HyperTET S/D

Tetanus Antitoxins and Immunoglobulins

Visually inspect parenteral products for particulate matter and discoloration prior to administration whenever solution and container permit.

Tetanus immune globulin is administered intramuscularly only. Do not administer intravenously.
Tetanus immune globulin should not be given in the same syringe or injected at the same site as tetanus toxoid.
Tetanus immune globulin does not contain preservatives.
 
Intramuscular injection:
Draw back on the syringe prior to injection to ensure the needle is not in a blood vessel. If a vessel is penetrated, withdraw the needle and use a new syringe and needle at a different injection site.
The gluteal region should not be routinely used as on injection site due to the risk of damage to the sciatic nerve. If the gluteal region is used, only the upper outer quadrant should be used; avoid the central region.
In adults and children: Intramuscular injections should be made into the deltoid muscle or into the anterolateral muscles of the thigh. The upper outer quadrant of the gluteus maximus should be used only if large volumes are administered or when large doses must be divided into multiple IM injections.
In neonates, infants, and small children: Intramuscular injections should be made into the anterolateral muscles of the thigh.

anaphylactic shock / Rapid / 0-1.0
angioedema / Rapid / 0-1.0
nephrotic syndrome / Delayed / Incidence not known

injection site reaction / Rapid / Incidence not known
fever / Early / Incidence not known
infection / Delayed / Incidence not known

HyperTET S/D

Rx

IgG containing tetanus antibodies; neutralizes exotoxin produced by Clostridium tetani; provides passive immunity; prophylaxis against tetanus post injury; adjunct in active tetanus infection.

The optimal dosage has not been established. 500 units IM once appears as effective as 3,000 to 6,000 units.[64478] May adjust the dose based on the infection severity.[64477]

The optimal dosage has not been established. 500 units IM once appears as effective as 3,000 to 6,000 units.[64478] May adjust the dose based on the infection severity.[64477]

The optimal dosage has not been established. 500 units IM once appears as effective as 3,000 to 6,000 units.[64478]   Consider maternal tetanus toxoid immunization history at the time of delivery in determining the need for therapy. May adjust the dose based on the infection severity.[64477]

The optimal dosage has not been established. 500 units IM once appears as effective as 3,000 to 6,000 units.[64478] Consider maternal tetanus toxoid immunization history at the time of delivery in determining the need for therapy. May adjust the dose based on the infection severity.[64477]

250 units IM once.

250 units IM once.

250 units IM once. Alternatively, 4 units/kg IM once.

250 units IM once.[64477] Alternatively, 4 units/kg IM once.[64477]

250 units IM once.[64477] Alternatively, 4 units/kg IM once.[64477] Consider maternal tetanus toxoid immunization history at the time of delivery in determining the need for therapy.

Specific guidelines for dosage adjustments in hepatic impairment are not available; it appears that no dosage adjustments are needed.

Specific guidelines for dosage adjustments in renal impairment are not available; it appears that no dosage adjustments are needed.

