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Mucormycosis in covid

Mucormycosis in covid FUNGISOME® i.v.
the most effective therapy

FUNGISOME® i.v. – Liposomal Amphotericin B in Saline, the Antifungal drug developed in India, is the safest, most effective drug at low dose of 1-3mg/kg daily for the treatment of dreadful fungi Mucor – Black Fungus i.e. Pandemic and Medical Emergency in Covid-19 treated patients.

Problem

Black fungus or Mucormycosis is a life-threatening Invasive Fungal Infection with mortality around 80% and usually occur in immune compromised patients, patients with uncontrolled diabetes and now reported frequently in steroids treated Covid-19 patients. This disease has led to worldwide medical emergency causing loss of eye, removal of the nose and jaw bone and up to 50-60% percent mortality in cases where it affects the brain.
Current Scenario clearly highlights Mucormycosis as emerging crisis without any definite boundaries.
Early suspicion, early diagnosis and urgent management which includes Antifungal therapy with Liposomal Amphotericin B in Saline as well as extensive debridement surgery for the removal of necrotic tissues is required to safe the life of the patient.

Only treatment option

Amphotericin B is the only Broad Spectrum Anti-Mucor (Zygomycotic) drug and Liposomal Amphotericin B in Saline (FUNGISOME® i.v.) is its only highly effective and Nephro-safe formulation.
FUNGISOME® i.v., is most effective and life-saving drug for the treatment of Fungal Infections including Mucormycosis at the dose of 1-3mg/kg whereas the other Liposomal Amphotericin B formulations has dose range of 5-10mg/kg daily and the dose has gone up to 10-15mg/kg in some of the reports.
Liposomal Amphotericin B in Saline Suspension (FUNGISOME® i.v.) is developed and Made in India under Government of India’s “Programme Aimed at Technological Self- Reliance” and has NO NEPHROTOXICITY as established by clinical trials (Clinical trials.1,2 ).
FUNGISOME® i.v. is also the most effective, most safe and most economical of all antifungal drugs.

1. Kshirsagar NA et al. (2005) Liposomal Drug Delivery System from Laboratory to Clinic. Journal of Postgraduate Medicine. 51(1): s5-s15.

2. Hegde S et al. (2005) Post-marketing study to assess the safety, tolerability and effectiveness of LAmB-Saline; An Indian Liposomal Amphotericin B preparation. Journal of Postgraduate Medicine. 51(suppl. 1): s58-s63.

The MIC of FUNGISOME® i.v. is 0.06 - 1mg/L against Zygomycetes. MIC90 of Liposomal Amphotericin B in Saline (FUNGISOME® i.v.) is 2-16-fold lower than Conventional Amphotericin B. Following isolates were examined
In vitro antifungal activity of Indian liposomal amphotericin B against clinical isolates of emerging species of yeast and moulds, and its comparison with amphotericin B deoxycholate, voriconazole, itraconazole and fluconazole. Rudramurthy SM, Jatana M, Singh R and Chakrabarti A. Mycoses 56: 39-46, 2013.

A patient suffering from Mucormycosis at SGPGI, Lucknow was successfully treated with FUNGISOME® i.v. and FUNGISOME® i.v. gel. He recovered in less than 1.5 months. Pictures from the case are attached below:

covid
Publication on Mucormycosis and Safety of FUNGISOME® i.v.
Publication On Mucormycosis:
Chakrabarti A et al. Cavitary pulmonary zygomycosis caused by Rhizopus homothallicus. J Clin Microbiol 48:1965-1969, 2010.

  • The isolate was presumptively identified as Rhizopus homothallicus. Liposomal amphotericin B (FUNGISOME® i.v.) Lifecare Innovations, India) was given at a dose of 1.5 mg/kg of body weight/day.
  • Follow up after total dose of 5.0 gm of Liposomal amphotericin B in Saline therapy showed striking improvement of the patient both clinically and on radiological investigations. No relapse or recurrence of the infection was noticed until 5 months of follow-up after recovery.
Safety of FUNGISOME® i.v.:
  • FUNGISOME® i.v. has been administered to patients as long as 8.5 months and maximum cumulative dose of 11.2 gram of Amphotericin B has been given without significant toxicity (Reference 2).
  • In Sir Ganga Ram Hospital 17 yrs. old patient had received more than 29gms of FUNGISOME® i.v. without any toxicity.

