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Description for Lymerix

LYMErix [Lyme Disease Vaccine (Recombinant OspA)] is a noninfectious recombinant vaccine developed and manufactured by Smith Kline Beecham Biologicals. The causative agent of Lyme disease is Borrelia burgdorferi; in North America, all Lyme disease is due to Borrelia burgdorferi sensu stricto. The vaccine contains lipoprotein OspA, an outer surface protein of Borrelia burgdorferi sensu stricto ZS7, as expressed by Escherichia coli. Lipoprotein OspA is a single polypeptide chain of 257 amino acids with lipids covalently bonded to the N terminus. No substance of animal origin is used in the commercial manufacturing process. Fermentation media consist primarily of inorganic salts, and vitamins, with small quantities of antifoam (contains silicon), kanamycin sulfate (an aminoglycoside antibiotic), and yeast extract. Silicon and kanamycin are removed to levels below detection (<7 ppm and <10 ppb, respectively). The vaccine is adsorbed onto aluminum hydroxide.

LYMErix (lipoprotein outer surface a vaccine) is supplied as a sterile suspension in single-dose vials and prefilled syringes for intramuscular administration. The vaccine is ready for use without reconstitution; it must be shaken before administration to ensure a uniform turbid white suspension.

Each 0.5 mL dose of vaccine consists of 30 mcg of lipoprotein OspA adsorbed onto 0.5 mg aluminum as aluminum hydroxide adjuvant. Each dose of the vaccine preparation contains 10 mM phosphate buffered saline and 2.5 mg of 2-phenoxyethanol, a bacteriostatic agent.

The potency of the vaccine is evaluated by immunizing mice with LYMErix (lipoprotein outer surface a vaccine) and measuring their serum antibody response to OspA by ELISA.

Uses for Lymerix

LYMErix (lipoprotein outer surface a vaccine) 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 (lipoprotein outer surface a vaccine) .

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

Dosage for Lymerix

Primary immunization against Lyme disease consists of a 30 mcg/0.5 mL dose of LYMErix (lipoprotein outer surface a vaccine) 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 (lipoprotein outer surface a vaccine) 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 (lipoprotein outer surface a vaccine) 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 (lipoprotein outer surface a vaccine) 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).

HOW SUPPLIED

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-Lokˆ 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 (lipoprotein outer surface a vaccine) and Tip-Lok are trademarks of SmithKline Beecham.
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Side Effects for Lymerix

During clinical trials involving 6,478 individuals receiving a total of 18,047 doses, LYMErix (lipoprotein outer surface a vaccine) has been generally well tolerated.

Subjects with the following conditions: chronic joint or neurologic illness related to Lyme disease; diseases associated with joint swelling (including rheumatoid arthritis) or diffuse musculoskeletal pain; second- or third-degree atrioventricular block or a pacemaker were excluded from the efficacy trial because such conditions could interfere with the assessment of Lyme disease in the trial. Therefore, data are limited regarding the safety of the vaccine in subjects with these conditions (see below).

Unsolicited Adverse Events

The most frequently reported (≥1%) unsolicited adverse events within 30 days of vaccination for all subjects receiving at least one dose (n= 10,936) in the double-blind, placebocontrolled efficacy trial are shown in Table 2.

Table 2. Incidence (≥1%) of Unsolicited Adverse Events Occurring Within 30 Days Following Each Dose* and Overall (after Doses 1, 2 or 3)

* Includes events obtained through spontaneous reports following each dose and events reported 1 month after doses 1 and 2 (when all subjects were queried regarding the occurrence of any adverse event since the previous vaccination).

a. p-value