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  • CLASSES

    Echinocandins Antifungals

    DEA CLASS

    Rx

    DESCRIPTION

    IV echinocandin antifungal
    Used for aspergillosis, candidemia, esophageal candidiasis, and empiric treatment in febrile neutropenia
    Fever and infusion-related reactions common

    COMMON BRAND NAMES

    Cancidas

    HOW SUPPLIED

    Cancidas/Caspofungin/Caspofungin Acetate Intravenous Inj Pwd F/Sol: 50mg, 70mg

    DOSAGE & INDICATIONS

    For the treatment of candidemia and invasive candidiasis.
    For the treatment of chronic disseminated (hepatosplenic) candidiasis†.
    Intravenous dosage
    Adults

    70 mg IV loading dose on day 1, then 50 mg IV once daily for several weeks and followed by oral fluconazole for patients who are unlikely to have a fluconazole-resistant isolate. Coadministration of certain drugs may need to be avoided or dosage adjustments may be necessary; review drug interactions.

    Infants 3 months and older, Children, and Adolescents

    70 mg/m2 IV (Max: 70 mg/dose) loading dose on day 1, then 50 mg/m2/dose IV (Max: 70 mg/dose) once daily. If the 50 mg/m2 daily dose is well tolerated but there is an inadequate clinical response, may increase maintenance dose to 70 mg/m2/day (Max: 70 mg/dose). Coadministration of certain drugs may need to be avoided or dosage adjustments may be necessary; review drug interactions. Treat for several weeks, followed by oral fluconazole for patients who are unlikely to have a fluconazole-resistant isolate.

    Intravenous dosage
    Adults

    70 mg IV loading dose on day 1, then 50 mg IV once daily. Coadministration of certain drugs may need to be avoided or dosage adjustments may be necessary; review drug interactions. Treat for 2 weeks after documented clearance from the bloodstream and resolution of signs and symptoms. For invasive candidiasis with a metastatic focus, therapy will be longer and depends on response. Ophthalmological examination is recommended for all patients. Consider intravascular catheter removal.

    Infants 3 months and older, Children, and Adolescents

    70 mg/m2 IV (Max: 70 mg/dose) loading dose on day 1, followed by 50 mg/m2/dose IV (Max: 70 mg/dose) once daily. If the 50 mg/m2 daily dose is well tolerated but there is an inadequate clinical response, may increase maintenance dose to 70 mg/m2/day (Max: 70 mg/dose). Coadministration of certain drugs may need to be avoided or dosage adjustments may be necessary; review drug interactions. Treat for 2 weeks after documented clearance from the bloodstream and resolution of signs and symptoms. For invasive candidiasis with a metastatic focus, therapy will be longer and depends on response. Ophthalmological examination is recommended for all patients. Consider intravascular catheter removal.

    Neonates† and Infants 1 to 2 months†

    Very limited data are available; CNS involvement should be presumed in neonates with candidemia. A dose of 25 mg/m2/dose IV once daily appears to provide comparable exposure to that seen in adults receiving 50 mg IV daily. Coadministration of certain drugs may need to be avoided or dosage adjustments may be necessary; review drug interactions. Successful treatment of invasive candidiasis has been reported in neonates and young infants; however, available data are limited to small case series and studies. For neonatal candidiasis, amphotericin B or fluconazole is the preferred therapy. Some experts suggest that if an echinocandin is used in neonates, micafungin is the preferred agent. Treat for 2 weeks after documented clearance from the bloodstream and resolution of signs and symptoms. For invasive candidiasis with a metastatic focus, therapy will be longer and depends on response. Ophthalmological examination is recommended for all patients. Consider intravascular catheter removal.

    For the treatment of invasive aspergillosis in patients who are refractory to or intolerant of other antifungal therapies.
    Intravenous dosage
    Adults

    70 mg IV loading dose on day 1, then 50 mg IV once daily. Coadministration of certain drugs may need to be avoided or dosage adjustments may be necessary; review drug interactions. Clinical practice guidelines suggest caspofungin as salvage therapy. Treat for at least 6 to 12 weeks with duration dependent on extent and length of immunosuppression, infection site, and disease improvement.

    Infants 3 months and older, Children, and Adolescents

    70 mg/m2 IV (Max: 70 mg/dose) loading dose on day 1, followed by 50 mg/m2/dose IV (Max: 70 mg/dose) once daily. If the 50 mg/m2 daily dose is well tolerated but there is an inadequate clinical response, may increase maintenance dose to 70 mg/m2/day (Max: 70 mg/dose). Coadministration of certain drugs may need to be avoided or dosage adjustments may be necessary; review drug interactions. Clinical practice guidelines suggest caspofungin as salvage therapy. Treat for at least 6 to 12 weeks with duration dependent on extent and length of immunosuppression, infection site, and disease improvement.

