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Boostrix

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Indications:

BOOSTRIX® is indicated for active booster immunization against tetanus, diphtheria, and pertussis. BOOSTRIX is approved for use as a single dose in individuals 10 years of age and older.

Contraindications:

Hypersensitivity A severe allergic reaction (e.g., anaphylaxis) after a previous dose of any tetanus toxoid-, diphtheria toxoid-, or pertussis antigen-containing vaccine or any component of this vaccine is a contraindication to administration of BOOSTRIX. Because of the uncertainty as to which component of the vaccine might be responsible, none of the components should be administered. Alternatively, such individuals may be referred to an allergist for evaluation if immunization with any of these components is considered. Encephalopathy Encephalopathy (e.g., coma, decreased level of consciousness, prolonged seizures) 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.

Adverse reactions:

Rates of injection site reactions (pain, redness, swelling) ranged from 10% to 53%, depending on reaction and dose number, and were highest following doses 4 and 5. Fever was common (20% to 30%) following doses 1-3. Other common solicited adverse events were drowsiness, irritability/fussiness, and loss of appetite, reported in approximately 15% to 60% of subjects, depending on event and dose number.

Interactions:

Concomitant Vaccine Administration In clinical trials, INFANRIX was given concomitantly with Hib conjugate vaccine, pneumococcal 7-valent conjugate vaccine, hepatitis B vaccine, IPV, and the second dose of MMR vaccine. When INFANRIX is administered concomitantly with other injectable vaccines, they should be given with separate syringes. INFANRIX should not be mixed with any other vaccine in the same syringe or vial. Immunosuppressive Therapies Immunosuppressive therapies, including irradiation, antimetabolites, alkylating agents, cytotoxic drugs, and corticosteroids (used in greater than physiologic doses), may reduce the immune response to INFANRIX.

Warnings:

Latex BOOSTRIX is available in vials and 2 types of prefilled syringes. One type of prefilled syringe has a tip cap which may contain natural rubber latex and a plunger which does not contain latex. The other type has a tip cap and a rubber plunger which contain dry natural latex rubber. Use of these syringes may cause allergic reactions in latex-sensitive individuals. The vial stopper does not contain latex. 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 brachial neuritis and Guillain-Barré syndrome. Progressive or Unstable Neurologic Disorders Progressive or unstable neurologic conditions (e.g., cerebrovascular events and 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. 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. Altered Immunocompetence As with any vaccine, if administered to immunosuppressed persons, including individuals receiving immunosuppressive therapy, the expected immune response may not be obtained. Prevention and Management of Acute Allergic Reactions Prior to administration, the healthcare provider should review the immunization history for possible vaccine sensitivity and previous vaccination-related adverse reactions to allow an assessment of benefits and risks. Epinephrine and other appropriate agents used for the control of immediate allergic reactions must be immediately available should an acute anaphylactic reaction occur.

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