Drugs Details

Drugs Info of HepaGam B, HepaGam B NovaPlus, Hyperhep B, Nabi-HB
Drugs Details
  • Drugs Type  : Multum
  • Date : 1st Feb 2015 09:17 pm
  • Brand Name : HepaGam B, HepaGam B NovaPlus, Hyperhep B, Nabi-HB
  • Generic Name : hepatitis B immune globulin (Pronunciation: HEP a TYE tis B im MYOON GLOB yoo lin)
Descriptions

Hepatitis B Immune Globulin (Human) — HyperHEP B™ S/D treated with solvent/detergent is a sterile solution of hepatitis B hyperimmune immune globulin for intramuscular administration; it is preservative-free and latex-free. HyperHEP B S/D is prepared by cold ethanol fractionation from the plasma of donors with high titers of antibody to the hepatitis B surface antigen (anti-HBs). The immune globulin is isolated from solubilized Cohn Fraction II. The Fraction II solution is adjusted to a final concentration of 0.3% tri-n-butyl phosphate (TNBP) and 0.2% sodium cholate. After the addition of solvent (TNBP) and detergent (sodium cholate), the solution is heated to 30°C and maintained at that temperature for not less than 6 hours. After the viral inactivation step, the reactants are removed by precipitation, filtration and finally ultrafiltration and diafiltration. HyperHEP B S/D is formulated as a 15–18% protein solution at a pH of 6.4–7.2 in 0.21–0.32 M glycine. HyperHEP B S/D is then incubated in the final container for 21–28 days at 20–27°C. Each vial contains anti-HBs antibody equivalent to or exceeding the potency of anti-HBs in a U.S. reference hepatitisB immune globulin (Center for Biologics Evaluation and Research, FDA). The U.S. reference has been tested against the World Health Organization standard Hepatitis B Immune Globulin and found to be equal to 220international units (IU) per mL.

The removal and inactivation of spiked model enveloped and non-enveloped viruses during the manufacturing process for HyperHEP B S/D has been validated in laboratory studies. Human Immunodeficiency Virus, Type 1 (HIV-1), was chosen as the relevant virus for blood products; Bovine Viral Diarrhea Virus (BVDV) was chosen to model Hepatitis C virus; Pseudorabies virus (PRV) was chosen to model Human Herpes viruses and other large enveloped DNA viruses; and Reo virus type 3 (Reo) was chosen to model non-enveloped viruses and for its resistance to physical and chemical inactivation. Significant removal of model enveloped and non-enveloped viruses is achieved at two steps in the Cohn fractionation process leading to the collection of Cohn Fraction II: the precipitation and removal of Fraction III in the processing of Fraction II + IIIW suspension to Effluent III and the filtration step in the processing of Effluent III to Filtrate III. Significant inactivation of enveloped viruses is achieved at the time of treatment of solubilized Cohn Fraction II with TNBP/sodium cholate.

Additionally, the manufacturing process was investigated for its capacity to decrease the infectivity of an experimental agent of transmissible spongiform encephalopathy (TSE), considered as a model for the vCJD and CJD agents.22–25

Studies of the HyperHEP B S/D manufacturing process demonstrate that TSE clearance is achieved during the Pooled Plasma to Effluent III Fractionation Process (6.7 log10). These studies provide reasonable assurance that low levels of CJD/vCJD agent infectivity, if present in the starting material, would be removed.

What are the possible side effects of hepatitis B immune globulin (HepaGam B, HepaGam B NovaPlus, Hyperhep B, Nabi-HB)?

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:

  • increased blood pressure (severe headache, blurred vision, trouble concentrating, chest pain, numbness, seizure);
  • left-sided stomach pain; or
  • nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or...

Read All Potential Side Effects and See Pictures of HyperHep B »

What are the precautions when taking hepatitis b immune globulin (human) (HyperHep B)?

See also Warning section.

Before receiving hepatitis B immune globulin, tell your doctor or pharmacist if you are allergic to it; or to other immune globulin products; 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...

Read All Potential Precautions of HyperHep B »

REFERENCES

What are the possible side effects of hepatitis B immune globulin (HepaGam B, HepaGam B NovaPlus, Hyperhep B, Nabi-HB)?

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:

  • increased blood pressure (severe headache, blurred vision, trouble concentrating, chest pain, numbness, seizure);
  • left-sided stomach pain; or
  • nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or...

Read All Potential Side Effects and See Pictures of HyperHep B »

What are the precautions when taking hepatitis b immune globulin (human) (HyperHep B)?

See also Warning section.

Before receiving hepatitis B immune globulin, tell your doctor or pharmacist if you are allergic to it; or to other immune globulin products; 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...

Read All Potential Precautions of HyperHep B »

22. Stenland CJ, Lee DC, Brown P, et al. Partitioning of human and sheep forms of the pathogenic prion protein during the purification of therapeutic proteins from human plasma. Transfusion 2002. 42(11):1497-500.

What are the possible side effects of hepatitis B immune globulin (HepaGam B, HepaGam B NovaPlus, Hyperhep B, Nabi-HB)?

