Documents
Hypermunes Patient Assistance Program Application
Get access to HyperHEP B for your patient
Hepatitis B Immune Globulin (Human)
Prescribing information for HyperHEP B
Patient Assistance Program
No patient should have to face the threat of hepatitis B. That's why Grifols created the Patient Assistance Program (PAP), to ensure uninsured patients have access to treatment with HyperHEP B. Patients applying for assistance through the PAP must meet the following criteria in order to be eligible for assistance:
- Earn an annual gross income of 250% of the Federal Poverty Level (FPL) or less. If the annual gross income exceeds 250% of FPL, PAP denial will be issued
- Patients must be uninsured in order to be eligible for product assistance
- Documentation of proof of income
- Diagnosis and dosing must be consistent with FDA-approved label
- Must be a US citizen or resident and must physically reside in the US or US territory, Puerto Rico, or other US territories
- Under the care of a US licensed prescriber with an established practice located in the US
- Documentation of proof of residency will not routinely be required but may be requested at any time by the program through an audit (eg, copy of current valid driver's license or recent utility bill)
- Patient will receive 1 dose as prescribed
- Federally funded patients are not eligible to receive assistance through the PAP. This includes but is not limited to Medicare, Medicaid (including spend downs), Tricare, and VA benefits
Frequently Asked Questions (FAQs)
What is hepatitis B?
Hepatitis B is liver infection caused by the hepatitis B virus (HBV). For some, HBV can cause sickness that lasts for a few weeks (known as "acute" infection), while others may contract a lifelong, chronic illness.1
How is hepatitis B contracted?
Hepatitis B can be transmitted through the blood or other bodily fluids of a contaminated person to a noncontaminated person. This happens through sexual contact with an infected person, sharing of drugs or needles, percutaneous (through the skin) exposures, needlesticks or sharps if you work in a medical environment, and, if a mother is infected, she can pass HBV to her child.1
What are the symptoms?
The symptoms patients may encounter if exposed to hepatitis B are fever, fatigue, nausea, loss of appetite, joint or abdominal pain, vomiting, dark urine, light-colored stool, and yellowing of the skin and whites of the eyes. About one-third to half of people with acute hepatitis B will show symptoms, but children—especially those <5 years of age—will not necessarily show any symptoms of hepatitis B.1
How can I prevent hepatitis B?
Hepatitis B vaccine is recommended by the CDC to prevent hepatitis B. If hepatitis B exposure is suspected, your doctor may give you a shot of hepatitis B immune globulin, such as HyperHEP B, instead of the vaccine or in conjunction with the vaccine, to prevent infection.1
What is a hepatitis B immune globulin, and why isn't a vaccine enough?
Hepatitis B immune globulin is a treatment that contains immediate antibodies against hepatitis B. An immune globulin works much faster than a vaccine but does not last as long. After exposure you may decide to give your patients a hepatitis B immune globulin shot like HyperHEP B and a vaccine to make sure they get the comprehensive care they need.2,3
Important Safety Information for HyperHEP B® (hepatitis B immune globulin [human])
HyperHEP B® (hepatitis B immune globulin [human]) is indicated for postexposure prophylaxis in the following situations: acute exposure to blood containing HBsAg, perinatal exposure of infants born to HBsAg-positive mothers, sexual exposure to an HBsAg-positive person, and household exposure to persons with acute HBV infection.
HyperHEP B 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.
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.
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 immunoglobulin preparations. Administration of live virus vaccines (eg, MMR) should be deferred for approximately 3 months after hepatitis B immune globulin (human) administration.
HyperHEP B 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. There is also the possibility that unknown infectious agents may be present in such products.
Please see full Prescribing Information for HyperHEP B.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
References
- Centers for Disease Control and Prevention. Hepatitis B Information. Frequently Asked Questions for the Public. http://www.cdc.gov/hepatitis/hbv/bfaq.htm. Accessed June 6, 2023.
- U.S. Public Health Service. Updated U.S. Public Health Service guidelines for the management of occupational exposures to HBV, HCV, and HIV and recommendations for postexposure prophylaxis. MMWR Recomm Rep. 2001;50(RR-11):1-52. 3
- Centers for Disease Control and Prevention. Hepatitis B. In: Hall E, Wodi AP, Hamborsky J, Morelli V, Schillie S, eds. Epidemiology and Prevention of Vaccine-Preventable Diseases. 14th ed. Washington, DC. Public Health Foundation; 2021.