Caspogin Medical FINAL
-
Upload
pankaj-kaundal -
Category
Documents
-
view
125 -
download
0
Transcript of Caspogin Medical FINAL
![Page 1: Caspogin Medical FINAL](https://reader033.fdocuments.in/reader033/viewer/2022061106/54483dd4b1af9f4c6d8b471d/html5/thumbnails/1.jpg)
Fungal Infections in the ICU
Global scenario
![Page 2: Caspogin Medical FINAL](https://reader033.fdocuments.in/reader033/viewer/2022061106/54483dd4b1af9f4c6d8b471d/html5/thumbnails/2.jpg)
EPIC II STUDY
Gram negative: 62%
Gram positive:47%
Fungi:19% JAMA 2009;302(21);2323-2329
N=14,414 patients from 1,256 ICUs of 75 countries
![Page 3: Caspogin Medical FINAL](https://reader033.fdocuments.in/reader033/viewer/2022061106/54483dd4b1af9f4c6d8b471d/html5/thumbnails/3.jpg)
Fungi
• The fungi are a group of eukaryotic microorganisms, some of which are capable of causing superficial, cutaneous, subcutaneous, or systemic disease
• There are more than a million spp. of fungi & about 400 spp. are pathogenic.
![Page 4: Caspogin Medical FINAL](https://reader033.fdocuments.in/reader033/viewer/2022061106/54483dd4b1af9f4c6d8b471d/html5/thumbnails/4.jpg)
CLASSIFICATION OF FUNGIYeasts Dimorphic fungi Molds
Candida Blastomyces Aspergillus
Cryptococcus Coccidioides Fusarium
Trichosporon Histoplasma Rhizopus
Sporothrix Mucor
Absidia
= Zygomycetes
J Pharmacy and Bioallied Sciences 2010; 2: 314-320
![Page 5: Caspogin Medical FINAL](https://reader033.fdocuments.in/reader033/viewer/2022061106/54483dd4b1af9f4c6d8b471d/html5/thumbnails/5.jpg)
Fungal cell - An overview
![Page 6: Caspogin Medical FINAL](https://reader033.fdocuments.in/reader033/viewer/2022061106/54483dd4b1af9f4c6d8b471d/html5/thumbnails/6.jpg)
Myco = Fungi
![Page 7: Caspogin Medical FINAL](https://reader033.fdocuments.in/reader033/viewer/2022061106/54483dd4b1af9f4c6d8b471d/html5/thumbnails/7.jpg)
High risk populations include• Use of broad spectrum antibiotics• Invasive devices• Hospitalization in ICU settings• Renal failure• Burns• GI/cardiac surgery• Parenteral nutrition• Neutropenic patients• Solid Organ Transplant patients • Diabetics• Immunocompromised patients• Premature infants • Surgical populations
Medical Microbiology. 4th edition: 1996
![Page 8: Caspogin Medical FINAL](https://reader033.fdocuments.in/reader033/viewer/2022061106/54483dd4b1af9f4c6d8b471d/html5/thumbnails/8.jpg)
Medical Microbiology. 4th edition: 1996
Clinical manifestations
![Page 9: Caspogin Medical FINAL](https://reader033.fdocuments.in/reader033/viewer/2022061106/54483dd4b1af9f4c6d8b471d/html5/thumbnails/9.jpg)
Fungal InfectionsMost common
Candidiasis
Aspergillosis
Zygomycosis / “Mucormycosis”
Cryptococcosis
![Page 10: Caspogin Medical FINAL](https://reader033.fdocuments.in/reader033/viewer/2022061106/54483dd4b1af9f4c6d8b471d/html5/thumbnails/10.jpg)
Less common
• Blastomycosis
• Coccidioidomycosis
• Histoplasmosis
• Paracoccidiomycosis
• Sporotrichosis
![Page 11: Caspogin Medical FINAL](https://reader033.fdocuments.in/reader033/viewer/2022061106/54483dd4b1af9f4c6d8b471d/html5/thumbnails/11.jpg)
Epidemiology of Fungal Infections
Candida and Aspergillus are the most common causes in invasive fungal infections, accounting for 70-90% and 10-20% of all invasive mycoses, respectively.