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:

  • increased blood pressure (severe headache, blurred vision, trouble concentrating, chest pain, numbness, seizure);
  • left-sided stomach pain; or
  • nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or...

Read All Potential Side Effects and See Pictures of HyperHep B »

What are the precautions when taking hepatitis b immune globulin (human) (HyperHep B)?

See also Warning section.

Before receiving hepatitis B immune globulin, tell your doctor or pharmacist if you are allergic to it; or to other immune globulin products; 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...

Read All Potential Precautions of HyperHep B »

23. Lee DC, Stenland CJ, Miller JL, et al. A direct relationship between the partitioning of the pathogenic prion protein and transmissible spongiform encephalopathy infectivity during the purification of plasma proteins. Transfusion 2001. 41(4):449-55.

What are the possible side effects of hepatitis B immune globulin (HepaGam B, HepaGam B NovaPlus, Hyperhep B, Nabi-HB)?

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:

  • increased blood pressure (severe headache, blurred vision, trouble concentrating, chest pain, numbness, seizure);
  • left-sided stomach pain; or
  • nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or...

Read All Potential Side Effects and See Pictures of HyperHep B »

What are the precautions when taking hepatitis b immune globulin (human) (HyperHep B)?

See also Warning section.

Before receiving hepatitis B immune globulin, tell your doctor or pharmacist if you are allergic to it; or to other immune globulin products; 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...

Read All Potential Precautions of HyperHep B »

24. Lee DC, Stenland CJ, Hartwell RC, et al. Monitoring plasma processing steps with a sensitive Western blot assay for the detection of the prion protein. J Virol Methods 2000. 84(1):77-89.

What are the possible side effects of hepatitis B immune globulin (HepaGam B, HepaGam B NovaPlus, Hyperhep B, Nabi-HB)?

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:

  • increased blood pressure (severe headache, blurred vision, trouble concentrating, chest pain, numbness, seizure);
  • left-sided stomach pain; or
  • nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or...

Read All Potential Side Effects and See Pictures of HyperHep B »

What are the precautions when taking hepatitis b immune globulin (human) (HyperHep B)?

See also Warning section.

Before receiving hepatitis B immune globulin, tell your doctor or pharmacist if you are allergic to it; or to other immune globulin products; 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...

Read All Potential Precautions of HyperHep B »

25. Cai K, Miller JL, Stenland CJ, et al. Solvent-dependent precipitation of prion protein. Biochim Biophys Acta 2002. 1597(1):28-35.

What are the possible side effects of hepatitis B immune globulin (HepaGam B, HepaGam B NovaPlus, Hyperhep B, Nabi-HB)?

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:

  • increased blood pressure (severe headache, blurred vision, trouble concentrating, chest pain, numbness, seizure);
  • left-sided stomach pain; or
  • nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or...

Read All Potential Side Effects and See Pictures of HyperHep B »

What are the precautions when taking hepatitis b immune globulin (human) (HyperHep B)?

See also Warning section.

Before receiving hepatitis B immune globulin, tell your doctor or pharmacist if you are allergic to it; or to other immune globulin products; 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...

Read All Potential Precautions of HyperHep B »


This monograph has been modified to include the generic and brand name in many instances.

Indications

Recommendations on post-exposure prophylaxis are based on available efficacy data and on the likelihood of future HBV exposure for the person requiring treatment. In all exposures, a regimen combining Hepatitis B Immune Globulin (Human) with hepatitis B vaccine will provide both short- and long-term protection, will be less costly than the two-dose Hepatitis B Immune Globulin (Human) treatment alone, and is the treatment of choice.8

HyperHEP B S/D is indicated for post-exposure prophylaxis in the following situations:

Acute Exposure to Blood Containing HBsAg

After either parenteral exposure, e.g., by accidental "needlestick" or direct mucous membrane contact (accidental splash), or oral ingestion (pipetting accident) involving HBsAg-positive materials such as blood, plasma or serum. For inadvertent percutaneous exposure, a regimen of two doses of Hepatitis B Immune Globulin (Human), one given after exposure and one a month later, is about 75% effective in preventing hepatitis B in this setting.

Perinatal Exposure of Infants Born to HBsAg-positive Mothers

Infants born to HBsAg-positive mothers are at risk of being infected with hepatitis B virus and becoming chronic carriers.5,8-10 This risk is especially great if the mother is HBeAg-positive.11-13 For an infant with perinatal exposure to an HBsAg-positive and HBeAg-positive mother, a regimen combining one dose of Hepatitis B Immune Globulin (Human) at birth with the hepatitis B vaccine series started soon after birth is 85%–95% effective in preventing development of the HBV carrier state.8,14 Regimens involving either multiple doses of Hepatitis B Immune Globulin (Human) alone or the vaccine series alone have 70%–90% efficacy, while a single dose of Hepatitis B Immune Globulin (Human) alone has only 50% efficacy.8,15

Sexual Exposure to an HBsAg-positive Person

Sex partners of HBsAg-positive persons are at increased risk of acquiring HBV infection. For sexual exposure to a person with acute hepatitis B, a single dose of Hepatitis B Immune Globulin (Human) is 75% effective if administered within 2 weeks of last sexual exposure.8

