HyperTET^®

(tetanus immune globulin [human])

Treating With HyperTET

HyperTET 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.

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 contains high titers of tetanus antibodies and provides passive immunity for postexposure prophylaxis to a tetanus exposure.¹

According to the Centers for Disease Control and Prevention (CDC), the use of a TIG such as HyperTET 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 65 years of consistent supply and product support⁶
Not made with mercury (thimerosal) or natural rubber latex
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

Clinical Efficacy

Immediate Protection With HyperTET¹

HyperTET 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.

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

HyperTET 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. 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 Tetanus^1,5

In a clinical study from 1961-1962

Twenty 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.

Six 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

Always a leader. Always dependable.

Grifols has provided more than 65 years of consistent supply and product support.

HyperTET offers^1,6:

A product that is preservative free and not made with mercury (thimerosal) or natural rubber latex
US Food and Drug Administration (FDA) labeling for capacity to remove pathogenic prions
Low procoagulant activity⁷
Low levels of immunoglobulin G (IgG) aggregates⁷
Tamper-evident packaging

Proven virus clearance capacity¹

HyperTET is produced using a sophisticated caprylate/chromatography purification process that employs the highest quality and safety standards.

Main steps of the manufacturing process:

Caprylate precipitation

Depth filtration

Nanofiltration

Caprylate incubation

Low pH final container incubation

Column chromatography

The capacity of the HyperTET manufacturing process to remove and/or inactivate viruses has been demonstrated by laboratory spiking studies on a scaled-down process model using a wide range of viruses with diverse physicochemical properties.

The caprylate/chromatography manufacturing process was also investigated for its capacity to decrease the infectivity of an experimental agent of transmissible spongiform encephalopathy (TSE), considered as a model for the variant Creutzfeldt-Jakob disease (vCJD) and Creutzfeldt-Jakob disease (CJD) agents. These studies provide reasonable assurance that low levels of vCJD/CJD agent infectivity, if present in the starting material, would be removed by the caprylate/chromatography manufacturing process.

HyperTET is made from human blood and may carry a risk of transmitting infectious agents, eg, viruses, the vCJD agent, and, theoretically, the CJD agent.

Traceability and Transparency of Information

Grifols employs a comprehensive tracking 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 HyperTET¹

Routine Prophylaxis Dosage Schedule

Children younger than 7 years of age

Dosage: 4.0 units/kg*

Children 7 years of age and older and adults

Dosage: 250-IU IM injection

Routine Prophylaxis Dosage Schedule	Dosage
Children younger than 7 years of age	4.0 units/kg*
Children 7 years of age and older and adults	250-IU IM injection

Active Tetanus

All ages

Dosage (under 250-IU IM): Standard therapy for the treatment of active tetanus including the use of HyperTET must be implemented immediately. The dosage should be adjusted according to the severity of the infection

*It may be advisable to administer the entire contents of the syringe of HyperTET (250 units) regardless of the child's size.
IM, intramuscular; IU, international unit.

*It may be advisable to administer the entire contents of the syringe of HyperTET (250 units) regardless of the child's size.
IM, intramuscular; IU, international unit.
Active Tetanus	Dosage (under 250-IU IM)
All ages	Standard therapy for the treatment of active tetanus including the use of HyperTET must be implemented immediately. The dosage should be adjusted according to the severity of the infection

Coding Information

Coding System

HCPCS (Healthcare Common Procedure Coding System) Code*

Coding for HyperTET: J1670

Description: Injection, tetanus immune globulin, human, up to 250 units

Administration Procedures CPT Code†

Coding for HyperTET: 96372

Description: Therapeutic, prophylactic, or diagnostic injection (specify substance or drug); intramuscular

ICD-10-CM‡

Coding for HyperTET: A35

Description: Other tetanus

Product NDC§

Coding for HyperTET: 13533-0634-02

Description: 250-unit syringe

*Centers for Medicare and Medicaid Services (CMS). HCPCS file located at:
http://www.cms.gov/Medicare/Coding/HCPCSReleaseCodeSets/Alpha-Numeric-HCPCS.html.
†Current Procedural Terminology (CPT) 5-digit codes, nomenclature, and other data are ©2019 American Medical Association (AMA).
‡Optum, ICD-10-CM for Hospitals and Payers, Volumes 1, 2, and 3, publisher of the official code set issued by the Department of Health and Human Services.
§For billing purposes, an 11-digit National Drug Code (NDC) is required.