    Neonates† and Infants 1 to 2 months†

    No data are available. A dosage of 25 mg/m2/dose IV once daily appears to provide comparable exposure to that seen in adults receiving 50 mg IV daily. Coadministration of certain drugs may need to be avoided or dosage adjustments may be necessary; review drug interactions. Successful treatment of invasive candidiasis has been reported in neonates and young infants; however, available data are limited to small case series and studies. Although specific neonatal recommendations are not available, clinical practice guidelines suggest caspofungin as salvage therapy. Treat for at least 6 to 12 weeks with duration dependent on extent and length of immunosuppression, infection site, and disease improvement.

    For the treatment of esophageal candidiasis.
    Intravenous dosage
    Adults

    50 mg IV once daily for 7 to 14 days is the FDA-approved dosage ; however, clinical practice guidelines recommend a 70 mg IV load on day 1 of therapy and treatment for 14 to 21 days. Coadministration of certain drugs may need to be avoided or dosage adjustments may be necessary; review drug interactions. Recommended as an alternative therapy in patients unable to tolerate oral therapy or those who are refractory to fluconazole. The risk of relapse is greater in HIV-infected patients for esophageal candidiasis, and suppressive antifungal therapy may be considered after a course of treatment.

    Infants 3 months and older, Children, and Adolescents

    50 mg/m2/dose IV (Max: 70 mg/dose) once daily for 7 to 14 days is the FDA-approved dosage. If the 50 mg/m2 daily dose is well tolerated but there is an inadequate clinical response, may increase maintenance dose to 70 mg/m2/day (Max: 70 mg/dose). Coadministration of certain drugs may need to be avoided or dosage adjustments may be necessary; review drug interactions. Clinical practice guidelines recommend treatment for 14 to 21 days; in HIV-infected patients, treat for a minimum of 21 days and for at least 14 days following resolution of symptoms. Recommended as an alternative therapy in patients unable to tolerate oral therapy or those who are refractory to fluconazole.

    Infants 1 to 2 months†

    Limited data are available. 25 mg/m2/dose IV once daily for 14 to 21 days; in HIV-infected patients, treat for a minimum of 21 days and for at least 14 days following resolution of symptoms. Coadministration of certain drugs may need to be avoided or dosage adjustments may be necessary; review drug interactions. Recommended as an alternative therapy in patients unable to tolerate oral therapy or those who are refractory to fluconazole.

    For the treatment of respiratory infections (i.e., pneumonia and pleural space infections).
    For the treatment of Candida pneumonia and pleural space infections.
    Intravenous dosage
    Adults

    Growth of Candida sp. from the respiratory tract typically reflects colonization and rarely requires antifungal therapy. In cases where pneumonia is associated with disseminated infection, 70 mg IV loading dose on day 1, then 50 mg IV once daily. Coadministration of certain drugs may need to be avoided or dosage adjustments may be necessary; review drug interactions.

    Infants 3 months and older, Children, and Adolescents

    Growth of Candida sp. from the respiratory tract typically reflects colonization and rarely requires antifungal therapy. In cases where pneumonia is associated with disseminated infection, 70 mg/m2 IV (Max: 70 mg/dose) loading dose on day 1, followed by 50 mg/m2/dose IV (Max: 70 mg/dose) once daily. If the 50 mg/m2 daily dose is well tolerated but there is an inadequate clinical response, may increase maintenance dose to 70 mg/m2/day (Max: 70 mg/dose). Coadministration of certain drugs may need to be avoided or dosage adjustments may be necessary; review drug interactions.

    Neonates† and Infants 1 to 2 months†

    Growth of Candida sp. from the respiratory tract typically reflects colonization and rarely requires antifungal therapy. Restrict treatment to pneumonia associated with disseminated infection. Very limited data are available. A dose of 25 mg/m2/dose IV once daily appears to provide comparable exposure to that seen in adults receiving 50 mg IV daily. Coadministration of certain drugs may need to be avoided or dosage adjustments may be necessary; review drug interactions. Successful treatment of invasive candidiasis has been reported in neonates and young infants; however, available data are limited to small case series and studies. For neonatal candidiasis, amphotericin B or fluconazole is the preferred therapy. Some experts suggest that if an echinocandin is used in neonates, micafungin is the preferred agent.

