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CANCIDAS is a brand name for Caspofungin, supplied as a powder for solution. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: AND CLINICAL USE ............................................................................. 3 CONTRAINDICATIONS .................................................................................................. 4 WARNINGS AND PRECAUTIONS…
Verbatim from this product's HC label. Tap a section to expand.
). 5 days). Fourteen patients (35%) developed transaminase elevations > 5 × upper limit of normal or > 3 × baseline during concomitant therapy or the 14-day follow-up period; five were considered possibly related to concomitant therapy.
One patient had elevated bilirubin considered possibly related to concomitant therapy. No patient developed clinical evidence of hepatotoxicity or serious hepatic events. Discontinuations due to laboratory abnormalities in hepatic enzymes from any cause occurred in four patients.
Of these, 2 were considered possibly related to therapy with CANCIDAS® and/or cyclosporine as well as to other possible causes. In the prospective invasive aspergillosis and compassionate use studies, there were 4 adult patients treated with CANCIDAS® (50 mg/day) and cyclosporine for 2 to 56 days.
None of these patients experienced increases in hepatic enzymes. Given the limitations of these data, CANCIDAS® and cyclosporine should only be used concomitantly in those 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 risk/benefit of continuing therapy should be evaluated. Hepatic Effects Laboratory abnormalities in liver function tests have been seen in healthy volunteers and adult and pediatric patients treated with CANCIDAS®.
In some adult and pediatric patients with serious underlying conditions who were receiving multiple concomitant medications with CANCIDAS®, cases of clinically significant hepatic dysfunction, hepatitis and hepatic failure have been reported; a causal relationship to CANCIDAS® has not been established.
Patients who develop abnormal liver function tests during CANCIDAS® therapy should be monitored for evidence of worsening hepatic function and the risk/benefit of continuing CANCIDAS® therapy should be re-evaluated.
Special Populations Pregnant Women:
There are no adequate and well controlled studies in pregnant women. CANCIDAS® should be used in pregnancy only if the potential benefit justifies the potential risk to the fetus. Caspofungin was shown to be embryotoxic in rats and rabbits.
Findings included incomplete ossification of the skull and torso and an increased incidence of cervical rib in rats. An increased incidence of incomplete ossifications of the talus/calcaneus was seen in rabbits. Caspofungin also produced increases in resorptions in rats and rabbits and perimplantation losses in rats.
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These findings were observed at doses which produced exposures similar to those seen in patients treated with a 70 mg dose. Caspofungin crossed the placental barrier in rats and rabbits and was detected in the plasma of fetuses of pregnant animals dosed with CANCIDAS®.
CANCIDAS® (caspofungin acetate) Page 6 of 50 Nursing Women:
It is not known whether caspofungin is excreted in human milk. Caspofungin has been found in the milk of lactating laboratory animals. Women receiving CANCIDAS® should not breast-feed.
Pediatrics (≤ 17 years of age):
The safety and effectiveness of CANCIDAS® in pediatric patients aged 12 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 12 months to 17 years of age (see CLINICAL TRIALS and DETAILED PHARMACOLOGY, Pharmacokinetics, Special Populations and Conditions).
The safety and efficacy of CANCIDAS® has not been adequately studied in neonates and infants under 3 months of age and children aged 3 to 11 months. Postmarketing hepatobiliary adverse reactions have been reported in pediatric patients with serious underlying medical conditions (see WARNINGS AND PRECAUTIONS, Hepatic Effects).
Geriatrics ( 65 years of age):
Clinical studies of CANCIDAS® did not include sufficient numbers of patients aged 65 and over to determine whether they respond differently from younger patients. In a limited number of patients 65 years of age, no overall differences in safety or efficacy have been observed between elderly and younger patients.
Plasma concentrations of caspofungin in healthy older men and women ( 65 years of age) were increased slightly (approximately 28% in area under the curve [AUC]) compared to young healthy men. In patients who were treated empirically or who had invasive candidiasis, a similar modest effect of age was seen in older patients relative to younger patients.
No dose adjustment is recommended for the elderly; however, greater sensitivity of some older individuals cannot be ruled out. Patients with Special Diseases or Conditions Hepatic Insufficiency Adult patients with mild hepatic insufficiency (Child-Pugh score 5 to 6) do not need a dosage adjustment.
For adult patients with moderate hepatic insufficiency (Child-Pugh score 7 to 9), CANCIDAS® 35 mg daily is recommended based upon pharmacokinetic data. However, where recommended, a 70 mg loading dose should still be administered on Day 1.
There is no clinical experience in adult patients with severe hepatic insufficiency (Child-Pugh score > 9) and in pediatric patients with any degree of hepatic insufficiency (see DOSAGE AND ADMINISTRATION and DETAILED PHARMACOLOGY, Pharmacokinetics, Special Populations and Conditions).
Renal Insufficiency Mild to advanced renal insufficiency does not alter significantly caspofungin plasma concentrations and does not require a change in dosing. Caspofungin is not dialyzable, thus supplementary dosing is not required following hemodialysis (see DETAILED PHARMACOLOGY, Renal Insufficiency).
CANCIDAS® (caspofungin acetate) Page 7 of 50 ADVERSE REACTIONS Hypersensitivity reactions have been reported (see WARNINGS AND PRECAUTIONS). Adverse Drug Reaction Overview Adverse Drug […]