TENIVAC

Vaccine Combinations with a Tetanus Component

 
Inform the patient, parent, guardian, or responsible adult of the benefits and risks of the toxoid. Provide the Vaccine Information Statements from the manufacturer to the recipient or guardian before each immunization. The action is required by the National Childhood Vaccine Injury Act of 1986.
Record the manufacturer and lot number of the toxoid, date of administration, and the name, address, and title of the person that administered the toxoid in the recipient's permanent medical record.
Health care professionals administering DT or Td toxoids should take appropriate precautions to prevent an allergic reaction. 
The health care professional should have immediate availability of epinephrine (1:1000) injection and other agents used in the treatment of severe anaphylaxis in the event of a serious allergic reaction to DT or Td.
If a prior DT or Td dose has been given, question the parent, guardian, or patient about any symptoms or signs of an adverse reaction after the previous dose. Complete a Vaccine Adverse Event Reporting System (VAERS) report form if adverse events have been identified. The reporting of events is required by the National Childhood Vaccine Injury Act of 1986. The toll-free number for VAERS is 1—800—822—7967. Also, report an adverse event to the manufacturer of the specific agent administered. Depending on the adverse reaction, a subsequent dose may be contraindicated (see Contraindications).

DT and Td are only administered intramuscularly; do not give intravenously or subcutaneously.
Visually inspect parenteral products for particulate matter and discoloration prior to administration whenever solution and container permit.

Preparation:
Shake vial or syringe vigorously just before withdrawing dose (use aseptic technique) to ensure a uniform, cloudy suspension. The suspension should be whitish-gray in color. If the vaccine cannot be resuspended, discard it.
A separate syringe and needle should be used for each person receiving DT or Td.
Do not mix in the same syringe with any other vaccine or medication.
Single use preparations do not contain preservatives. Unused product should be discarded immediately.
 
Intramuscular (IM) injection:
Before administration, clean skin over the injection site with a suitable cleansing agent.
Intramuscular injections should be made into the lateral mid-thigh (vastus lateralis) for infants or the outer aspect of the upper arm (deltoid) for older children and adults. Do NOT inject into the gluteal area or other areas where there may be a major nerve trunk.
If administering multiple vaccines or toxoids concurrently, inject into different areas within the recommended sites.

angioedema / Rapid / 0-1.0
bronchospasm / Rapid / 0-1.0
anaphylactoid reactions / Rapid / 0-1.0
Guillain-Barre syndrome / Delayed / 0-1.0
seizures / Delayed / Incidence not known

erythema / Early / 0-25.6
Arthus reaction / Early / Incidence not known
lymphadenopathy / Delayed / Incidence not known
peripheral edema / Delayed / Incidence not known
neuritis / Delayed / Incidence not known

injection site reaction / Rapid / 0-80.1
weakness / Early / 4.9-32.3
headache / Early / 10.8-25.1
malaise / Early / 8.8-17.0
arthralgia / Delayed / 7.4-15.7
fever / Early / 0.7-6.6
pruritus / Rapid / Incidence not known
dizziness / Early / Incidence not known
nausea / Early / Incidence not known
drowsiness / Early / Incidence not known
maculopapular rash / Early / Incidence not known
vomiting / Early / Incidence not known
myalgia / Early / Incidence not known
rash / Early / Incidence not known
fatigue / Early / Incidence not known
urticaria / Rapid / Incidence not known
syncope / Early / Incidence not known
paresthesias / Delayed / Incidence not known

TDVAX, TENIVAC

Rx

DT or Td (diphtheria and tetanus toxoid) is an adsorbed immunization; 90—100% immunogenicity conferred; serological correlate of protection (0.01 antitoxin units/ml); not for acute infection; DT formulation is only for children with contraindication to DTP; Td formulation is only for patients >= 7 years of age; thimerosal as a preservative is being phased-out.

0.5 mL IM at 2, 4, 6, 15 to 18 months, and 4 to 6 years.

