Tetanus Immune Globulin (Human)

• Blood Product Derivative
• Immune Globulin

There are no contraindications listed in the manufacturer’s labeling.

There are no dosage adjustments provided in the manufacturer’s labeling.

Frequency not defined.

Central nervous system: Increased body temperature

Local: Local soreness/soreness at injection site, pain at injection site, tenderness at injection site

<1% (Limited to important or life-threatening): Anaphylactic shock, angioedema, nephrotic syndrome

• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

• Patient may experience short-term pain (HCAHPS).

• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for healthcare professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience and judgment in diagnosing, treating and advising patients.

Tetanus Immune Globulin (Human) -- BayTet treated with solvent/detergent is a sterile solution of tetanus hyperimmune immune globulin for intramuscular administration; it contains no preservative. BayTet 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 is formulated as a 15-18% protein solution at a pH of 6.4-7.2 in 0.21-0.32 M glycine. BayTet 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.

BayTet 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:

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.

BayTet 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

Rx only

U.S. federal law prohibits dispensing without prescription.