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ZYGOMYCOSIS: an UPDATE Gastrointestinal Tract ® Volume 24, Issue 4 January 2009 halation of zygomycete spores. In normal individu- als, these spores will be transported via cilia to the pharynx and eliminated from the body through the ZYGOMYCOSIS: AN UPDATE gastrointestinal tract. In susceptible individuals, the ON TREATMENT OPTIONS fungus begins growing in the nasal turbinates or al- 1 veoli of the lungs. The present article will discuss Erin Brady, Pharm.D. Candidate the pathophysiology of zygomycosis, with a focus on reviewing current treatment options and medical lit- erature. RISK FACTORS Zygomycosis, also referred to as Mucormycosis, Individuals who are immunocompromised, either is a rare angioinvasive fungal infection caused by a from hematologic disease, diabetes, or solid organ or class of fungi called Zygomycetes. The class is com- hematopoetic cell transplant, are the most likely to prised of orders Mucorales, Mortierellales, and Ento- develop zygomycosis. A review of 929 cases of zy- mophthorales. Infection with zygomycetes pro- gomycosis found diabetes to be the most common gresses rapidly, frequently resulting in fatality in pa- risk factor (36%), followed by hematologic malig- tients with underlying illnesses. Zygomycetes are nancies (17%), and solid organ or hematopoietic commonly found in the environment, mostly on soil stem cell transplantation (12%). 1,2 Predisposing fac- and decaying vegetation; these fungi reproduce rap- tors to infection are also related to the site of infec- idly and release airborne spores which are frequently tion. The majority of infections in diabetics occur in inhaled. Zygomycete spores are inhaled frequently, the rhino-orbital-cerebral area whereas many infec- yet rarely cause infection, supporting the knowledge tions in patients with hematologic malignancies oc- that some predisposing factor usually exists in pa- cur in the lungs. 2 Other underlying factors that may tients who develop zygomycosis. It is estimated that impart risk for infection are metabolic acidosis, de- there are approximately 1.7 cases per million people feroxamine therapy, iron overload, glucocorticoids, per year, or 500 cases per year in the United States. 5 HIV/AIDS, intravenous drug use, and malnutrition. Almost all human infections caused by zygomycetes have some underlying compromising condition. 1 The most common organisms within the zygomy- cetes class causing infection are Rhizopus , Mucor , and Cunnighamella , while the genera Rhizomucor , INSIDE THIS ISSUE : Saksenaea , and Apophysomyces are implicated in fewer infections. There are several sites within the ZYGOMYCOSIS : A N UPDATE ON TREATMENT body where infection may arise: rhino-orbital- OPTIONS cerebral sites, pulmonary, renal, gastrointestinal, and cutaneous. Rhino-orbital-cerebral and pulmonary infections are the most common. Rhino-orbital- cerebral and pulmonary infections are caused by in- PharmaNote 1 Volume 24, Issue 4 January 2009 Table 1. Comparison of Antifungal Drug Therapy Options Amphotericin B (Fungizone®) Posaconazole (Noxafil®) Caspofungin (Cancidas®) • Binds ergosterol in fungal cell • Inhibits synthesis of beta (1,3)-D- MECHANISM membrane, altering cellular per- • Inhibits fungal cell membrane syn- glucan, a major fungal cell wall meability, causing leakage of cellu- thesis via fungal CYP inhibition OF ACTION component lar components • Deoxycholate: 1-1.5 mg/kg/d IV • Available as suspension only infusion • Dose: 800 mg/d in 2-4 divided • Not established for zygomycosis DOSE • Lipid Formulations: Initially 5 mg/ doses • 70 mg IV infusion on day (loading kg/d IV infusion • Must be administered with a full dose), followed by 50 mg IV • Max: 15 mg/kg/d IV meal • Metabolism unknown • Metabolized by hydrolysis and N- • Slowly excreted by the kidneys • Substrate of p-gp acetylation Dosage Adjustments : • Metabolized by glucuronidation • Small amount (1%) excreted un- KINETICS • Use cautiously in renal impair- • t1/2 = 35h changed in urine ment; may extend dosing interval • >98% bound to albumin • Active metabolites cleared through to 24-36 h biliary system • Infusion-related reactions • Well-tolerated • Nephrotoxicity • Occasional : Histamine-related re- • Normochromic, normocytic ane- actions ADVERSE mia • Rare : • >10%: Fever, headache, N/V/D EFFECTS • Electrolyte abnormalities • Fever • GI toxicity • Phlebitis • Increased LFTs • N/V • Neurologic effects • Headache AmB deoxycholate : • $17/day @ 1mg/kg/d ABLC : • $805/day @ 5mg/kg/d ~$190/day $411.80/day 13 COST AmBi : • $1,316/day @ 5mg/kg/d ABCD : 14 • $448/day @ 4mg/kg/d P-gp = p-glycoprotein; T 1/2 = elimination half-life; LFT = liver function test; IV = intravenous; GI = gastrointestinal; N/V/D = nau- sea/vomiting/diarrhea; CYP = cytochrome P450 enzyme system Patients in diabetic