OM-89
| Clinical data | |
|---|---|
| Trade names | Uro-Vaxom |
| Synonyms | OM 89 |
| Identifiers | |
| E number | {{#property:P628}} |
| ECHA InfoCard | {{#property:P2566}} |
OM-89, sold under the brand names Uro-Vaxom and Uro-munal by OM Pharma, is an immune modulator containing 6 mg per capsule of bacterial lysates derived from 18 selected and standardized E.coli strains known to be the most common isolated uro-pathogens responsible for cystitis.[1] It is an orally administered medicine that modulates the immune system and enhances the immune response.[2]
OM-89 was first registered in Switzerland in September 1987.[3] It is one of the most widely studied immunostimulants currently available.[4]
Medical uses
OM-89 is used for the prevention (prophylaxis) of recurrent lower urinary tract infections (UTIs, commonly known as cystitis), and as co-medication to conventional antimicrobial therapy for the treatment of acute UTIs.[2]
Dosage and Administration*
OM-89 is administered orally as one capsule daily on an empty stomach for 3 consecutive months (90 days):[5]
| Month 1 | Month 2 | Month 3 | Month 4 | Month 5 | Month 6 |
|---|---|---|---|---|---|
| 90 Days | |||||
*The indication and dosage information are based on the Swiss Prescribing Information; this information should be updated based on the local prescribing information.
In Germany, OM-89 booster posology is currently registered. In this perspective, 3 months after discontinuing standard drug therapy, one OM-89 capsule is given daily for the first 10 days of each month for 3 consecutive months.[6]
Contraindications
- Known hypersensitivity to the active ingredients/substances or to any of the excipients[5]
Side effects
The favourable safety profile of OM-89 is supported by a large body of clinical trial and post-marketing data.
- Exanthema was the only adverse event (1.6%) reported in the OM-89 group from a 1986 double-blind, placebo-controlled, multicentre study.[7]
- Gastrointestinal disorders, headaches, vertigo, pruritus, nausea, erythema, and hair growth interruption were reported among 4.4% of patients from a 1988 open multicentre trial.[8]
- Vertigo with visual troubles, and subcutaneous nodules were the only two adverse events reported in the OM-89 group versus 11 events in the placebo group from a 1993 double-blind multicentre study.[9]
- In a 1994 double-blind multicentre study, no adverse events were reported among 58 patients who received OM-89.[10]
- Meta-analyses have found OM-89 to have a similar safety and tolerability to placebo.[11][12]
Interactions
No drug interaction is known to date.[5]
Mode of action
The safe microbial content of OM-89 is manufactured as a lyophilized powder of bacterial lysates containing active components derived from 18 selected and standardised E. coli strains known to be the most common isolated uro-pathogens responsible for cystitis.[1]
OM-89 is an immunotherapy that activates multiple host’s immune defence mechanisms via the mucosal-associated lymphoid tissue (MALT), thereby keeping host defences in an alert state mode. OM-89 is a proven immune-modulator preparing the patient to better respond to an recurrent infection by stimulating both the innate [13][14] and adaptive immune systems[13][15] while concomitantly preventing inflammation of bladder tissue[16] thereby increasing the patient’s natural defences against lower recurrent UTIs.
Pharmacokinetics
Pharmacokinetic studies of bacterial extracts are difficult to perform since the active component is not defined by a single molecule.[17]
However, in vivo investigation of the absorption of a high molecular weight fraction of a lysate from a single bacterial strain of OM-89 showed that the maximum plasma level of this bacterial lysate was reached 4 hours following oral administration in rats.[18]
Clinical benefit
Among patients who have received OM-89 in clinical trials, 82% experienced a reduction of dysuria symptoms,[10] 67% were free of cystitis recurrence,[10] and patients reduced antibiotic consumption by 67%.[19]
Preclinical mechanistic studies suggest that this clinical benefit is caused by modulation of the innate and adaptive immune response through an increase and a stimulation of innate immune cells[20], polyclonal antibodies[13] and macrophages. [21][22]
OM-89 has also been shown to reduce inflammation by increasing anti-inflammatory cytokines in vitro[23] and decreasing bladder inflammation in animals.[16]
Legal status
The European Association of Urology (EAU) Guidelines recommend the use of immuno-active prophylaxis with OM-89 in women with recurrent UTIs, with recommendation “Strong” based on 1A level of evidence.[24]
OM-89 is also recommended in several local guidelines and consensus papers including in Brazil, Germany, Mexico, Russia, and South Korea and Switzerland, along with the Latin American Regional consensus.[25][26][27][28][29][30][31][32]
References
- ↑ 1.0 1.1 Ho, Pak-leung; Yip, King-Sun; Chow, Kin-Hung; Lo, Janice Y. C.; Que, Tak-Lun; Yuen, Kwok-yung (2010-01-01). "Antimicrobial resistance among uropathogens that cause acute uncomplicated cystitis in women in Hong Kong: a prospective multicenter study in 2006 to 2008". Diagnostic Microbiology and Infectious Disease. 66 (1): 87–93. doi:10.1016/j.diagmicrobio.2009.03.027. ISSN 0732-8893.
