A1,
A2,
B,
C1,
C2,
D,
E,
F,
G-H,
I-K,
L,
M,
N,
O,
P1,
P2,
Q-R,
S,
T,
U-V,
W-Z
Cancidas Indications, Dosage, Storage, Stability - Caspofungin acetate
Cancidas Indications, Dosage, Storage, Stability - Caspofungin acetate
INDICATIONS AND USAGE
CANCIDAS is indicated for the treatment of:
- Esophageal Candidiasis (see CLINICAL STUDIES).
- 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.
DOSAGE AND ADMINISTRATION
General Recommendations
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.
Esophageal Candidiasis
50 mg daily should be administered by slow IV infusion over approximately 1 hour. 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. CANCIDAS should be administered by slow
IV infusion of approximately 1 hour. Duration of treatment should be based upon
the severity of the patient’s underlying disease, recovery from immunosuppression,
and clinical response. Do not mix or co-infuse CANCIDAS with other medications.
DO NOT USE DILUENTS CONTAINING DEXTROSE (α-D-GLUCOSE).
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 suggests 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. However, for patients with moderate
hepatic insufficiency (Child-Pugh score 7 to 9), after the initial 70-mg loading
dose, CANCIDAS 35 mg daily is recommended. There is no clinical experience in
patients with severe hepatic insufficiency (Child-Pugh score >9) (see CLINICAL
PHARMACOLOGY, Pharmacokinetics, Special Populations.).
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 Day 1 loading-dose infusion for Invasive
Aspergillosis
1. Equilibrate the refrigerated vial of CANCIDAS to room temperature.
2. Aseptically add 10.5 mL of 0.9% Sodium Chloride Injection 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 mLc of reconstituted CANCIDAS to an IV bag (or bottle) containing 250 mL
0.9% Sodium Chloride Injection.d (If a 70-mg vial is unavailable, see below: Alternative Infusion
Preparation Methods, Preparation of 70-mg Day 1 loading dose from two 50-mg vials.)
Preparation of the daily 50-mg infusion
1. Equilibrate the refrigerated vial of CANCIDAS to room temperature.
2. Aseptically add 10.5 mL of 0.9% Sodium Chloride Injection 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 mLc of reconstituted CANCIDAS to an IV bag (or bottle) containing 250 mL
0.9% Sodium Chloride Injection.d (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 Day 1 loading dose from two 50-mg vials for Invasive Aspergillosis
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 of 0.9% Sodium Chloride Injection or, if medically necessary,
to 100 mL of 0.9%, 0.45%, or 0.225% Sodium Chloride Injection or Lactated Ringer’s
Injection.
|
Preparation notes:
a The white to off-white cake will dissolve completely.
Mix gently until a clear solution is obtained.
b 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.
c CANCIDAS is formulated to provide the full labeled
vial dose (70 mg or 50 mg) when 10 mL is withdrawn from the vial.
d This infusion solution must be used within 24 hours,
during which time it should be kept at ≤25°C (≤77°F).
|
TABLE 5 : 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*
|
5.2 mg/mL
|
257 mL
|
0.14 mg/mL
|
|
(from one 50 mg vial) for Moderate
|
or
|
or
|
or
|
|
Hepatic Insufficiency
|
5.2 mg/mL
|
107 mL
|
0.34 mg/mL
|
|
*See preceding text for these special situations
|
*See preceding text for these special situations
HOW SUPPLIED
No. 3822 — CANCIDAS 50 mg is a white to off-white powder/cake
for infusion in a vial labeled with a red aluminum band and a plastic cap.
NDC 0006-3822-10 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 one single-use vial.
Storage Vials
The lyophilized vials should be stored refrigerated at 2° to
8°C (36° to 46°F)
Reconstituted concentrate
Reconstituted CANCIDAS may be stored at ≤25°C (≤77°F)
for one hour prior to the preparation of the patient infusion solution.
Diluted Product
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.
.
MERCK & CO., INC., Whitehouse Station,
NJ 08889,USA
Revised Apr 02, 2003
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