does not provide an adequate clinical response, the daily dose can be increased to 70 mg/m2 daily (not to exceed 70 mg). Although an increase in efficacy with 70 mg/m2 daily has not been demonstrated, limited safety data suggest that an increase in dose to 70 mg/m2 daily is well tolerated.
2.4 Patients with Hepatic Insufficiency
Adult patients with mild hepatic insufficiency (Child-Pugh score 5 to 6) do not need a dosage adjustment. For adult patients with moderate hepatic insufficiency (Child-Pugh score 7 to 9), CANCIDAS 35 mg daily is recommended based upon pharmacokinetic data [see Clinical Pharmacology (12.3)]. However, where recommended, a 70-mg loading dose should still be administered on Day 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.
2.5 Patients Receiving Concomitant Inducers of Drug Clearance
Adult patients on rifampin should receive 70 mg of CANCIDAS daily. Adult patients on nevirapine, efavirenz, carbamazepine, dexamethasone, or phenytoin may require an increase in dose to 70 mg of CANCIDAS daily [see Drug Interactions (7)].
When CANCIDAS is co-administered to pediatric patients with inducers of drug clearance, such as rifampin, efavirenz, nevirapine, phenytoin, dexamethasone, or carbamazepine, a CANCIDAS dose of 70 mg/m2 daily (not to exceed 70 mg) should be considered [see Drug Interactions (7)].
2.6 Preparation and Reconstitution for Administration
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 CANCIDAS for Infusion
Equilibrate the refrigerated vial of CANCIDAS to room temperature.
Aseptically add 10.8 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.
Note: Each vial of CANCIDAS contains an intentional overfill of CANCIDAS. Thus, the drug concentration of the resulting solution is listed in Table 1 below.
TABLE 1: Information for Preparation of CANCIDAS CANCIDAS vial Total Drug Content
(including overfill) Reconstitution Volume
to be added Resulting Concentration
following Reconstitution
50 mg 54.6 mg 10.8 mL 5 mg/mL
70 mg 75.6 mg 10.8 mL 7 mg/mL
The white to off-white cake will dissolve completely. Mix gently until a clear solution is obtained. Visually inspect the reconstituted solution for particulate matter or discoloration during reconstitution and prior to infusion. Do not use if the solution is cloudy or has precipitated.
The reconstituted solution may be stored for up to one hour at ≤25°C (≤77°F).
CANCIDAS vials are for single use only; the remaining solution should be discarded.
Aseptically transfer the appropriate volume (mL) of reconstituted CANCIDAS to an IV bag (or bottle) containing 250 mL of 0.9%, 0.45%, or 0.225% Sodium Chloride Injection or Lactated Ringers Injection. Alternatively, the volume (mL) of reconstituted CANCIDAS can be added to a reduced volume of 0.9%, 0.45%, or 0.225% Sodi
