July 23, 2016
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Cancidas

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Cancidas




Indications
Dosage
How Supplied

INDICATIONS

Empirical Therapy For Presumed Fungal Infections In Febrile, Neutropenic Patients

CANCIDAS® is indicated as empirical therapy for presumed fungal infections in febrile, neutropenic adult and pediatric patients (3 months of age and older) [see Clinical Studies].

Treatment Of Candidemia And Other Candida Infections

CANCIDAS is indicated for the treatment of candidemia and the following candida infections: intra-abdominal abscesses, peritonitis, and pleural space infections in adult and pediatric patients (3 months of age and older) [see Clinical Studies].

Limitation Of Use

CANCIDAS has not been studied in endocarditis, osteomyelitis, and meningitis due to Candida.

Treatment Of Esophageal Candidiasis

CANCIDAS is indicated for the treatment of esophageal candidiasis in adult and pediatric patients (3 months of age and older) [see Clinical Studies].

Limitation Of Use

CANCIDAS has not been approved for the treatment of oropharyngeal candidiasis (OPC). In the study that evaluated the efficacy of caspofungin in the treatment of esophageal candidiasis, patients with concomitant OPC had higher relapse rate of the OPC [see Clinical Studies].

Treatment Of Invasive Aspergillosis In Patients Who Are Refractory To Or Intolerant Of Other Therapies

CANCIDAS is indicated for the treatment of invasive aspergillosis in adult and pediatric patients (3 months of age and older) who are refractory to or intolerant of other therapies [see Clinical Studies].

Limitation Of Use

CANCIDAS has not been studied as initial therapy for invasive aspergillosis.

DOSAGE AND ADMINISTRATION

Important Administration Instructions For Use In All Patients

Administer CANCIDAS by slow intravenous (IV) infusion over approximately 1 hour. Do not administer CANCIDAS by IV bolus administration.

Recommended Dosage In Adult Patients [18 years of age and older]

The dosage and duration of CANCIDAS treatment for each indication are as follows:

Empirical Therapy For Presumed Fungal Infections In Febrile Neutropenic Patients

Administer a single 70-mg loading dose on Day 1, followed by 50 mg once daily thereafter. Duration of treatment should be based on the patient's clinical response. Continue empirical therapy until resolution of neutropenia. In general, treat patients found to have a fungal infection for a minimum of 14 days after the last positive culture and continue treatment 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.

Candidemia And Other Candida Infections

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

Esophageal Candidiasis

The dose is 50 mg once daily for 7 to 14 days after symptom resolution. A 70-mg loading dose has not been studied for this indication. Because of the risk of relapse of oropharyngeal candidiasis in patients with HIV infections, suppressive oral therapy could be considered [see Clinical Studies].

Invasive Aspergillosis

Administer a single 70-mg loading dose on Day 1, followed by 50 mg once daily thereafter. Duration of treatment should be based upon the severity of the patient's underlying disease, recovery from immunosuppression, and clinical response.

Recommended Dosing In Pediatric Patients [3 months to 17 years of age]

For all indications, administer a single 70 mg/m² loading dose on Day 1, followed by 50 mg/m² once daily thereafter. The maximum loading dose and the daily maintenance dose should not exceed 70 mg, regardless of the patient's calculated dose. Dosing in pediatric patients (3 months to 17 years of age) should be based on the patient's body surface area (BSA) as calculated by the Mosteller Formula [see REFERENCES]:

BSA (m²)= Height (cm) x Weight (kg)
3600

Following calculation of the patient's BSA, the loading dose in milligrams should be calculated as BSA (m²) X 70 mg/m². The maintenance dose in milligrams should be calculated as BSA (m²) X 50 mg/m² .

Duration of treatment should be individualized to the indication, as described for each indication in adults [see Recommended Dosage in Adult Patients [18 years of age and older]]. If the 50-mg/m² daily dose is well tolerated but does not provide an adequate clinical response, the daily dose can be increased to 70 mg/m² daily (not to exceed 70 mg).

Dosage Adjustments In Patients With Hepatic Impairment

Adult patients with mild hepatic impairment (Child-Pugh score 5 to 6) do not need a dosage adjustment. For adult patients with moderate hepatic impairment (Child-Pugh score 7 to 9), CANCIDAS 35 mg once daily is recommended based upon pharmacokinetic data [see CLINICAL PHARMACOLOGY] with a 70-mg loading dose administered on Day 1 where appropriate. There is no clinical experience in adult patients with severe hepatic impairment (Child-Pugh score greater than 9) and in pediatric patients with any degree of hepatic impairment.

Dosage Adjustments In Patients Receiving Concomitant Inducers Of Hepatic CYP Enzymes

Adult Patients

Adult patients on rifampin should receive 70 mg of CANCIDAS once daily. W hen CANCIDAS is coadministered to adult patients with other inducers of hepatic CYP enzymes such as nevirapine, efavirenz, carbamazepine, dexamethasone, or phenytoin, administration of a daily dose of 70 mg of CANCIDAS should be considered [see DRUG INTERACTIONS].

