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FOR PATIENTS WITH A TETANUS-PRONE WOUND* AND AN UNKNOWN VACCINATION HISTORY,

WHEN IN DOUBT,
DON'T LEAVE ONE OUT.

A TETANUS VACCINE ALONE IS NOT
ALWAYS ENOUGH.

According to the CDC, the use of a TIG may, if promptly administered, reduce the potentially life-threatening risk of tetanus when administered concomitantly with the tetanus vaccine.1

CDC=Centers for Disease Control and Prevention.
*Puncture wounds, deep wounds, burns, frostbite, or any wounds with clinical evidence of sepsis or contamination.2

HyperTET S/D is indicated for prophylaxis against tetanus following injury in patients whose immunization is incomplete or uncertain.

MassBiologics' Tetanus and Diphtheria Toxoids Adsorbed (Td) is a vaccine indicated for active immunization for the prevention of tetanus and diphtheria. This vaccine is approved for use in persons 7 years of age and older.

FOR PATIENTS WITH A TETANUS-PRONE WOUND* AND AN UNKNOWN VACCINATION HISTORY,

A TETANUS VACCINE ALONE IS NOT ALWAYS ENOUGH

Why Use Tetanus Immune Globulin (TIG) in Postexposure Prophylaxis?1,3-5

Td=tetanus and diphtheria
*Puncture wounds, deep wounds, burns, frostbite, or any wounds with clinical evidence of sepsis or contamination.2

Provide an option for COMPLETE COVERAGE against tetanus with HyperTET S/D and Grifols Td vaccine to eliminate the unknowns around their tetanus infection

Established history with Grifols.
More than 15 years of consistent supply and product support.

HyperTET S/D

  • High titers of specific tetanus antibodies for postexposure prophylaxis
  • Mercury (thimerosal) and latex free
  • FDA labeling for pathogenic prion removal
  • Convenient prefi lled syringes with BD UltraSafe® Needle Guards to protect against needlestick injury
  • 36-month shelf life

NDC # 13533-634-02

Grifols Td vaccine

  • Meets FDA-approved tests to demonstrate efficacy
  • Preservative and latex free
  • 36-month shelf life

Individual single-dose
(0.5 mL) vial
NDC # 13533-131-00

Package of 10 single-dose
(0.5 mL) vials
NDC # 13533-131-01

HyperTET® S/D (tetanus immune globulin [human]) is made from human plasma. Products made from human plasma may contain infectious agents, such as viruses and theoretically, the Creutzfeldt-Jakob (CJD) agent that can cause disease. There is also the possibility that unknown infectious agents may be present in such products.

A severe allergic reaction (eg, anaphylaxis) occurring after a previous dose of this vaccine, or any other tetanus or diphtheria toxoid-containing vaccine, or any component of this vaccine is a contraindication to administration.

CONTACT INFORMATION

Customer Service: 1-800-243-4153

Medical Information: 1-800-520-2807

Grifols Td vaccine works WITHIN 2 WEEKS but is good for up to 10 years as a booster dose for routine vaccination and postexposure prophylaxis (PEP)4,6*

CDC GUIDELINES FOR TETANUS PEP1

An animal bite or severe dirty wound would leave patients at risk for tetanus1,7

*Tdap vaccine (tetanus, diphtheria, pertussis) may be substituted for Td vaccine if the person has not previously received Tdap and is aged ?10 years.

According to CDC tetanus surveillance data, an analysis of sufficiently complete case reports of patients with acute wounds who sought medical care revealed that 96% did not receive recommended PEP.8

Detectable passive antibody titers have been observed in patients WITHIN 24 HOURS post injection with immune globulin products such as HyperTET S/D. Peak blood levels of IgG are obtained approximately 48 HOURS post injection.4

Tetanus remains a rare but life-threatening disease in the United States. It leads to death in about 1 in 10 cases.1,9

CERTAIN HIGH-RISK PATIENTS ARE AT IMMINENT THREAT:

Immigrants and
visitors10

Patients not vaccinated
in childhood8

IV drug users8,11

Patients with diabetes,
or a chronic wound
or infection1

IgG=immunoglobulin G.
IV=intravenous.

isi

Important Safety Information for Tetanus Diphtheria Toxoids Adsorbed (Td)

MassBiologics' Tetanus and Diphtheria Toxoids Adsorbed (Td) is a vaccine indicated for active immunization for the prevention of tetanus and diphtheria. This vaccine is approved for use in persons 7 years of age and older.

A severe allergic reaction (eg, anaphylaxis) occurring after a previous dose of this vaccine, or any other tetanus or diphtheria toxoid-containing vaccine, or any component of this vaccine is a contraindication to administration. Because of the uncertainty as to which component of the vaccine might be responsible, no further vaccination with diphtheria or tetanus components should be carried out. Alternatively, such individuals may be referred to an allergist for evaluation if further immunizations are to be considered.

More frequent administration than described in the product insert may be associated with an increased incidence and severity of adverse reactions.