Mortality in candidemia cases can be as high as 70%
Swiss Med Wkly 2006;136:447-463
Jpn.J Med.Mycol 2008; 49:165-172
![Page 12: Caspogin Medical FINAL](https://reader033.fdocuments.in/reader033/viewer/2022061106/54483dd4b1af9f4c6d8b471d/html5/thumbnails/12.jpg)
Why is India a favorable ground for fungal infections
• Tropical climate: hot and humid weather• HIV +ve: 3-6 million• >30 million diabetics• Systemic steroids available over the counter and
misused• IV drug users • Gross overuse of broad spectrum antibiotics• Inadequate infection control practices
Jpn.J Med.Mycol 2008; 49:165-172
![Page 13: Caspogin Medical FINAL](https://reader033.fdocuments.in/reader033/viewer/2022061106/54483dd4b1af9f4c6d8b471d/html5/thumbnails/13.jpg)
Candida prevalence in ICUIndia
• Most common invasive mycotic infection across India
• Most common cause of bacteremia
Jpn.J Med.Mycol 2008; 49:165-172J. Hosp Inf 2009 71, 143-148
![Page 14: Caspogin Medical FINAL](https://reader033.fdocuments.in/reader033/viewer/2022061106/54483dd4b1af9f4c6d8b471d/html5/thumbnails/14.jpg)
Risk factors for Invasive Candidiasis
• Use of broad spectrum antibiotics• Parenteral nutrition• Central catheters• Hospitalization in ICU settings• Renal failure• Burns• GI/cardiac surgery• Candida colonization
J Hosp Med 2009;4:102-110
![Page 15: Caspogin Medical FINAL](https://reader033.fdocuments.in/reader033/viewer/2022061106/54483dd4b1af9f4c6d8b471d/html5/thumbnails/15.jpg)
Earlier……….
![Page 16: Caspogin Medical FINAL](https://reader033.fdocuments.in/reader033/viewer/2022061106/54483dd4b1af9f4c6d8b471d/html5/thumbnails/16.jpg)
![Page 17: Caspogin Medical FINAL](https://reader033.fdocuments.in/reader033/viewer/2022061106/54483dd4b1af9f4c6d8b471d/html5/thumbnails/17.jpg)
Non albicans candida
• C. albicans • C. glabrata • C. tropicalis • C. parapsilosis • C. krusei • C. guilliermondii • C. lusitaniae • C. kefyr • C. rugosa • C. famata • C. inconspicua • C. norvegensis • C. dubliniensis • C. lipolytica • C. zeylanoides • C. pelliculosa
Now…………
![Page 18: Caspogin Medical FINAL](https://reader033.fdocuments.in/reader033/viewer/2022061106/54483dd4b1af9f4c6d8b471d/html5/thumbnails/18.jpg)
![Page 19: Caspogin Medical FINAL](https://reader033.fdocuments.in/reader033/viewer/2022061106/54483dd4b1af9f4c6d8b471d/html5/thumbnails/19.jpg)
Steep rise in Non-albicans
24
46
74
1980s 1997-2000 2011
NA
C pr
eval
ence
(%
)
Year
Jpn.J Med.Mycol 2008; 49:165-172Ind J.Medical Microbiol 2011;29;3:309-311
![Page 20: Caspogin Medical FINAL](https://reader033.fdocuments.in/reader033/viewer/2022061106/54483dd4b1af9f4c6d8b471d/html5/thumbnails/20.jpg)
1980s
C albicans—76%
Non-albicans—24%
1997–2000
C albicans—54%
Non-albicans—46%
C glabrata—16%
C parapsilosis—15%
C tropicalis—10%
C krusei—2%
Other—3%
Shift from albicans to
Non-albicans
Jpn.J Med.Mycol 2008; 49:165-172
![Page 21: Caspogin Medical FINAL](https://reader033.fdocuments.in/reader033/viewer/2022061106/54483dd4b1af9f4c6d8b471d/html5/thumbnails/21.jpg)
AIIMS New Delhin=7297 patients with suspected candidemia over 5 yrs
Infection 2007; 35:256-259
80% of candidemia were caused due to non-albicans
![Page 22: Caspogin Medical FINAL](https://reader033.fdocuments.in/reader033/viewer/2022061106/54483dd4b1af9f4c6d8b471d/html5/thumbnails/22.jpg)
