an Arthus-type hypersensitivity reaction following a prior dose of a tetanus toxoid-containing vaccine usually have high serum tetanus antitoxin levels and should not receive tetanus-containing vaccines more frequently than every 10 years, even for tetanus prophylaxis as part of wound management Evidence supports a causal relation between tetanus toxoid and both brachial neuritis and Guillain-Barré syndrome; if Guillain-Barré syndrome occurred within 6 weeks of receipt of prior vaccine containing tetanus toxoid, the decision to give any vaccine containing tetanus toxoid should be based on careful consideration of the potential benefits and possible risks Vaccination may not protect all individuals Administration to immunocompromised individuals may not obtain expected immune response Prior to administration of the vaccine, patients, parents, or guardians should be informed by the health care provider of the benefits and risks of immunization and of the importance of completing the primary immunization series or receiving recommended booster doses Drug interaction overview Immunosuppressive therapies, including irradiation, antimetabolites, alkylating agents, cytotoxic drugs, and corticosteroids (used in greater than physiologic doses), may reduce the immune response Pregnancy There are insufficient human data from Td administered during pregnancy to establish the presence or absence of a vaccine-associated risk ACIP guidelines include immunizing pregnant women during every pregnancy with 1 dose of Tdap to convey immunity for pertussis to fetus during gestational weeks 27-36 Animal studies Female rabbits received a single human dose (0.5 mL) of Td IM 17 and 10 days before mating, and on gestation days 6 and 29; no adverse effects on preweaning development up to postnatal day 35 were observed There were no vaccine-related fetal malformations or variations observed Lactation Unknown if excreted in human milkPregnancy Categories A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk. B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk. C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done. D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk. X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist. NA: Information not available. Mechanism of Action Tetanus: Tetanus is an acute disease caused by an extremely potent neurotoxin produced by C tetani; protection against disease is imparted by the development of neutralizing antibodies to tetanus toxin; serum tetanus antitoxin level of at least 0.01 IU/mL, measured by neutralization assay is considered the minimum protective level Diphtheria: Diphtheria is an acute toxin-mediated disease caused by toxigenic strains of C diphtheriae; protection against disease is imparted by the development of neutralizing antibodies to diphtheria toxin; serum diphtheria antitoxin level of 0.01 IU/mL is the lowest level giving some degree of protection; antitoxin levels of at least 0.1 IU/mL are generally regarded as protective IM Preparation Just before use, shake the single-dose vial or syringe well until a uniform, white, cloudy suspension results Inspected visually for particulate matter and discoloration; if these conditions exist, do not administer. Do not combine through reconstitution or mix with any other vaccine IM Administration For IM administration only; do not administer IV, SC, or intradermally Adults and children aged 7 years or older Administer IM in the deltoid muscle (preferred site) Do not inject into the gluteal area or areas where there may be a major nerve trunk Children aged younger than 7 years Infants aged <1 year: Inject IM in anterolateral aspect of the thigh provides the largest muscle and is the preferred site of injection Older children: Administer IM in the deltoid muscle is usually large enough for injection; do not inject into the gluteal area or areas where there may be a major nerve trunk Storage Refrigerate at 2-8ºC (36-46ºF) Do not freeze; discard if exposed to freezing No images available for this drug. No images available for this drug.A Patient Handout is not currently available for this monograph.Print FormularyPatient DiscountsAdding plans allows you to compare formulary status to other drugs in the same class.To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.Create Your List of PlansAdding plans allows you to:View the formulary and any restrictions for each plan.Manage and view all your plans together – even plans in different states.Compare formulary status to other drugs in the same class.Access your plan list on any device – mobile or desktop. The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information. View explanations for tiers and restrictions Tier Description 1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs. 2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs. 3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs. 4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products. 5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products. 6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products. NC NOT COVERED – Drugs that are not covered by the plan. Code Definition PA Prior Authorization Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription. 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