ketoacidosis (DKA) are at highest chronic overload conditions. Individuals with renal risk for infection due to elevated blood glucose and insufficiency or individuals requiring frequent blood metabolic acidosis. Rhizopus organisms contain an transfusions are generally the population of patients enzyme, ketone reductase, that allows survival in an prescribed this medication. Deferoxamine can in- acidic environment with high glucose content. Ke- crease not only growth of the fungus, but also patho- tone reductase places both uncontrolled type I and genicity; many patients infected with zygomycosis type II diabetics at a high risk for zygomycosis infec- with concomitant use of deferoxamine will develop tions, especially if in diabetic ketoacidosis. generalized disseminated infection associated with Deferoxamine is an iron and aluminum chelator an extremely high mortality rate. used to treat iron and/or aluminum toxicity or PharmaNote 2 Volume 24, Issue 4 January 2009 Posaconazole (Noxafil®) is a new triazole anti- receiving immunosuppressive therapy coupled with fungal with a broad spectrum of activity. The fol- the use of antifungal therapies that do not have activ- lowing organisms are generally considered suscepti- ity against zygomycetes. 7 ble to posaconazole: Aspergillus sp, Candida sp, In a study by Greenberg et al., data of 24 partici- Coccidioides immitis, Cryptococcus neoformans, pants from two open-label, nonrandomized, multi- Fusarium sp, Mucor sp, Rhizopus sp, and Scedospo- center compassionate trials were analyzed. Posa- rium sp . Posaconazole is available only as an oral conazole was administered at 800 mg/day in divided suspension, and must be administered with full meals doses to 19 patients refractory to standard zygomy- in 2 to 4 divided doses daily. The C max and AUC are cosis treatment and 5 patients intolerant to standard approximately 3 times higher when posaconazole is therapy. The mean and median duration of treatment given with a full meal; C max and AUC are approxi- with posaconazole was 292 and 182 days respec- mately 4 times higher when administered with a high tively with a 79% treatment success rate (complete -fat meal, relative to the fasting state. 12 Posaconazole and partial responses). Seventy-nine percent (19 of possesses a 35 hour half-life, thus it takes approxi- 24 enrollees) survived the infection; none of the mately 5-7 days to reach steady state levels. This is treatment failures received greater than 31 days of not an ideal kinetic profile for use as monotherapy in treatment, with most investigators reporting evidence initial treatment of zygomycosis. Zygomycosis is not of improvement within 2 weeks of initiating posa- currently an FDA-approved indication for posacona- conazole. 6 zole but has been shown in two compassionate trials Alexander and colleagues reported the findings to be effective as salvage therapy for refractory in- of a post-hoc analysis from an open-label, multicen- fection. 6,7 ter study in which posaconazole was administered as Van Burik and colleagues conducted a retrospec- salvage therapy to 23 solid organ transplant patients tive study in 91 patients with either refractory zygo- with proven or probable invasive fungal infections mycosis or intolerance to amphotericin B treatment. (IFIs). 16 Primary causative pathogens were: Aspergil- Most subjects were initially treated with lipid formu- lus (n = 12), Candida (n = 3), Fusarium (n = 2), lations of AmB with 26% of subjects receiving con- Cryptococcus (n = 1), Zygomycetes (n = 2), and oth- ventional AmB. Subjects were given posaconazole ers (n = 4). Participants with zygomycosis were con- 800 mg/d in divided doses with meals or enteral sidered refractory to standard therapy if they showed feedings to optimize drug exposure. Overall success, disease progression or no clinical improvement after defined as complete or partial response 12 weeks af- 7 days of treatment. Intolerance to standard therapy ter initiation of posaconazole, was achieved in 60% was classified as renal impairment, severe infusion- of the study subjects. Complete response was defined related toxicity, or high-risk for toxicity based on as resolution of infection, while partial response was underlying conditions or medications. The primary defined as a clinically meaningful improvement. endpoint was response at the end of treatment with Fourteen percent of patients had a complete re- complete and partial responses defined as success, sponse, 46% had a partial response, 21% had stable and stable disease or failure defined as non-success. disease, 17% experienced treatment failure, and 2% Posaconazole was administered as 800mg per day in had an undetermined outcome. Most participants divided doses with food; most patient received posa- (80%) were given posaconazole
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