LYMErix'"

LYMErix'"

Lyme Disease Vaccine (Recombinant OspA)

•Hef Summary. Please see complete prescribing information m SmithKIine Beecham Pharmaceuticals literature MDICATION AND USAGE: LYMEnx is indicated for active immunization against Lyme disease in individuals 15 to 70 years of age individuals most at risk may be those who live or work m BorreHa burgdorfen-mfacted tick-infested grassy or wooded areas (eg landscaping, brush clearing, forestry, and wildlife and parks management), as well as those who plan travel to or pursue recreational activities (e g., hiking, camping, fishing and hunting) in such areas Most cases of Lyme disease in the United States are thought to be acquired in the pen-residential environment, through routine activities of property maintenance. recreation. ancVor exercise of pets Previous infection with B burgdorferi may not confer protective immunity Therefore people with a prior history of Lyme disease may benefit from vaccination with LYMEnx Safety and efficacy for this vaccine are based on administration of the second and third doses several weeks prior to the onset of the Borreha transmission season m the local geographic area (see DOSAGE AND ADMINISTRATION in complete prescribing information) lYMEnx is not a treatment for Lyme disease As with any vaccine. LYMEnx may not protect 100% of individuals Do not administer Lynrmnx to persons outside of the indicated age range CONTRAINDICATIONS: Contraindicated in people with known hypersensitivity to any component of LYMEnx PRKAUTIONS: General: LYMEnx wiN not prevent disease m those who have unrecognized infection at the time of vaccination LYMErix will not provide protection against other tick-borne diseases such as babesiosis or ehrlichiosis Treatment-resistant Lyme arthritis (antibiotic refractory), a rare complication of B burgdorferi infection, has been associated with immune reactivity to OspA of B buradorfen Since the underlying etiology is not dearly understood, it is recommended that LYMEnx not be administered to such patients As with other vaccines, although a moderate or severe febrile illness 'S sufficient reason to postpone vaccination, minor illnesses such as mild upper respiratory infections with or without low-grade fever are not contraindications Before the injection of any biological, the physician should take all reasonable precautions to prevent allergic or other adverse reactions, including understanding the use of the product concerned, and the nature of the side effects and adverse reactions that may follow its use Prior to immunization with any vaccine, the physician should review the patient's immunization history for possible vaccine sensitivity, p' evious vaccination-related adverse reactions and occurrence of any adverse event-related symptoms and/or signs, in order to determine the existence of any contraindication to immunization and to allow an assessment of benefits and risks Epinephrine injection (1 1000) and other appropriate agents used for the control of immediate allergic reactions must be immediately available should an acute anaphylactic reaction occur Packaging for the LYMEnx Tip-Lok™ syringe contains dry natural rubber, which may cause allergic reactions, packaging for the vial does not contain natural rubber Use a separate sterile syringe and needle or a sterile disposable unit for each patient to prevent transmission of infectious agents from person to person Dispose of needles properly and do not recap As with any vaccine administered to immunosuppressed persons or persons receiving immunosuppressive therapy, the expected immune response may nor be obtained For individuals receiving immunosuppressive therapy, consider defer ring vaccination tor 3 months after therapy LAoritaqi Teat Interactions: LYMEnx immunization results m the generation of antiOspA antibodies, which can be detected by an enzyme-linked immunosorbent assay (EUSA) for B burgdorferi The incidence of positive igG ELISA tests depends on the sensitivity and specificity of the ELISA assay and the titer of anti-OspA antibody In general. there is an association between anti-OspA titer and IgG ELISA index or Optical Density (OO) ratio, the higher the titer of anti-OspA achievea the higher the IgG ELISA index or 00 ratio Therefore, because vaccination may result m a positive IgG ELISA in the absence of infection, it. is important to perform Western blot testing if the ELISA test is positive or equivocal m vaccinated individuals who are being evaluated tor suspected Lyme disease Following vaccination, the appearance of a 31 kD OspA band, possibly accompanied by other lower molecular weight bands on an immunowot (Western blot) should not interfere with the determination of positivity when assessed by CDC/AST