0.5 mL IM for 3 doses. For Tenivac dosing, the first 2 doses are administered 2 months apart and the third dose is administered 6 to 8 months after the second dose. For TDVAX dosing, the first 2 doses are administered 1 to 2 months apart and the third dose is administered 6 to 12 months after the second dose.[48527] [64016] Wait at least 10 years before giving a tetanus toxoid-containing vaccine if a serious Arthus-type hypersensitivity reaction occurred after previous tetanus toxoid receipt.[48527]

0.5 mL IM for 3 doses. For Tenivac dosing, the first 2 doses are administered 2 months apart, and the third dose is administered 6 to 8 months after the second dose. For TDVAX dosing, the first 2 doses are administered 1 to 2 months apart, and the third dose is administered 6 to 12 months after the second dose.[48527] [64016] For patients never immunized against diphtheria, tetanus, or pertussis, or with unknown immunization, a 3-dose series is recommended, with an interval of 4 to 8 weeks between doses 1 and 2, and an interval of 6 to 8 months between doses 2 and 3. Tdap is recommended for the first dose, followed by doses of Td or Tdap as necessary to complete the catch-up series. For catch-up immunization in patients who are not fully vaccinated, a single dose of Tdap is recommended if the patient has not received Tdap before, followed by doses of Td or Tdap as necessary to complete the catch-up series. If the first dose of diphtheria or tetanus toxoid-containing vaccine was administered before 12 months of age, the minimum interval between doses 2 and 3 may be lowered to 4 weeks, and a fourth dose of Td or Tdap is recommended at least 6 months after the third dose.[53026] [64951] Wait at least 10 years before giving a tetanus toxoid-containing vaccine if a serious Arthus-type hypersensitivity reaction occurred after previous tetanus toxoid receipt.[48527]

0.5 mL IM.[48527] [64016] A Td or Tdap booster is recommended every 10 years.[53026] [64951] Wait at least 10 years before giving a tetanus toxoid-containing vaccine for emergency prophylaxis if a serious Arthus-type hypersensitivity reaction occurred after previous tetanus toxoid receipt.[48527]

0.5 mL IM.[48527] [64016] A single dose of Tdap is recommended, followed by Td or Tdap booster every 10 years; Td may be substituted for Tdap if immunization against pertussis is not indicated.[53026] [64951] Wait at least 10 years before giving a tetanus toxoid-containing vaccine if a serious Arthus-type hypersensitivity reaction occurred after previous tetanus toxoid receipt.[48527]

0.5 mL IM when at least 5 years have passed since the last dose of toxoid-containing vaccine.[48527] [64016] Tdap is recommended if there are no contraindications, followed by Td or Tdap booster every 10 years; Td may be substituted for Tdap if immunization against pertussis is not indicated.[53026] [64951]

0.5 mL IM.[48527] [64016] A single dose of Tdap is preferred to Td in patients 10 years and older if the patient has not previously received Tdap. If immunization history is unknown or less than 3 doses of a tetanus toxoid vaccine have previously been given, give vaccine for clean, minor wounds or other severe or contaminated wounds. If 3 doses or more of a tetanus toxoid-containing vaccine have been given, give vaccine for clean, minor wounds if 10 years or more have elapsed since the last tetanus toxoid-containing vaccine, or for other severe or contaminated wounds if 5 years or more have elapsed since the last tetanus toxoid-containing vaccine.[64478] Wait at least 10 years before giving a tetanus toxoid-containing vaccine for emergency prophylaxis if a serious Arthus-type hypersensitivity reaction occurred after previous tetanus toxoid receipt.[48527]

0.5 mL IM.[48527] [64016] A single dose of Tdap is preferred to Td in patients 10 years and older if the patient has not previously received Tdap. If immunization history is unknown or less than 3 doses of a tetanus toxoid vaccine have previously been given, give vaccine for clean, minor wounds or other severe or contaminated wounds. If 3 doses or more of a tetanus toxoid-containing vaccine have been given, give vaccine for clean, minor wounds if 10 years or more have elapsed since the last tetanus toxoid-containing vaccine, or for other severe or contaminated wounds if 5 years or more have elapsed since the last tetanus toxoid-containing vaccine.[64478] Wait at least 10 years before giving a tetanus toxoid-containing vaccine for emergency prophylaxis if a serious Arthus-type hypersensitivity reaction occurred after previous tetanus toxoid receipt.[48527]