    For the treatment of Aspergillus pneumonia and pleural space infections in patients who are refractory to or intolerant of other antifungal therapies.
    Intravenous dosage
    Adults

    70 mg IV loading dose on day 1, then 50 mg IV once daily. Coadministration of certain drugs may need to be avoided or dosage adjustments may be necessary; review drug interactions. Clinical practice guidelines suggest caspofungin as salvage therapy. Treat for at least 6 to 12 weeks with duration dependent on extent and length of immunosuppression, infection site, and disease improvement. In lung transplant recipients with tracheobronchial aspergillosis (TBA) associated with anastomotic endobronchial ischemia or ischemic reperfusion injury, inhaled amphotericin B deoxycholate is suggested in addition to systemic therapy; treat for at least 3 months or until TBA is resolved, whichever is longer. Surgery alone may be used to treat Aspergillus fungal ball of the paranasal sinus.

    Infants 3 months and older, Children, and Adolescents

    70 mg/m2 IV (Max: 70 mg/dose) loading dose on day 1, followed by 50 mg/m2/dose IV (Max: 70 mg/dose) once daily. If the 50 mg/m2 daily dose is well tolerated but there is an inadequate clinical response, may increase maintenance dose to 70 mg/m2/day (Max: 70 mg/dose). Coadministration of certain drugs may need to be avoided or dosage adjustments may be necessary; review drug interactions. Clinical practice guidelines suggest caspofungin as salvage therapy. Treat for at least 6 to 12 weeks with duration dependent on extent and length of immunosuppression, infection site, and disease improvement. In lung transplant recipients with tracheobronchial aspergillosis (TBA) associated with anastomotic endobronchial ischemia or ischemic reperfusion injury, inhaled amphotericin B deoxycholate is suggested in addition to systemic therapy; treat for at least 3 months or until TBA is resolved, whichever is longer. Surgery alone may be used to treat Aspergillus fungal ball of the paranasal sinus.

    Neonates† and Infants 1 to 2 months†

    No data are available. A dosage of 25 mg/m2/dose IV once daily appears to provide comparable exposure to that seen in adults receiving 50 mg IV daily. Coadministration of certain drugs may need to be avoided or dosage adjustments may be necessary; review drug interactions. Successful treatment of invasive candidiasis has been reported in neonates and young infants; however, available data are limited to small case series and studies. Although specific neonatal recommendations are not available, clinical practice guidelines suggest caspofungin as salvage therapy. Treat for at least 6 to 12 weeks with duration dependent on extent and length of immunosuppression, infection site, and disease improvement. In lung transplant recipients with tracheobronchial aspergillosis (TBA) associated with anastomotic endobronchial ischemia or ischemic reperfusion injury, inhaled amphotericin B deoxycholate is suggested in addition to systemic therapy; treat for at least 3 months or until TBA is resolved, whichever is longer. Surgery alone may be used to treat Aspergillus fungal ball of the paranasal sinus.

    For the treatment of intraabdominal infections (i.e., peritonitis, intraabdominal abscess).
    For the treatment of intraabdominal candidiasis.
    Intravenous dosage
    Adults

    70 mg IV loading dose on day 1, then 50 mg IV once daily. Coadministration of certain drugs may need to be avoided or dosage adjustments may be necessary; review drug interactions. Duration of therapy is dependent on clinical response.

    Infants 3 months and older, Children, and Adolescents

    70 mg/m2 IV (Max: 70 mg/dose) loading dose on day 1, followed by 50 mg/m2/dose IV (Max: 70 mg/dose) once daily. If the 50 mg/m2 daily dose is well tolerated but there is an inadequate clinical response, may increase maintenance dose to 70 mg/m2/day (Max: 70 mg/dose). Coadministration of certain drugs may need to be avoided or dosage adjustments may be necessary; review drug interactions. Duration of therapy is dependent on clinical response.

    Neonates† and Infants 1 to 2 months†

    Very limited data are available; a dose of 25 mg/m2/dose IV once daily appears to provide comparable exposure to that seen in adults receiving 50 mg IV daily. Coadministration of certain drugs may need to be avoided or dosage adjustments may be necessary; review drug interactions. Successful treatment of invasive candidiasis has been reported in neonates and young infants; however, available data are limited to small case series and studies. For neonatal candidiasis, amphotericin B or fluconazole is the preferred therapy. Some experts suggest that if an echinocandin is used in neonates, micafungin is the preferred agent. Duration of therapy is dependent on clinical response.