Multi super-speciality care in S.IndiaN=68 candidemia episodes
Ind J.Medical Microbiol 2011;29;3:309-311
74% candidemia cases due to NACs
![Page 23: Caspogin Medical FINAL](https://reader033.fdocuments.in/reader033/viewer/2022061106/54483dd4b1af9f4c6d8b471d/html5/thumbnails/23.jpg)
Fungal biofilms
• Biofilms can be defined as communities of microorganisms attached to a surface
• Majority of diseases caused by Candida are associated with biofilm formation
• Candida biofilms exhibit enhanced resistance against most antifungal agents
Antimicrob Agents Chemother 2009:4377–4384
![Page 24: Caspogin Medical FINAL](https://reader033.fdocuments.in/reader033/viewer/2022061106/54483dd4b1af9f4c6d8b471d/html5/thumbnails/24.jpg)
ANTIFUNGALS
The armamentarium
![Page 25: Caspogin Medical FINAL](https://reader033.fdocuments.in/reader033/viewer/2022061106/54483dd4b1af9f4c6d8b471d/html5/thumbnails/25.jpg)
Medical Mycology:The Last 50 Years
Nys
tatin
Am
phot
eric
in B
(195
8)
Gris
eofu
lvin
5-FCMiconazole
KetoconazoleFluconazole
Itraconazole
L-AmB ABCD ABLC
Terbinafine
Voriconazole
Posaconazole
XM
P
Cas
po
fun
gin
MicafunginRavucon
Ani
du
lafu
ngi
n
![Page 26: Caspogin Medical FINAL](https://reader033.fdocuments.in/reader033/viewer/2022061106/54483dd4b1af9f4c6d8b471d/html5/thumbnails/26.jpg)
CLASSIFICATION
![Page 27: Caspogin Medical FINAL](https://reader033.fdocuments.in/reader033/viewer/2022061106/54483dd4b1af9f4c6d8b471d/html5/thumbnails/27.jpg)
Cell wallEchinocandins:CaspofunginMicafunginAnidulafungin
CytoplasmAzoles: FluconazoleKetoconazoleItraconazoleVoriconazolePosaconazole
Cell membranePolyenes:Amphotericin BLipid AmB formulations*
Nystatin
DNAAntimetabolites:5-fluorocytosine
Site of action of Antifungal classes
![Page 28: Caspogin Medical FINAL](https://reader033.fdocuments.in/reader033/viewer/2022061106/54483dd4b1af9f4c6d8b471d/html5/thumbnails/28.jpg)
Polyenes
Examples Conventional Amphotericin B (AmB-d) Liposomal Amphotericin B (LAmB) Colloidal Amphotericin B (ABCD) Lipid complex Amphotericin B (ABLC)
Mechanism Binds directly to ergosterol to alter cell membrane activity
Adverse effects Fever, chills, phlebitis, anaphylaxis ,increased creatinine, hypokalemia, renal tubular
acidosis.
![Page 29: Caspogin Medical FINAL](https://reader033.fdocuments.in/reader033/viewer/2022061106/54483dd4b1af9f4c6d8b471d/html5/thumbnails/29.jpg)
• Examples Fluconazole, Itraconazole, Ketoconazole, Voriconazole,
Posaconazole. • Mechanism
Inhibits ergosterol biosynthesis by inhibition of 14-a-demethylase.
• Adverse effects Nausea; diarrhoea; abdominal pain; rash; edema; CHF*;
pulmonary edema, visual disturbances
*Cardiac heart failure
Azoles
![Page 30: Caspogin Medical FINAL](https://reader033.fdocuments.in/reader033/viewer/2022061106/54483dd4b1af9f4c6d8b471d/html5/thumbnails/30.jpg)
Echinocandins Examples:
Caspofungin,Micafungin,Anidulafungin
Mechanism Inhibitor of fungal beta-(1,3)-D-glucan synthesis
Adverse effects Chills,GI disorders, hives, itching, difficulty in breathing,swelling
of the mouth, face, lips, or tongue, coughing,rapid breathing, or wheezing, fainting, fast heartbeat, high fever, pain, swelling, or redness at the infusion site or in the infused limb.
