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Prescribing Information Prescribing Information

Indications: Experience in a broad range of indications

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CANCIDAS is indicated for:

  • Empirical therapy for presumed fungal infections in febrile neutropenic patients.
  • Treatment of candidemia and the following Candida infections: intraabdominal abscesses, peritonitis, and pleural space infections. CANCIDAS has not been studied in endocarditis, osteomyelitis, or meningitis due to Candida.
  • Treatment of esophageal candidiasis.
  • Treatment of invasive aspergillosis in patients who are refractory to or intolerant of other therapies (ie, amphotericin B, lipid formulations of amphotericin B, and/or itraconazole). CANCIDAS has not been studied as initial therapy for invasive aspergillosis.

References

  8.
Drugs@FDA [U.S. Food and Drug Administration website]. Available at: http://www.accessdata.fda.gov/scripts/cder/
drugsatfda/index.cfm?fuseaction=
Search.Label_ApprovalHistory#apphist.
Accessed July 15, 2005.

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Selected Important Risk Information
  • 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.

CANCIDAS® (caspofungin acetate)

 
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