Cancidas Special Precautions

Anaphylaxis has been reported during administration of CANCIDAS. If this occurs, CANCIDAS should be discontinued and appropriate treatment administered. Possibly histamine-mediated adverse reactions, including rash, facial swelling, angioedema, pruritus, sensation of warmth, or bronchospasm have been reported and may require discontinuation and/or administration of appropriate treatment.
Cases of Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) have been reported after post marketing use of caspofungin. Caution should apply in patients with history of allergic skin reactions.
Laboratory abnormalities in liver function tests have been seen in healthy volunteers and patients treated with CANCIDAS. In some patients with serious underlying conditions who were receiving multiple concomitant medications with CANCIDAS, isolated 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 evaluated for risk/benefit of continuing CANCIDAS therapy.
Concomitant use of CANCIDAS with cyclosporine has been evaluated in adult healthy volunteers and in adult patients. Some healthy adult subjects who received two 3 mg/kg doses of cyclosporine with caspofungin showed transient increases in alanine transaminase (ALT) and aspartate transaminase (AST) of less than or equal to 3-fold the upper limit of normal (ULN) that resolved with discontinuation of the drugs. There was also an increase of approximately 35% in the area under the curve (AUC) of caspofungin when CANCIDAS and cyclosporine were co-administered; blood levels of cyclosporine remained unchanged. In a retrospective study of 40 patients treated during marketed use with CANCIDAS and cyclosporine for 1 to 290 days (median 17.5 days), no serious hepatic adverse events were noted. As expected in patients with allogeneic hematopoietic stem cell transplants or solid organ transplants, hepatic enzyme abnormalities occurred commonly; however, no patient had elevations in ALT that were considered drug-related. Elevations in AST considered at least possibly related to therapy with CANCIDAS and/or cyclosporine occurred in 5 patients, but all were less than 3.6 times the ULN. Discontinuations due to laboratory abnormalities in hepatic enzymes from any cause occurred in 4 patients. Of these, 2 were considered possibly related to therapy with CANCIDAS and/or cyclosporine as well as other possible causes. In the prospective invasive aspergillosis and compassionate use studies, there were 6 adult patients treated with CANCIDAS and cyclosporine for 2 to 56 days; none of these patients experienced increases in hepatic enzymes. These data suggest that CANCIDAS can be used in patients receiving cyclosporine when the potential benefit outweighs the potential risk. Close monitoring of liver enzymes should be considered if CANCIDAS and cyclosporine are used concomitantly.
The safety information on treatment durations longer than 4 weeks is limited, however, available data suggest that caspofungin continues to be well tolerated with longer courses of therapy (up to 162 days in adult patients and up to 87 days in pediatric patients).
Use in Children: The safety and effectiveness of CANCIDAS in pediatric patients 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 for the following indications (see Indications/Usage): Empirical therapy for presumed fungal infections (such as Candida or Aspergillus) in febrile, neutropenic patients.
Treatment of Candidemia and the following Candida infections: intra-abdominal abscesses, peritonitis and pleural space infections. In the prospective pediatric study, the pediatric patient population studied with Candida intra-abdominal abscesses, peritonitis and pleural space infections was limited.
Treatment of esophageal candidiasis. In the prospective pediatric study, the pediatric patient population studied with esophageal candidiasis was limited.
Treatment of invasive aspergillosis in patients who are refractory to or intolerant of other therapies.
The efficacy and safety of CANCIDAS have not been adequately studied in prospective clinical trials involving neonates and infants under 3 months of age and children aged 3 to 11 months.
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.
Use in the Elderly: The plasma concentration of caspofungin in healthy older men and women (65 years of age or more) was increased slightly (approximately 28% in AUC) compared to young healthy males. 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 dosage adjustment is necessary for elderly patients (65 years of age or more).