.
This medication is made from human blood. Even though...
Last reviewed on RxList: 10/29/2009
This monograph has been modified to include the generic and brand name in many instances.
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