BayTet

BayTet information, interactions and side effects, Tetanus Immune Globulin (Human) — BayTet® (tetanus immune globulin human solvent/detergent treated 250 units) treated with solvent/detergent is a sterile solution of tetanus hyperimmune immune globulin for intramuscular administration; it contains no preservative. BayTet (tetanus immune globulin human solvent/detergent treated 250 units) is prepared by cold ethanol fractionation from the plasma of donors immunized with tetanus toxoid. The immune globulin is isolated from solubilized Cohn Fraction II. The Fraction II solution is adjusted to a final concentration of 0.3% tri-n-butyl phosphate (TNBP) and 0.2% sodium cholate. After the addition of solvent (TNBP) and detergent (sodium cholate), the solution is heated to 30°C and maintained at that temperature for not less than 6 hours. After the viral inactivation step, the reactants are removed by precipitation, filtration and finally ultrafiltration and diafiltration. BayTet (tetanus immune globulin human solvent/detergent treated 250 units) is formulated as a 15–18% protein solution at a pH of 6.4–7.2 in 0.21–0.32 M glycine. BayTet (tetanus immune globulin human solvent/detergent treated 250 units) is then incubated in the final container for 21–28 days at 20–27°C. The product is standardized against the U.S. Standard Antitoxin and the U.S. Control Tetanus Toxin and contains not less than 250 tetanus antitoxin units per container.

The removal and inactivation of spiked model enveloped and non-enveloped viruses during the manufacturing process for BayTet has been validated in laboratory studies. Human Immunodeficiency Virus, Type 1 (HIV-1), was chosen as the relevant virus for blood products; Bovine Viral Diarrhea Virus (BVDV) was chosen to model Hepatitis C virus; Pseudorabies virus (PRV) was chosen to model Hepatitis B virus and the Herpes viruses; and Reo virus type 3 (Reo) was chosen to model non-enveloped viruses and for its resistance to physical and chemical inactivation. Significant removal of model enveloped and non-enveloped viruses is achieved at two steps in the Cohn fractionation process leading to the collection of Cohn Fraction II: the precipitation and removal of Fraction III in the processing of Fraction II + IIIW suspension to Effluent III and the filtration step in the processing of Effluent III to Filtrate III. Significant inactivation of enveloped viruses is achieved at the time of treatment of solubilized Cohn Fraction II with TNBP/sodium cholate.

INDICATIONS

BayTet (tetanus immune globulin (human) solvent/detergent treated 250 units) is indicated for prophylaxis against tetanus following injury in patients whose immunization is incomplete or uncertain (see below). It is also indicated, although evidence of effectiveness is limited, in the regimen of treatment of active cases of tetanus.7,8,15

A thorough attempt must be made to determine whether a patient has completed primary vaccination. Patients with unknown or uncertain previous vaccination histories should be considered to have had no previous tetanus toxoid doses. Persons who had military service since 1941 can be considered to have received at least one dose, and although most of them may have completed a primary series of tetanus toxoid, this cannot be assumed for each individual. Patients who have not completed a primary series may require tetanus toxoid and passive immunization at the time of wound cleaning and debridement.2

The following table is a summary guide to tetanus prophylaxis in wound management:

Guide to Tetanus Prophylaxis in Wound Management2

 

History of Tetanus Immunization (Doses) Clean, Minor Wounds All Other Wounds*
Td TIG Td TIG
Uncertain or less than 3 Yes No Yes Yes
3 or more§ No|| No No No
* Such as, but not limited to, wounds contaminated with dirt, feces, soil, and saliva; puncture wounds; avulsions; and wounds resulting from missiles, crushing, burns and frostbite.
Adult type tetanus and diphtheria toxoids. If the patient is less than 7 years old, DT or DTP is preferred to tetanus toxoid alone. For persons ≥ 7 years of age, Td is preferred to tetanus toxoid alone. (see DOSAGE AND ADMINISTRATION)
Tetanus Immune Globulin (Human). §If only three doses of fluid tetanus toxoid have been received, a fourth dose of toxoid, preferably an adsorbed toxoid, should be given.
|| Yes if more than 10 years since the last dose.
Yes if more than 5 years since the last dose. (More frequent boosters are not needed and can accentuate side effects).

