DOSAGE AND ADMINISTRATION
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 (α-D-GLUCOSE), as CANCIDAS is not stable in diluents containing dextrose. CANCIDAS should be administered by slow IV infusion over approximately 1 hour.
Empirical Therapy
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 patient’s 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 patient’s 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.
Esophageal Candidiasis
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.
Invasive Aspergillosis
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 patient’s 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 an increase in dose to 70 mg daily is well tolerated. The safety and efficacy of doses above 70 mg have not been adequately studied.
Hepatic Insufficiency
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).
Concomitant Medication with Inducers of Drug Clearance
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).
Preparation of CANCIDAS for use:
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 (α-D-GLUCOSE), as CANCIDAS is not stable in diluents containing dextrose.
Preparation of the 70-mg infusion
- Equilibrate the refrigerated vial of CANCIDAS to room temperature.
- 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. This reconstituted solution may be stored for up to one hour at ≤25°C (≤77°F).
- Aseptically transfer 10 mL of reconstituted CANCIDAS to an IV bag (or bottle) containing 250 mL 0.9%, 0.45%, or 0.225% Sodium Chloride Injection, or Lactated Ringer’s 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.)
Preparation notes:
Preparation of the daily 50-mg infusion
- Equilibrate the refrigerated vial of CANCIDAS to room temperature.
- 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. This reconstituted solution may be stored for up to one hour at ≤25°C (≤77°F).
- Aseptically transfer 10 mL of reconstituted CANCIDAS to an IV bag (or bottle) containing 250 mL 0.9%, 0.45%, or 0.225% Sodium Chloride Injection, or Lactated Ringer’s 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.)
Alternative Infusion Preparation Methods
Preparation of 70-mg dose from two 50-mg vials
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 Ringer’s Injection.
Preparation of 50-mg daily doses at reduced volume
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 Ringer’s Injection (see Preparation of the daily 50-mg infusion).
Preparation of a 35-mg daily dose for patients with moderate Hepatic Insufficiency
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 Ringer’s Injection.
TABLE 14: CANCIDAS Concentrations | Dose | Reconstituted Solution Concentration | Infusion Volume | Infusion Solution Concentration |
| 70-mg initial dose | 7.2 mg/mL | 260 mL | 0.28 mg/mL |
| 50-mg daily dose | 5.2 mg/mL | 260 mL | 0.20 mg/mL |
| 70-mg initial dose
(from two 50 mg vials) | 5.2 mg/mL | 264 mL | 0.28 mg/mL |
| 50-mg daily dose (reduced volume) | 5.2 mg/mL | 110 mL | 0.47 mg/mL |
| 35-mg daily dose (from one 50 mg vial) for Moderate Hepatic Insufficiency | 5.2 mg/mL
or
5.2 mg/mL | 257 mL
or
107 mL | 0.14 mg/mL
or
0.34 mg/mL |
|