    For the treatment of intraabdominal aspergillosis in patients who are refractory to or intolerant of other antifungal therapies.
    Intravenous dosage
    Adults

    70 mg IV loading dose on day 1, then 50 mg IV once daily. Coadministration of certain drugs may need to be avoided or dosage adjustments may be necessary; review drug interactions. Clinical practice guidelines suggest caspofungin as salvage therapy. Treat for at least 6 to 12 weeks with duration dependent on extent and length of immunosuppression, infection site, and disease improvement. Remove peritoneal dialysis catheter.

    Infants 3 months and older, Children, and Adolescents

    70 mg/m2 IV (Max: 70 mg/dose) loading dose on day 1, followed by 50 mg/m2/dose IV (Max: 70 mg/dose) once daily. If the 50 mg/m2 daily dose is well tolerated but there is an inadequate clinical response, may increase maintenance dose to 70 mg/m2/day (Max: 70 mg/dose). Coadministration of certain drugs may need to be avoided or dosage adjustments may be necessary; review drug interactions. Clinical practice guidelines suggest caspofungin as salvage therapy. Treat for at least 6 to 12 weeks with duration dependent on extent and length of immunosuppression, infection site, and disease improvement. Remove peritoneal dialysis catheter.

    Neonates† and Infants 1 to 2 months†

    No data are available. A dosage of 25 mg/m2/dose IV once daily appears to provide comparable exposure to that seen in adults receiving 50 mg IV daily. Coadministration of certain drugs may need to be avoided or dosage adjustments may be necessary; review drug interactions. Successful treatment of invasive candidiasis has been reported in neonates and young infants; however, available data are limited to small case series and studies. Although specific neonatal recommendations are not available, clinical practice guidelines suggest caspofungin as salvage therapy. Treat for at least 6 to 12 weeks with duration dependent on extent and length of immunosuppression, infection site, and disease improvement. Remove peritoneal dialysis catheter.

    For the treatment of bone and joint infections, including osteomyelitis and infectious arthritis.
    For the treatment of Candida osteomyelitis† or infectious arthritis†.
    Intravenous dosage
    Adults

    70 mg IV loading dose on day 1, then 50 mg IV once daily. Coadministration of certain drugs may need to be avoided or dosage adjustments may be necessary; review drug interactions. Treat for at least 2 weeks followed by fluconazole for 6 to 12 months for osteomyelitis or 4 weeks for infectious arthritis. Recommended as an alternative to fluconazole as initial therapy. Surgical debridement may be helpful in some cases of osteomyelitis and is recommended for all cases of septic arthritis. For infection involving a prosthetic device, device removal in addition to antifungal therapy is recommended.

    Infants 3 months and older, Children, and Adolescents

    70 mg/m2 IV (Max: 70 mg/dose) loading dose on day 1, followed by 50 mg/m2/dose IV (Max: 70 mg/dose) once daily. If the 50 mg/m2 daily dose is well tolerated but there is an inadequate clinical response, may increase maintenance dose to 70 mg/m2/day (Max: 70 mg/dose). Coadministration of certain drugs may need to be avoided or dosage adjustments may be necessary; review drug interactions. Treat for at least 2 weeks followed by fluconazole for 6 to 12 months for osteomyelitis or 4 weeks for infectious arthritis. Recommended as an alternative to fluconazole as initial therapy. Surgical debridement may be helpful in some cases of osteomyelitis and is recommended for all cases of septic arthritis. For infection involving a prosthetic device, device removal in addition to antifungal therapy is recommended.

    Neonates and Infants 1 to 2 months

    Very limited data are available. A dose of 25 mg/m2/dose IV once daily appears to provide comparable exposure to that seen in adults receiving 50 mg IV daily. Coadministration of certain drugs may need to be avoided or dosage adjustments may be necessary; review drug interactions. Successful treatment of invasive candidiasis has been reported in neonates and young infants; however, available data are limited to small case series and studies. For neonatal candidiasis, amphotericin B or fluconazole is the preferred therapy. Some experts suggest that if an echinocandin is used in neonates, micafungin is the preferred agent. Treat for at least 2 weeks followed by fluconazole for 6 to 12 months for osteomyelitis or 4 weeks for infectious arthritis. Surgical debridement may be helpful in some cases of osteomyelitis and is recommended for all cases of septic arthritis.

