FUNGISOME® i.v. is a sterile, yellow suspension for intravenous infusion. Each ml of FUNGISOME® i.v. infusion contains 1 mg of Amphotericin B intercalated in Liposomes. It is available in two presentations, viz. 10ml and 50ml.
Each ml of FUNGISOME® i.v. contains 1mg of Amphotericin B USP in Liposomes made up of Lecithin and Cholesterol in Sodium Chloride Intravenous Infusion 0.9% (w/v) {Normal Saline}.
Amphotericin B is a macrolide polyene antibiotic produced by strain of Streptomyces nodosus.
Liposomes are artificial vesicles, composed of concentric lipid bilayers which enclose an aqueous space. Amphotericin B being lipophilic is intercalated into the lipid bilayer.
Amphotericin B shows a high order of in vitro activity against many species of fungi viz. Histoplasma capsulatum, Cryptococcus immitis, Candida sp., Blastomyces dematitidis, Rhodotorula, Cryptococcus neoformans, Sporothrix schenckii, Mucor sp., Aspergillus sp., Malassezia furfur, Trhosporon beigelii, Saccharomyces cerevisae, Schedosporium sp., Paecilomyces sp., Penicillum sp., Fusarium sp., Bipolaris sp., Exophiala sp., Cladophialophora sp., Absidia sp., Apophysomyces sp., Cunninghamella sp., Rhizomucor sp., Rhizopus sp., and Saksenaea sp. These fungi are inhibited by concentrations of Amphotericin B ranging from 0.03 to 1 µg/ml in vitro. Amphotericin B also has activity against species of Leishmania and its found to be effective in the treatment of Kala-Azar. It has minimal or no effect on bacteria and viruses.
Patients treated with conventional Amphotericin B develop toxicities such as nephrotoxicity, cardiotoxicity, CNS toxicity, electrolyte disturbances beside acute reactions like fever, chills, nausea, vomiting , etc.
FUNGISOME® i.v. is indicated for treatment of Invasive Systemic Fungal Infections and as empirical treatment.
FUNGISOME® i.v. is also indicated for Visceral Leishmaniasis and found to be effective even in cases resistant to standard Antifungal and Antileishmanial drugs.
Ready to use suspension and does not require reconstitution and filtration (Follow the Instructions given in the Product Insert)
The recommended dose of FUNGISOME® i.v. is 1-3mg/kg body weight/day.
The results of the studies done till now indicated the following dose schedule as mg/kg body wt./day in respective infections :
| Candiduria | 1mg/kg/day for 3 weeks |
| Candidemia | 1mg/kg/day for 4 weeks |
| Disseminated candidiasis | 1mg/kg/day for 6 weeks or longer |
| Mucormycosis | 1mg/kg/day for 6 weeks or longer |
| Aspergillosis | 1mg/kg/day for 6 weeks or longer |
| Cryptococcal meningitis | 1mg/kg/day for 6 weeks or longer |
Leishmania is a Macrophage resident parasite (amastigote) and Liposomes are taken up by macrophages through phagocytic action with high propensity. This leads to passive targeting of FUNGISOME® i.v. to Leishmania parasite and confers high Antileishmanial efficacy.
FUNGISOME® i.v. has been used successfully for the treatment of Visceral Leishmaniasis with a dose. of 1mg/kg body wt./day for 21 days to single high dose of 10-15mg/kg body wt. In difficult to treat cases, physician may recommend the treatment for longer duration
A dose of 7.5 mg/kg of FUNGISOME® i.v. for two consecutive days gives 100% efficacy without recurrence and no Post-kala-azar Dermal Leishmaniasis in the Clinical trials when followed for 5-7 years Read more
Prevention - Goswami R.P., Rahman M., Das S., Tripathi S.K. and Goswami R.P. Combination Therapy against Indian Visceral Leishmaniasis with Liposomal Amphotericin B (FUNGISOME® i.v.) and Short-Course Miltefosine in Comparison to Miltefosine Monotherapy. Am J Trop Med Hyg, doi: 10.4269/ajtmh.19-09312020.
Cure - Akansha Anil Chadha, Vidya Kharkar, Uday Khopkar, Bhushan Darkase, Shivangi Patel1, Nilima A. Kshirsagar1 Treatment of Post Kala-Azar Dermal Leishmaniasis with FUNGISOME® i.v. – A Novel Indian Liposomal Amphotericin B. Indian J Drugs Dermatol. 6:28-31,2020.
Pediatric patients of Systemic Fungal Infections and Visceral Leishmaniasis have been treated successfully with doses comparable to adults on a per kilogram body weight basis without any significant adverse effect
Candidemia in neonates has been treated with FUNGISOME® i.v. It is essential to monitor serum levels of electrolytes and withhold FUNGISOME® i.v. if serum electrolyte values are below normal range. If FUNGISOME® i.v. therapy induces vomiting, subsequent administration of FUNGISOME® i.v. is recommended on empty stomach to minimize chances of related aspiration.
Based on studies done till now, no specific dosage alteration or precautions are recommended.
Patients with high creatinine levels have been administered FUNGISOME® i.v. and have been treated successfully. If rise in creatinine is noted following FUNGISOME® i.v. administration, dose can be reduced to 0.8mg/kg body wt./day.
In patients with high bilirubin or liver enzymes (SGOT, SGPT) before or during FUNGISOME® i.v. treatment, dose should be reduced to 0.8mg/kg body wt./day.
Further dose alterations or discontinuation should be individualized.
The treating Physician should use discretion for FUNGISOME® i.v. administration after ascertaining that benefits outweigh the risks.
FUNGISOME® i.v. is contraindicated in patients who have developed serious hypersensitivity reaction during previous infusion of Amphotericin B i.v. or any of the lipid constituents of FUNGISOME® i.v. Experience with such cases is limited.
One patient who developed bronchospasm after infusion of Conventional Amphotericin B did not suffer bronchospasm with FUNGISOME® i.v.
The problem of fever or rigor could be avoided to some extent by lowering the rate of infusion.
If any serious adverse effects are noted, the infusion should be stopped and the drug withdrawn.
Renal, hepatic, hematological parameters along with serum electrolytes levels should be monitored regularly during treatment. If any deterioration occurs in these parameters, administration of the drug should cease immediately. Subsequent dosage should be administered based on above mentioned parameters.
Although FUNGISOME® i.v. is safer than Conventional Amphotericin B yet if the creatinine exceeds 2.5mg %, dosage should be reduced or discontinued till renal function improves. Hypokalemia during FUNGISOME® i.v. therapy should be treated appropriately.
In neonates, if there is fall in packed cell volume (PCV), it should be treated with transfusions.
Do not mix FUNGISOME® i.v. with any drug, diluent, or fluid other than Normal Saline for infusion.
Do not use FUNGISOME® i.v. if there is any evidence of crystals, foreign material, or foreign particle in the bottle.
The use of FUNGISOME® i.v. enables to overcome dose related nephrotoxicity of Amphotericin B, thus allowing concomitant use of nephrotoxic drugs and bone marrow suppressants with due precautions and on the advice of the treating physician. Drug interactions due to possible hypokalemia appropriately managed.
Drug interactions due to possible hypokalemia with FUNGISOME® i.v. must be borne in mind and hypokalemia appropriately managed.
Unopened bottles of FUNGISOME® i.v. must be stored at 2-8ºC.