Tdap vaccine (tetanus, diphtheria, pertussis): uses, appearance and warnings

BOOSTRIX is indicated for: • active booster immunization against tetanus, diphtheria, and pertussis in individuals aged 10 years and older, • immunization during the third trimester of pregnancy to prevent pertussis in infants younger than 2 months of age. BOOSTRIX is a vaccine indicated for: • active booster immunization against tetanus, diphtheria, and pertussis in individuals aged 10 years and older, ( 1 ) • immunization during the third trimester of pregnancy to prevent pertussis in infants younger than 2 months of age. ( 1 )

BOOSTRIX is an injectable suspension. Each dose is 0.5 mL. Injectable suspension. Each dose is 0.5 mL. ( 3 )

BOOSTRIX is available in 0.5 mL single‑dose, disposable, prefilled TIP‑LOK syringes (Luer Lock syringes) packaged without needles. TIP-LOK syringes are to be used with Luer Lock compatible needles. The tip cap and rubber plunger stopper of the prefilled syringe are not made with natural rubber latex. Prefilled syringe: NDC 58160-842-43 Package of 10 prefilled syringes: NDC 58160-842-52 Store refrigerated between 2º and 8ºC (36º and 46ºF). Do not freeze. Discard if the vaccine has been frozen. Protect prefilled syringes from light.

• Severe allergic reaction (e.g., anaphylaxis) after a previous dose of any tetanus toxoid-, diphtheria toxoid-, or pertussis antigen-containing vaccine or to any component of BOOSTRIX. ( 4.1 ) • Encephalopathy within 7 days of administration of a previous pertussis antigen-containing vaccine. ( 4.2 ) 4.1 Hypersensitivity BOOSTRIX is contraindicated in individuals with a known history of severe allergic reaction (e.g., anaphylaxis) to any component of BOOSTRIX or after a previous dose of any tetanus toxoid‑, diphtheria toxoid‑, or pertussis antigen‑containing vaccine [see Description ( 11 )] . 4.2 Encephalopathy Encephalopathy within 7 days of administration of a previous dose of a pertussis antigen-containing vaccine that is not attributable to another identifiable cause is a contraindication to administration of any pertussis antigen-containing vaccine, including BOOSTRIX.

• If Guillain-Barré syndrome occurred within 6 weeks of receipt of a prior vaccine containing tetanus toxoid, the risk of Guillain-Barré syndrome may be increased following a subsequent dose of tetanus toxoid-containing vaccine, including BOOSTRIX. ( 5.2 ) • Progressive or unstable neurologic conditions are reasons to defer vaccination with a pertussis-containing vaccine, including BOOSTRIX. ( 5.3 ) • Persons who experienced an Arthus-type hypersensitivity reaction following a prior dose of a tetanus toxoid-containing vaccine should not receive BOOSTRIX unless at least 10 years have elapsed since the last dose of a tetanus toxoid-containing vaccine. ( 5.4 ) 5.1 Preventing and Managing Allergic Reactions Appropriate medical treatment must be immediately available to manage potential anaphylactic reactions following administration of BOOSTRIX. 5.2 Guillain-Barré Syndrome and Brachial Neuritis If Guillain-Barré syndrome occurred within 6 weeks of receipt of a prior vaccine containing tetanus toxoid, the risk of Guillain-Barré syndrome may be increased following a subsequent dose of tetanus toxoid-containing vaccine, including BOOSTRIX. A review by the Institute of Medicine (IOM) found evidence for a causal relationship between receipt of tetanus toxoid and both Guillain-Barré syndrome and brachial neuritis. 1 5.3 Progressive or Unstable Neurologic Disorders Progressive or unstable neurologic conditions (e.g., cerebrovascular events, acute encephalopathic conditions) are reasons to defer vaccination with a pertussis-containing vaccine, including BOOSTRIX. It is not known whether administration of BOOSTRIX to persons with an unstable or progressive neurologic disorder might hasten manifestations of the disorder or affect the prognosis. Administration of BOOSTRIX to persons with an unstable or progressive neurologic disorder may result in diagnostic confusion between manifestations of the underlying illness and possible adverse effects of vaccination. 5.4 Arthus-Type Hypersensitivity Persons who experienced an Arthus-type hypersensitivity reaction following a prior dose of a tetanus toxoid-containing vaccine usually have a high serum tetanus antitoxin level and should not receive BOOSTRIX or other tetanus toxoid-containing vaccines unless at least 10 years have elapsed since the last dose of tetanus toxoid-containing vaccine. 5.5 Altered Immunocompetence As with any vaccine, if administered to immunosuppressed persons, including individuals receiving immunosuppressive therapy, the expected immune response may not be obtained. Immunosuppressive therapies, including irradiation, antimetabolites, alkylating agents, cytotoxic drugs, and corticosteroids (used in greater than physiologic doses), may reduce the immune response to BOOSTRIX. 5.6 Syncope Syncope (fainting) may occur in association with administration of injectable vaccines, including BOOSTRIX. Procedures should be in place to avoid injury from fainting.

• Common solicited adverse reactions (≥15%) in adolescents (aged 10 to 18 years) were pain, redness, and swelling at the injection site; increase in arm circumference of the injected arm; headache; fatigue; and gastrointestinal symptoms. ( 6.1 ) • Common solicited adverse reactions (≥15%) in adults (aged 19 to 64 years) were pain, redness, and swelling at the injection site; headache; fatigue; and gastrointestinal symptoms. ( 6.1 ) • The most common solicited adverse reaction (≥15%) in the elderly (aged 65 years and older) was pain at the injection site. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact GlaxoSmithKline at 1-888-825-5249 or VAERS at 1-800-822-7967 or www.vaers.hhs.gov. …