    For the treatment of Aspergillus osteomyelitis or infectious arthritis in patients who are refractory to or intolerant of other antifungal therapies.
    Intravenous dosage
    Adults

    70 mg IV loading dose on day 1, then 50 mg IV once daily. Coadministration of certain drugs may need to be avoided or dosage adjustments may be necessary; review drug interactions. Clinical practice guidelines suggest caspofungin as salvage therapy. Treat for at least 8 weeks with duration dependent on extent and length of immunosuppression, infection site, and disease improvement. Longer courses (greater than 6 months) are frequently necessary.

    Infants 3 months and older, Children, and Adolescents

    70 mg/m2 IV (Max: 70 mg/dose) loading dose on day 1, followed by 50 mg/m2/dose IV (Max: 70 mg/dose) once daily. If the 50 mg/m2 daily dose is well tolerated but there is an inadequate clinical response, may increase maintenance dose to 70 mg/m2/day (Max: 70 mg/dose). Coadministration of certain drugs may need to be avoided or dosage adjustments may be necessary; review drug interactions. Clinical practice guidelines suggest caspofungin as salvage therapy. Treat for at least 8 weeks with duration dependent on extent and length of immunosuppression, infection site, and disease improvement. Longer courses (greater than 6 months) are frequently necessary.

    Neonates† and Infants 1 to 2 months†

    No data are available. A dosage of 25 mg/m2/dose IV once daily appears to provide comparable exposure to that seen in adults receiving 50 mg IV daily. Coadministration of certain drugs may need to be avoided or dosage adjustments may be necessary; review drug interactions. Successful treatment of invasive candidiasis has been reported in neonates and young infants; however, available data are limited to small case series and studies. Although specific neonatal recommendations are not available, clinical practice guidelines suggest caspofungin as salvage therapy. Treat for at least 8 weeks with duration dependent on extent and length of immunosuppression, infection site, and disease improvement. Longer courses (greater than 6 months) are frequently necessary.

    For empirical therapy for presumed fungal infection in patients with febrile neutropenia.
    Intravenous dosage
    Adults

    70 mg IV loading dose on day 1, followed by 50 mg IV once daily. If 50 mg/day is well tolerated but there is an inadequate clinical response, may increase maintenance dose to 70 mg/day. Coadministration of certain drugs may need to be avoided or dosage adjustments may be necessary; review drug interactions. Duration of treatment is based on clinical response. Empirical therapy should be continued until neutropenia resolution. Treatment for at least 14 days and for at least 7 days after neutropenia and symptoms resolve is recommended for patients found to have a fungal infection. Recommended in patients with persistent or recurrent fever after 4 to 7 days of antibiotics and anticipated neutropenia duration more than 7 days. Aspergillosis clinical practice guidelines suggest caspofungin as a first line empiric therapy.

    Infants 3 months and older, Children, and Adolescents

    70 mg/m2/dose IV (Max: 70 mg/dose) loading dose on day 1, followed by 50 mg/m2/dose IV (Max: 70 mg/dose) once daily. If the 50 mg/m2 daily dose is well tolerated but there is an inadequate clinical response, may increase maintenance dose to 70 mg/m2/day (Max: 70 mg/dose). Coadministration of certain drugs may need to be avoided or dosage adjustments may be necessary; review drug interactions. Duration of treatment is based on clinical response. Empirical therapy should be continued until neutropenia resolution. Treatment for at least 14 days and for at least 7 days after neutropenia and symptoms resolve is recommended for patients found to have a fungal infection. Recommended in patients with persistent or recurrent fever after 4 to 7 days of antibiotics and anticipated neutropenia duration more than 7 days. Aspergillosis clinical practice guidelines suggest caspofungin as a first line empiric therapy.

    For the treatment of oropharyngeal candidiasis (thrush)†.
    Intravenous dosage
    Adults

    70 mg IV loading dose on day 1, then 50 mg IV once daily for 7 to 14 days. Coadministration of certain drugs may need to be avoided or dosage adjustments may be necessary; review drug interactions. Recommended as an alternative therapy for fluconazole-refractory oropharyngeal candidiasis. Oral antifungal agents (e.g., itraconazole, posaconazole) should be utilized first.

    Infants 3 months and older, Children, and Adolescents

    50 mg/m2/dose IV (Max: 70 mg/dose) once daily for 7 to 14 days. If the 50 mg/m2 daily dose is well tolerated but there is an inadequate clinical response, may increase maintenance dose to 70 mg/m2/day (Max: 70 mg/dose). Coadministration of certain drugs may need to be avoided or dosage adjustments may be necessary; review drug interactions. Recommended as an alternative therapy for fluconazole-refractory oropharyngeal candidiasis. Oral antifungal agents (e.g., itraconazole) should be utilized first.