 

DOSAGE AND ADMINISTRATION

Routine prophylactic dosage schedule

Adults and children 7 years and older: BayTet, 250 units should be given by deep intramuscular injection (see PRECAUTIONS). At the same time, but in a different extremity and with a separate syringe, Tetanus and Diphtheria Toxoids Adsorbed (For Adult Use) (Td) should be administered according to the manufacturer’s package insert. Adults with uncertain histories of a complete primary vaccination series should receive a primary series using the combined Td toxoid. To ensure continued protection, booster doses of Td should be given every 10 years.2

Children less than 7 years old: In small children the routine prophylactic dose of BayTet (tetanus immune globulin (human) solvent/detergent treated 250 units) may be calculated by the body weight (4.0 units/kg). However, it may be advisable to administer the entire contents of the vial or syringe of BayTet (tetanus immune globulin (human) solvent/detergent treated 250 units) (250 units) regardless of the child’s size, since theoretically the same amount of toxin will be produced in the child’s body by the infecting tetanus organism as it will in an adult’s body. At the same time but in a different extremity and with a different syringe, Diphtheria and Tetanus Toxoids and Pertussis Vaccine Adsorbed (DTP) or Diphtheria and Tetanus Toxoids Adsorbed (For Pediatric Use) (DT), if pertussis vaccine is contraindicated, should be administered per the manufacturer’s package insert.

Note: The single injection of tetanus toxoid only initiates the series for producing active immunity in the recipient. The physician must impress upon the patient the need for further toxoid injections in 1 month and 1 year. Without such, the active immunization series is incomplete. If a contraindication to using tetanus toxoid-containing preparations exists for a person who has not completed a primary series of tetanus toxoid immunization and that person has a wound that is neither clean nor minor, only passive immunization should be given using tetanus immune globulin.2 See table under INDICATIONS.

Available evidence indicates that complete primary vaccination with tetanus toxoid provides long lasting protection ≥ 10 years for most recipients. Consequently, after complete primary tetanus vaccination, boosters-even for wound management-need be given only every 10 years when wounds are minor and uncontaminated. For other wounds, a booster is appropriate if the patient has not received tetanus toxoid within the preceding 5 years. Persons who have received at least two doses of tetanus toxoid rapidly develop antibodies.2 The prophylactic dosage schedule for these patients and for those with incomplete or uncertain immunity is shown on the table in INDICATIONS.

Since tetanus is actually a local infection, proper initial wound care is of paramount importance. The use of antitoxin is adjunctive to this procedure. However, in approximately 10% of recent tetanus cases, no wound or other breach in skin or mucous membrane could be implicated.17

Treatment of active cases of tetanus

Standard therapy for the treatment of active tetanus including the use of BayTet (tetanus immune globulin (human) solvent/detergent treated 250 units) must be implemented immediately. The dosage should be adjusted according to the severity of the infection.7,8

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. They should not be used if particulate matter and/or discoloration are present.

BayTet (tetanus immune globulin (human) solvent/detergent treated 250 units) is supplied with a syringe and an attached UltraSafe® Needle Guard for your protection and convenience. Please follow instructions below for proper use of syringe and UltraSafe® Needle Guard.

Directions for Syringe Usage

  1. Remove the prefilled syringe from the package. Lift syringe by barrel, not by plunger.
  2. Twist the plunger rod clockwise until the threads are seated.
  3. With the rubber needle shield secured on the syringe tip, push the plunger rod forward a few millimeters to break any friction seal between the rubber stopper and the glass syringe barrel.
  4. Remove the needle shield and expel air bubbles. [Do not remove the rubber needle shield to prepare the product for administration until immediately prior to the anticipated injection time.]
  5. Proceed with hypodermic needle puncture.
  6. Aspirate prior to injection to confirm that the needle is not in a vein or artery.
  7. Inject the medication.
  8. Keeping your hands behind the needle, grasp the guard with free hand and slide forward toward needle until it is completely covered and guard clicks into place. If audible click is not heard, guard may not be completely activated. (See Diagrams A and B)
  9. Place entire prefilled glass syringe with guard activated into an approved sharps container for proper disposal. (See Diagram C)

baytet1

A number of factors beyond our control could reduce the efficacy of this product or even result in an ill effect following its use. These include improper storage and handling of the product after it leaves our hands, diagnosis, dosage, method of administration, and biological differences in individual patients. Because of these factors it is important that this product be stored properly and that the directions be followed carefully during use.

HOW SUPPLIED

BayTet (tetanus immune globulin (human) solvent/detergent treated 250 units) is supplied in 250 unit prefilled disposable syringes with attached needles.

 

NDC Number Size
0026-0634-02 250 unit syringe

 

Storage

Store at 2–8°C (36–46°F). Solution that has been frozen should not be used.

Caution

U.S. federal law prohibits dispensing without prescription.

REFERENCES

2. Diphtheria, Tetanus, and Pertussis: Recommendations for Vaccine Use and Other Preventive Measures. Recommendations of the Immunization Practices Advisory Committee (ACIP). MMWR 40 (RR-10): 1-28, 1991.

7. Nation NS, Pierce NF, Adler SJ, et al: Tetanus: the use of human hyperimmune globulin in treatment. Calif Med 98(6):305-6, 1963.

