Treating With HyperTET S/D

HyperTET S/D is a tetanus immune globulin (TIG) that provides rapid immune coverage, indicated for prophylaxis against tetanus following injury in patients whose immunization is incomplete or uncertain. It is also indicated, although evidence of effectiveness is limited, in the regimen of treatment of active cases of tetanus. HyperTET is the only TIG currently available in the United States.1  

Although vaccines can provide lifelong protection, they can take weeks to build efficacy. A TIG provides immediate protection, which allows the vaccine the time needed to establish active immunity in high-risk situations.2,3 HyperTET S/D contains high titers of tetanus antibodies and provides passive immunity for postexposure prophylaxis to a tetanus exposure.2,3

According to the Centers for Disease Control and Prevention (CDC), the use of a TIG such as HyperTET S/D may, if promptly administered, reduce the potentially life-threatening risk of tetanus when administered concomitantly with the tetanus vaccine.1,4  

Trusted Dependability

  • Established history—more than 45 years of consistent supply and product support
  • Mercury (thimerosal) and latex free
  • US Food and Drug Administration (FDA) labeling for capacity to remove pathogenic prions
  • Convenient prefilled syringes with BD UltraSafe® Needle Guards* to protect against needlestick injury
  • Tamper-evident packaging
  • 36-month shelf life

Clinical Efficacy

Immediate Protection With HyperTET S/D1

HyperTET S/D supplies passive immunity to those individuals who have low or no immunity to the toxin produced by the tetanus organism, Clostridium tetani. The antibodies act to neutralize the free form of the powerful exotoxin produced by this bacterium.1  

If passive immunization is needed, the human tetanus immune globulin HyperTET S/D, the only TIG available in the United States, is indicated.1  

HyperTET S/D contains high titers of tetanus antibodies for PEP, providing rapid immune protection for up to 21 days. Peak blood levels of immunoglobulin G (IgG) are obtained approximately 2 days after intramuscular injection.1  The half-life of IgG in the circulation of individuals with normal IgG levels is approximately 23 days.

The Value of Human Tetanus Antitoxin in the Treatment of Active Tetanus1,5

In a clinical study from 1961-19625

20 patients were treated with HyperTET (single doses of 3000 to 6000 international units) in combination with other clinical and nursing procedures on admission to the hospital or as soon as the diagnosis was made. Larger doses were given to patients with either a rapidly progressing illness or short incubation period.

  • 6 patients 45 years of age or older died of causes other than tetanus

Prior to this study, the reported national death rate for tetanus was 60%.

Safety Is a Priority1

The removal and inactivation of spiked model enveloped and nonenveloped viruses during the manufacturing process has been validated in laboratory studies.

  • Studies of the HyperTET S/D manufacturing process have demonstrated that transmissible spongiform encephalopathy (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 Creutzfeldt-Jakob disease (CJD) or variant CJD agent infectivity, if present in the starting material, would be removed
  • HyperTET S/D is made from human blood and may carry a risk of transmitting infectious agents, eg, viruses, the variant Creutzfeldt-Jakob disease (vCJD) agent, and, theoretically, the CJD agent

Traceability and Transparency of Information

Grifols' manufacturing process has a comprehensive computer system called PediGri® that ensures full traceability from every donation.

  • Each plasma unit is coded and computer-traced from the start of the process until the units are transformed into a final product
  • Users can access the donation number and the viral screening conducted at the origin of the donation with the product lot number
    • Specific information is also available, including the total number of plasma units, the total volume of plasma, the certificate of analysis showing the plasma origin viral screening, and biochemical characteristics of the final product
  • Users can access the applicable product SPC/package insert for their country
 

For immediate, easy, and convenient access to all the information on the origin and quality of Grifols' plasma derivatives, visit www.pedigri.grifols.com.

Dosing Recommendations for HyperTET S/D1

Coding Information

Download an informational guide about the Hypermunes portfolio. 

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

HyperTET S/D 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 S/D 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 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. There is also the possibility that unknown infectious agents may be present in such products.

Please see full Prescribing Information for HyperTET S/D.

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:

  1. HyperTET S/D (tetanus immune globulin [human]) Prescribing Information. Grifols.
  2. Baxter D. Active and passive immunity, vaccine types, excipients and licensing. Occup Med (Lond). 2007;57(8):552-556.
  3. Centers for Disease Control and Prevention. Principles of vaccination. In: Hamborsky J, Kroger A, Wolfe S, eds. Epidemiology and Prevention of Vaccine-Preventable Diseases. 13th ed. Washington, DC: Public Health Foundation; 2015:1-8. http://cdc.gov/vaccines/pubs/pinkbook/downloads/prinvac.pdf. Accessed July 1, 2019.
  4. 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.
  5. Nation NS, Pierce NF, Adler SJ, Chinnock RF, Wehrle PF. Tetanus: the use of human hyperimmune globulin in treatment. Calif Med. 1963;98:305-307.