- ↑ 2.0 2.1 Meredith, Marit; Chiavaroli, Carlo; Bauer, Hartwig G. (2009). "Immunotherapy for Recurrent Urinary Tract Infections: Effects of an Escherichia coli Extract". Current Urology. 3 (1): 1. doi:10.1159/000189674. ISSN 1661-7649.
- ↑ Wagenlehner, Florian M. E.; Ballarini, Stefania; Pilatz, Adrian; Weidner, Wolfgang; Lehr, Lorenz; Naber, Kurt G. (2015). "A Randomized, Double-Blind, Parallel-Group, Multicenter Clinical Study of Escherichia coli-Lyophilized Lysate for the Prophylaxis of Recurrent Uncomplicated Urinary Tract Infections". Urologia Internationalis. 95 (2): 167–176. doi:10.1159/000371894. ISSN 0042-1138. PMID 25721866.
- ↑ Sihra, Néha; Goodman, Anna; Zakri, Rhana; Sahai, Arun; Malde, Sachin (December 2018). "Nonantibiotic prevention and management of recurrent urinary tract infection". Nature Reviews Urology. 15 (12): 750–776. doi:10.1038/s41585-018-0106-x. ISSN 1759-4820.
- ↑ 5.0 5.1 5.2 myHealthbox. "Uro-Vaxom". myHealthbox. Retrieved 2023-01-16.
- ↑ myHealthbox. "Uro-Vaxom 6 mg". myHealthbox. Retrieved 2023-01-16.
- ↑ Frey, Ch; Obolensky, W.; Wyss, H. (1986). "Treatment of Recurrent Urinary Tract Infections: Efficacy of an Orally Administered Biological Response Modifier". Urologia Internationalis. 41 (6): 444–446. doi:10.1159/000281253. ISSN 0042-1138. PMID 3547993.
- ↑ Tammen, H (1988). "Treatment of Recurrent Urinary Tract Infections with Uro-Vaxom: Open Multicenter Study with 521 Patients" (PDF). Urologe (B). 28: 294–296 – via Infecciones Urinarias.
- ↑ Schulman, CC (1993). "Oral immunotherapy of recurrent urinary tract infections: a double-blind placebo-controlled multicenter study" (PDF). The Journal of Urology. 150 (3): 917–921 – via Infecciones Urinarias.
- ↑ 10.0 10.1 10.2 Magasi, P; Pánovics, J; Illés, A; Nagy, M (1994). "Uro-Vaxom and the management of recurrent urinary tract infection in adults: a randomized multicenter double-blind trial" (PDF). European Urology. 26 (2): 137–140. doi:10.1159/000475363. ISSN 0302-2838 – via Infecciones Urinarias.
- ↑ Beerepoot, M. a. J.; Geerlings, S. E.; van, Haarst E. P.; van, Charante N. Mensing; ter, Riet G. (2013-12-01). "Nonantibiotic Prophylaxis for Recurrent Urinary Tract Infections: A Systematic Review and Meta-Analysis of Randomized Controlled Trials". Journal of Urology. 190 (6): 1981–1989. doi:10.1016/j.juro.2013.04.142. ISSN 0022-5347.