0.5 mL IM.[48527] [64016] For patients never immunized against diphtheria, tetanus, or pertussis, or with unknown immunization, a 3-dose series is recommended, with an interval of 4 to 8 weeks between doses 1 and 2, and an interval of 6 to 8 months between doses 2 and 3. Tdap is recommended for the first dose, followed by doses of Td or Tdap as necessary to complete the catch-up series. For catch-up immunization in patients who are not fully vaccinated, a single dose of Tdap is recommended if the patient has not received Tdap before, followed by doses of Td or Tdap as necessary to complete the catch-up series. If the first dose of diphtheria or tetanus toxoid-containing vaccine was administered before 12 months of age, the minimum interval between doses 2 and 3 may be lowered to 4 weeks, and a fourth dose of Td or Tdap is recommended at least 6 months after the third dose.[53026] [64951] Close contacts who have completed a primary series of 3 or more doses of a diphtheria toxoid-containing vaccine and who have not been vaccinated with diphtheria toxoid in the previous 5 years should receive a booster dose of a diphtheria toxoid-containing vaccine.[48527] Tdap is recommended in patients 11 years and older who have not previously received the vaccine.[53026] Wait at least 10 years before giving a tetanus toxoid-containing vaccine if a serious Arthus-type hypersensitivity reaction occurred after previous tetanus toxoid receipt.[48527]

0.5 mL IM.[48527] [64016] For patients never immunized against diphtheria, tetanus, or pertussis, or with unknown immunization, a 3-dose series is recommended, with an interval of 4 to 8 weeks between doses 1 and 2, and an interval of 6 to 8 months between doses 2 and 3. Tdap is recommended for the first dose, followed by doses of Td or Tdap as necessary to complete the catch-up series. For catch-up immunization in patients who are not fully vaccinated, a single dose of Tdap is recommended if the patient has not received Tdap before, followed by doses of Td or Tdap as necessary to complete the catch-up series. If the first dose of diphtheria or tetanus toxoid-containing vaccine was administered before 12 months of age, the minimum interval between doses 2 and 3 may be lowered to 4 weeks, and a fourth dose of Td or Tdap is recommended at least 6 months after the third dose.[53026] [64951] Close contacts who have completed a primary series of 3 or more doses of a diphtheria toxoid-containing vaccine and who have not been vaccinated with diphtheria toxoid in the previous 5 years should receive a booster dose of a diphtheria toxoid-containing vaccine.[48527] Tdap is recommended in patients 11 years and older who have not previously received the vaccine.[53026] Wait at least 10 years before giving a tetanus toxoid-containing vaccine if a serious Arthus-type hypersensitivity reaction occurred after previous tetanus toxoid receipt.[48527]

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.

Deucravacitinib: (Moderate) Patients receiving immunosuppressant medications may have a diminished vaccine response. When feasible, administer indicated vaccines at least two weeks prior to initiating immunosuppressant medications. If vaccine administration is necessary, consider revaccination following restoration of immune competence. Counsel patients receiving immunosuppressant medications about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure after receiving the vaccine.
Elivaldogene Autotemcel: (Moderate) Patients receiving immunosuppressant medications may have a diminished response to non-live vaccines. When feasible, administer indicated vaccines at least six weeks prior to initiating immunosuppressant medications. If vaccine administration is necessary, consider revaccination following restoration of immune competence. Counsel patients receiving immunosuppressant medications about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure after receiving the vaccine.
Ocrelizumab: (Moderate) Administer all non-live vaccines at least 2 weeks before ocrelizumab initiation, whenever possible. Ocrelizumab may interfere with the effectiveness of non-live virus vaccines. Attenuated antibody responses to tetanus toxoid-containing vaccine, pneumococcal polysaccharide and pneumococcal conjugate vaccines, and seasonal influenza vaccine were observed in patients exposed to ocrelizumab at the time of vaccination during an open-label study. Infants born to mothers exposed to ocrelizumab during pregnancy may receive non-live vaccines as indicated before B-cell recovery; however, consider assessing the immune response to the vaccine. ACIP recommends that patients receiving any vaccination during immunosuppressive therapy or in the 2 weeks prior to starting therapy should be considered unimmunized and should be revaccinated a minimum of 3 months after discontinuation of therapy. Passive immunoprophylaxis with immune globulins may be indicated for immunocompromised persons instead of, or in addition to, vaccination.
Ofatumumab: (Major) Administer all needed non-live vaccines according to immunization guidelines at least 2 weeks before initiation of ofatumumab. Ofatumumab may interfere with the effectiveness of inactivated vaccines due to its actions, which cause B-cell depletion.
Satralizumab: (Major) Administer all non-live vaccines according to immunization guidelines at least 2 weeks before initiation of satralizumab.
Siponimod: (Moderate) Administer all non-live vaccines at least 2 weeks before siponimod initiation, whenever possible. Vaccines may be less effective if given during siponimod treatment. Patients should be considered unimmunized if vaccinated within a 14-day period before starting immunosuppresive therapy or during immunosuppressive therapy, and should they be revaccinated at least 3 months after therapy is discontinued if immune competence is restored.
Ublituximab: (Moderate) Patients receiving immunosuppressant medications may have a diminished response to non-live vaccines. When feasible, administer indicated vaccines at least two weeks prior to initiating immunosuppressant medications. If vaccine administration is necessary, consider revaccination following restoration of immune competence. Counsel patients receiving immunosuppressant medications about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure after receiving the vaccine.