Pediatric Patients

Pediatric patients on rifampin should receive 70 mg/m² of CANCIDAS daily (not to exceed an actual daily dose of 70 mg. W hen CANCIDAS is co-administered to pediatric patients with other inducers of hepatic CYP enzymes, such as efavirenz, nevirapine, phenytoin, dexamethasone, or carbamazepine, a CANCIDAS dose of 70 mg/m² once daily (not to exceed 70 mg) should be considered [see DRUG INTERACTIONS].

Preparation For Administration

Reconstitution Of CANCIDAS For Intravenous Infusion
  1. Equilibrate the refrigerated vial of CANCIDAS to room temperature.
  2. Aseptically add 10.8 mL of 0.9% Sodium Chloride Injection, Sterile W ater for Injection, Bacteriostatic W ater for Injection with methylparaben and propylparaben, or Bacteriostatic W ater for Injection with 0.9% benzyl alcohol to the vial.
  3. 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

  4. 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.
  5. The reconstituted solution of CANCIDAS in the vial may be stored for up to one hour at ≤ 25°C ( ≤ 77°F) prior to the preparation of the infusion solution in the intravenous bag or bottle.
  6. CANCIDAS vials are for single use only. Discard unused portion.
Dilution Of The Reconstituted Solution In The Intravenous Bag For Infusion
  1. Aseptically transfer the appropriate volume (mL) of reconstituted CANCIDAS to an intravenous (IV) bag (or bottle) containing 250 mL of 0.9%, 0.45%, or 0.225% Sodium Chloride Injection or Lactated Ringers Injection.
  2. Alternatively, the volume (mL) of reconstituted CANCIDAS can be added to a reduced volume of 0.9%, 0.45%, or 0.225% Sodium Chloride Injection or Lactated Ringers Injection, not to exceed a final concentration of 0.5 mg/mL.
  3. This diluted infusion solution in the intravenous bag or bottle 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).
Important Reconstitution And Dilution Instructions For Pediatric Patients 3 Months Of Age And Older

Follow the reconstitution procedures described above using either the 70-mg or 50-mg vial to create the reconstituted solution [see Recommended Dosing in Pediatric Patients [3 months to 17 years of age]]. From the reconstituted solution in the vial, remove the volume of drug equal to the calculated loading dose or calculated maintenance dose based on a concentration of 7 mg/mL (if reconstituted from the 70-mg vial) or a concentration of 5 mg/mL (if reconstituted from the 50-mg vial).

The choice of vial should be based on total milligram dose of drug to be administered to the pediatric patient. To help ensure accurate dosing, it is recommended for pediatric doses less than 50 mg that 50mg vials (with a concentration of 5 mg/mL) be used if available. The 70-mg vial should be reserved for pediatric patients requiring doses greater than 50 mg.

The maximum loading dose and the daily maintenance dose should not exceed 70 mg, regardless of the patient's calculated dose.

Drug Incompatibilities

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.

HOW SUPPLIED

Dosage Forms And Strengths

CANCIDAS 50 mg is a white to off-white lyophilized cake or powder for reconstitution in a single-dose glass vial with a red aluminum band and a plastic cap. CANCIDAS 50-mg vial contains 54.6 mg of caspofungin.

CANCIDAS 70 mg is a white to off-white lyophilized cake or powder for reconstitution in a single-dose glass vial with a yellow/orange aluminum band and a plastic cap. CANCIDAS 70-mg vial contains 75.6 mg of caspofungin.

Storage And Handling

CANCIDAS 50 mg is a lyophilized white to off-white cake or powder for intravenous infusion supplied in single-dose vials with a red aluminum band and a plastic cap.

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

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. Storage and Handling

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

REFERENCES

1. Mosteller RD: Simplified Calculation of Body Surface Area. N Engl J Med 1987 Oct 22;317(17): 1098 (letter).

2. Clinical and Laboratory Standards Institute (CLSI). Reference Method for Broth Dilution Antifungal Susceptibility Testing of Yeasts; Approved Standard-Third Edition. CLSI document M27-A3. Clinical and Laboratory Standards Institute, 940 W est Valley Road, Suite 1400, W ayne, Pennsylvania 19087, USA, 2008.

3. Clinical and Laboratory Standards Institute (CLSI). Reference Method for Broth Dilution Antifungal Susceptibility Testing of Yeasts; Third Informational Supplement. CLSI document M27-S3. Clinical and Laboratory Standards Institute, 940 W est Valley Road, Suite 1400, W ayne, Pennsylvania 19087, USA, 2008.

Distributed by: Merck Sharp & Dohme Corp., a subsidiary of MERCK & CO., INC., Whitehouse Station, NJ 08889, USA. Revised: Apr 2016

This monograph has been modified to include the generic and brand name in many instances.

Last reviewed on RxList: 4/25/2016

Indications
Dosage
How Supplied

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