Liposomal Amphotericin B in Saline suspension (LAmB-S) has significant Clinical advantages over other Liposomal Amphotericin B (LAmB). Liposomal Amphotericin B in Saline suspension (LAmB-S) is distinguished for being free of any significant Nephrotoxicity (no Nephrotoxicity reported in 17 years of its use of more than 300,000 infusions) and has high Efficacy of more than 90% as delineated from Phase II, Phase III and Phase IV multicenter Clinical Trial data. Published data shows that Liposomal Amphotericin B (without Saline) has Nephrotoxicity of 26.9% and efficacy of 42-77%.

The dose of LAmB-S is 1-3mg/kg/day whereas that of LAmB is 3-6mg/kg/day respectively and thus, in addition to matchless Clinical advantages, LAmB-S is also the most Economical of all Liposomal Amphotericin B.

Comparison Between FUNGISOME® i.v. And AmBisome

table

References

  1. Post-marketing study to assess the safety, tolerability and effectiveness of FUNGISOME® i.v. TM: An Indian liposomal amphotericin B preparation. Sanath SS, Gogtay NJ and Kshirsagar NA. J Postgrad Med 51 Suppl 1: S58-63, 2005.
  2. Liposomal drug delivery system from laboratory to clinic. Kshirsagar NA, Pandya SK, Kirodian B G and Sanath S. J Postgrad Med 51 Suppl 1: S5-15, 2005.
  3. In vitro antifungal activity of Indian liposomal amphotericin B against clinical isolates of emerging species of yeast and moulds, and its comparison with amphotericin B deoxycholate, voriconazole, itraconazole and fluconazole. Rudramurthy SM, Jatana M, Singh R and Chakrabarti A. Mycoses 56: 39-46, 2013.
  4. Adler-Moore, Jill, and Richard T. Proffitt. "AmBisome: liposomal formulation, structure, mechanism of action and pre-clinical experience." Journal of Antimicrobial Chemotherapy 49. suppl_1 (2002): 21-30.
    Cavitary pulmonary zygomycosis caused by Rhizopus homothallicus. Chakrabarti A, Marak RS, Shivaprakash MR, Gupta S, Garg R, Sakhuja V., Singhal S, Baghela A, Dixit A, Garg MK and Padhye AA. J Clin Microbiol 48: 1965-1969, 2010.
  5. Wingard, J. R., White, M. H., Anaissie, E., Raffalli, J., Goodman, J., Arrieta, A., & L Amph/ABLC Collaborative Study Group. (2000). A randomized, double-blind comparative trial evaluating the safety of liposomal amphotericin B versus amphotericin B lipid complex in the empirical treatment of febrile neutropenia. Clinical infectious diseases, 31(5):1155-1163.
  6. Ringdén, O. (2002) "Ten years' experience with liposomal amphotericin B in transplant recipients at Huddinge University Hospital." Journal of Antimicrobial Chemotherapy 49. (supp1): 51-55.
  7. Walsh, T. J., Finberg, R. W., Arndt, C., Hiemenz, J., Schwartz, C., Bodensteiner, D & Schuster, M. (1999). Liposomal amphotericin B for empirical therapy in patients with persistent fever and neutropenia. New England Journal of Medicine, 340(10):764-771.

CLINICAL ADVANTAGES of FUNGISOME® i.v. (LAmB-S):

  • Liposomal Amphotericin-B Injection in Saline Suspension (LAmB-S) is the most broad-spectrum all Antifungal drugs including other liposomal Amphotericin B formulations .
  • It is most Potent (lowest MIC of all antifungals including Liposomal and non-Liposomal Amphotericin B).
  • LAmB-S is proven to be effective against Mucor sp., Candida haemulonii & Candida auris.
  • As shown in Table:1 above, it is proven from the data including clinical data that Liposomal Amphotericin-B Injection in Saline Suspension has no nephrotoxicity.
  • Conventional Amphotericin B Injection and Amphotericin B Lipid Complex injection do not have Cholesterol and thus Amphotericin B is delivered non-specifically including to the Kidneys and thus these AmB formulations have very high inherent Nephrotoxicity.
  • All the three Formulations, Amphotericin B Lipid Complex injection and AmBisome are suspended in Dextrose and do not have Saline, thus devoid of advantage to overcome nephrotoxicity caused by Amphotericin B action to distal tubular membrane of kidneys.
  • Saline is known to reduce Nephrotoxicity of Amphotericin B
  • Liposomal Amphotericin in Saline is suitable for Diabetics also.

Owing to its significant clinical advantages, “Inj. Liposomal Amphotericin B in Saline 50mg and 10mg” (FUNGISOME® i.v.) should rationally be Drug of choice for Systemic mycosis particularly for Mucormycosis patients needing a sugar free and potent drug.

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Lifecare – Innovators of FUNGISOME® i.v.