Diphtheria Toxoid Adsorbed, Tetanus Toxoid, Adsorbed/TENIVAC Intramuscular Inj Susp: 0.5mL, 2-2Lf, 5-2Lf, 5-6.7Lf

0.5 mL/dose IM for Td; safety and efficacy for DT have not been established.

0.5 mL/dose IM for Td; safety and efficacy for DT have not been established.

0.5 mL/dose IM for Td; safety and efficacy for DT have not been established.

>= 7 years: 0.5 mL/dose IM for Td; safety and efficacy for DT have not been established.
2—6 years: 0.5 mL/dose IM for DT; safety and efficacy for Td have not been established.

>= 6 weeks: 0.5 mL/dose IM for DT; safety and efficacy for Td have not been established.

Safety and efficacy have not been established.

The pathologic sequelae of Corynebacterium diphtheriae and Clostridium tetani infections are mediated by diphtheria and tetanus exotoxins, respectively. Exotoxins are extracellular protein metabolites of toxigenic strains of these organisms. Tetanus or diphtheria disease does not necessarily confer immunity because of the very small amount of exotoxin required to produce illness, therefore, previously infected individuals should still receive toxoid. The DT and Td products are adsorbed onto an aluminum salt, which prolongs and enhances the antigenic properties by retarding the rate of injected toxoid absorption into the body. Diphtheria and tetanus toxoids induce the production of antibodies against the exotoxin, which inactivate it. The presumed mechanism by which toxoids produce immunity is by activating antigen-presenting cells to secrete cytokines that enhance the recruitment of antigen-specific T and B cells to the site of inoculation.

DT or Td toxoid formulations are administered intramuscularly. Clinical studies have been performed to determine the serological responses after immunization. Protective levels of diphtheria and tetanus antitoxins (0.01 AU/mL) were detected in 100% of children after receiving 2 doses of DT; however, maternal antibody may have contributed to the additional immunity. Immunization with Td provided protective levels of antibody in greater than 90% of the study population after the entire primary immunization series. Antitoxin titers wane over the years, resulting in decreased efficacy. Most individuals have antitoxin levels below the optimal level 10 years after their last toxoid dose. Booster doses provide immunity in 100% of the individuals with preexisting antibody responses.

No adequate and well-controlled studies have been conducted with diphtheria toxoid; tetanus toxoid, adsorbed (Td) in pregnant women and the risk to a human fetus or effect on reproductive capacity is unknown. According to the Advisory Committee on Immunization Practices (ACIP), there are no data to suggest risk of fetal harm after administration of toxoids to pregnant women and pregnant women should receive Td vaccine, if indicated. Previously vaccinated pregnant women who have not received a Td vaccination within the last 10 years should receive a booster dose during the second or third trimester. Pregnant women who are not vaccinated or only partially immunized against tetanus should complete the primary series. Women for whom the vaccine is indicated but who have not completed the recommended 3-dose series during pregnancy should receive follow-up after delivery to ensure series completion. Pregnant adolescents and adults who received the last tetanus-containing vaccine less than 10 years previously are generally recommended to receive Tdap after delivery to ensure pertussis immunity. To prevent neonatal tetanus, pregnant adolescents who received the last dose of tetanus-toxoid containing vaccine more than 10 years previously should generally receive Td in preference to Tdap while they are pregnant, although Tdap is not contraindicated during pregnancy. If the pregnant woman has an indication for Td but is likely to have sufficient protection against tetanus and diphtheria and has not previously received a dose of Tdap, the ACIP states that Tdap may be administered in the immediate postpartum period rather than Td being administered during pregnancy.[33936] [43236] [48527] [53131]

Data are limited regarding use of the diphtheria toxoid; tetanus toxoid, adsorbed vaccine during breast-feeding and its' excretion in human milk is unknown. The FDA-approved labeling recommends caution when administering to nursing mothers; however, according to the Advisory Committee on Immunization Practices (ACIP), toxoids pose no risk to mothers or their infants. 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.[43236] [48527] [53131]