Household Exposure to Persons with Acute HBV Infection

Since infants have close contact with primary care-givers and they have a higher risk of becoming HBV carriers after acute HBV infection, prophylaxis of an infant less than 12 months of age with Hepatitis B Immune Globulin (Human) and hepatitis B vaccine is indicated if the mother or primary care-giver has acute HBV infection.8

Administration of Hepatitis B Immune Globulin (Human) either preceding or concomitant with the commencement of active immunization with Hepatitis B Vaccine provides for more rapid achievement of protective levels of hepatitis B antibody, than when the vaccine alone is administered.16 Rapid achievement of protective levels of antibody to hepatitis B virus may be desirable in certain clinical situations, as in cases of accidental inoculations with contaminated medical instruments.16 Administration of Hepatitis B Immune Globulin (Human) either 1 month preceding or at the time of commencement of a program of active vaccination with Hepatitis B Vaccine has been shown not to interfere with the active immune response to the vaccine.16

Dosage Administration

Acute Exposure to Blood Containing HBsAg15

Table 1 summarizes prophylaxis for percutaneous (needlestick or bite), ocular, or mucous-membrane exposure to blood according to the source of exposure and vaccination status of the exposed person. For greatest effectiveness, passive prophylaxis with Hepatitis B Immune Globulin (Human) should be given as soon as possible after exposure (its value beyond 7 days of exposure is unclear). If Hepatitis B Immune Globulin (Human) is indicated (see Table 1), an injection of 0.06 mL/kg of body weight should be administered intramuscularly (see PRECAUTIONS) as soon as possible after exposure and within 24 hours, if possible. Consult Hepatitis B Vaccine package insert for dosage information regarding that product.

Table 1. (adapted from 20) Recommendations for Hepatitis B Prophylaxis Following Percutaneous or Permucosal Exposure

  Exposed Person
Source Unvaccinated Vaccinated
HBsAg-Positive 1. Hepatitis B Immune Globulin (Human) x 1 immediately* 1. Test exposed person for anti-HBs.
2. Initiate HB Vaccine Series† 2. If inadequate antibody,‡ Hepatitis B Immune Globulin (Human) (x1) immediately plus HB Vaccine booster dose, or 2 doses of HBIG,* one as soon as possible after exposure and the second 1 month later.
Known Source (High Risk) 1. Initiate HB Vaccine Series 1. Test Source for HBsAg only if exposed is vaccine nonresponder; if source is HBsAg-positive, give Hepatitis B Immune Globulin (Human) x 1 immediately plus HB Vaccine booster dose, or 2 doses of HBIG*, one as soon as possible after exposure and the second 1 month later.
2. Test source for HBsAg. If positive, Hepatitis B Immune Globulin (Human) x 1
Low Risk HBsAg-Positive Initiate HB Vaccine series Nothing required.
Unknown Source Initiate HB Vaccine series within 7 days of exposure Nothing required.
*Hepatitis B Immune Globulin (Human), dose 0.06 mL/kg IM.
†HB Vaccine dose 20 µg IM for adults; 10 µg IM for infants or children under 10 years of age. First dose within 1 week; second and third doses, 1 and 6 months later.
‡Less than 10 sample ratio units (SRU) by radioimmunoassay (RIA), negative by enzyme immunoassay (EIA). For persons who refuse Hepatitis B Vaccine, a second dose of Hepatitis B Immune Globulin (Human) should be given 1 month after the first dose.

Prophylaxis of Infants Born to HBsAg and HBeAg Positive Mothers

Efficacy of prophylactic Hepatitis B Immune Globulin (Human) in infants at risk depends on administering Hepatitis B Immune Globulin (Human) on the day of birth. It is therefore vital that HBsAg-positive mothers be identified before delivery.

Hepatitis B Immune Globulin (Human) (0.5 mL) should be administered intramuscularly (IM) to the newborn infant after physiologic stabilization of the infant and preferably within 12 hours of birth. Hepatitis B Immune Globulin (Human) efficacy decreases markedly if treatment is delayed beyond 48 hours. Hepatitis B Vaccine should be administered IM in three doses of 0.5 mL of vaccine (10 µg) each. The first dose should be given within 7 days of birth and may be given concurrently with Hepatitis B Immune Globulin (Human) but at a separate site. The second and third doses of vaccine should be given 1 month and 6 months, respectively, after the first. If administration of the first dose of Hepatitis B Vaccine is delayed for as long as 3 months, then a 0.5 mL dose of Hepatitis B Immune Globulin (Human) should be repeated at 3 months. If Hepatitis B Vaccine is refused, the 0.5 mL dose of Hepatitis B Immune Globulin (Human) should be repeated at 3 and 6 months. Hepatitis B Immune Globulin (Human) administered at birth should not interfere with oral polio and diphtheria-tetanus-pertussis vaccines administered at 2 months of age.15

