LYMErix 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 in B. burgdorferi-infected, tick-infested grassy or wooded areas (e.g., landscaping brush clearing, forestry, and wildlife and parks management), 4,18-21 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 peri-residential environment, through routine activities of property maintenance, recreation, and/or exercise of pets.^{19, 22}

Previous infection with B. burgdorferi may not confer protective immunity.²³ Therefore people with a prior history of Lyme disease may benefit from vaccination with LYMErix.

Safety and efficacy for this vaccine are based on administration of the second and third doses several weeks prior to the onset of the Borrelia transmission season in the local geographic area (see DOSAGE AND ADMINISTRATION).

LYMErix is not a treatment for Lyme disease. As with any vaccine, LYMErix may not protect 100% of individuals. The vaccine should not be administered to persons outside of the indicated age range.

Primary immunization against Lyme disease consists of a 30 mcg/0.5 mL dose of LYMErix given at 0, 1 and 12 months.

Vaccination with all three doses is required to achieve optimal protection.

Safety and efficacy for this vaccine are based on administration of the second and third doses several weeks prior to the onset of the Borrelia transmission season in the local geographic area (see INDICATIONS). For example, in the pivotal efficacy trial performed primarily in the Northeast United States (see CLINICAL PHARMACOLOGY, Clinical Efficacy), individuals were vaccinated between January and April in both years of the trial.

LYMErix [Lyme Disease Vaccine (Recombinant OspA)] should be administered by intramuscular injection in the deltoid region. Do not inject intravenously, intradermally or subcutaneously.

Preparation for Administration: Shake well before withdrawal and use. Parenteral drug products should be inspected visually for particulate matter or discoloration prior to administration. With thorough agitation, LYMErix is a turbid white suspension. Discard if it appears otherwise. Any vaccine remaining in a single-dose vial should be discarded.

The vaccine should be used as supplied; no dilution or reconstitution is necessary. The full recommended dose of the vaccine should be used.

As with other intramuscular injections, LYMErix should not be given to individuals on anticoagulant therapy or with clotting disorders, unless the potential benefit clearly outweighs the risk of administration.

No data are available on the immune response to LYMErix when administered concurrently with other vaccines. When concomitant administration of other vaccines is required, they should be given with different syringes and at different injection sites (see DRUG INTERACTIONS).

LYMErix [Lyme Disease Vaccine (Recombinant OspA)] is supplied in Single-Dose (30 mcg/0.5 mL) Vials and Prefilled Syringes

NDC 58160-845-01 Package of 1 Single-Dose Vial

NDC 58160-845-11 Package of 10 Single-Dose Vials

NDC 58160-845-35 Package of 5 Prefilled Disposable Tip-LokÔ Syringes with 1-inch 23-gauge needles

STORAGE

Store between 2° and 8°C (36° and 46°F). Do not freeze; discard if product has been frozen.

