CANCIDAS PACKAGE INSERT PDF
drug-related adverse reaction leading to caspofungin discontinuation was The printed package leaflet of the medicinal product must state the name and. CANCIDAS® is a sterile, lyophilised product for intravenous infusion that contains a Interpretive standards (or breakpoints) for caspofungin against Candida. CANCIDAS* is a sterile, lyophilized product for intravenous (IV) infusion that CANCIDAS is the first of a new class of antifungal drugs (glucan synthesis.
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Because of the risk of relapse of oropharyngeal candidiasis in patients with HIV infections, suppressive oral therapy could be considered [see see package insert Clinical Studies In addition, some Candida sp.
Cancidas (caspofungin acetate) dose, indications, adverse effects, interactions from
No adjustment in the loading dose is needed. Because of its unique mechanism of action, cross-resistance with amphotericin B and the azoles is not expected. In lung transplant recipients with tracheobronchial aspergillosis TBA associated with anastomotic endobronchial ischemia or ischemic reperfusion injury, inhaled amphotericin B deoxycholate is suggested in addition to systemic therapy; treat for at least 3 months or until TBA is resolved, whichever is longer.
A short alpha-phase is followed by a beta-phase half-life of 9—11 hours ; once daily dosing is adequate. Cyclosporine concentrations are not altered by coadministration with caspofungin.
Administering inducers of hepatic cytochrome P, such as ethotoin, concurrently with caspofungin may reduce the plasma concentrations of caspofungin. The final diluted infusion may be stored for up to 24 hours at 25 degrees C or less 77 degrees F or lessor for up to 48 hours under refrigeration at 2 to 8 degrees C.
It has no activity against Cryptococcus neoformans, but in vitro has shown synergistic activity against C. The clinical significance of the extensive tissue accumulation is unknown, but may contribute to the activity of the drug against localized tissue infections.
Inzert adjustment information is only available for adults. Duration of treatment should be individualized to the indication, as described for each indication in adults [see Dosage and Administration paciage. Embryotoxic effects have been observed at doses in animals that produced exposure similar to those seen in humans treated with a 70 mg dose. Reconstituted caspofungin in the vial may be stored at 25 degrees C or less 77 degrees F or less for 1 hour prior to dilution.
Treat for several weeks, inserg by oral fluconazole for patients who are unlikely to have a fluconazole-resistant isolate. The efficacy of a mg dose regimen in patients who are not clinically responding to the mg daily dose is not known.
Aspergillosis clinical practice guidelines suggest caspofungin as a first line empiric therapy. Neonates and Infants 1 to 2 months. Treat for at least 6 to 12 weeks with duration dependent on extent and length of immunosuppression, infection site, and disease improvement. If this occurs, discontinue Caspofungin and ihsert appropriate treatment.
Caspofungin Acetate for Injection Now Available from Fresenius Kabi
Caspofungin does not interact substantially with the cytochrome P enzyme system, but does undergo significant hepatic metabolism. Caspofungin can cause abnormalities in liver enzymes.
Metabolism occurs by hydrolysis and N-acetylation. Standardized susceptibility testing using microbroth dilution methods read at 24 hours are available for Candida sp. Mix gently until the solution is clear. The pharmacokinetic parameters of caspofungin are not altered by tacrolimus. Recommended as an alternative therapy in patients unable to tolerate oral therapy or those who are refractory to fluconazole.
Limited data are available.
Also recommended in patients with substantial risk of invasive candidiasis, such as allogeneic hematopoietic stem cell transplant HSCT recipients or those undergoing intensive remission-induction or salvage-induction chemotherapy for acute leukemia, and in patients with previous invasive aspergillosis, anticipated prolonged neutropenic periods of at least 2 weeks, or a prolonged period of neutropenia immediately prior to HSCT.
Activity in vitro Caspofungin has been shown to be active both in vitro and in clinical infections against most strains of the following microorganisms:. IV echinocandin antifungal Used for aspergillosis, candidemia, esophageal candidiasis, and empiric treatment in febrile neutropenia Fever and infusion-related reactions common. Recommended in patients with persistent or recurrent fever after 4 to 7 days of antibiotics and anticipated neutropenia duration more than 7 days.
It is not known how caspofungin drug clearance is induced. Please review the latest applicable package insert for additional information and possible updates.
Patients who remain persistently neutropenic may warrant a longer course of therapy pending resolution of the neutropenia. Fresenius Kabi is a global health care company that specializes in medicines and technologies for infusion, transfusion and clinical nutrition.
Aspergillus fumigatus Aspergillus flavus Aspergillus terreus Candida albicans Candida glabrata Candida guilliermondii Candida krusei Candida parapsilosis Candida tropicalis. In murine models, caspofungin has been shown to have less activity against histoplasmosis than amphotericin B.
Caspofungin should be used in pregnancy only when the benefits clearly outweigh the risks. Treat suppurative thrombophlebitis for at least 2 weeks after candidemia if present has cleared.
The reductions pxckage be clinically significant. Caspofungin is classified in FDA pregnancy risk category C. Caspofungin is contraindicated in patients with known hypersensitivity to any component of this product.
Empirical inserrt should be continued until neutropenia resolution. Recipient’s Email Separate multiple email address with a comma Please enter valid email address Recipient’s email is required. Treat for 2 weeks after documented clearance from the bloodstream and resolution of signs and symptoms. Longer courses greater than 6 months are frequently necessary. Monitor potentially exposed infants for gastrointestinal adverse events and signs of histamine release.
Caspofungin Acetate for Injection Now Available from Fresenius Kabi – Fresenius Kabi USA
The pathway of chemical degradation is uncertain. The Important Safety Information does not include all the information needed to use Caspofungin Acetate for Injection safely and effectively. Administering inducers of hepatic cytochrome P, such as nevirapine, concurrently with caspofungin may reduce the plasma concentrations of caspofungin.
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