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 80 percent mortality in cases where it affects the brain.
There are reports by Dr. Parth Rana, Dr. Atul Patel, Gujrat, Dr. Manish Munjal, Delhi. More than 38 mucor cases are reported in last three months in Delhi NCR & Gujrat which is 5 times higher than the Covid-19 pandemic. Current Scenario clearly highlights Mucormycosis as emerging crisis without any definite boundaries.
Only treatment option-
Amphotericin B is the only Broad Spectrum Anti-Mucor (Zygomycotic) drug and Liposomal Amphotericin B in Saline (FUNGISOME) is its only highly effective and nephron-safe formulation.
FUNGISOME is effective and life-saving for fungal infections including Mucor at the dose of 1-3mg whereas for other liposomal Amphotericin B formulations like AmBisome, reports suggest the use in the dose range of 10-15mg/kg daily.
Liposomal Amphotericin B in Saline Suspension (FUNGISOME) is developed and Made in India under Government of India’s “Programme Aimed at Technological Self- Reliance” and is the most recent of all the Liposomal Amphotericin B and has NO NEPHROTOXICITY as established by clinical trials (Reference 1, 2). FUNGISOME is also the most effective, most safe and most economical of all antifungal drugs.
The MIC of FUNGISOME is 0.06 - 1mg/L against Zygomycetes. MIC90 of Liposomal Amphotericin B in Saline (FUNGISOME) is 2-16-fold lower than Conventional Amphotericin B. Following isolates were examined- (Reference 3).
- Apophysomyces elegans (N = 1)
- Rhizopus oryzae (N = 17)
- Lichtheimia corymbifera (N = 6)
- Rhizomucor pusillus (N = 2)
- Rhizopus homothallicus (N = 2)
- Mucor circinelloides (N = 2)
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%.
- A patient suffering from Mucormycosis at SGPGI, Lucknow was successfully treated with FUNGISOME i.v. and FUNGISOME gel. He recovered in less than 1.5 months. Pictures from the case are attached below:
- Publication: 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.(Reference 5)
- The isolate was presumptively identified as Rhizopus homothallicus. Liposomal amphotericin B (FUNGISOME)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.
- FUNGISOME 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 without any toxicity.
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 And AmBisome
CLINICAL ADVANTAGES of FUNGISOME (LAmB-S):
Owing to its significant clinical advantages, “Inj. Liposomal Amphotericin B in Saline 50mg and 10mg” (FUNGISOME) should rationally be Drug of choice for Systemic mycosis particularly for Mucormycosis patients needing a sugar free and potent drug.
- 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.
- Post-marketing study to assess the safety, tolerability and effectiveness of FungisomeTM: An Indian liposomal amphotericin B preparation. Sanath SS, Gogtay NJ and Kshirsagar NA. J Postgrad Med 51 Suppl 1: S58-63, 2005.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.