* Breakthrough infections defined as fungal infections with onset on or after the third day of study therapy.1
CANCIDAS should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
The rate of successful treatment of documented baseline infections was not statistically different between treatment groups. Baseline infections were defined as fungal infections suspected at study entry and confirmed subsequent to initiation of therapy.1
References
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. Patients who develop abnormal liver function tests during concomitant therapy should be monitored and the risk/benefit of continuing therapy should be evaluated.
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 therapy with CANCIDAS should be monitored for evidence of worsening hepatic function and evaluated for risk/benefit of continuing therapy with CANCIDAS.
When CANCIDAS is co-administered to pediatric patients with inducers of drug clearance, such as rifampin, efavirenz, nevirapine, phenytoin, dexamethasone, or carbamazepine, a dose of 70 mg/m2 daily (not to exceed an actual daily dose of 70 mg) should be considered.
The most common adverse reactions in adult patients treated with CANCIDAS (≥10%), regardless of causality, are: diarrhea, pyrexia, chills, ALT/AST increase, blood alkaline phosphatase increase, and decrease of blood potassium.
The most common adverse reactions in pediatric patients treated with CANCIDAS, regardless of causality, were pyrexia (29.2%), blood potassium decreased (15.2%), diarrhea (14%), increased aspartate aminotransferase (11.7%), rash (11.7%), increased alanine aminotransferase (11.1%), hypotension (11.1%), and chills (11.1%).
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.
Administer by slow intravenous infusion (IV) over approximately 1 hour. Not for IV bolus administration.
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 (CANCIDAS 17.0%, AmBisome 19.4%), chills (13.8%, 24.7%), rash (6.2%, 5.3%), headache (4.3%, 5.7%), hypokalemia (3.7%, 4.2%), nausea (3.5%, 11.3%), vomiting (3.5%, 8.6%), perspiration/diaphoresis (2.8%, 2.2%), diarrhea (2.7%, 2.4%), and dyspnea (2.0%, 4.2%).
Before prescribing CANCIDAS, please read the Prescribing Information.
