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Progress, The (Newspaper) - February 24, 1999, Clearfield, Pennsylvania THE Moshannon February I got Lyme disease last spring and Im being treated for serious health I couldnt prevent it but now you Lyme Disease Vaccine Recombinant OspA Manufactured by SmithKline Beecham Belgium Distributed by SmithKline Beecham PA 19101 LYMErix is a trademark of SmithKline SmithKline 1999 LY8680E Lyme Disease Vaccine Recombinant OspA Brief Please see complete prescribing information m SmithKline Beecham Pharmaceuticals literature INDICATION AND USAGE LYMErix is indicated lor active immunization against Lyme dis ease in individuals 15 to 70 years ol Individuals most at nsk may be those who live or work in Borrelta tickinlested grassy or wooded areas le g land brush and wildlife and parts managemenll as well asthose who plan travel to or pursue recreational activities fishing and hunt ing in such Most cases ol Lyme disease in the United States are thought to bfi acquired in the penresidential through routine activities ol property mainte exercise ol pels j Previous infection with burgdorlen may not confer protective immunity Therefore peo ple with a prior history of Lyme disease may benefit from vaccination with Safety and efficacy for this vaccine are based on administration of the second and third doses several weeks prior to the onset ol Ihe Borrelm transmission season in the local geo graphic area Isee DOSAGE AND ADMINISTRATION in complete prescribing LYMErix is not a treatment lor Lyme As with any LYMErix may not pro tect 100 of Do not administer Lymenx to persons outside of the indicated age CONTRAINDICATIONS Contraindicated in people with known hypersensinvitv lo any component of LYMErix PRECAUTIONS Ganwal LYMEm will not prevent disease in those who have unrecog nized inlection at the time ol vaccination LYMEm not provide protection against other tickborne diseases such as babosiosis or Treatmentresistant Lyme arthritis antibiotic a rare complication of burgdorwi infection has been associated with immune reaclivity to OspA ol burgdorlen Since the undeilying etiology is not clearly it is recommended that LYMErix not be administered lo such As with other although a moderate or severe lebnle illness is sufficient reason to postpone minor illnesses such as mild upper respiraloryuifeclioris with or without lowgrade fever are not Before Ihe injection of arm Biological the physician should take all reasonable precautions to prevent allergic or other adverse including understanding Ihe use ol the product and Ihe nature ol the side effects and adverse reactions that may follow its Prior to immunization with any the physician should review the patients immunization history for possible vaccine previous vaccinationrelated adverse reactions and occurrence of any adverse eventrelated symptoms in order to determine the existence of any contra indication to immunization and lo allow an assessment of benefits and Epinephrine injection and other appropriate agents used lor the control of immediate allergic reactions must be immediately available should an acute anaphylactic reaction Packaging lor the LYMErix TipLokM syringe contains dry natural which may cause allergic reactions packaging for the vial does not contain natural Use a separate sterile syringe and needle or a sterile disposable unit lor each patient to prevent transmission of infectious agents from person lo Dispose ol needles properly and do not As with any vaccine administered to immunosuppressed per sons or persons receiving irnmunosuppressive the expected immune response may not be For individuals receiving immunosuppressive consider defer ring vaccination for 3 months after 1 Laboratory Test Interactions LYMErix immunization results in the generation of anli OspA which can be detected by an enzymelinked immunosorbent assay 1 ELISA tor The incidence of positive IgG ELISA tests depends on the sensitivity and specificity of the ELISA assay and the liter ofantiOspA In gen eral there is an association between antiOspA liter and IgG ELISA index or Oplical Density ratio the higher the tiler of antiOspA the higher the IgG ELISA index or OD because vaccination may result in a positive IgG ELISA in the absence of it is important to perform Western blot testing if the ELISA test is positive or equivocal in vaccinated individuals who are being evaluated lor suspected Lyme Following the appearance of a 31 kD OspA possibly accompanied by other lower molecular weight bands on an immunoblot Western should not interfere with the determination of positivity when assessed by PHLD Drug Interactions No data are available on the immune response to LYMErix when admin istered concurrently with other As with other intramuscular injections do not give LYMErix to individuals on anticoagulant unless potential benefit clearly outweighs risk ol u Impalrmant ol Fertility LYMErix has not been evaluated lor carcinogenic or mutagenic or lor impairment ol Pregnancy Effects Pragnancy Catagory Animal reproductive studies have not been conducted with II is also not known whether LYMErix can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity Grve LYMErix to a pregnant woman only if clearly Health care providers are encouraged reAi58r who receive LYMErix ILyme Disease Vaccine IRecombmant leDcnam Pharmaceuticals vaccination pregnancy registry by call i Nursing Mothars It is not known whether LYMErix is excreted in human milk Because many drugs are excreted in human use caution when LYMErix is administered lo a nursing Padiatric Usa Safety and elficacy in pediatric subjects younger than 15 years of ago have not been evaluated the vaccine is not indicated for this age group at this time Riafyngitis Rlnnilis Smusilis upoci lespiialoiy tiact 39 1 12 150 KG 1 H 1 57 263 120 1 26 1 27 1 65 52 2 45 241 247 316 293 435 498 SkiivMpiMlidtgM 108 7 H ials involving individuals receiving a total LYMErix has been generally well Subjects with the following conditions chronic pint or neurologic illness related to Lyme disease diseases associated with joint swelling