Sexual Exposure to an HBsAg-positive Person

All susceptible persons whose sex partners have acute hepatitis B infection should receive a single dose of HBIG (0.06 mL/kg) and should begin the hepatitis B vaccine series if prophylaxis can be started within 14 days of the last sexual contact or if sexual contact with the infected person will continue (see Table 2 below). Administering the vaccine with HBIG may improve the efficacy of postexposure treatment. The vaccine has the added advantage of conferring long-lasting protection.8

Table 2. (adapted from 21) Recommendations for Postexposure Prophylaxis for Sexual Exposure to Hepatitis B

  HBIG*   Vaccine
Dose Recommended timing Dose Recommended timing
0.06 mL/kg IM† Single dose within 14 days of last sexual contact 1.0 mL IM† First dose at time of HBIG* treatment¶
* HBIG = Hepatitis B Immune Globulin (Human)
† IM = intramuscularly
¶ The first dose can be administered the same time as the HBIG dose but at a different site; subsequent doses should be administered as recommended for specific vaccine.

Household Exposure to Persons with Acute HBV Infection

Prophylactic treatment with a 0.5 mL dose of Hepatitis B Immune Globulin (Human) and hepatitis B vaccine is indicated for infants 12 months of age who have been exposed to a primary care-giver who has acute hepatitis B. Prophylaxis for other household contacts of persons with acute HBV infection is not indicated unless they have had identifiable blood exposure to the index patient, such as by sharing toothbrushes or razors. Such exposures should be treated like sexual exposures. If the index patient becomes an HBV carrier, all household contacts should receive hepatitis B vaccine.8

Hepatitis B Immune Globulin (Human) may be administered at the same time (but at a different site), or up to 1 month preceding Hepatitis B Vaccination without impairing the active immune response from Hepatitis B Vaccination.16

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

Administer intramuscularly. Do not inject intravenously.

Hepatitis B Immune Globulin (Human) — HyperHEP B™ S/D is supplied in a syringe with an attached UltraSafe® Needle Guard for your protection and convenience, as well as in vials. Please follow instructions below for proper use of syringe and UltraSafe® Needle Guard.

Directions for Syringe Usage

  1. Remove the prefilled syringe from the package. Lift syringe by barrel, not by plunger.
  2. Twist the plunger rod clockwise until the threads are seated.
  3. With the rubber needle shield secured on the syringe tip, push the plunger rod forward a few millimeters to break any friction seal between the rubber stopper and the glass syringe barrel.
  4. Remove the needle shield and expel air bubbles. [Do not remove the rubber needle shield to prepare the product for administration until immediately prior to the anticipated injection time.]
  5. Proceed with hypodermic needle puncture.
  6. Aspirate prior to injection to confirm that the needle is not in a vein or artery.
  7. Inject the medication.
  8. Keeping your hands behind the needle, grasp the guard with free hand and slide forward toward needle until it is completely covered and guard clicks into place. If audible click is not heard, guard may not be completely activated. (See Diagrams A and B)
  9. Place entire prefilled glass syringe with guard activated into an approved sharps container for proper disposal. (See Diagram C)

 

Directions for Syringe Usage - Illustration

A number of factors could reduce the efficacy of this product or even result in an ill effect following its use. These include improper storage and handling of the product after it leaves our hands, diagnosis, dosage, method of administration and biological differences in individual patients. Because of these factors, it is important that this product be stored properly and that the directions be followed carefully during use.

How Supplied

HyperHEP B S/D is supplied in a 0.5 mL neonatal single dose syringe with attached needle, a 1 mL single dose syringe with attached needle and a 1mL and a 5 mL single dose vial. HyperHEP B S/D is preservative-free and latex-free.

NDC Number Size
13533-636-03 0.5 mL syringe
13533-636-02 1 mL syringe
13533-636-01 1 mL vial
13533-636-05 5 mL vial

Storage

Store at 2–8°C (36–46°F). Do not freeze. Do not use after expiration date.

CAUTION

U.S. federal law prohibits dispensing without prescription.

REFERENCES

5. Jhaveri R, Rosenfeld W, Salazar JD, et al: High titer multiple dose therapy with HBIG in newborn infants of HBsAg positive mothers. J Pediatr 97(2):305–8, 1980.

8. Recommendations of the Immunization Practices Advisory Committee (ACIP): Hepatitis B Virus: A Comprehensive Strategy for Eliminating Transmission in the United States Through Universal Childhood Vaccination. Appendix A: Postexposure Prophylaxis for Hepatitis B. MMWR 40(RR-13):21-25, 1991.

9. Stevens CE, Beasley RP, Tsui J, et al: Vertical transmission of hepatitis B antigen in Taiwan. N Engl J Med 292(15):771-4, 1975.

10. Shiraki K, Yoshihara N, Kawana T, et al: Hepatitis B surface antigen and chronic hepatitis in infants born to asymptomatic carrier mothers. Am J Dis Child 131(6):644-7, 1977.

11. Recommendation of the Immunization Practices Advisory Committee (ACIP): Immune globulins for protection against viral hepatitis. MMWR 30(34):423-8; 433-5, 1981.

