CANCIDAS is indicated for:

·Empirical therapy for presumed fungal infections in febrile, neutropenic patients.

·Treatment of Candidemia and the following Candida infections: intra-abdominal abscesses, peritonitis and pleural space infections. CANCIDAS has not been studied in endocarditis, osteomyelitis, and meningitis due to Candida.

·Treatment of Esophageal Candidiasis (see CLINICAL STUDIES).

·Treatment of Invasive Aspergillosis in patients who are refractory to or intolerant of other therapies (i.e., amphotericin B, lipid formulations of amphotericin B, and/or itraconazole). CANCIDAS has not been studied as initial therapy for invasive aspergillosis.

Do not mix or co-infuse CANCIDAS with other medications, as there are no data available on the compatibility of CANCIDAS with other intravenous substances, additives, or medications. DO NOT USE DILUENTS CONTAINING DEXTROSE (a-D GLUCOSE), as CANCIDAS is not stable in diluents containing dextrose. CANCIDAS should be administered by slow IV infusion over approximately 1 hour.

A single 70-mg loading dose should be administered on Day 1, followed by 50 mg daily thereafter. Duration of treatment should be based on the patients clinical response. Empirical therapy should be continued until resolution of neutropenia. Patients found to have a fungal infection should be treated for a minimum of 14 days; treatment should continue for at least 7 days after both neutropenia and clinical symptoms are resolved. If the 50-mg dose is well tolerated but does not provide an adequate clinical response, the daily dose can be increased to 70 mg. Although an increase in efficacy with 70 mg daily has not been demonstrated, limited safety data suggest that an increase in dose to 70 mg daily is well tolerated.

Candidemia and other Candida infections (see CLINICAL STUDIES)

A single 70-mg loading dose should be administered on Day 1, followed by 50 mg daily thereafter. Duration of treatment should be dictated by the patients clinical and microbiological response. In general, antifungal therapy should continue for at least 14 days after the last positive culture. Patients who remain persistently neutropenic may warrant a longer course of therapy pending resolution of the neutropenia.

The dose should be 50 mg daily. Because of the risk of relapse of oropharyngeal candidiasis in patients with HIV infections, suppressive oral therapy could be considered (see CLINICAL STUDIES). A 70-mg loading dose has not been studied with this indication.

A single 70-mg loading dose should be administered on Day 1, followed by 50 mg daily thereafter. Duration of treatment should be based upon the severity of the patients underlying disease, recovery from immunosuppression, and clinical response. The efficacy of a 70-mg dose regimen in patients who are not clinically responding to the 50 mg daily dose is not known. Limited safety data suggest that anincrease in dose to 70 mg daily is well tolerated. The safety and efficacy of doses above 70 mg have not been adequately studied.

Patients with mild hepatic insufficiency (Child-Pugh score 5 to 6) do not need a dosage adjustment. For patients with moderate hepatic insufficiency (Child-Pugh score 7 to 9), CANCIDAS 35 mg daily is recommended. However, where recommended, a 70-mg loading dose should still be administered on Day 1. There is no clinical experience in patients with severe hepatic insufficiency (Child-Pugh score >9).

Patients on rifampin should receive 70 mg of CANCIDAS daily. Patients on nevirapine, efavirenz, carbamazepine, dexamethasone, or phenytoin may require an increase in dose to 70 mg of CANCIDAS daily (see PRECAUTIONS, Drug Interactions).

Do not mix or co-infuse CANCIDAS with other medications, as there are no data available on the compatibility of CANCIDAS with other intravenous substances, additives, or medications. DO NOT USE DILUENTS CONTAINING DEXTROSE (a-D GLUCOSE), as CANCIDAS is not stable in diluents containing dextrose.

1. Equilibrate the refrigerated vial of CANCIDAS to room temperature.

2. Aseptically add 10.5 mL of 0.9% Sodium Chloride Injection, Sterile Water for Injection, Bacteriostatic Water for Injection with methylparaben and propylparaben, or Bacteriostatic Water for Injection with 0.9% benzyl alcohol to the vial.^a This reconstituted solution may be stored for up to one hour at ≤25°C (≤77°F).^b

3. Aseptically transfer 10 mL^c of reconstituted CANCIDAS to an IV bag (or bottle) containing 250 mL 0.9%, 0.45%, or 0.225% Sodium Chloride Injection, or Lactated Ringers Injection. This infusion solution must be used within 24 hours if stored at ≤25°C (≤77°F) or within 48 hours if stored refrigerated at 2 to 8°C (36 to 46°F). (If a 70-mg vial is unavailable, see below: Alternative Infusion Preparation Methods, Preparation of 70 mg dose from two 50-mg vials.)

1. Equilibrate the refrigerated vial of CANCIDAS to room temperature.

2. Aseptically add 10.5 mL of 0.9% Sodium Chloride Injection, Sterile Water for Injection, Bacteriostatic Water for Injection with methylparaben and propylparaben, or Bacteriostatic Water for Injection with 0.9% benzyl alcohol to the vial.^a This reconstituted solution may be stored for up to one hour at ≤25°C (≤77°F).^b

3. Aseptically transfer 10 mL^c of reconstituted CANCIDAS to an IV bag (or bottle) containing 250 mL 0.9%, 0.45%, or 0.225% Sodium Chloride Injection, or Lactated Ringers Injection. This infusion solution must be used within 24 hours if stored at ≤25°C (≤77°F) or within 48 hours if stored refrigerated at 2 to 8°C (36 to 46°F). (If a reduced infusion volume is medically necessary, see below: Alternative Infusion Preparation Methods, Preparation of 50-mg daily doses at reduced volume.)

Reconstitute two 50-mg vials with 10.5 mL of diluent each (see Preparation of the daily 50-mg infusion). Aseptically transfer a total of 14 mL of the reconstituted CANCIDAS from the two vials to 250 mL of 0.9%, 0.45%, or 0.225% Sodium Chloride Injection, or Lactated Ringers Injection.

When medically necessary, the 50-mg daily doses can be prepared by adding 10 mL of reconstituted CANCIDAS to 100 mL of 0.9%, 0.45%, or 0.225% Sodium Chloride Injection, or Lactated Ringers Injection (see Preparation of the daily 50-mg infusion).

Reconstitute one 50-mg vial (see above: Preparation of the daily 50-mg infusion). Aseptically transfer 7 mL of the reconstituted CANCIDAS from the vial to 250 mL or, if medically necessary, to 100 mL of 0.9%, 0.45%, or 0.225% Sodium Chloride Injection, or Lactated Ringers Injection.

*See preceding text for these special situations.

No. 3822 CANCIDAS 50 mg is a white to off-white powder/cake for infusion in a vial with a red aluminum band and a plastic cap.

NDC 0006-3822-10 supplied as one single-use vial.

No. 3823 CANCIDAS 70 mg is a white to off-white powder/cake for infusion in a vial with a yellow/orange aluminum band and a plastic cap.

NDC 0006-3823-10 supplied as one single-use vial.

The lyophilized vials should be stored refrigerated at 2° to 8°C (36° to 46°F).

Reconstituted CANCIDAS may be stored at ≤25°C (≤77°F) for one hour prior to the preparation of the patient infusion solution.

The final patient infusion solution in the IV bag or bottle can be stored at ≤25°C (≤77°F) for 24 hours or at 2 to 8°C (36 to 46°F) for 48 hours.

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