- ↑ Aziminia, Nikoo; Hadjipavlou, Marios; Philippou, Yiannis; Pandian, Shivkumar S.; Malde, Sachin; Hammadeh, Mohamed Y. (2019). "Vaccines for the prevention of recurrent urinary tract infections: a systematic review". BJU International. 123 (5): 753–768. doi:10.1111/bju.14606. ISSN 1464-410X.
- ↑ 13.0 13.1 13.2 Huber, M; Baier, W; Serr, A; Bessler, W. G (2000-01-01). "Immunogenicity of an E. coli extract after oral or intraperitoneal administration: induction of antibodies against pathogenic bacterial strains". International Journal of Immunopharmacology. 22 (1): 57–68. doi:10.1016/S0192-0561(99)00064-8. ISSN 0192-0561.
- ↑ Macpherson, Andrew J.; Geuking, Markus B.; McCoy, Kathy D. (2011). "Immunoglobulin A: a bridge between innate and adaptive immunity". Current Opinion in Gastroenterology. 27 (6): 529. doi:10.1097/MOG.0b013e32834bb805. ISSN 0267-1379.
- ↑ Marchant, A.; Duchow, J.; Goldman, M. (1992). "Adhesion Molecules in Antibacterial Defenses: Effects of Bacterial Extracts". Respiration. 59 (Suppl. 3): 24–27. doi:10.1159/000196127. ISSN 0025-7931. PMID 1439236.
- ↑ 16.0 16.1 Lee, Seung-Ju; Kim, Sae Woong; Cho, Yong-Hyun; Yoon, Moon Soo (2006-02-01). "Anti-inflammatory effect of an Escherichia coli extract in a mouse model of lipopolysaccharide-induced cystitis". World Journal of Urology. 24 (1): 33–38. doi:10.1007/s00345-005-0046-y. ISSN 1433-8726.
- ↑ Chiavaroli, Carlo; Moore, Adrian (2006-05-01). "An Hypothesis to Link the Opposing Immunological Effects Induced by the Bacterial Lysate OM-89 in Urinary Tract Infection and Rheumatoid Arthritis". BioDrugs. 20 (3): 141–149. doi:10.2165/00063030-200620030-00001. ISSN 1179-190X.
- ↑ van Dijk, A; Bauer, J; Sedelmeier, EA; Bessler, WG (1997). "Absorption, kinetics, antibody-bound and free serum determination of a 14C-labeled Escherichia coli extract after single oral administration in rats" (PDF). Arzneimittelforschung. 47 (3): 329–334. ISSN 0004-4172. PMID 9105555 – via Infecciones Urinarias.
- ↑ Schulman, C. C.; Corbusier, A.; Michiels, H.; Taenzer, H. J. (1993-09-01). "Oral Immunotherapy of Recurrent Urinary Tract Infections: A Double-Blind Placebo-Controlled Multicenter Study". The Journal of Urology. 150 (3): 917–921. doi:10.1016/S0022-5347(17)35648-3. ISSN 0022-5347.
- ↑ Schmidhammer, Silvia; Ramoner, Reinhold; Höltl, Lorenz; Bartsch, Georg; Thurnher, Martin; Zelle-Rieser, Claudia (2002-09-01). "An Escherichia coli-based oral vaccine against urinary tract infections potently activates human dendritic cells". Urology. 60 (3): 521–526. doi:10.1016/S0090-4295(02)01767-3. ISSN 0090-4295.
- ↑ Bessler, Wolfgang G.; Esche, Ulrichvordem; Zgaga-Griesz, Andrea; Ataullakhanov, Ravshan (2010). "Immunostimulatory properties of the bacterial extract OM-89 in vitro and in vivo". Arzneimittelforschung. 60 (6): 324–329. doi:10.1055/s-0031-1296295. ISSN 0004-4172.
- ↑ Van Pham, T; Kreis, B; Corradin-Betz, S; Bauer, J; Mauël, J (1990). "Metabolic and functional stimulation of lymphocytes and macrophages by an Escherichia coli extract (OM-89): in vitro studies" (PDF). Journal of Biological Response Modifiers. 9 (2): 231–240. ISSN 0732-6580. PMID 2160522 – via Infecciones Urinarias.