![Page 31: Caspogin Medical FINAL](https://reader033.fdocuments.in/reader033/viewer/2022061106/54483dd4b1af9f4c6d8b471d/html5/thumbnails/31.jpg)
Amphotericin B
Caspofungin
Antifungal Spectrum
FungistaticFungicidal 10-50 %Fungicidal >90 %
InactiveC. a
lbicans
C. glabrata
C. tropica
lis
C. parapsilo
sis
C. kruse
i
Cryptoco
ccus
A. fumigatus
A. flavu
s
A. terre
us
Mucorales
Scedosp
orium
Itraconazole
Fluconazole
Ketoconazole
Voriconazole
![Page 32: Caspogin Medical FINAL](https://reader033.fdocuments.in/reader033/viewer/2022061106/54483dd4b1af9f4c6d8b471d/html5/thumbnails/32.jpg)
At a glance
Ind Pediatr 2008;45:905-910
![Page 33: Caspogin Medical FINAL](https://reader033.fdocuments.in/reader033/viewer/2022061106/54483dd4b1af9f4c6d8b471d/html5/thumbnails/33.jpg)
![Page 34: Caspogin Medical FINAL](https://reader033.fdocuments.in/reader033/viewer/2022061106/54483dd4b1af9f4c6d8b471d/html5/thumbnails/34.jpg)
Need for Caspofungin
• Shifting trends of fungal infections – – Rise in NAC– Emergence of antifungal resistance against
candidal isolates
• Greater potential of drug-drug interactions with existing antifungals
![Page 35: Caspogin Medical FINAL](https://reader033.fdocuments.in/reader033/viewer/2022061106/54483dd4b1af9f4c6d8b471d/html5/thumbnails/35.jpg)
EchinocandinsComparison
Similiar spectrum Similiar safety profile
But....Drugs 2011; 71; 1: 11-41
![Page 36: Caspogin Medical FINAL](https://reader033.fdocuments.in/reader033/viewer/2022061106/54483dd4b1af9f4c6d8b471d/html5/thumbnails/36.jpg)
US FDA approved Indications
Caspofungin Micafungin AnidulafunginEmpiric in FN Yes No NoCandidemia Yes No Yes
Candidal abscesses Yes No YesCandida peritonitis Yes No Yes
Esophageal candidiasis Yes Yes YesInvasive aspergillosis Yes No NoCandida prophylaxis No Yes No
Drugs 2011; 71; 1: 11-41
![Page 37: Caspogin Medical FINAL](https://reader033.fdocuments.in/reader033/viewer/2022061106/54483dd4b1af9f4c6d8b471d/html5/thumbnails/37.jpg)
Caspofungin The only echinocandin that is US FDA approved for
the broadest range of indications4
– Invasive Candidiasis– Invasive aspergillosis in patients intolerant of or
refractory to other therapies– Empirical treatment of presumed invasive fungal
infections in febrile neutropenic patients.– Fungal infections in paediatric patients, 3 months of age
and older
![Page 38: Caspogin Medical FINAL](https://reader033.fdocuments.in/reader033/viewer/2022061106/54483dd4b1af9f4c6d8b471d/html5/thumbnails/38.jpg)
![Page 39: Caspogin Medical FINAL](https://reader033.fdocuments.in/reader033/viewer/2022061106/54483dd4b1af9f4c6d8b471d/html5/thumbnails/39.jpg)
Novel mechanism of action
• Blocks beta-(1,3)-d-glucan synthesis
• Acts on cell wall:a unique target not encountered in mammalian cells
• Lower human related toxicity
• Lack of cross-resistance
Drugs 2005; 65; 14:2049–2068
![Page 40: Caspogin Medical FINAL](https://reader033.fdocuments.in/reader033/viewer/2022061106/54483dd4b1af9f4c6d8b471d/html5/thumbnails/40.jpg)
Spectrum
Fungicidal agent against Candida Fungistatic against Aspergillius
Drugs 2005; 65; 14:2049–2068
![Page 41: Caspogin Medical FINAL](https://reader033.fdocuments.in/reader033/viewer/2022061106/54483dd4b1af9f4c6d8b471d/html5/thumbnails/41.jpg)
• Fungicidal against C. albicans and NAC spp1
High susceptibility of >99% against non-albicans Candida species 1
• Kills >99% of Candidal biofilm cells at therapeutically achievable concentrations 2
• Fungistatic against A. fumigatus, A. flavus, A. niger, A. versicolor and A. terreus 1
High susceptibility of >98% against Aspergillus spp 1
• Echinocandins are inactive against Fusarium spp., Zygomycetes, Trichosporon spp., or C. neoformans 3
1. Drugs 2005; 65; 14: 2049-20682. Int J of Antimicrob Agents 2007; 29:136–1433. Proc Am Thorac Soc 2010; 7: 222–228
![Page 42: Caspogin Medical FINAL](https://reader033.fdocuments.in/reader033/viewer/2022061106/54483dd4b1af9f4c6d8b471d/html5/thumbnails/42.jpg)
Pharmacokinetics
Cmax (mg/L) 50 mg single dose70 mg single dose
7.612.3
Protein binding (%) 90
t½ (h) 9–11
Distribution Distributes well into tissues including lung, liver and spleen
Elimination 35% in faeces, 41% in urine, 1.4% as unchanged drug
CSF & eye penetration Low
Drugs 2011; 71; 1:11–41
![Page 43: Caspogin Medical FINAL](https://reader033.fdocuments.in/reader033/viewer/2022061106/54483dd4b1af9f4c6d8b471d/html5/thumbnails/43.jpg)
INDICATIONS
• Empirical therapy for presumed fungal infections in febrile, neutropenic patients
• Treatment of candidaemia and the following Candida infections.
