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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Send the page ” ” to a friend, relative, colleague or yourself. We do not record any personal information entered above. IV echinocandin antifungal Used for aspergillosis, candidemia, esophageal candidiasis, and empiric treatment in febrile neutropenia Fever and infusion-related reactions common.

Coadministration of certain drugs may need to be avoided or dosage adjustments may be necessary; review drug interactions. Treat for several weeks, followed by oral fluconazole for patients who are unlikely to have a fluconazole-resistant camcidas.

Treat for 2 weeks after documented clearance from the bloodstream and resolution of signs and symptoms. For invasive candidiasis with canciidas metastatic focus, therapy will be longer and depends on response. Ophthalmological examination is recommended for all patients. Consider intravascular catheter removal.

Very limited data ;ackage available; CNS involvement should be presumed in neonates with candidemia. Successful treatment of invasive candidiasis has been reported in neonates and young infants; however, available data are limited to small case series and studies. For neonatal candidiasis, amphotericin B or fluconazole is the preferred therapy.

Some experts suggest that if an echinocandin is used in neonates, micafungin is the preferred agent. Clinical practice guidelines suggest caspofungin as salvage therapy. Treat for at least 6 to 12 weeks with duration dependent on extent and length of immunosuppression, infection site, and disease improvement.

No data are available. Although specific neonatal recommendations are not available, lnsert practice guidelines suggest caspofungin as salvage therapy. Recommended as an alternative therapy in patients unable to tolerate oral therapy or those who are refractory to fluconazole.

The risk of relapse is greater in HIV-infected patients for esophageal candidiasis, and suppressive antifungal therapy may be considered after a course of treatment.

Caspofungin Acetate for Injection Now Available from Fresenius Kabi

Clinical practice guidelines recommend treatment for 14 to 21 days; in HIV-infected patients, treat for a minimum of cncidas days and for at least 14 days following resolution of symptoms. Limited data are available. Growth of Candida sp. In cases where pneumonia is associated with disseminated infection, 70 mg IV loading dose on day 1, then 50 mg IV once daily. Restrict treatment to pneumonia associated with disseminated infection.

Very limited data are available. In lung transplant inserrt with tracheobronchial aspergillosis TBA associated with anastomotic endobronchial ischemia or ischemic reperfusion inssrt, 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.

Surgery alone may be used to treat Aspergillus fungal ball of the paranasal sinus. Duration of therapy is dependent on clinical response. Remove peritoneal dialysis catheter. Treat for at least 2 weeks followed by fluconazole for 6 to 12 months for osteomyelitis or 4 weeks for infectious arthritis.

Recommended as an alternative to fluconazole as initial therapy. Surgical debridement may be helpful in some cases of osteomyelitis and is recommended for all cases of septic arthritis. For infection involving a prosthetic inssrt, device removal in addition to antifungal therapy is recommended. Treat for at least 8 weeks with duration dependent on extent and length of immunosuppression, infection site, and disease improvement.

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Longer courses greater than 6 months are frequently necessary. Duration of treatment is based on clinical response. Empirical therapy should be continued until neutropenia resolution. Treatment for at least 14 days and for at least 7 days after neutropenia and symptoms resolve is recommended for patients found to have a fungal infection.

Recommended in patients with persistent or recurrent fever after 4 to 7 days of antibiotics and anticipated neutropenia duration more than 7 days. Aspergillosis clinical practice guidelines suggest caspofungin as a first line empiric therapy. Recommended as an alternative therapy for fluconazole-refractory oropharyngeal candidiasis. Oral antifungal agents e. For endocarditis, treat for at least 6 weeks after valve replacement. For infected cardiac hardware, treat for at least 4 to 6 weeks after hardware removal.

When valve replacement or hardware removal is not possible, chronic suppressive therapy with fluconazole is recommended after initial treatment. Treat suppurative thrombophlebitis for at least 2 weeks after candidemia if present has cleared. After surgical replacement of an infected valve, consider lifelong antifungal therapy.

Clinical practice guidelines suggest caspofungin as an alternative to posaconazole for aspergillosis prophylaxis in high-risk patients i. 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.