8. Ellis M: Human antitetanus serum in the treatment of tetanus. Br Med J 1(5338):1123-6, 1963.

15. McCracken GH Jr., Dowell DL, Marshall FN: Double-blind trial of equine antitoxin and human immune globulin in tetanus neonatorum. Lancet 1(7710):1146-9, 1971.

17. Tetanus-Rates by year, United States, 1955-1984. Annual Summary 1984. MMWR 33 (54):61, 1986.

Bayer Corporation, Pharmaceutical Division, Elkhart, IN 46515 USA. Rev: March 2004.

SIDE EFFECTS

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.

DRUG INTERACTIONS

Antibodies in immunoglobulin preparations may interfere with the response to live viral vaccines such as measles, mumps, polio, and rubella. Therefore, use of such vaccines should be deferred until approximately 3 months after Tetanus Immune Globulin (Human) — BayTet® (tetanus immune globulin (human) solvent/detergent treated 250 units) administration. No interactions with other products are known.

WARNINGS

BayTet is made from human plasma. Products made from human plasma may contain infectious agents, such as viruses, that can cause disease. The risk that such products will transmit an infectious agent has been reduced by screening plasma donors for prior exposure to certain viruses, by testing for the presence of certain current virus infections, and by inactivating and/or removing certain viruses. Despite these measures, such products can still potentially transmit disease. There is also the possibility that unknown infectious agents may be present in such products. Individuals who receive infusions of blood or plasma products may develop signs and/or symptoms of some viral infections, particularly hepatitis C. ALL infections thought by a physician possibly to have been transmitted by this product should be reported by the physician or other healthcare provider to Bayer Corporation [1-800-288-8371].

The physician should discuss the risks and benefits of this product with the patient, before prescribing or administering it to the patient.

BayTet (tetanus immune globulin (human) solvent/detergent treated 250 units) 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, BayTet (tetanus immune globulin (human) solvent/detergent treated 250 units) should be given only if the expected benefits outweigh the risks.

PRECAUTIONS

General

BayTet (tetanus immune globulin (human) solvent/detergent treated 250 units) should not be given intravenously. Intravenous injection of immunoglobulin intended for intramuscular use can, on occasion, cause a precipitous fall in blood pressure, and a picture not unlike anaphylaxis. Injections should only be made intramuscularly and care should be taken to draw back on the plunger of the syringe before injection in order to be certain that the needle is not in a blood vessel. Intramuscular injections are preferably administered in the anterolateral aspects of the upper thigh and the deltoid muscle of the upper arm. The gluteal region should not be used routinely as an injection site because of the risk of injury to the sciatic nerve. If the gluteal region is used, the central region MUST be avoided; only the upper, outer quadrant should be used.16

Chemoprophylaxis against tetanus is neither practical nor useful in managing wounds. Wound cleaning, debridement when indicated, and proper immunization are important. The need for tetanus toxoid (active immunization), with or without TIG (passive immunization), depends on both the condition of the wound and the patient’s vaccination history. Rarely has tetanus occurred among persons with documentation of having received a primary series of toxoid injections.2 See table under INDICATIONS.

Skin tests should not be done. The intradermal injection of concentrated IgG solutions often causes a localized area of inflammation which can be misinterpreted as a positive allergic reaction. In actuality, this does not represent an allergy; rather, it is localized tissue irritation. Misinterpretation of the results of such tests can lead the physician to withhold needed human antitoxin from a patient who is not actually allergic to this material. True allergic responses to human IgG given in the prescribed intramuscular manner are rare. Although systemic reactions to human immunoglobulin preparations are rare, epinephrine should be available for treatment of acute anaphylactic reactions.

Pregnancy Category C

Animal reproduction studies have not been conducted with BayTet (tetanus immune globulin (human) solvent/detergent treated 250 units) . It is also not known whether BayTet (tetanus immune globulin (human) solvent/detergent treated 250 units) can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. BayTet (tetanus immune globulin (human) solvent/detergent treated 250 units) should be given to a pregnant woman only if clearly needed.

Pediatric Use

Safety and effectiveness in the pediatric population have not been established.

REFERENCES

2. Diphtheria, Tetanus, and Pertussis: Recommendations for Vaccine Use and Other Preventive Measures. Recommendations of the Immunization Practices Advisory Committee (ACIP). MMWR 40 (RR-10): 1-28, 1991.

16. Recommendations of the Immunization Practices Advisory Committee (ACIP): General recommendations on immunization. MMWR 38(13): 205-14; 219-27, 1989.

OVERDOSE

Although no data are available, clinical experience with other immunoglobulin preparations suggests that the only manifestations would be pain and tenderness at the injection site.

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