CANCIDAS PACKAGE INSERT PDF

Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Cancidas did not increase the plasma levels of cyclosporine. Tacrolimus: For patients receiving Cancidas and tacrolimus, standard monitoring of tacrolimus trough whole blood concentrations and appropriate tacrolimus dosage adjustments are recommended. Other Inducers of Hepatic CYP Enzymes Adults: When Cancidas is co-administered to adult patients with other inducers of hepatic CYP enzymes, such as efavirenz, nevirapine, phenytoin, dexamethasone, or carbamazepine, administration of a daily dose of 70 mg of Cancidas should be considered [see Dosage and Administration 2. There are insufficient human data to establish whether there is a drug-associated risk for major birth defects, miscarriage, or adverse maternal or fetal outcomes with Cancidas use in pregnant women.

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Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Cancidas did not increase the plasma levels of cyclosporine. Tacrolimus: For patients receiving Cancidas and tacrolimus, standard monitoring of tacrolimus trough whole blood concentrations and appropriate tacrolimus dosage adjustments are recommended.

Other Inducers of Hepatic CYP Enzymes Adults: When Cancidas is co-administered to adult patients with other inducers of hepatic CYP enzymes, such as efavirenz, nevirapine, phenytoin, dexamethasone, or carbamazepine, administration of a daily dose of 70 mg of Cancidas should be considered [see Dosage and Administration 2. There are insufficient human data to establish whether there is a drug-associated risk for major birth defects, miscarriage, or adverse maternal or fetal outcomes with Cancidas use in pregnant women.

In animal studies, caspofungin caused embryofetal toxicity, including increased resorptions, increased peri-implantation loss, and incomplete ossification at multiple fetal sites when administered intravenously to pregnant rats and rabbits during organogenesis at doses up to 0.

Advise patients of the potential risk to the fetus. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U. Data Animal Data In animal reproduction studies, pregnant rats dosed intravenously with caspofungin during organogenesis gestational days [GD] 6 to 20 at 0.

Caspofungin crossed the placenta in rats and rabbits and was detectable in fetal plasma. In peri- and postnatal development study in rats, intravenous caspofungin administered at 0. Lactation Risk Summary There are no data on the presence of caspofungin in human milk, the effects on the breast-fed child, or the effects on milk production.

Caspofungin was found in the milk of lactating, drug-treated rats. Pediatric Use The safety and effectiveness of Cancidas in pediatric patients 3 months to 17 years of age are supported by evidence from adequate and well-controlled studies in adults, pharmacokinetic data in pediatric patients, and additional data from prospective studies in pediatric patients 3 months to 17 years of age for the following indications [see Indications and Usage 1 ]: Empirical therapy for presumed fungal infections in febrile, neutropenic patients.

Treatment of candidemia and the following Candida infections: intra-abdominal abscesses, peritonitis, and pleural space infections. Treatment of esophageal candidiasis.

Treatment of invasive aspergillosis in patients who are refractory to or intolerant of other therapies e. The efficacy and safety of Cancidas has not been adequately studied in prospective clinical trials involving neonates and infants under 3 months of age. Although limited pharmacokinetic data were collected in neonates and infants below 3 months of age, these data are insufficient to establish a safe and effective dose of caspofungin in the treatment of neonatal candidiasis.

Invasive candidiasis in neonates has a higher rate of CNS and multi-organ involvement than in older patients; the ability of Cancidas to penetrate the blood-brain barrier and to treat patients with meningitis and endocarditis is unknown. Cancidas has not been studied in pediatric patients with endocarditis, osteomyelitis, and meningitis due to Candida. Cancidas has also not been studied as initial therapy for invasive aspergillosis in pediatric patients.

In clinical trials, pediatric patients 0 months to 17 years of age , including 18 patients who were less than 3 months of age, were given intravenous Cancidas. Pharmacokinetic studies enrolled a total of 66 pediatric patients, and an additional pediatric patients received Cancidas in safety and efficacy studies [see Clinical Pharmacology In all studies, safety was assessed by the investigator throughout study therapy and for 14 days following cessation of study therapy.

Postmarketing hepatobiliary adverse reactions have been reported in pediatric patients with serious underlying medical conditions [see Warnings and Precautions 5. Geriatric Use Clinical studies of Cancidas did not include sufficient numbers of patients aged 65 and over to determine whether they respond differently from younger patients.

Although the number of elderly patients was not large enough for a statistical analysis, no overall differences in safety or efficacy were observed between these and younger patients. A similar effect of age on pharmacokinetics was seen in patients with candidemia or other Candida infections intra-abdominal abscesses, peritonitis, or pleural space infections. No dose adjustment is recommended for the elderly; however, greater sensitivity of some older individuals cannot be ruled out.

Patients with Hepatic Impairment Adult patients with mild hepatic impairment Child-Pugh score 5 to 6 do not need a dosage adjustment. For adult patients with moderate hepatic impairment Child-Pugh score 7 to 9 , Cancidas 35 mg once daily is recommended based upon pharmacokinetic data [see Clinical Pharmacology However, where recommended, a mg loading dose should still be administered on Day 1 [see Dosage and Administration 2.