- ↑ Wybran, J.; Libin, M.; Schandene, L. (1989). "Enhancement of Cytokine Production and Natural Killer Activity By an Escherichia Coli Extract". Oncology Research and Treatment. 12 (Suppl. 3): 22–25. doi:10.1159/000216699. ISSN 2296-5270. PMID 2514401.
- ↑ Bonkat G. et al. European Association of Urology Guidelines on Urological Infections 2020. Available at: https://uroweb.org/wp-content/uploads/EAU-Guidelineson-Urological-infections-2020.pdf
- ↑ Wagenlehner, F; Schmiemann, G (2017). "Interdisziplinäre S3 Leitlinie Epidemiologie, Diagnostik, Therapie ävention und Management unkomplizierter, bakterieller, ambulant erworbener Harnwegsinfektionen bei erwachsenen Patienten Aktualisierung 2017" (PDF). AWMF Online. Retrieved 16 January 2023. Unknown parameter
|url-status=ignored (help) - ↑ Perepanova, TS (2015). "The 2015 Federal Clinical Guidelines for Antimicrobial Therapy and Prevention of Infections of the Kidney, Urinary Tract, and Male Genitals" (PDF). Terapevticheskii Arkhiv. 88 (4): 100–104 – via ResearchGate.
- ↑ Lee, S-J; Choe, H-S; Na, YG; Kim, KH; Kim, JH; Chung, H; Chung, JM; Jung, JH; Choi, H; Lee, S-J; Cho, Y-H (2017). "2017 Guidelines of The Korean Association of Urogenital Tract Infection and Inflammation: Recurrent Urinary Tract Infection". Urogenital Tract Infection. 12 (1): 7–14 – via Urogenital Tract Infection.
- ↑ Velázquez, MDP; Nava, LER; de Avalos, DRL; Garza, GQ; Sánchez, RS; Chávez, VG; de la Cruz, SI; Zesatti, RV; García, JLA; Damián, RF. "Clinical practice guidelines. Recurrent infection of the urinary tract in women. Colegio Mexicano de Especialistas en Ginecología y Obstetricia" (PDF). Ginecología y obstetricia de México. 78 (5): S437–S459 – via ResearchGate.
- ↑ de Zavaleta, MS; de León Garduño, AP; Guzman-Esquivel, J; Nava, ER; Rodríguez Covarrubias, FT; Ramírez, AG; Hernández, JLA; del Barco, LGE; Alpuche, JOC; Narváez, JLC; Juárez, JPC; González, PT; Escoto, PG; Carrera, OF; Grajales, LS (2015). "Recomendaciones de expertos mexicanos en el tratamiento de las infecciones del tracto urinario en pacientes adultos, embarazadas y niños" (PDF). Revista Mexicana de Urología. 75 (2): 1–46 – via ResearchGate.
- ↑ Sacomani, CAR; Truzzi, JC; Resplande, J; de Carvalho, M; Simões, R; Bernardo, WM (2015). "Infecção Urinária de Repetição, Sociedade Brazileira De Urologia Guidelines" (PDF). Sociedade Brasileira de Urologia. Retrieved 16 January 2023. Unknown parameter
|url-status=ignored (help) - ↑ Betschart, Cornelia; Albrich, Werner C.; Brandner, Sonja; Faltin, Daniel; Kuhn, Annette; Surbek, Daniel; Geissbühler, Verena (2020-05-04). "Guideline of the Swiss Society of Gynaecology and Obstetrics (SSGO) on acute and recurrent urinary tract infections in women, including pregnancy". Swiss Medical Weekly. 150 (1920): w20236–w20236. doi:10.4414/smw.2020.20236. ISSN 1424-3997.
- ↑ Haddad, Jorge Milhem; Ubertazzi, Enrique; Cabrera, Oscar Storme; Medina, Martha; Garcia, Jorge; Rodriguez-Colorado, Silvia; Toruno, Efrain; Matsuoka, Priscila Katsumi; Castillo-Pino, Edgardo (2020-01-01). "Latin American consensus on uncomplicated recurrent urinary tract infection—2018". International Urogynecology Journal. 31 (1): 35–44. doi:10.1007/s00192-019-04079-5. ISSN 1433-3023.
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