Also recommended in patients with substantial ibsert of invasive candidiasis, such as allogeneic 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.

Dosage adjustment information is only available for adults. No adjustment needed in mild impairment. No adjustment in the loading dose is needed.

Cancidas (caspofungin acetate) dose, indications, adverse effects, interactions from

There is no clinical experience in those with severe hepatic impairment Child-Pugh score more than 9, class C. No dosage adjustment is needed in patients with renal impairment. Intermittent and Continuous Hemodialysis Caspofungin is not dialyzable. Supplemental dosing is not required following hemodialysis. Visually inspect prepared infusions for particulate matter and discoloration prior to administration. Mix gently until the solution is clear.

Caspofungin vials are single use only; discard any unused reconstituted solution. 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. Dilution Add appropriate dose to mL of 0. For fluid restricted patients, may dilute dose to a final concentration not to exceed 0. Do not use any diluents containing dextrose to prepare 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 canicdas 8 degrees C.

Do not administer as an IV bolus injection. Do not mix or co-infuse caspofungin with other medications or infuse with dextrose-containing solutions. Do not store for later use. Caspofungin is contraindicated for use cancisas patients with hypersensitivity to the drug or any of its components. Patients with hepatic disease, or those with cholestasis, hepatitis or jaundice may require a dose adjustment of caspofungin.

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Clinically significant elevations in caspofungin plasma concentrations have been noted in patients with moderate hepatic impairment i. No data are available on the use of caspofungin in patients cancixas severe hepatic disease i.

Caspofungin has not been studied for safety and efficacy in infants less than 3 months of age, including neonates. In general, the safety profile of caspofungin in pediatric patients is comparable to that of adult patients.

Caspofungin is classified in FDA pregnancy risk category C. There have been no well-controlled studies in pregnant women.

Embryotoxic effects have been observed at doses in animals that produced exposure similar to those seen in humans treated with a 70 mg dose. Caspofungin crosses the placenta in animal models and is detected in the plasma of animal fetuses. Caspofungin should be used in pregnancy only when the benefits clearly outweigh the risks. Data inesrt limited regarding use candidas caspofungin during breast-feeding and it is not known if it is excreted into human milk.

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Caution is advised when administering to nursing mothers. Studies to evaluate the effects of exposure on a breast-fed infant have not been conducted; however, based on caspofungin’s poor oral absorption, the risks appear to be low. Monitor potentially exposed infants for gastrointestinal adverse events and cancidqs of histamine release.

Fluconazole may be a potential alternative to consider during breast-feeding. However, site of infection, local susceptibility patterns, and specific microbial susceptibility should be assessed before choosing an alternative agent. Consider the benefits of breast-feeding, the risk of potential infant drug exposure, and the risk of an untreated or inadequately treated condition.

If a breast-feeding infant experiences an adverse effect related to a maternally ingested or administered drug, health care providers are encouraged to report the adverse effect to the FDA. The reductions may be clinically significant.

According to the manufacturer, drugs that may lead to reductions in caspofungin concentrations include carbamazepine. Cyclosporine concentrations are not altered by coadministration with caspofungin. As determined retrospectively, 14 of 40 patients who received caspofungin and cyclosporine 1 to days, median Five of the 14 cases and one case of elevated bilirubin were considered possibly related to concomitant therapy; no clinical evidence of hepatotoxicity or serious hepatic events occurred.

The manufacturer recommends against the concomitant use of caspofungin with cyclosporine unless the potential benefit outweighs the risk. Monitor patients who develop abnormal liver enzyme concentrations; a risk versus benefit pafkage for therapy continuation is recommended. It is not known how caspofungin drug clearance is inaert.

Drugs that may lead to reductions in caspofungin concentrations include dexamethasone. Moderate Use dichlorphenamide and caspofungin together with caution. Dichlorphenamide cncidas potassium excretion and can cause hypokalemia and should be used cautiously with other drugs that may cause hypokalemia including antifungals.

Measure potassium concentrations at baseline and periodically during dichlorphenamide treatment.

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