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Lymerix

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Lymerix

Discontinued Warning IconPlease Note: This Brand Name drug is no longer available in the US.
(Generic versions may still be available.)

WARNINGS

No information provided.

PRECAUTIONS

General

LYMErix (lipoprotein outer surface a vaccine) will not prevent disease in those who have unrecognized infection at the time of vaccination. LYMErix (lipoprotein outer surface a vaccine) 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. burgdorferi.24 Since the underlying etiology is not clearly understood, it is recommended that LYMErix (lipoprotein outer surface a vaccine) not be administered to such patients.

As with other vaccines, although a moderate or severe febrile illness is sufficient reason to postpone vaccination, minor illnesses such as mild upper respiratory infections with or without low-grade fever are not contraindications.25

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 patient's history should be reviewed. The physician should review the patient's immunization history for possible vaccine sensitivity, previous 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 LYMErix (lipoprotein outer surface a vaccine) Tip-Lok® syringe contains dry natural rubber, which may cause allergic reactions; packaging for the vial does not contain natural rubber.

A separate sterile syringe and needle or a sterile disposable unit must be used for each patient to prevent the transmission of infectious agents from person to person. Needles should be disposed of properly and should not be recapped.

As with any vaccine administered to immunosuppressed persons or persons receiving immunosuppressive therapy, the expected immune response may not be obtained. For individuals receiving immunosuppressive therapy, deferral of vaccination for three months after therapy may be considered.26

Laboratory Test Interactions

LYMErix (lipoprotein outer surface a vaccine) immunization results in the generation of anti-OspA antibodies, which can be detected by an enzyme-linked immunosorbent assay (ELISA) for B. burgdorferi. The incidence of positive IgG ELISA tests is dependent 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 (OD) ratio; the higher the titer of anti-OspA achieved, the higher the IgG ELISA index or OD ratio.

Therefore, because vaccination may result in 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 in vaccinated individuals who are being evaluated for suspected Lyme disease.

Following vaccination, the appearance of a 31kD OspA band, possibly accompanied by other lower molecular weight bands on an immunoblot (Western blot), should not interfere with the determination of positivity when assessed by CDC/ASTPHLD criteria.11

Carcinogenesis, Mutagenesis, Impairment of Fertility

LYMErix (lipoprotein outer surface a vaccine) has not been evaluated for carcinogenic or mutagenic potential, or for impairment of fertility.

Pregnancy

Teratogenic Effects: Pregnancy Category C. Animal reproductive studies have not been conducted with LYMErix (lipoprotein outer surface a vaccine) .

It is also not known whether LYMErix (lipoprotein outer surface a vaccine) can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. LYMErix (lipoprotein outer surface a vaccine) should be given to a pregnant woman only if clearly needed.

Health care providers are encouraged to register pregnant women who receive LYMErix (lipoprotein outer surface a vaccine) [Lyme Disease Vaccine (Recombinant OspA)] in the SmithKline Beecham Pharmaceuticals vaccination pregnancy registry by calling1-800-366-8900, ext. 5231.

Nursing Mothers

It is not known whether LYMErix (lipoprotein outer surface a vaccine) is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when LYMErix (lipoprotein outer surface a vaccine) is administered to a nursing woman.

Pediatric Use

Safety and efficacy in pediatric subjects younger than 15 years of age have not been evaluated. Therefore, the vaccine is not indicated for this age group at this time.

Last reviewed on RxList: 12/8/2004
This monograph has been modified to include the generic and brand name in many instances.

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