    Infants 1 to 2 months

    Limited data are available. 25 mg/m2/dose IV once daily for 7 to 14 days. Coadministration of certain drugs may need to be avoided or dosage adjustments may be necessary; review drug interactions. Recommended as an alternative therapy for fluconazole-refractory oropharyngeal candidiasis. Oral antifungal agents (e.g., itraconazole) should be utilized first.

    For the treatment of cardiovascular system infections, including endocarditis†, suppurative thrombophlebitis†, and infected pacemaker†, implantable cardiac defibrillator (ICD)†, or ventricular assist devices (VAD)†.
    For the treatment of Candida cardiovascular system infections†.
    Intravenous dosage
    Adults

    150 mg IV once daily. Coadministration of certain drugs may need to be avoided or dosage adjustments may be necessary; review drug interactions. For endocarditis, treat for at least 6 weeks after valve replacement. For infected cardiac hardware, treat for at least 4 to 6 weeks after hardware removal. When valve replacement or hardware removal is not possible, chronic suppressive therapy with fluconazole is recommended after initial treatment. Treat suppurative thrombophlebitis for at least 2 weeks after candidemia (if present) has cleared.

    Infants 3 months and older, Children, and Adolescents

    70 mg/m2 IV (Max: 70 mg/dose) loading dose on day 1, followed by 50 mg/m2/dose IV (Max: 70 mg/dose) once daily. If the 50 mg/m2 daily dose is well tolerated but there is an inadequate clinical response, may increase maintenance dose to 70 mg/m2/day (Max: 70 mg/dose). Coadministration of certain drugs may need to be avoided or dosage adjustments may be necessary; review drug interactions. Although the FDA-approved maximum dose is 70 mg/day, clinical practice guidelines recommend 150 mg IV once daily for adults with cardiac infections. For endocarditis, treat for at least 6 weeks after valve replacement. For infected cardiac hardware, treat for at least 4 to 6 weeks after hardware removal. When valve replacement or hardware removal is not possible, chronic suppressive therapy with fluconazole is recommended after initial treatment. Treat suppurative thrombophlebitis for at least 2 weeks after candidemia (if present) has cleared.

    Neonates and Infants 1 to 2 months

    Very limited data are available; a dose of 25 mg/m2/dose IV once daily appears to provide comparable exposure to that seen in adults receiving 50 mg IV daily. Coadministration of certain drugs may need to be avoided or dosage adjustments may be necessary; review drug interactions. Successful treatment of invasive candidiasis has been reported in neonates and young infants; however, available data are limited to small case series and studies. For neonatal candidiasis, amphotericin B or fluconazole is the preferred therapy. Some experts suggest that if an echinocandin is used in neonates, micafungin is the preferred agent. For endocarditis, treat for at least 6 weeks after valve replacement. For infected cardiac hardware, treat for at least 4 to 6 weeks after hardware removal. When valve replacement or hardware removal is not possible, chronic suppressive therapy with fluconazole is recommended after initial treatment. Treat suppurative thrombophlebitis for at least 2 weeks after candidemia (if present) has cleared.

    For the treatment of Aspergillus cardiovascular system infections in patients who are refractory to or intolerant of other antifungal therapies.
    Intravenous dosage
    Adults

    70 mg IV loading dose on day 1, then 50 mg IV once daily.  Coadministration of certain drugs may need to be avoided or dosage adjustments may be necessary; review drug interactions. Clinical practice guidelines suggest caspofungin as salvage therapy. Treat for at least 6 to 12 weeks with duration dependent on extent and length of immunosuppression, infection site, and disease improvement. After surgical replacement of an infected valve, consider lifelong antifungal therapy.

    Infants 3 months and older, Children, and Adolescents

    70 mg/m2 IV (Max: 70 mg/dose) loading dose on day 1, followed by 50 mg/m2/dose IV (Max: 70 mg/dose) once daily. If the 50 mg/m2 daily dose is well tolerated but there is an inadequate clinical response, may increase maintenance dose to 70 mg/m2/day (Max: 70 mg/dose). Coadministration of certain drugs may need to be avoided or dosage adjustments may be necessary; review drug interactions. Clinical practice guidelines suggest caspofungin as salvage therapy. Treat for at least 6 to 12 weeks with duration dependent on extent and length of immunosuppression, infection site, and disease improvement. After surgical replacement of an infected valve, consider lifelong antifungal therapy.