• Treatment of oesophageal and oropharyngeal candidiasis.
• Treatment of invasive aspergillosis in patients who are refractory to or intolerant of other therapies
![Page 44: Caspogin Medical FINAL](https://reader033.fdocuments.in/reader033/viewer/2022061106/54483dd4b1af9f4c6d8b471d/html5/thumbnails/44.jpg)
EFFICACY STUDIES
![Page 45: Caspogin Medical FINAL](https://reader033.fdocuments.in/reader033/viewer/2022061106/54483dd4b1af9f4c6d8b471d/html5/thumbnails/45.jpg)
Invasive candidiasisN=212 patients with proven IC
Favourable response at the end of therapy
Effective first-line therapy for invasive candidiasis caused by Candida & NAC
Antimicrob Agents Chemother 2010:1864–1871
The time to negative blood culture was similar for all the species
Site of Infection:Abscess(Intra abd),Blood,Bone & joint space,peritoneal fluid,pleural fluid
![Page 46: Caspogin Medical FINAL](https://reader033.fdocuments.in/reader033/viewer/2022061106/54483dd4b1af9f4c6d8b471d/html5/thumbnails/46.jpg)
Empirical treatment for persistent febrile neutropeniaN=1,095 patientsGroup 1 (N=556): Caspofungin I.V. 50 mg OD . , following a 70 mg loading dose on day 1Group 2 (N=539): Liposomal amphotericin B I.V. 3 mg/kg OD
Caspofungin recipients had better outcomes than LAmB recipeints w.r.t.: •Successful treatment of fungal infections•Better survival rates•Absence of premature discontinuation as a result of lack of efficacy or toxicity
N Engl J Med 2004; 351:1391–402
![Page 47: Caspogin Medical FINAL](https://reader033.fdocuments.in/reader033/viewer/2022061106/54483dd4b1af9f4c6d8b471d/html5/thumbnails/47.jpg)
Invasive aspergillosis in patients refractory /intolerant of standard therapy
N=90; immunocompromised patients with proven or probable invasive aspergillosis
Primary: Patients receiving at least one dose of the study drug and having sufficient information to permit evaluation. Secondary: Evaluable patients who received at least 7 days of caspofungin therapy.
Clin. Infect. Dis. 2004; 39:1563–71
Well tolerated in 97.8% patients, with the most common infusion-related events being fever, nausea and vomiting.