REFERENCES

1. Dennis DT. Epidemiology. In: Coyle P (ed). Lyme Disease. Mosby Year Book, Inc. 1993; 27-36.
2. Centers for Disease Control and Prevention. Lyme Disease-United States, 1996. MMWR. June 13, 1997; Vol. 46: 23; 533-534.
3. Centers for Disease Control and Prevention. Lyme DiseaseUnited States, 1996. MMWR. October 31, 1997; Vol. 45: 53; 41.
4. Goldstein MD, Schwartz BS, Friedmann C, et al. Lyme disease in New Jersey outdoor workers: a statewide survey of seroprevalence and tick exposure. Am J Public Health. 1990; 80: 1225-1229.
5. Dennis DT. Lyme disease. Dermatol Clin. 1995; 13( 3): 537-551.
6. Data on file from Centers for Disease Control and Prevention (LYR198), SmithKline Beecham Pharmaceuticals.
7. Data on file from Centers for Disease Control and Prevention (LYR598: 12 monthly incidence tables for Lyme Disease. MMWR. 1997; 46: Nos. 5, 8, 13, 17, 22, 23, 31, 35, 39, 44, 47, 51), SmithKline Beecham Pharmaceuticals.
8. Fish D. Environmental risk and prevention of Lyme disease. Am J Med. 1995; 98 (suppl 4A): 4A2S-4A9S.
9. Steere AC. Borrelia burgdorferi (Lyme Disease, Lyme Borreliosis). In: Mandell, Bennett, Dolin (eds). Mandell, Douglas and Bennett's Principles and Practices of Infectious Disease. 4th ed. 1995: chapter 219: 2143-2155.
10. Nocton JJ, Steere AC. Lyme Disease. In: Advances in Internal Medicine. Mosby Year Book, Inc. 1995; 40: 69-115.
11. Centers for Disease Control and Prevention. Recommendations for test performance and interpretation from the Second National Conference on Serologic Diagnosis of Lyme Disease. MMWR. 1995; 44: 590-591.
12. Fikrig E, Barthold SW, Marcantonio N, et al. Roles of OspA, OspB, and flagellin in protective immunity to Lyme borreliosis in the laboratory mouse. Infect Immun. 1992; 60: 657-661.
13. Fikrig E, Telford SR, Barthold SW, et al. Elimination of Borrelia burgdorferi from vector ticks feeding on OspAimmunized mice. Proc Natl Acad Sci (USA). 1992; 89: 5418-5421.
14. Golde WT, Piesman J, Dolan MC, et al. Reactivity with a specific epitope of outer surface protein A predicts protection from infection with the Lyme disease spirochete, Borrelia burgdorferi. Infect Immun. 1997; 65: 882-889.
15. Schwan TG, Piesman J, Golde WT, et al. Induction of an outer surface protein on Borrelia burgdorferi during tick feeding. Proc Natl Acad Sci (USA). 1995; 92: 2909-2913.
16. Data on file (LYR1098), SmithKline Beecham Pharmaceuticals.
17. Wormser GP, Horowitz HW, Nowakowski J, et al. Positive Lyme disease serology in patients with clinical and laboratory evidence of human granulocytic ehrlichiosis. Am J Clin Pathol. 1997; 107: 142-147.
18. Bowen GS, Schulze TL, Hayne C, et al. A focus of Lyme disease in Monmouth County, New Jersey. Am J Epidemiol. 1984; 120: 387-394.
19. Smith PF, Benach JL, White DJ, et al. Occupational risk of Lyme disease in endemic areas of New York State. Ann NY Acad Sci. 1988; 539: 289-301.
20. Schwartz BS, Goldstein MC, Childs JE. Longitudinal study of Borrelia burgdorferi infection in New Jersey outdoor workers, 1988-1991. Am J Epidemiol. 1994; 139( 5): 504-512.
21. Schwartz BS, Goldstein MD. Lyme disease in outdoor workers: risk factors, preventive measures, and tick removal methods. Am J Epidemiol. 1990; 131( 5): 877-885.
22. Steere AC, Broderick TF, Malawista SE. Erythema chronicum migrans and Lyme arthritis: epidemiologic evidence for a tick vector. Am J Epidemiol. 1978; 108( 4): 312-321.
23. Nowakowski J, Schwartz I, Nadelman RB, et al. Cultureconfirmed infection and reinfection with Borrelia burgdorferi. Ann Intern Med. 1997; 127: 130-132.
24. Gross DM, Forsthuber T, Tary-Lehmann M, et al. Identification of LFA-1 as a candidate autoantigen in treatment-resistant Lyme arthritis. Science. 1998; 281: 703-706.
25. Centers for Disease Control and Prevention. Update: Vaccine side effects, adverse reactions, contraindications and precautions--recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR. 1996; Vol. 45( RR12): 1-35.
26. Centers for Disease Control and Prevention. General recommendations on immunization recommendations of the Advisory Committee on Immunization Practices (ACIP).

U.S. License No. 1090

Manufactured by SmithKline Beecham Biologicals, Rixensart,
Belgium
Distributed by SmithKline Beecham Pharmaceuticals,
Philadelphia, PA 19101

Rx only

DATE OF ISSUANCE DEC. 1998
©SmithKline Beecham, 1998
LYMErix and Tip-Lok are trademarks of SmithKline Beecham.
LY:L1

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