There is no clinical experience in adult patients with severe hepatic impairment Child-Pugh score greater than 9 and in pediatric patients 3 months to 17 years of age with any degree of hepatic impairment. Patients with Renal Impairment No dosage adjustment is necessary for patients with renal impairment.

Caspofungin is not dialyzable; thus, supplementary dosing is not required following hemodialysis [see Clinical Pharmacology Overdosage In 6 healthy subjects who received a single mg dose, no significant adverse reactions were reported. Multiple doses above mg daily have not been studied. Caspofungin is not dialyzable. In clinical trials, one pediatric patient 16 years of age unintentionally received a single dose of caspofungin of mg on Day 1 , followed by 80 mg daily for an additional 7 days.

No clinically significant adverse reactions were reported. Cancidas Description Cancidas is a sterile, lyophilized product for intravenous IV infusion that contains a semisynthetic lipopeptide echinocandin compound synthesized from a fermentation product of Glarea lozoyensis. Cancidas caspofungin acetate is 1-[ 4R,5S [ 2-aminoethyl amino]-N2- 10,dimethyloxotetradecyl hydroxy-L-ornithine][ 3R hydroxy-L-ornithine] pneumocandin B0 diacetate salt.

Cancidas 50 mg contains 50 mg of caspofungin equivalent to Cancidas 50 mg also contains: 39 mg sucrose, 26 mg mannitol, glacial acetic acid, and sodium hydroxide. Cancidas 70 mg contains 70 mg of caspofungin equivalent to Cancidas 70 mg also contains 54 mg sucrose, 36 mg mannitol, glacial acetic acid, and sodium hydroxide. Caspofungin acetate is a hygroscopic, white to off-white powder. It is freely soluble in water and methanol, and slightly soluble in ethanol.

The pH of a saturated aqueous solution of caspofungin acetate is approximately 6. The structural formula is: Cancidas - Clinical Pharmacology Caspofungin is an echinocandin antifungal drug [see Microbiology Pharmacokinetics Adult and pediatric pharmacokinetic parameters are presented in Table 8. Distribution Plasma concentrations of caspofungin decline in a polyphasic manner following single 1-hour IV infusions.

Distribution, rather than excretion or biotransformation, is the dominant mechanism influencing plasma clearance. There is little excretion or biotransformation of caspofungin during the first 30 hours after administration.

Metabolism Caspofungin is slowly metabolized by hydrolysis and N-acetylation. Caspofungin also undergoes spontaneous chemical degradation to an open-ring peptide compound, L Additional metabolism involves hydrolysis into constitutive amino acids and their degradates, including dihydroxyhomotyrosine and N-acetyl-dihydroxyhomotyrosine. These two tyrosine derivatives are found only in urine, suggesting rapid clearance of these derivatives by the kidneys.

Excretion Two single-dose radiolabeled pharmacokinetic studies were conducted. In one study, plasma, urine, and feces were collected over 27 days, and in the second study plasma was collected over 6 months. Plasma concentrations of radioactivity and of caspofungin were similar during the first 24 to 48 hours postdose; thereafter drug levels fell more rapidly.

In plasma, caspofungin concentrations fell below the limit of quantitation after 6 to 8 days postdose, while radiolabel fell below the limit of quantitation at However, in adult patients with invasive aspergillosis, candidemia, or other Candida.

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CANCIDAS PACKAGE INSERT PDF

Samuro Remove peritoneal dialysis catheter. Reconstituted caspofungin in the czncidas may be stored at 25 degrees C or less 77 degrees F or less for 1 hour prior to dilution. Very limited data are available. Limited data are available. The clinical significance of the extensive tissue accumulation is unknown, but may contribute to the activity of the drug against localized tissue infections. Do not mix or co-infuse caspofungin with other medications or infuse with dextrose-containing solutions.

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Yozshugrel Administering inducers of hepatic cytochrome P, such as efavirenz, concurrently with caspofungin may reduce the plasma concentrations of caspofungin. Treat for several weeks, followed by oral fluconazole for patients who are unlikely to have a fluconazole-resistant isolate. It has no activity against Cryptococcus neoformans, but in vitro has shown synergistic activity against C. Clinically significant elevations in caspofungin plasma concentrations have been noted in patients with moderate hepatic impairment i. Our website uses cookies to enhance the user experience and provide the best possible service.

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Vulkis Caspofungin has not been studied for safety insery efficacy in infants less than 3 months of age, including neonates. Activity against Trichosporon beigelii, Fusarium sp. Fresenius Kabi is a global health care company that specializes in medicines and technologies for infusion, transfusion and clinical nutrition. Oral antifungal agents e. Coadministration of certain drugs may insrrt to be avoided or dosage adjustments may be necessary; review drug interactions.

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