12. Okada K, Kamiyama I, Inomata M, et al: e antigen and anti-e in the serum of asymptomatic carrier mothers as indicators of positive and negative transmission of hepatitis B virus to their infants. N Engl J Med 294(14):746-9, 1976.

13. Beasley RP, Trepo C, Stevens CE, et al: The e antigen and vertical transmission of hepatitis B surface antigen. Am J Epidemiol 105(2):94-8, 1977.

14. Beasley RP, Hwang LY, Lee GCY, et al: Prevention of perinatally transmitted hepatitis B virus infections with hepatitis B immune globulin and hepatitis B vaccine. Lancet 2(8359): 1099-102, 1983.

15. Recommendation of the Immunization Practices Advisory Committee (ACIP): Recommendations for protection against viral hepatitis. MMWR 34(22):313–35, 1985.

16. Szmuness W, Stevens CE, Olesko WR, et al: Passive-active immunisation against hepatitis B: immunogenicity studies in adult Americans. Lancet 1:575–77, 1981.

20. Recommendations of the Immunization Practices Advisory Committee (ACIP): Update on Adult Immunization. Table 9. Recommendations for postexposure prophylaxis for percutaneous or permucosal exposure to hepatitis B, United States. MMWR 40(RR-12):70, 1991.

21. Recommendations of the Immunization Practices Advisory Committee (ACIP): Update on Adult Immunization. Table 10. Recommendations for postexposure prophylaxis for perinatal and sexual exposure to hepatitis B, United States. MMWR 40(RR-12):71, 1991.

Talecris Biotherapeutics, Inc. Research Triangle Park, NC 27709 USA. (Rev. June 2007). FDA Rev date: n/a


This monograph has been modified to include the generic and brand name in many instances.

Side Effects

Local pain and tenderness at the injection site, urticaria and angioedema may occur; anaphylactic reactions, although rare, have been reported following the injection of human immune globulin preparations.19

Read the HyperHep B (hepatitis b immune globulin (human)) Side Effects Center for a complete guide to possible side effects

Interactions

Although administration of Hepatitis B Immune Globulin (Human) did not interfere with measles vaccination,18 it is not known whether Hepatitis B Immune Globulin (Human) may interfere with other live virus vaccines. Therefore, use of such vaccines should be deferred until approximately 3 months after Hepatitis B Immune Globulin (Human) administration. Hepatitis B Vaccine may be administered at the same time, but at a different injection site, without interfering with the immune response.16 No interactions with other products are known.

REFERENCES

16. Szmuness W, Stevens CE, Olesko WR, et al: Passive-active immunisation against hepatitis B: immunogenicity studies in adult Americans.Lancet1:575–77, 1981.

18. Beasley RP, Hwang LY: Measles vaccination not interfered with by hepatitis B immune globulin. Lancet 1:161, 1982.

19. Ellis EF, Henney CS: Adverse reactions following administration of human gamma globulin. J Allerg 43(1):45-54, 1969.

Read the HyperHep B Drug Interactions Center for a complete guide to possible interactions

Learn More »


This monograph has been modified to include the generic and brand name in many instances.

Warnings

HyperHEP B S/D is made from human plasma. Products made from human plasma may contain infectious agents, such as viruses, and, theoretically, the Creutzfeldt-Jakob Disease (CJD) agent that can cause disease. The risk that such products will transmit an infectious agent has been reduced by screening plasma donors for prior exposure to certain viruses, by testing for the presence of certain current virus infections, and by inactivating and/or removing certain viruses. Despite these measures, such products can still potentially transmit disease. There is also the possibility that unknown infectious agents may be present in such products. Individuals who receive infusions of blood or plasma products may develop signs and/or symptoms of some viral infections, particularly hepatitis C. ALL infections thought by a physician possibly to have been transmitted by this product should be reported by the physician or other healthcare provider to Talecris Biotherapeutics, Inc. [1-800-520-2807].

The physician should discuss the risks and benefits of this product with the patient, before prescribing or administering it to the patient.

HyperHEP B S/D should be given with caution to patients with a history of prior systemic allergic reactions following the administration of human immune globulin preparations. Epinephrine should be available.

In patients who have severe thrombocytopenia or any coagulation disorder that would contraindicate intramuscular injections, Hepatitis B Immune Globulin (Human) should be given only if the expected benefits outweigh the risks.

Precautions

General

HyperHEP B S/D should not be administered intravenously because of the potential for serious reactions. Injections should be made intramuscularly, and care should be taken to draw back on the plunger of the syringe before injection in order to be certain that the needle is not in a blood vessel.

Intramuscular injections are preferably administered in the anterolateral aspects of the upper thigh and the deltoid muscle of the upper arm. The gluteal region should not be used routinely as an injection site because of the risk of injury to the sciatic nerve. An individual decision as to which muscle is injected must be made for each patient based on the volume of material to be administered. If the gluteal region is used when very large volumes are to be injected or multiple doses are necessary, the central region MUST be avoided; only the upper, outer quadrant should be used.17

Laboratory Tests

None required.