including rheumatoid arthritis or difluse musculoskeletal pain second er thirddegree atrioyentricular block or a pacemaker were excluded Irom the efficacy trial because such conditions could interfere with the assessment of Lyme disease in the trial data are limited regarding the safety of the vaccine in subiects with these con ditions see Unsolicited Adverse Events The most frequently reported 21 unsolicited adverse events within 30 days of vaccination for all subjects receiving at least one dose 936 in the placebocontrolled ellicacy trial are shown in Table Table Incidence of Unsolicited Adverse Events Occurring Within 30 Davs Following Each and Ovarell letter Doses or 31 VKCIM PliulM VKCIH HKIM VHCIM Pliciko MB UNI 54171 SOT 90111 IN SO IH fW7 loci Injection lite pain Injection site 691 I54b 091 MylKlWlMlt Acluneij Fugue tern Infection viral Inlluenttliko symptom 119 103 1 135s 091 IBS 166 144s 090 1 72 1 225 205C 073 3B6 342 2 58C 161 283 245 JMC IE6 112 104 MiKntoluMil IpM AiiNalgia Back pain Myalgia 267 1 260 I52a 24 1 605 190 155 4B31 294 095 121 NwnulrMM Diuiness 108 561 509 lUiplntny foricrtfs 128 150 146 Includes events oblainud ttuougli spontaneous epoits following each dose and events repotted 1 month alter dosus 1 and 7 wtwii all subjects vwe queried regarding itw occurrence ol any adverse event since he previous vaccination a p valued 05 b pvaluo OQ1 c pvalue 0001 The most frequently eported unsolicited adverse events occurring more than 30 days late alter vaccination tor all subjects were similar in nature to those listed in Table and most occurred at a frequency of in both the vaccine or placebo groups The only late adverse events occurring with an incidence of 5 in vaccine or placebo recipients were arthratgia respectively and headache vs No significant differences in late adverse events were noted between treatment groups after any dose and Separate post hoc analyses were conducted to assess two subsets of musculoskeletal events which occurred either early days or late 30 days There were no significant either early or between Ihe vaccine and placebo recipients with regard to experiencing aggravated arthropathy or arthro vaccine recipients were significantly more likely lhan placebo recipients lo experience early events of arthralgia or myalgia after each dose for dose 1 odds ratio 95 CD dose 2 OR 1 56 dose 3 OR With regard to late events of arthralgia or there were no significant differ ences between vaccine and placebo There was no significant difference in the rates of cardiac adverse events between vaccine and placebo Neurologic adverse events which occurred at a rale 1 in the vac cine group and were noted to occur with a similar frequency in placebo recipients included carpal tunnel multiple scle myasthenia tngemmal nerve root hyper km and intracranial approximately 18 of subjects enrolled in the study had a prior history of some muscufoskelotat condition 19 18 placebo recipients In a post hoc subgroup there wasnp significant difference between vaccine and placebo recipients with regard to musculoskeletal events Idolmed as arthro tendinithj polymyalgia bursitis or iheumalotd arthritis and lasting more than 30 days in those with a prior history of niusculoskeletal both vaccine and ptacebo recipients with a prior history of musculoskelelal conditions wore more likely to experience musculoskelotal events lhan subjects without such prior Solicited Adverse Events The frequency of solicited local and systemic adverse events was evaluated in a subset of subjects who comprised the total enrollment at one study center in the efficacy Of these 938 BOO completed a 4day diary card following each of three and were evaluable according to Table 2 snows Ihe percentage of subjects reporting a solicited symptom following any one ol the thrf doses and The majority of the solicited events wore mild to moderate in seven and limited in any Anhraliju 452 07 70 B 29 02 43b 7 62b 1633 any 16 83 05 1181 Ib 1633 10 3291 any severe any severe Fevui2995DF Fever I02 2 1910 05 005 4231 151 00 00 149 00 1231 12 05 4 98 201 00 00 100 050 00 1834 12 18 547 176 02 00 100 101 00 3719 30 28 HI691 528 02 00 348 22G 00 00 Scvuie measuring 3 0 CHI and longer 24 I Seveie pievenling everyday noimal aclivily a pvalue005 b Rvalue 0 01 c pvjlue0001 Subjects with Previous Lvirw Disease Subjects with previous Lyme disease were assessed using two definitions subjects whose baselino sera wore evaluated lor Western blot IWBI positivity and subjects who al study entiy selfreported a previous history oILyrno disease Study participants did not routinely have baselino sera tested by WB lor Lvme disease WB WaS Pelormed who were noted to haVo a i no or etw cmees determined to have been WBpositive at baseline conij to vacaneos determined to have been WBnogative at baselino 151 vaccineos There were subjects enrolled in the study who sellrojwrted a previous hislorv ol Lyme disease 610 696 placebo recipients For adverse s Sum g the first 30 there was an increased incidence ol musculoskelelal symptoms Tin vac with no inco of psy system disor orders between vaccine and placebo recipients with a prior history ol Lymo disease Amiinn thn in CMK j u Subjects with a sellreported prior history ol Lyme disease had a greater incident chiatric disorders early and and autonomic nervous svs ders and gastrointestinal disorders fete than subjects win no prior histor V M1J MtMUH i seventy Table Tht Incidence of Local and Gtntril Solicited Including VKClH PlKIlM 4021 Ml I VicclM VKCIM Vicclu IN IN Ml local Symptom any severe any severe any Hc 829 00 81 3868 12 00 I44JC 427 00 704 r 10 oo 7037C 3090 10 03 II44C 327 00 1181 00 82 52 26 03 I915C 67B 05 2085 42C 00 9353C 6809 00 29B5C 1131 05 00 As with all it is possible that expanded commercial use ol the vrsccine could reveal rare adverse events not observed in clinical studios vaccine Manufactured by SmithKline Beecham Biologlcals Belgium Distributed by SmithKline Beecham Pharmaceuticals PA 19101 SmithKline 1993 and TipLokaie trademarks of SrnithKlmo Beecham
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