    Neonates† and Infants 1 to 2 months†

    No data are available. A dosage of 25 mg/m2/dose IV once daily appears to provide comparable exposure to that seen in adults receiving 50 mg IV daily. Coadministration of certain drugs may need to be avoided or dosage adjustments may be necessary; review drug interactions. Successful treatment of invasive candidiasis has been reported in neonates and young infants; however, available data are limited to small case series and studies. Although specific neonatal recommendations are not available, clinical practice guidelines suggest caspofungin as salvage therapy. Treat for at least 6 to 12 weeks with duration dependent on extent and length of immunosuppression, infection site, and disease improvement. After surgical replacement of an infected valve, consider lifelong antifungal therapy.

    For candidiasis prophylaxis† and aspergillosis prophylaxis† in high-risk patients.
    Intravenous dosage
    Adults

    70 mg IV loading dose on day 1, then 50 mg IV once daily. Coadministration of certain drugs may need to be avoided or dosage adjustments may be necessary; review drug interactions. An echinocandin, such as caspofungin, is recommended as an alternative therapy to fluconazole for candidiasis prophylaxis in high-risk patients in intensive care units with a high rate (more than 5%) of invasive candidiasis. Clinical practice guidelines suggest caspofungin as an alternative to posaconazole for aspergillosis prophylaxis in high-risk patients (i.e., patients with graft-versus-host disease and neutropenic patients with acute myelogenous leukemia or myelodysplastic syndrome). Also recommended in patients with substantial risk of invasive candidiasis, such as allogeneic hematopoietic stem cell transplant (HSCT) recipients or those undergoing intensive remission-induction or salvage-induction chemotherapy for acute leukemia, and in patients with previous invasive aspergillosis, anticipated prolonged neutropenic periods of at least 2 weeks, or a prolonged period of neutropenia immediately prior to HSCT.

    Infants 3 months and older, Children, Adolescents

    50 mg/m2/dose IV (Max: 50 mg/dose) once daily. Coadministration of certain drugs may need to be avoided or dosage adjustments may be necessary; review drug interactions. In a retrospective study of pediatric patients (n = 120; 4 months to less than 18 years) undergoing hematopoietic stem cell transplantation (HSCT), caspofungin was initiated on day 1 after HSCT and continued for a median of 24 days (range, 14 to 49 days). An echinocandin, such as caspofungin, is recommended as an alternative therapy to fluconazole for candidiasis prophylaxis in high-risk patients in intensive care units with a high rate (more than 5%) of invasive candidiasis. Clinical practice guidelines suggest caspofungin as an alternative to posaconazole for aspergillosis prophylaxis in high-risk patients (i.e., patients with graft-versus-host disease and neutropenic patients with acute myelogenous leukemia or myelodysplastic syndrome). Also recommended in patients with substantial risk of invasive candidiasis, such as allogeneic HSCT recipients or those undergoing intensive remission-induction or salvage-induction chemotherapy for acute leukemia, and in patients with previous invasive aspergillosis, anticipated prolonged neutropenic periods of at least 2 weeks, or a prolonged period of neutropenia immediately prior to HSCT.

    †Indicates off-label use

    MAXIMUM DOSAGE

    Adults

    70 mg/day IV; doses up to 150 mg/day IV have been recommended for cardiovascular infections.

    Geriatric

    70 mg/day IV; doses up to 150 mg/day IV have been recommended for cardiovascular infections.

    Adolescents

    70 mg/m2/day IV, not to exceed 70 mg IV.

    Children

    70 mg/m2/day IV, not to exceed 70 mg IV.

    Infants

    >= 3 months: 70 mg/m2/day IV, not to exceed 70 mg IV.
    < 3 months: Safety and efficacy have not been established; however, doses up to 25 mg/m2/day IV are used off-label.

    Neonates

    Safety and efficacy have not been established; however, doses up to 25 mg/m2/day IV are used off-label.

    DOSING CONSIDERATIONS

    Hepatic Impairment

    Dosage adjustment information is only available for adults. No adjustment needed in mild impairment. A reduced maintenance dose of 35 mg/day IV (30% dose reduction) is recommended for patients with moderate hepatic impairment (Child-Pugh score 7 to 9, class B). For pediatric patients, this would be equivalent to a maintenance dose of 35 mg/m2/day. No adjustment in the loading dose is needed. There is no clinical experience in those with severe hepatic impairment (Child-Pugh score more than 9, class C).

    Renal Impairment

    No dosage adjustment is needed in patients with renal impairment.
     