The information is provided for informational purposes only and is subject to change. Providers are encouraged to contact their payers for specific information. Coding rules and guidelines are subject to payer discretion and should always be verified by the paying entity. Healthcare providers make the ultimate determination as to when to use a specific product, based on clinical appropriateness for a patient. This guide is not intended to provide specific guidance on how to use, code, bill, or charge for any product or service. Third-party payment for medical products and services is affected by numerous factors, and Grifols cannot make any representation or guarantee concerning reimbursement or coverage for any service or item.

*Centers for Medicare and Medicaid Services (CMS). HCPCS file located at:
http://www.cms.gov/Medicare/Coding/HCPCSReleaseCodeSets/Alpha-Numeric-HCPCS.html.
†Current Procedural Terminology (CPT) 5-digit codes, nomenclature, and other data are ©2019 American Medical Association (AMA).
‡Optum, ICD-10-CM for Hospitals and Payers, Volumes 1, 2, and 3, publisher of the official code set issued by the Department of Health and Human Services.
§For billing purposes, an 11-digit National Drug Code (NDC) is required.

The information is provided for informational purposes only and is subject to change. Providers are encouraged to contact their payers for specific information. Coding rules and guidelines are subject to payer discretion and should always be verified by the paying entity. Healthcare providers make the ultimate determination as to when to use a specific product, based on clinical appropriateness for a patient. This guide is not intended to provide specific guidance on how to use, code, bill, or charge for any product or service. Third-party payment for medical products and services is affected by numerous factors, and Grifols cannot make any representation or guarantee concerning reimbursement or coverage for any service or item.
Coding System	Coding for HyperTET	Description
HCPCS (Healthcare Common Procedure Coding System) Code*	J1670	Injection, tetanus immune globulin, human, up to 250 units
Administration Procedures CPT Code†	96372	Therapeutic, prophylactic, or diagnostic injection (specify substance or drug); intramuscular
ICD-10-CM‡	A35	Other tetanus
	Z23	Encounter for immunization
	Z41.8	Encounter for other procedures for purposes other than remedying health state
Product NDC§	13533-0634-02	250-unit syringe

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Important Safety Information for HyperTET^® (tetanus immune globulin [human])

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.

References:

HyperTET (tetanus immune globulin [human]) Prescribing Information. Grifols.
Baxter D. Active and passive immunity, vaccine types, excipients and licensing. Occup Med (Lond). 2007;57(8):552-556.
Wodi AP, Morelli V. Principles of vaccination. In: Hall E, Wodi AP, Hamborsky J, et al, eds. Epidemiology and Prevention of Vaccine-Preventable Diseases. 14th ed. Public Health Foundation; 2021:1-8. Accessed November 17, 2023. https://www.cdc.gov/vaccines/pubs/pinkbook/downloads/prinvac.pdf.
Tiwari TSP, Moro PL, Acosta AM. Tetanus. In: Hall E, Wodi AP, Hamborsky J, et al, eds. Epidemiology and Prevention of Vaccine-Preventable Diseases. 14th ed. Public Health Foundation; 2021:315-328. Accessed November 17, 2023. https://www.cdc.gov/vaccines/pubs/pinkbook/downloads/tetanus.pdf.
Nation NS, Pierce NF, Adler SJ, Chinnock RF, Wehrle PF. Tetanus; the use of human hyperimmune globulin in treatment. Calif Med. 1963;98(6):305-307.
Data on file, Grifols.
Srivastava J, Talton C, Vandeberg P, Woznichak M, Merritt WK, Jose M. Caprylate/chromatography process to produce highly purified tetanus immune globulin from human plasma. Epidemiol Infect. 2022;150:e172.

HyperTET®