![Page 48: Caspogin Medical FINAL](https://reader033.fdocuments.in/reader033/viewer/2022061106/54483dd4b1af9f4c6d8b471d/html5/thumbnails/48.jpg)
Oesophageal and oropharyngeal candidiasisN=128; patients with symptomatically and microbiologically documented Candida oesophagitis
Clin. Infect. Dis. 2001; 33:1529–35
Equally effective but safer and, hence, is an alternative treatment option to conventional amphotericin B therapy
![Page 49: Caspogin Medical FINAL](https://reader033.fdocuments.in/reader033/viewer/2022061106/54483dd4b1af9f4c6d8b471d/html5/thumbnails/49.jpg)
WELL TOLERATED WITH MINIMAL ADVERSE EVENTS
Drugs 2005; 65; 14:2049–2068
Clinical adverse events Laboratory related adverse events findings
![Page 50: Caspogin Medical FINAL](https://reader033.fdocuments.in/reader033/viewer/2022061106/54483dd4b1af9f4c6d8b471d/html5/thumbnails/50.jpg)
Safety & Efficacy in paediatric population N=49; patients aged 3 mths-17 yrs of age with proven or probable invasive
aspergillosis, proven invasive candidiasis or proven oesophageal candidiasis
Effective, well-tolerated alternative for the treatment of Candida and Aspergillus infections in paediatric patients
![Page 51: Caspogin Medical FINAL](https://reader033.fdocuments.in/reader033/viewer/2022061106/54483dd4b1af9f4c6d8b471d/html5/thumbnails/51.jpg)
DOSAGE
Empirical therapy in febrile neutropenia, candidaemia and other Candida infections; invasive aspergillosis
Single 70 mg loading dose on day 1, followed by 50 mg once daily
Oesophageal and oropharyngeal candidiasis
Single 50 mg dose once a day for 7-14 days
Adults (above 18 years of age)
![Page 52: Caspogin Medical FINAL](https://reader033.fdocuments.in/reader033/viewer/2022061106/54483dd4b1af9f4c6d8b471d/html5/thumbnails/52.jpg)
Paediatric Patients (3 months to 17 years of age)
• Single 70 mg/m2 loading dose on day 1, followed by 50 mg/m2 once daily.
• Loading dose is calculated as BSA (m2) ×70 mg/m2.
• Maintenance dose is calculated as BSA (m2) × 50 mg/m2
• BSA(m2) = √ Height (Cm) X Weight(Kg)3600
![Page 53: Caspogin Medical FINAL](https://reader033.fdocuments.in/reader033/viewer/2022061106/54483dd4b1af9f4c6d8b471d/html5/thumbnails/53.jpg)
Dosing in hepatic impairment
• No dose adjustment in mild hepatic impairment
• 70-mg loading dose, followed by 35 mg O.D. in moderate hepatic impairment
• No clinical experience in severe hepatic impairment and paediatric patients with any degree of hepatic impairment.
![Page 54: Caspogin Medical FINAL](https://reader033.fdocuments.in/reader033/viewer/2022061106/54483dd4b1af9f4c6d8b471d/html5/thumbnails/54.jpg)
Dosage in special conditions
Higher dosage of caspofungin (70 mg/OD)• Is required when co-administered with drugs
like ciclosporins, tacrolimus, rifampicin, dexamethazone, carbamazapine, phenytoin and other inducers of drug clearance
![Page 55: Caspogin Medical FINAL](https://reader033.fdocuments.in/reader033/viewer/2022061106/54483dd4b1af9f4c6d8b471d/html5/thumbnails/55.jpg)
Dose adjustment in renal impairment No
Dose adjustment in geriatric patients No
Dose in pregnancy & lactation
Use only if the potential benefit justifies the potential risk to the foetus
Women receiving caspofungin should not breast-feed
![Page 56: Caspogin Medical FINAL](https://reader033.fdocuments.in/reader033/viewer/2022061106/54483dd4b1af9f4c6d8b471d/html5/thumbnails/56.jpg)
METHOD OF PREPARATION AND ADMINISTRATION
![Page 57: Caspogin Medical FINAL](https://reader033.fdocuments.in/reader033/viewer/2022061106/54483dd4b1af9f4c6d8b471d/html5/thumbnails/57.jpg)
STORAGE AND HANDLING INSTRUCTIONS
![Page 58: Caspogin Medical FINAL](https://reader033.fdocuments.in/reader033/viewer/2022061106/54483dd4b1af9f4c6d8b471d/html5/thumbnails/58.jpg)
Warnings & Precautions
Concomitant use with cyclosporine Do not use cyclosporine concomitantly in patients for
whom the potential benefit outweighs the potential risk.
Patients who develop abnormal liver function tests during concomitant therapy should be monitored and the risks/benefits of continuing therapy should be evaluated.
