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The products discussed herein may only be dispensed with a prescription from a doctor or healthcare provider.
Hepatitis B virus (HBV) infection is a growing problem with serious long-term consequences. It can be a critical illness, associated with progressive and often fatal liver disease. Administration of hepatitis B vaccine alone may not be sufficient in protecting patients following exposure to the virus.
Effective Prophylaxis or Treatment
Administration of HyperHEP B™ S/D, Hepatitis B Immune Globulin (Human), provides rapid passive immunity and protection from HBV following exposure. HyperHEP B™ S/D when used with hepatitis B vaccine will provide both short-term and long-term protection. This combination therapy is the treatment of choice in preventing serious illness in the vulnerable population.
Recommended Use of HyperHEP B™ S/D, Hepatitis B Immune Globulin (Human)
Indications for post-exposure prophylaxis for persons requiring treatment, a regimen including both HyperHEP B™ S/D and hepatitis vaccine will provide both short-term and long-term protection against HBV in the following high risk populations: acute exposure to blood containing HBsAg, perinatal exposure of infants born to HBsAg and/or HBeAg-positive mothers, sexual exposure to an HBsAg-positive person, household exposure to persons with acute HBV infection.
In patients whose HBV antibody titer levels are inadequate, treatment with HyperHEP B™ S/D is recommended to provide added immune protection. Treatment should be administered as soon as possible following exposure.
For short-term, passive, transient post-exposure prevention of hepatitis B infection.
For Intramuscular Administration Only
Needle guard can protect against post-injection needlesticks
Available on selected Hypermunes™ products.
Product attributes
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Solvent/Detergent treatment for virus removal/inactivation (See Product Insert [PDF])
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Pre-filled syringes and vials for single-use IM injection only
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Tamper-evident packaging |
Contraindications, side effects, and precautions
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Use caution in persons with a history of prior systemic allergic reaction to human immune globulin products or a history of IgA deficiency
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Side effects such as local injection site reactions, urticaria and angioedema may occur
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Administration of live virus vaccines (eg, MMR) should be deferred for approximately 3 months after hepatitis B immune globulin (human) administration |
Hepatitis B (HBV) Information
Hepatitis B is an inflammation of the liver caused by the hepatitis B virus. The virus is transmitted in bodily fluids, such as blood, semen, breast milk, and in some circumstances, saliva. Some infected individuals experience no illness or symptoms at all. It is considered primarily a sexually transmitted disease. IV drug users who share syringes and healthcare workers also are at risk of contracting the disease.
Hepatitis B also can be spread from an infected mother to her fetus. Individuals infected with hepatitis B experience fatigue, skin rashes, loss of appetite, jaundice, and a tender, enlarged liver. The infection can be acute or chronic and can lead to a wide range of serious complications causing permanent damage to the liver, including cirrhosis and hepatocellular carcinoma (HCC).
Important Safety Information
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HyperHEP B S/D should be given with caution to patients with a history of prior systemic allergic reactions following the administration of human immunoglobulin preparations. Epinephrine should be available.
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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.
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Local pain and tenderness at the injection site, urtcaria, and angioedema, may occur; Anaphylactic reactions, although rare, have been reported following the injection of human immunoglobulin preparations.
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Administration of live virus vaccines (.e.g., MMR) should be deferred for approximately 3 months after Hepatitis B immune globulin (human) administration.
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As with all plasma-directed therapeutics, the potential to transmit infectious agents, such as viruses, cannot be totally eliminated. |
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