Pregnancy Category C

Animal reproduction studies have not been conducted with HyperHEP B S/D . It is also not known whether HyperHEP B S/D can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. HyperHEP B S/D should be given to a pregnant woman only if clearly needed.

Pediatric Use

Safety and effectiveness in the pediatric population have not been established.

REFERENCES

17. Recommendations of the Immunization Practices Advisory Committee (ACIP): General recommendations on immunization. MMWR 38(13):205-14; 219-27, 1989.


This monograph has been modified to include the generic and brand name in many instances.

OverDose

Although no data are available, clinical experience with other immunoglobulin preparations suggests that the only manifestations would be pain and tenderness at the injection site.

ContrainDications

None known.


This monograph has been modified to include the generic and brand name in many instances.

Clinical Pharamacology

Hepatitis B Immune Globulin (Human) provides passive immunization for individuals exposed to the hepatitis B virus (HBV) as evidenced by a reduction in the attack rate of hepatitis B following its use.1-6 The administration of the usual recommended dose of this immune globulin generally results in a detectable level of circulating anti-HBs which persists for approximately 2 months or longer. The highest antibody (IgG) serum levels were seen in the following distribution of subjects studied: 7

DAY % OF SUBJECTS
3 38.9%
7 41.7%
14 11.1%
21 8.3%

Mean values for half-life were between 17.5 and 25 days, with the shortest being 5.9 days and the longest 35 days.7

Cases of type B hepatitis are rarely seen following exposure to HBV in persons with preexisting anti-HBs. No confirmed instance of transmission of hepatitis B has been associated with this product.

In a clinical study in eight healthy human adults receiving another hyperimmune immune globulin product treated with solvent/detergent, Rabies Immune Globulin (Human), HyperRAB™ S/D, prepared by the same manufacturing process, detectable passive antibody titers were observed in the serum of all subjects by 24 hours post injection and persisted through the 21 day study period. These results suggest that passive immunization with immune globulin products is not affected by the solvent/detergent treatment.

REFERENCES

1. Grady GF, Lee VA: Hepatitis B immune globulin — prevention of hepatitis from accidental exposure among medical personnel. N Engl J Med 293(21):1067–70, 1975.

2. Seeff LB, Zimmerman HJ, Wright EC, et al: Efficacy of hepatitis B immune serum globulin after accidental exposure. Lancet2(7942):939-41, 1975.

3. Krugman S, Giles JP: Viral hepatitis, type B (MS-2-strain). Further observations on natural history and prevention. N Engl J Med 288(15):755-60, 1973.

4. Current trends: Health status of Indochinese refugees: malaria and hepatitis B. MMWR 28(39):463-4; 469-70, 1979.

5. Jhaveri R, Rosenfeld W, Salazar JD, et al: High titer multiple dose therapy with HBIG in newborn infants of HBsAg positive mothers. J Pediatr 97(2):305–8, 1980.

6. Hoofnagle JH, Seeff LB, Bales ZB, et al: Passive-active immunity from hepatitis B immune globulin. Ann Intern Med 91(6):813-8, 1979.

7. Scheiermann N, Kuwert EK: Uptake and elimination of hepatitis B immunoglobulins after intramuscular application in man. Dev Biol Stand 54:347-55, 1983.


This monograph has been modified to include the generic and brand name in many instances.

Patient Information

No information provided. Please refer to the WARNINGS and PRECAUTIONS sections.


This monograph has been modified to include the generic and brand name in many instances.

Consumer Overview Uses

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

 

HEPATITIS B IMMUNE GLOBULIN - INJECTION

 

(hep-a-TYE-tis bee i-MYUN-GLOB-yoo-lin)

 

COMMON BRAND NAME(S): Hepagam B, Hyperhep B S-D, Nabi-HB

 

WARNING: This medication may rarely cause serious blood clots (such as pulmonary embolism, stroke, heart attack, deep vein thrombosis). You may be at increased risk for blood clots if you are an older adult, are severely dehydrated, have a catheter in a vein close to your heart for administering medications, or have a history of blood clots, heart/blood vessel disease, heart failure, stroke, or if you are immobile (such as very long plane flights or bedridden). If you use estrogen-containing products, these may also increase your risk. Before using this medication, discuss the risks and benefits and if you have any of these conditions, report them to your doctor or pharmacist.

Being adequately hydrated before and after receiving this medication may help reduce your risk of blood clots. If you are receiving this medication into a vein, the risk may also be decreased by infusing this medication more slowly or by using a less concentrated form of this medication if available.

Get medical help right away if any of these side effects occur: shortness of breath/rapid breathing, chest/jaw/left arm pain, unusual sweating, sudden dizziness/fainting, pain/swelling/warmth in the arm/leg, sudden/severe headache, slurred speech, weakness on one side of the body, sudden vision changes, or confusion.

 

USES: This medication is used to prevent a certain serious virus infection (hepatitis B) in people who have been exposed to this virus under certain conditions (such as direct contact with blood or body fluids containing this virus). Certain brands of this medication may also be given after a liver transplant to prevent return of hepatitis B infection in people with previous infection. Ask your doctor or pharmacist if you have questions about your particular brand. This medication is made from healthy human blood that has high levels of certain defensive substances (antibodies) that help fight hepatitis B.