![Page 59: Caspogin Medical FINAL](https://reader033.fdocuments.in/reader033/viewer/2022061106/54483dd4b1af9f4c6d8b471d/html5/thumbnails/59.jpg)
Hepatic effects• Laboratory abnormalities in liver function tests have been
seen in healthy volunteers and in adult and paediatric patients treated with caspofungin acetate.
• Patients who develop abnormal liver function tests during caspofungin acetate therapy should be monitored for evidence of worsening hepatic function and evaluated for the risk/benefit of continuing caspofungin acetate therapy.
![Page 60: Caspogin Medical FINAL](https://reader033.fdocuments.in/reader033/viewer/2022061106/54483dd4b1af9f4c6d8b471d/html5/thumbnails/60.jpg)
Drug-drug interactions• Cyclosporine: Transient increases in liver ALT and AST when
caspofungin acetate and cyclosporine were co-administered.
• Tacrolimus: For patients receiving both therapies, both standard monitoring of tacrolimus blood concentrations and appropriate tacrolimus dosage adjustments are recommended.
• Rifampin: Decrease in caspofungin trough concentrations. Adult patients on rifampin should receive 70 mg of CASPOGIN I.V. daily.
![Page 61: Caspogin Medical FINAL](https://reader033.fdocuments.in/reader033/viewer/2022061106/54483dd4b1af9f4c6d8b471d/html5/thumbnails/61.jpg)
Contraindications
Contraindicated in patients with a hypersensitivity to any component of this
product.
![Page 62: Caspogin Medical FINAL](https://reader033.fdocuments.in/reader033/viewer/2022061106/54483dd4b1af9f4c6d8b471d/html5/thumbnails/62.jpg)
HIGHLIGHTS• Novel mechanism of action ensures low
potential to develop cross-resistance and a better tolerability profile
• Highly active against most Candida spp., including azole-resistant strains and biofilms
• Effective first-line agent for invasive candidiasis caused by non-albicans Candida species
![Page 63: Caspogin Medical FINAL](https://reader033.fdocuments.in/reader033/viewer/2022061106/54483dd4b1af9f4c6d8b471d/html5/thumbnails/63.jpg)
• Favourable efficacy and safety profiles against infections caused by clinically relevant Candida and Aspergillus spps
• The only echinocandin that is US FDA approved for the broadest range of indications
o Invasive Candidiasiso Invasive aspergillosis in patients intolerant of or refractory to
other therapieso Empirical treatment of presumed invasive fungal infections in
febrile neutropenic patients.o Fungal infections in paediatric patients, 3 months of age and
older
![Page 64: Caspogin Medical FINAL](https://reader033.fdocuments.in/reader033/viewer/2022061106/54483dd4b1af9f4c6d8b471d/html5/thumbnails/64.jpg)
Candidemia• Moderate to severe candidal infection or
recent azole exposure• Culture result shows presence of
C.glabrata.C.krusei
Clin Inf Dis 2009; 48:503–35
![Page 65: Caspogin Medical FINAL](https://reader033.fdocuments.in/reader033/viewer/2022061106/54483dd4b1af9f4c6d8b471d/html5/thumbnails/65.jpg)
Oesophageal candidiasisCaspofungin is recommended is oesophageal candidiasis when patient is unable to tolerate oral therapy
Clin Inf Dis 2009; 48:503–35
![Page 66: Caspogin Medical FINAL](https://reader033.fdocuments.in/reader033/viewer/2022061106/54483dd4b1af9f4c6d8b471d/html5/thumbnails/66.jpg)
Oropharyngeal candidiasis:• Caspofungin is recommended as alternative
therapy to nystatin, clotrimazole or fluconazole.
Clin Inf Dis 2009; 48:503–35
![Page 67: Caspogin Medical FINAL](https://reader033.fdocuments.in/reader033/viewer/2022061106/54483dd4b1af9f4c6d8b471d/html5/thumbnails/67.jpg)
Invasive Aspergillosis
Clin Inf Dis 2008; 46:327–60
![Page 68: Caspogin Medical FINAL](https://reader033.fdocuments.in/reader033/viewer/2022061106/54483dd4b1af9f4c6d8b471d/html5/thumbnails/68.jpg)
![Page 69: Caspogin Medical FINAL](https://reader033.fdocuments.in/reader033/viewer/2022061106/54483dd4b1af9f4c6d8b471d/html5/thumbnails/69.jpg)
Thank you!!