Caspofungin Acetate

Trade Names:
Cancidas
- Injection, lyophilized powder for solution 50 mg
- Injection, lyophilized powder for solution 70 mg

Pharmacology

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Inhibits synthesis of β-(1,3)-D-glucan, an integral component of fungal cell wall.

Pharmacokinetics

Distribution

About 97% protein bound (albumin).

Metabolism

Slowly metabolized by hydrolysis and N-acetylation, and undergoes spontaneous chemical degradation.

Elimination

The half-life is 9 to 11 h (beta phase) and 40 to 50 h (gamma phase). 35% is excreted in feces. 41% in urine (about 1.4% as unchanged drug). Renal Cl is about 0.15 mL/min. Total Cl is 12 mL/min. Not dialyzable.

Special Populations

AUC is increased 30% to 49% in patients with CrCl 49 mL/min or less.

AUC is increased by about 55%.

AUC is increased by 76%.

AUC is increased by about 28%. No dosage adjustment is needed.

No dosage adjustment is needed based on gender.

No dosage adjustment is needed based on race.

Indications and Usage

Treatment of invasive aspergillosis in patients refractory to or intolerant of other antifungal therapies; empirical treatment for presumed fungal infections in febrile, neutropenic patients; treatment of esophageal candidiasis; treatment of candidemia and the following Candida infections: intra-abdominal abscesses, peritonitis, and pleural space infections.

Contraindications

Standard considerations.

Dosage and Administration

IV 50 mg daily by slow infusion of about 1 h.

In mild hepatic insufficiency (Child-Pugh score 7 to 9), reduce maintenance dose to 35 mg daily.

IV

Antifungal therapy should be continued for at least 14 days after the last positive culture. Patients who remain neutropenic may warrant a longer duration of therapy pending resolution of the neutropenia.

Treatment should be continued until resolution of neutropenia. Patients with 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.

Duration of treatment should be based upon the severity of the underlying disease, recovery from immunosuppression, and clinical response.

70 mg given by slow infusion over approximately 1 h on day 1.

50 mg daily by slow infusion over approximately 1 h thereafter.

IV

70 mg/m ² by slow infusion over approximately 1 h on day 1.

50 mg/m ² daily thereafter. The maximum loading and maintenance dose should not exceed 70 mg, regardless of the patient's calculated dose. The duration of treatment should be individualized to each indication as described in adults.

General Advice

• Follow manufacturer's instructions for reconstitution and administration.
• For IV infusion only. Not for intra-abdominal, intra-pleural, intradermal, subcutaneous, IM, IV bolus, or intra-arterial administration. Do not administer reconstituted solution directly into patient.
• Allow refrigerated vial of caspofungin to come to room temperature before reconstituting. Reconstitute powder for injection by adding 10.8 mL of sodium chloride 0.9% injection, sterile water for injection, or bacteriostatic water for injection with benzyl alcohol 0.9% or with methylparaben and propylparaben to the appropriate vial (50 or 70 mg). Mix gently until a clear solution is obtained.
• Transfer 10 mL of reconstituted solution to IV bag or bottle containing 250 mL of sodium chloride 0.9%, 0.45%, or 0.225% injection, or Ringer's lactate injection.
• To prepare 70 mg dose from two 50 mg vials: reconstitute two 50 mg vials with 10.8 mL of diluent each. Transfer a total of 14 mL of the reconstituted solution from the 2 vials to the infusion bag or bottle.
• To prepare 50 mg daily dose at reduced volume, add 10 mL of reconstituted solution to 100 mL of compatible infusion fluid in IV bag or bottle.
• To prepare 35 mg daily dose for patient with moderate hepatic impairment, add 7 mL of reconstituted 50 mg vial to 250 mL or 100 mL of compatible infusion fluid in IV bag or bottle.
• Visually inspect reconstituted solution. Do not use if particulate matter, cloudiness, or discoloration is noted.

Storage/Stability

Store unopened vials in refrigerator (36° to 46°F). Reconstituted caspofungin solution may be stored at temperature less than 77°F for 1 h prior to preparing diluted IV infusion solution. IV infusion solution in IV bag or bottle can be stored at temperatures less than 77°F for 24 h or in refrigerator (36° to 46°F) for 48 h.

Drug Interactions

Avoid coadministration if possible. Both caspofungin and cyclosporine plasma levels may be elevated, increasing the pharmacologic effects and adverse reactions.

Caspofungin plasma levels may be reduced, decreasing the efficacy. In adults, coadministration may require an increase in dose to caspofungin 70 mg daily. In children, coadministration may require an increase in dose to caspofungin 70 mg/m ² daily (max, 70 mg/day).

Tacrolimus blood levels may be decreased, reducing the efficacy.

Incompatibility

Do not mix or co-infuse with other medications. Do not use diluents containing dextrose. Caspofungin is not stable in diluents containing dextrose.

Laboratory Test Interactions

None well documented.

Adverse Reactions

Cardiovascular

Phlebitis (18%); hypotension (12%); tachycardia (11%); hypertension (10%); arrhythmia, atrial fibrillation, bradycardia, cardiac arrest, MI.

CNS

Headache (15%); convulsion, depression.

Dermatologic

Rash (23%); erythema (9%); pruritus (7%); erythema multiforme, skin exfoliation, Stevens-Johnson syndrome (postmarketing).

GI

Diarrhea (27%); vomiting (17%); nausea (15%); abdominal pain (9%); pancreatitis (postmarketing).

Genitourinary

Hematuria, renal dysfunction, renal failure (postmarketing).

Hepatic

Hepatic failure, hepatic necrosis, hepatomegaly, hepatotoxicity, hyperbilirubinemia, jaundice (postmarketing).

Hematologic-Lymphatic

Anemia (11%); coagulopathy, febrile neutropenia, neutropenia, thrombocytopenia.

Lab Tests

Decreased serum potassium (23%); decreased hemoglobin, increased alkaline phosphatase (21%); decreased hematocrit, increased ALT (18%); increased AST (17%); increased serum bilirubin (13%); decreased WBC (12%); increased serum creatinine (11%); positive urine RBC (10%); increased blood urea, increased conjugated bilirubin (8%); decreased serum albumin, decreased serum magnesium (7%); increased blood glucose (6%); increased serum potassium (3%).

Metabolic-Nutritional

Hypokalemia (8%).

Musculoskeletal

Back pain (4%).

Respiratory

Cough, pneumonia, respiratory failure (11%); dyspnea, plural effusion (9%); respiratory distress (8%); rales (7%).

Miscellaneous

Pyrexia (30%); chills (23%); peripheral edema, septic shock (11%); mucosal inflammation (10%); central line infection (9%); edema, graft-versus-host disease (4%); bacteremia, sepsis, swelling (postmarketing).

Precautions

Pregnancy

Category C .

Lactation

Undetermined.

Children

Safety and efficacy have not been established in pediatric patients younger than 3 mo of age.

Renal Function

No dosage adjustment is needed in patients with renal insufficiency.

Overdosage

Symptoms

In clinical studies, single doses of 210 mg were generally well tolerated.

Patient Information

• Advise patient or caregiver that medication will be prepared and administered by health care providers in a hospital setting.
• Advise patient to immediately report any discomfort at injection site or the vein above the injection site.
• Instruct patient to report any of the following to health care provider: chills, fever, headache, nausea, any unusual or unexplained symptoms.

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