 

HOW TO USE: If this medication is given for prevention of hepatitis B after direct exposure to the virus, it is given by injection into a muscle by a healthcare professional. It is best to receive this medication as soon as possible after exposure. If you wait too long after being exposed, the medication may not be effective. Your doctor may also recommend vaccination after receiving this medication. Talk with your doctor about the best treatment for you.

If this medication is given after a liver transplant to prevent return of hepatitis B infection, it is given by injection into a vein by a healthcare professional. For this use, it should be given on a regular schedule. To help you remember, mark your calendar with an appointment reminder.

The dosage and schedule of injections is based on your medical condition, weight, and response to treatment.

Consumer Overview Side Effect

SIDE EFFECTS: See also Warning section.

Redness, pain, or tenderness at the injection site may occur. Nausea, vomiting, fever, chills, dizziness, headache, or back/joint pain may also occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist promptly.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

 

Read the HyperHep B (hepatitis b immune globulin (human)) Side Effects Center for a complete guide to possible side effects

Learn More »

PRECAUTIONS: See also Warning section.

Before receiving hepatitis B immune globulin, tell your doctor or pharmacist if you are allergic to it; or to other immune globulin products; 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 the blood is carefully tested, and this medication goes through a special manufacturing process, there is an extremely small chance that you may get infections (such as hepatitis A) from the medication. Consult your doctor or pharmacist for more information.

Some immune globulin products are made with maltose. This substance can cause false high blood sugar levels when your blood sugar is normal or even low. If you have diabetes, check with your doctor or pharmacist whether the product you are using contains maltose and whether your blood sugar testing supplies will work with this product. Rarely, serious problems have occurred when too much insulin was given because of false high sugar readings or when low blood sugar went untreated.

Tell your doctor of any recent or planned immunizations/vaccinations. This medication may prevent a good response to certain live viral vaccines (such as measles, mumps, rubella, varicella). If you have recently received any of these vaccines, your doctor may have you tested for a response or have you vaccinated again later. If you plan on getting any of these vaccines, your doctor will instruct you about the best time to receive them so you get a good response.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is not known whether this drug passes into breast milk. Consult your doctor before breast-feeding.

Consumer Overview Missed Dose

DRUG INTERACTIONS: See also Warning section.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

This medication may interfere with certain tests (including certain blood sugar tests, Coomb's test), possibly causing false test results. The blood sugar interference can lead to serious (possibly fatal) consequences. Tell all laboratory personnel and all your doctors and pharmacists that you use this medication, and which type of blood sugar testing strips you use.

 

OVERDOSE: If overdose is suspected, contact a poison control center or emergency room immediately. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

 

NOTES: If you are receiving this medication on a regular schedule, laboratory and/or medical tests (such as levels of antibody in the blood) may be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.

 

MISSED DOSE: For the best possible benefit, it is important to receive each scheduled dose of this medication as directed. If you miss a dose, contact your doctor immediately to establish a new dosing schedule.

 

STORAGE: Not applicable. This medication is given in a hospital or doctor's office and will not be stored at home.

 

Information last revised June 2013. Copyright(c) 2013 First Databank, Inc.

Patient Detailed Side Effect

Brand Names: HepaGam B, HepaGam B NovaPlus, Hyperhep B, Nabi-HB

Generic Name: hepatitis B immune globulin (Pronunciation: HEP a TYE tis B im MYOON GLOB yoo lin)

  • What is hepatitis B immune globulin (HyperHep B)?
  • What are the possible side effects of hepatitis B immune globulin (HyperHep B)?
  • What is the most important information I should know about hepatitis B immune globulin (HyperHep B)?
  • What should I discuss with my health care provider before receiving hepatitis B immune globulin (HyperHep B)?
  • How is hepatitis B immune globulin given (HyperHep B)?
  • What happens if I miss a dose (HyperHep B)?
  • What happens if I overdose (HyperHep B)?
  • What should I avoid while receiving hepatitis B immune globulin (HyperHep B)?
  • What other drugs will affect hepatitis B immune globulin (HyperHep B)?
  • Where can I get more information?

What is hepatitis B immune globulin (HyperHep B)?

Hepatitis B immune globulin is made from human plasma containing proteins that protect against the type B form of hepatitis (inflammation of the liver).

Hepatitis B immune globulin is used to prevent hepatitis B in people receiving a liver transplant, and in babies born to mothers infected with hepatitis B. It is also used to prevent hepatitis B in people who have been exposed to contaminated blood products, or through household or sexual contact with an infected person.

Hepatitis B immune globulin is not a vaccine. Therefore it will not provide long-term protection from hepatitis B. For long-term protection you must receive a hepatitis B vaccine such as Engerix-B, Recombivax HB, or Twinrix.

Hepatitis B immune globulin may also be used for other purposes not listed in this medication guide.

What are the possible side effects of hepatitis B immune globulin (HyperHep B)?

