Drugplain

CANCIDAS 5 mg/mL

CASPOFUNGIN ACETATE · INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION · Merck Sharp & Dohme LLC

1 Recall on RecordCurrently in Shortage
Plain English

CANCIDAS is a injection, powder, lyophilized, for solution containing caspofungin acetate at 5 mg/mL, taken intravenous. Manufactured by Merck Sharp & Dohme LLC.

Key Facts

Brand Name
CANCIDAS
Generic Name
CASPOFUNGIN ACETATE
NDC Code (Product)
0006-3822
Manufacturer
Merck Sharp & Dohme LLC
Strength
5 mg/mL
Dosage Form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAVENOUS
Marketing Status
Application #
NDA021227
Marketing Start
01/26/2001

Recall History

1 Recall on Record
Class II09/18/2015

Sentara Enterprises

Lack of Assurance of Sterility: Product sterility cannot be guaranteed.

TerminatedVoluntary: Firm initiated

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

drug ineffective657 reports
off label use238 reports
death223 reports
product use in unapproved indication207 reports
pneumonia202 reports
pyrexia196 reports
sepsis192 reports
septic shock185 reports
febrile neutropenia166 reports
multiple organ dysfunction syndrome139 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

1 INDICATIONS AND USAGE CANCIDAS is an echinocandin antifungal indicated in adults and pediatric patients (3 months of age and older) for: Empirical therapy for presumed fungal infections in febrile, neutropenic patients. ( 1 ) Treatment of candidemia and the following Candida infections: intra-abdominal abscesses, peritonitis and pleural space infections. ( 1 ) Treatment of esophageal candidiasis. ( 1 ) Treatment of invasive aspergillosis in patients who are refractory to or intolerant of other therapies. ( 1 ) 1.1 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 (14.1 , 14.5) ]. 1.2 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 (14.2 , 14.5) ]. Limitations of Use: CANCIDAS has not been studied in endocarditis, osteomyelitis, a…

Dosage & Administration

2 DOSAGE AND ADMINISTRATION Important Administration Instructions for All Patients ( 2.1 ): Administer by slow intravenous (IV) infusion over approximately 1 hour. Do not administer by IV bolus administration. Do not mix or co-infuse CANCIDAS with other medications. Do not use diluents containing dextrose (α–D-glucose). Dosage in Adults [18 years of age and older] ( 2.2 ): Administer a single 70-mg loading dose on Day 1, followed by 50 mg once daily for all indications except esophageal candidiasis. For esophageal candidiasis, use 50 mg once daily with no loading dose. Dosage in Pediatric Patients [3 months to 17 years of age] ( 2.3 ): Dosing should be based on the patient's body surface area. For all indications, administer a single 70-mg/m 2 loading dose on Day 1, followed by 50 mg/m 2 once daily thereafter. Maximum loading dose and daily maintenance dose should not exceed 70 mg, regardless of the patient's calculated dose. Dosage Adjustments in Patients with Hepatic Impairment ( 2.4 ): Reduce dosage for adult patients with moderate hepatic impairment (35 mg once daily, with a 70 mg loading dose on Day 1 where appropriate). Dosage Adjustment in Patients Receiving Concomitant Indu…

Contraindications

4 CONTRAINDICATIONS CANCIDAS is contraindicated in patients with known hypersensitivity (e.g., anaphylaxis) to any component of this product [see Adverse Reactions (6) ] . CANCIDAS is contraindicated in patients with known hypersensitivity to any component of this product. ( 4 )

Drug Interactions

7 DRUG INTERACTIONS Cyclosporine: In two adult clinical studies, cyclosporine (one 4 mg/kg dose or two 3 mg/kg doses) increased the AUC of CANCIDAS. CANCIDAS did not increase the plasma levels of cyclosporine. There were transient increases in liver ALT and AST when CANCIDAS and cyclosporine were co-administered . Monitor patients who develop abnormal liver enzymes during concomitant therapy and evaluate the risk/benefit of continuing therapy [see Warnings and Precautions (5.2) and Clinical Pharmacology (12.3) ]. Tacrolimus: For patients receiving CANCIDAS and tacrolimus, standard monitoring of tacrolimus trough whole blood concentrations and appropriate tacrolimus dosage adjustments are recommended. Inducers of Hepatic CYP Enzymes Rifampin: Rifampin is a potent CYP3A4 inducer and concomitant administration with CANCIDAS is expected to reduce the plasma concentrations of CANCIDAS. Therefore, adult patients on rifampin should receive 70 mg of CANCIDAS daily and pediatric patients on rifampin should receive 70 mg/m 2 of CANCIDAS daily (not to exceed an actual daily dose of 70 mg) [see Dosage and Administration (2.5) and Clinical Pharmacology (12.3) ] . Other Inducers of Hepatic CYP E…

Adverse Reactions

6 ADVERSE REACTIONS The following serious adverse reactions are discussed in detail in another section of the labeling: Hypersensitivity [see Warnings and Precautions (5.1) ] Hepatic Effects [see Warnings and Precautions (5.2) ] Elevated Liver Enzymes During Concomitant Use With Cyclosporine [see Warnings and Precautions (5.3) ] Adults: Most common adverse reactions (incidence 10% or greater) are diarrhea, pyrexia, ALT/AST increased, blood alkaline phosphatase increased, and blood potassium decreased. ( 6.1 ) Pediatric Patients: Most common adverse reactions (incidence ≥10%) are pyrexia, diarrhea, rash, ALT/AST increased, blood potassium decreased, hypotension, and chills. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Merck Sharp & Dohme LLC at 1-877-888-4231 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in clinical trials of CANCIDAS cannot be directly compared to rates in clinical trials of another drug and may not reflect the rates observed in practice. Clinical Trials Experience in Adults The overall safety of CANCIDAS was assessed …

Frequently Asked Questions

What is CANCIDAS used for?

CANCIDAS contains CASPOFUNGIN ACETATE. It is a injection, powder, lyophilized, for solution taken intravenous. Consult your doctor for specific uses.

Is CANCIDAS a controlled substance?

CANCIDAS is not classified as a controlled substance by the DEA.

What is the generic name for CANCIDAS?

The generic name for CANCIDAS is CASPOFUNGIN ACETATE. There are 10 other brand versions of CASPOFUNGIN ACETATE.

What is the NDC code for CANCIDAS 5 mg/mL?

The NDC (National Drug Code) for CANCIDAS 5 mg/mL is 0006-3822, listed by Merck Sharp & Dohme LLC.

Product NDC

0006-3822

Package NDC

0006-3822-10

Other CANCIDAS Dosages

Other Caspofungin Brands

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