Persons who experienced an Arthus-type hypersensitivity reaction following a prior dose of a tetanus toxoid-containing vaccine usually have high serum tetanus antitoxin levels and should not receive Td more frequently than every 10 years, even for tetanus prophylaxis as part of wound management.

A review by the Institute of Medicine found evidence for a causal relation between tetanus toxoid and Guillain-Barré syndrome. If Guillain-Barré syndrome occurred within 6 weeks after receipt of a previous dose of tetanus toxoid-containing vaccine, the decision to give subsequent doses of this Td vaccine or any vaccine containing tetanus toxoid should be based on careful consideration of the potential benefits and possible risks.

Vaccination with MassBiologics' Td may not protect all individuals.

Epinephrine injection (1:1000) and other appropriate agents and equipment must be immediately available should an acute anaphylactic reaction occur.

Prior to the administration of MassBiologics' Td, the vaccine recipient's current health status and health history should be reviewed, including immunization history, presence of any contraindications to immunization, and any adverse events after previous immunizations.

If MassBiologics' Td is administered to immunocompromised persons (whether from disease or treatment) the expected immune response may not be obtained.

Prior to administration of MassBiologics' Td, healthcare providers should inform patients, parents, or guardians of the benefits and risks of immunization with Td; the importance of completing the primary immunization series or receiving recommended booster doses; the potential for adverse reactions associated with Mass Biologics' Td or other vaccines containing similar ingredients; and to report any suspected adverse reactions to the healthcare provider.

Patients who are on immunosuppressive therapy, including alkylating agents, antimetabolites, cytotoxic drugs, irradiation, or corticosteroids (used in greater than physiologic doses), may have a reduced immune response to vaccines.

No safety and immunogenicity data are available on the concomitant administration of MassBiologics' Td vaccine with other US licensed vaccines.

Data on adverse reactions following fluid and adsorbed preparations of MassBiologics' Td with various doses of the diphtheria and tetanus components have been reported in a series of studies.

The following adverse events have been identified during post-approval use of MassBiologics' Td and are included because of seriousness or frequency of reporting: Injection-site reactions, including pain, tenderness, erythema, induration, pruritus, swelling, and warmth; peripheral oedema; pyrexia; malaise; dizziness; headache; convulsions; myalgia; musculoskeletal stiffness or pain; arthralgia; rash; nausea; and cellulitis.

To report SUSPECTED ADVERSE REACTIONS, contact MassBiologics at 1-800-457-4626 or Vaccine Adverse Event Reporting System (VAERS) at 1-800-822-7967 or www.vaers.hhs.gov.

Please see full Prescribing Information for Tetanus Diphtheria Toxoids Adsorbed (Td).

Important Safety Information for HyperTET® S/D (tetanus immune globulin [human])

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

References:
  1. Centers for Disease Control and Prevention (CDC). 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.
  2. World Health Organization (WHO). Prevention and management of wound infection: guidance from WHO's Department of Violence and Injury Prevention and Disability and the Department of Essential Health Technologies. http://www.who.int/hac/techguidance/tools/guidelines_prevention_and_management_wound_infection.pdf. Accessed July 26, 2017.
  3. Abrahamian FM. Tetanus: an update on an ancient disease. Infect Dis Clin Pract. 2000;9(6):228-235.
  4. HyperTET® S/D (tetanus immune globulin [human]) Prescribing Information. Grifols.
  5. Siegrist CA. Vaccine immunology. In: Plotkin SA, Orenstein WA, Offit PA, eds. Vaccines. 6th ed. China: Saunders; 2013:17-36.
  6. Porter JD, Perkin MA, Corbel MJ, Farrington CP, Watkins JT, Begg NT. Lack of early antitoxin response to tetanus booster. Vaccine. 1992;10(5):334-336.
  7. Baddour LM, Harper M. Patient education: animal bites (beyond the basics). UpToDate website. http://www.uptodate.com/contents/animal-bites-beyond-the-basics. Updated February 15, 2017. Accessed July 11, 2017.
  8. Centers for Disease Control and Prevention (CDC). Tetanus surveillance—United States, 2001-2008. MMWR Morb Mortal Wkly Rep. 2011;60(12):365-369.
  9. Centers for Disease Control and Prevention (CDC). Td (tetanus, diphtheria) vaccine information statement. CDC website. https://www.cdc.gov/vaccines/hcp/vis/vis-statements/td.html. Updated April 11, 2017. Accessed July 11, 2017.
  10. Centers for Disease Control and Prevention (CDC). Update on adult immunization recommendations of the Immunization Practices Advisory Committee (ACIP). MMWR Morb Mortal Wkly Rep. 1991;40(RR-12):1-52.
  11. Centers for Disease Control and Prevention (CDC). Tetanus among injection-drug users—California, 1997. MMWR Morb Mortal Wkly Rep. 1998;47(8):149-151.

UltraSafe® Needle Guard is a registered trademark of Becton, Dickinson and Company.