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:

  • increased blood pressure (severe headache, blurred vision, trouble concentrating, chest pain, numbness, seizure);
  • left-sided stomach pain; or
  • nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Less serious side effects may include:

  • upset stomach, diarrhea;
  • tremors or shaking;
  • joint or back pain;
  • fever, chills;
  • headache; or
  • tired feeling.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

Read the HyperHep B (hepatitis b immune globulin (human)) Side Effects Center for a complete guide to possible side effects

Learn More »

What is the most important information I should know about hepatitis B immune globulin (HyperHep B)?

Hepatitis B immune globulin is not a vaccine. Therefore it will not provide long-term protection from hepatitis B. For long-term protection you must receive a hepatitis B vaccine such as Engerix-B, Recombivax HB, or Twinrix.

You should not receive this medication if you are allergic to human globulins, or if you have an immunoglobulin A deficiency. Hepatitis B immune globulin should not be injected into your muscle if you have a bleeding or blood clotting disorder such as hemophilia.

Hepatitis B immune globulin is made from human plasma (part of the blood) and may contain viruses and other infectious agents that can cause disease. Although donated human plasma is screened, tested, and treated to reduce the risk of it containing anything that could cause disease, there is still a small possibility it could transmit disease. Talk with your doctor about the risks and benefits of using this medication.

To be sure this medication is helping your condition, your blood will need to be tested often. This will help your doctor determine how long to treat you with hepatitis B immune globulin. Your liver function will also need to be tested. Do not miss any scheduled visits to your doctor.

Do not receive a "live" vaccine while you are being treated with hepatitis B immune globulin, and for at least 3 months after your treatment ends. The live vaccine may not work as well during this time, and may not fully protect you from disease.

Side Effects Centers
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  • HyperHep B
  • Nabi HB

Patient Detailed How Take

What should I discuss with my health care provider before receiving hepatitis B immune globulin (HyperHep B)?

You should not receive this medication if you are allergic to human globulins, or if you have an immunoglobulin A deficiency. Hepatitis B immune globulin should not be injected into your muscle if you have a bleeding or blood clotting disorder such as hemophilia.

Hepatitis B immune globulin is made from human plasma (part of the blood) and may contain viruses and other infectious agents that can cause disease. Although donated human plasma is screened, tested, and treated to reduce the risk of it containing anything that could cause disease, there is still a small possibility it could transmit disease. Talk with your doctor about the risks and benefits of using this medication.

FDA pregnancy category C. This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment.

It is not known whether hepatitis B immune globulin passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How is hepatitis B immune globulin given (HyperHep B)?

Hepatitis B immune globulin is given as an injection into a muscle or through a needle placed into a vein. Your doctor, nurse, or other healthcare provider will give you this injection.

Hepatitis B immune globulin is given to liver transplant patients as part of the transplant procedure, and then for several weeks or months afterward. The medication is usually given to transplant patients as an IV (injected into a vein) every day for 7 days, then every 2 weeks for the next 11 weeks, followed by monthly injections from then on.

To be sure this medication is helping your condition, your blood will need to be tested often. This will help your doctor determine how long to treat you with hepatitis B immune globulin after your transplant. Your liver function will also need to be tested. Do not miss any scheduled visits to your doctor.

To protect against hepatitis B after exposure to the disease, this medication is usually given as soon as possible after exposure to an infected person. A booster medication is then given 24 hours later.

Babies born to mothers infected with hepatitis B should receive this medication within 12 hours of birth, or when the newborn is otherwise medically stable.

For people who have had sexual contact with someone infected with hepatitis B, this medication should be given within 14 days after the last contact. The medication may also be given at any time if contact with the infected person will continue.

Any infant whose parent or caregiver is infected with hepatitis B should receive this medication.

This medication can cause you to have unusual results with certain medical tests, including some blood glucose tests. Tell any doctor who treats you that you are receiving hepatitis B immune globulin.

Side Effects Centers
  • HepaGam B
  • HyperHep B
  • Nabi HB

Patient Detailed Avoid Taking

What happens if I miss a dose (HyperHep B)?

Call your doctor for instructions if you miss a dose, or if you miss an appointment to have your injection given.

What happens if I overdose (HyperHep B)?

An overdose of this medication is not expected to produce life-threatening side effects. Overdose symptoms may include pain or tenderness where the injection was given.

What should I avoid while receiving hepatitis B immune globulin (HyperHep B)?

Do not receive a "live" vaccine while you are being treated with hepatitis B immune globulin, and for at least 3 months after your treatment ends. The live vaccine may not work as well during this time, and may not fully protect you from disease.

What other drugs will affect hepatitis B immune globulin (HyperHep B)?

There may be other drugs that can interact with hepatitis B immune globulin. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

Where can I get more information?

Your doctor or pharmacist may have information about this medication written for health professionals that you may read. You may also find additional information from your local health department or the Centers for Disease Control and Prevention.


Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2013 Cerner Multum, Inc. Version: 1.06. Revision date: 12/15/2010.

Your use of the content provided in this service indicates that you have read,understood and agree to the End-User License Agreement,which can be accessed by clicking on this link.

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