Candidemia and Other Candida Infections
Invasive Aspergillosis
Esophageal Candidiasis
A Long History of Experience
Empirical Therapy
- The safety profile of CANCIDAS was superior to that of AmBisome
with respect to the following prespecified parameters:- Nephrotoxicity (2.6% vs 11.5%)
- Drug-related adverse events (54.4% vs 69.3%)
- Discontinuation because of drug-related adverse events (5.0% vs 8.0%)
- The rate of infusion-related adverse events was significantly lower with CANCIDAS than with AmBisome (35.1% vs 51.6%)
- Drug-related clinical adverse events with an incidence of >2% reported in patients treated with CANCIDAS (n=564) in the randomized, double-blind empirical therapy study were fever (17.0%), chills (13.8%), rash (6.2%), headache (4.3%), hypokalemia (3.7%), nausea (3.5%), vomiting (3.5%), perspiration/diaphoresis (2.8%), diarrhea (2.7%), and dyspnea (2.0%).
Candidemia and Other Candida Infectionsa
- The incidence of drug-related adverse events was significantly lower among patients receiving CANCIDAS than among those receiving amphotericin B.
- Drug-related clinical adverse events with an incidence of >2% reported in patients treated with CANCIDAS (n=114) in the randomized, double-blind study of candidemia and other Candida infectionsa were fever (7.0%), chills (5.3%), phlebitis/thrombophlebitis (3.5%), vomiting (3.5%) and diarrhea (2.6%).
a
Intraabdominal abscesses, peritonitis, and pleural space infections. CANCIDAS has not been studied in patients with endocarditis, osteomyelitis, or meningitis due to Candida.
Invasive Aspergillosis
- In a clinical study of 69 patients with invasive aspergillosis, the incidence of drug related laboratory adverse events was <5%.
- Drug-related clinical adverse events with an incidence of >2% reported in patients treated with CANCIDAS (n=69) in the noncomparative aspergillosis study were flushing (2.9%), fever (2.9%), nausea (2.9%), vomiting (2.9%), and infused-vein complications (2.9%).
Esophageal Candidiasis
- In clinical studies of patients with esophageal and/or oropharyngeal candidiasis (N=411), CANCIDAS demonstrated safety comparable to that of fluconazole.
- Drug-related clinical adverse events with an incidence of >2% reported in patients treated with CANCIDAS (n=83) in the randomized, double-blind study of esophageal candidiasis were phlebitis/thrombophlebitis (16%), infused-vein complication (12%), nausea (6%), headache (6%), fever (4%), abdominal pain (4%), and diarrhea (4%).
b
Relationship to drug was determined by the investigator to be possibly, probably, or definitely drug related.
c
Derived from Phase II and Phase III comparator-controlled clinical studies.
d
Derived from Phase II comparator-controlled clinical studies.
A Long History of Experience
- More than 5 years’ experience.15
References
15.
The Hospital Antifungal Market Guide and The Hospital Anti-Infective Market Guide. United States Editions 2001–2005. AMR/Arlington Medical Resources, Inc, Malvern, Pa.
- CANCIDAS is contraindicated in patients with hypersensitivity to any component of this product.
- Concomitant use of CANCIDAS with cyclosporine should be limited to patients for whom the potential benefit outweighs the potential risk of increased hepatic enzyme abnormalities. See the Warning in the Prescribing Information.
- 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 along with CANCIDAS, clinical hepatic abnormalities have also occurred. Isolated cases of significant hepatic dysfunction, hepatitis, or worsening hepatic failure have been reported in patients; a causal relationship to CANCIDAS has not been established. Patients who develop abnormal liver function tests during therapy with CANCIDAS should be monitored for evidence of worsening hepatic function and evaluated for risk/benefit of continuing therapy with CANCIDAS.
- For patients receiving CANCIDAS and tacrolimus, standard monitoring of tacrolimus blood concentrations and appropriate tacrolimus dosage adjustments are recommended.
- Patients receiving rifampin should receive 70 mg of CANCIDAS daily. Patients receiving nevirapine, efavirenz, carbamazepine, dexamethasone, or phenytoin may require an increase in dose to 70 mg of CANCIDAS daily.
- Possible histamine-mediated symptoms have been reported, including rash, facial swelling, pruritus, sensation of warmth, and bronchospasm. Anaphylaxis has been reported during administration of CANCIDAS.
Before prescribing CANCIDAS, please read the Prescribing Information.
