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patient assistance program

Patient Assistance Program

No patient should have to face the threat of tetanus. That's why Grifols created the Patient Assistance Program (PAP), to ensure uninsured patients have access to treatment with HyperTET. 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 it not limited to Medicare, Medicaid (including spend downs), Tricare, and VA benefits

Download either the print friendly or the electronically editable Patient Assistance Program application to get access to HyperTET for your patient.

resources FAQ

Frequently Asked Questions (FAQs)

Tetanus is a toxin that is produced by a bacterium called Clostridium tetani. These bacteria cannot grow if exposed to oxygen, which is why very deep wounds can be prone to infection. The spores produced by the bacteria cause an acute, life-threatening disease and are extremely hard to kill because they are resistant to both heat and many chemical agents that are used to eliminate bacteria.1

The spores responsible for tetanus can be found in soil and in intestines and feces of many household and farm animals. The bacteria can enter the body through a puncture wound. Tetanus cannot be spread from person to person.

There are 3 types of tetanus, with generalized tetanus being the most common type. The symptoms of generalized tetanus most commonly seen are spasms in the jaw muscle, followed by stiffness of the neck, difficulty swallowing, and rigidity of the abdominal muscles. Other symptoms include fever, sweating, elevated blood pressure, and rapid heart rate. Spasms often occur and may last for several minutes and continue for 3 to 4 weeks. Complete recovery, if it occurs, may take months.

Tetanus can be fatal; the best treatment for tetanus is prevention. You should make sure that your patients are up-to-date with tetanus vaccinations. If your patient has a wound that could possibly be contaminated by tetanus, or you're unsure of their immunization status, they will need both a dose of tetanus immune globulin (TIG)—such as HyperTET—as soon as possible and a tetanus-and-diphtheria-containing vaccine (Td or Tdap).

TIG is a treatment that contains high levels of tetanus antibodies and provides immediate protection by removing unbound tetanus toxin. Active immunization is still needed by a vaccine.

HyperTET should be administered following injury in patients whose tetanus immunization is incomplete or uncertain. Standard therapy for the treatment of active tetanus, including the use of HyperTET, must be implemented immediately. View dosage information in the full Prescribing Information to make sure you are administering the proper dosage for the severity of the infection.

HyperTET provides rapid immune protection for up to 21 days. Peak blood levels of immunoglobulin G (IgG) are obtained approximately 2 days after intramuscular injection. The half-life of IgG in the circulation of individuals with normal IgG levels is approximately 23 days.2

isi-hypertet

HyperTET® (tetanus immune globulin [human]) is indicated for prophylaxis against tetanus following injury in patients whose immunization is incomplete or uncertain.

HyperTET should be given with caution to patients with a history of prior systemic allergic reactions following the administration of human immunoglobulin preparations.

In patients who have severe thrombocytopenia or any coagulation disorder that would contraindicate intramuscular injections, HyperTET should be given only if the expected benefits outweigh the risks.

Slight soreness at the site of injection and slight temperature elevation may be noted at times. Sensitization to repeated injections of human immunoglobulin is extremely rare. In the course of routine injections of large numbers of persons with immunoglobulin, there have been a few isolated occurrences of angioneurotic edema, nephrotic syndrome, and anaphylactic shock after injection. Administration of live virus vaccines (eg, MMR) should be deferred for approximately 3 months after tetanus immune globulin (human) administration.

HyperTET 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 HyperTET.

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.


resources references

References:

  1. Centers for Disease Control and Prevention. Tetanus. In: Hamborsky J, Kroger A, Wolfe S, eds. Epidemiology and Prevention of Vaccine-Preventable Diseases. 13th ed. Washington, DC: Public Health Foundation; 2015:341-352. https:/www.cdc.gov/vaccines/pubs/pinkbook/downloads/tetanus.pdf. Accessed July 1, 2019.
  2. HyperTET (tetanus immune globulin [human]) Prescribing Information. Grifols.