Empirical Therapy for fungal infections at cancidas.com

In the largest empirical antifungal trial to date, CANCIDAS demonstrated efficacy comparable to AmBisome.
Favorable overall response to therapy was defined as meeting all 5 secondary end points:
- Survival for 7 days posttreatment
- Prevention of breakthrough fungal infection^a for up to 7 days posttreatment
- Absence of premature discontinuation due to toxicity or lack of efficacy
- Resolution of fever during period of neutropenia
- Successful treatment of baseline fungal infection^b
In this trial, therapy with CANCIDAS demonstrated impressive results across all efficacy end points

Favorable response (modified intention-to-treat analysis).

Breakthrough infections are defined as fungal infections with onset on or after the third day of study therapy.¹

Baseline infections are defined as fungal infections that were suspected at study entry and confirmed after initiation of therapy.¹

Adverse reactions among adult patients with persistent fever and neutropenia, regardless of causality, with an incidence of ≥10% reported in patients treated with CANCIDAS (n=564) in the randomized double-blinded empirical therapy study were pyrexia (27.1%), chills (22.5%), diarrhea (20.2%), alanine aminotransferase increased (18.1%), rash (16.0%), blood potassium decreased (15.2%), blood alkaline phosphatase increased (14.5%), aspartate aminotransferase increased (14.2%), nausea (11.3%), pneumonia (11.3%), edema peripheral (10.6%), cough (10.6%), headache (10.5%), and blood bilirubin increased (10.3%).

References

Walsh TJ, Teppler H, Donowitz GR, et al. Caspofungin versus liposomal amphotericin B for empirical antifungal therapy in patients with persistent fever and neutropenia. N Engl J Med. 2004;351:1391–1402.

Vazquez JA, Dembry LM, Sanchez V, et al. Nosocomial Candida glabrata colonization: an epidemiologic study. J Clin Microbiol. 1998;36:421–426.

Fridkin SK, Jarvis WR. Epidemiology of nosocomial fungal infections. Clin Microbiol Rev. 1996;9:499–511.

Marr KA, Carter RA, Boeckh M, Martin P, Corey L. Invasive aspergillosis in allogeneic stem cell transplant recipients: changes in epidemiology and risk factors. Blood. 2002;100:4358–4366.

See All References

See all 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.

For patients receiving CANCIDAS and tacrolimus, standard monitoring of tacrolimus blood concentrations and appropriate tacrolimus dosage adjustments are recommended.

Adult patients on rifampin should receive 70 mg of CANCIDAS daily. When CANCIDAS is co-administered to adult patients with inducers of drug clearance, such as efavirenz, nevirapine, phenytoin, dexamethasone, or carbamazepine, use of a daily dose of 70 mg of CANCIDAS should be considered.

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.

Possible histamine-mediated symptoms have been reported including rash, facial swelling, pruritus, sensation of warmth, or bronchospasm. Anaphylaxis has been reported during administration of CANCIDAS.

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.

Before prescribing CANCIDAS, please read the Prescribing Information.