Measles Virus; Mumps Virus; Rubella Virus; Varicella Virus Vaccine, Live: (Major) Do not give immune globulin including varicella zoster immune globulin concurrently with the varicella-zoster virus vaccine, live. Because of the potential inhibition of the immune response to vaccination by passively transferred antibodies, it is advisable not to give varicella-zoster virus vaccine, live to any patient who has received blood (except washed red blood cells), plasma transfusions, or immunoglobulins within the previous 5 months. After varicella vaccination, the CDC recommends that immune globulin products should not be given for 3 weeks, unless the benefit outweighs the risk; the manufacturer recommends waiting 2 months before administering immunoglobulins. In the case that IgG products are administered within 3 weeks of vaccination, the vaccinee should be either revaccinated at 5 months or tested for immunity and revaccinated if seronegative. Consult current CDC guidelines for recommendations. (Major) Do not vaccinate patients with live virus vaccines for 3 months following administration of tetanus immune globulin. TIG contains antibodies that can interact with live virus vaccines. If is necessary to administer TIG simultaneously with live vaccines, administer at different sites and revaccinate or test for sero-conversion after 3 months.
Measles/Mumps/Rubella Vaccines, MMR: (Major) Do not vaccinate patients with live virus vaccines for 3 months following administration of tetanus immune globulin. TIG contains antibodies that can interact with live virus vaccines. If is necessary to administer TIG simultaneously with live vaccines, administer at different sites and revaccinate or test for sero-conversion after 3 months.
Rotavirus Vaccine: (Major) Defer vaccination with live virus vaccines such as Rotavirus Vaccine until approximately 3 months after Tetanus immune globulin administration. Inform the immunizing physician of recent therapy with the immune globulin so that appropriate measures can be taken. The efficacy of live attenuated virus vaccines such as Rotavirus Vaccine may be impaired by Tetanus immune globulin administration; revaccination may be necessary. The passive transfer of antibodies from the immune globulin may impair the efficacy of live attenuated virus vaccines.
Varicella-Zoster Virus Vaccine, Live: (Major) Do not give immune globulin including varicella zoster immune globulin concurrently with the varicella-zoster virus vaccine, live. Because of the potential inhibition of the immune response to vaccination by passively transferred antibodies, it is advisable not to give varicella-zoster virus vaccine, live to any patient who has received blood (except washed red blood cells), plasma transfusions, or immunoglobulins within the previous 5 months. After varicella vaccination, the CDC recommends that immune globulin products should not be given for 3 weeks, unless the benefit outweighs the risk; the manufacturer recommends waiting 2 months before administering immunoglobulins. In the case that IgG products are administered within 3 weeks of vaccination, the vaccinee should be either revaccinated at 5 months or tested for immunity and revaccinated if seronegative. Consult current CDC guidelines for recommendations.

HyperTET S/D Intramuscular Inj Sol: 1mL, 250U

250 units IM for prophylaxis; up to 6000 units IM has been suggested for treatment.

250 units IM for prophylaxis; up to 6000 units IM has been suggested for treatment.

250 units IM for prophylaxis; up to 6000 units IM has been suggested for treatment.

>= 7 years: 250 units IM for prophylaxis; up to 6000 units IM has been suggested for treatment.
< 7 years: 4 units/kg IM or 250 units IM for prophylaxis; up to 6000 units IM has been suggested for treatment.

Mechanism of Action: Tetanus immune globulin is a sterile solution of primarily immunoglobulin G (IgG) containing 15—18% protein. TIG is standardized against the US Standard Antitoxin and US Control Tetanus Toxin and contains not less than 250 tetanus antitoxin units per vial. The pooled monomeric IgG present in TIG provides a variety of antibodies capable of neutralizing the Clostridium tetani exotoxin by opsonization, resulting in complement activation and stimulation of cell-mediated immunity. The passive immunity imparted by TIG is capable of attenuating or preventing tetanus infection by binding free exotoxin. TIG will not reverse the effects of exotoxin already bound to nerve tissue. Passive immunization is not affected by solvent/detergent treatment.

Tetanus immune globulin is administered intramuscularly. Peak IgG levels are obtained approximately 2 days after administration. The half-life of IgG in the circulation is approximately 23 days.

Peak IgG levels are obtained approximately 2 days after administration of tetanus immune globulin (TIG).

Tetanus immune globulin (TIG) is an FDA pregnancy risk category C drug. No well-controlled studies have been conducted in pregnant women and it is unknown if TIG can cause fetal harm or affect the reproductive system. According to the Advisory Committee on Immunization Practices, administration of immune globulin preparations to pregnant women results in no known risk to the fetus.

No data are available from the manufacturer regarding use of tetanus immune globulin (TIG) during breast-feeding and it is not known if TIG is excreted in breast milk. Case reports of two nursing mothers receiving intravenous immune globulin therapy suggest transfer of IgG and IgM into the colostrum and breast milk. Consider the benefits of breast-feeding, the risk of potential infant drug exposure, and the risk of an untreated or inadequately treated condition. If a breast-feeding infant experiences an adverse effect related to a maternally administered drug, health care providers are encouraged to report the adverse effect to the FDA.