    Intermittent and Continuous Hemodialysis
    Caspofungin is not dialyzable. Supplemental dosing is not required following hemodialysis.

    ADMINISTRATION

    Injectable Administration

    Visually inspect prepared infusions for particulate matter and discoloration prior to administration.

    Intravenous Administration

    Reconstitution
    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 50-mg vial or 70-mg vial for a resultant concentration of 5 mg/mL or 7 mg/mL, respectively.
    Mix gently until the solution is clear.
    Caspofungin vials are single use only; discard any unused reconstituted solution.
    Storage: Reconstituted caspofungin in the vial may be stored at 25 degrees C or less (77 degrees F or less) for 1 hour prior to dilution.
     
    Dilution
    Add appropriate dose to 250 mL of 0.9% Sodium Chloride Injection, 0.45% Sodium Chloride Injection, 0.225% Sodium Chloride Injection, or Lactated Ringer's Injection. For fluid restricted patients, may dilute dose to a final concentration not to exceed 0.5 mg/mL.
    Do not use any diluents containing dextrose to prepare caspofungin.
    Storage: The final diluted infusion may be stored for up to 24 hours at 25 degrees C or less (77 degrees F or less), or for up to 48 hours under refrigeration at 2 to 8 degrees C.
     
    Intermittent IV Infusion
    Administer as a slow IV infusion over approximately 1 hour. Do not administer as an IV bolus injection.
    Do not mix or co-infuse caspofungin with other medications or infuse with dextrose-containing solutions.

    STORAGE

    Cancidas:
    - Discard unused portion. Do not store for later use.
    - Store reconstituted product in accordance with package insert instructions
    - Store unreconstituted product in refrigerator (36 to 46 degrees F)

    CONTRAINDICATIONS / PRECAUTIONS

    General Information

    Caspofungin is contraindicated for use in patients with hypersensitivity to the drug or any of its components. If anaphylaxis and/or histamine-mediated adverse events (e.g., rash, facial swelling, angioedema, pruritus, bronchospasms, sensation of warmth) develop while on caspofungin, use of the drug should be discontinued and appropriate treatment initiated.

    Cholestasis, hepatic disease, hepatitis, jaundice

    Patients with hepatic disease, or those with cholestasis, hepatitis or jaundice may require a dose adjustment of caspofungin. Clinically significant elevations in caspofungin plasma concentrations have been noted in patients with moderate hepatic impairment (i.e., Child-Pugh score 7—9, class B). No data are available on the use of caspofungin in patients with severe hepatic disease (i.e., Child-Pugh score >9, class C).

    Infants, neonates

    Caspofungin has not been studied for safety and efficacy in infants less than 3 months of age, including neonates. In general, the safety profile of caspofungin in pediatric patients is comparable to that of adult patients.

    Pregnancy

    Caspofungin is classified in FDA pregnancy risk category C. There have been no well-controlled studies in pregnant women. Animal data revealed embryotoxic effects of caspofungin including increased fetal resorptions, increased peri-implantation loss, and incomplete ossification at multiple fetal sites including incomplete ossification of the talus/calcaneus, skull, and torso. Embryotoxic effects have been observed at doses in animals that produced exposure similar to those seen in humans treated with a 70 mg dose. Caspofungin crosses the placenta in animal models and is detected in the plasma of animal fetuses. Caspofungin should be used in pregnancy only when the benefits clearly outweigh the risks.

    Breast-feeding

    Data are limited regarding use of caspofungin during breast-feeding and it is not known if it is excreted into human milk. Caution is advised when administering to nursing mothers. Studies to evaluate the effects of exposure on a breast-fed infant have not been conducted; however, based on caspofungin's poor oral absorption, the risks appear to be low. Monitor potentially exposed infants for gastrointestinal adverse events and signs of histamine release. Fluconazole may be a potential alternative to consider during breast-feeding. However, site of infection, local susceptibility patterns, and specific microbial susceptibility should be assessed before choosing an alternative agent. Consider the benefits of breast-feeding, the risk of potential infant drug exposure, and the risk of an untreated or inadequately treated condition. If a breast-feeding infant experiences an adverse effect related to a maternally ingested or administered drug, health care providers are encouraged to report the adverse effect to the FDA.

    ADVERSE REACTIONS

    Severe

    pleural effusion / Delayed / 9.0-9.0
    hepatic failure / Delayed / 0-5.0
    coagulopathy / Delayed / 0-5.0
    bradycardia / Rapid / 0-5.0
    atrial fibrillation / Early / 0-5.0
    cardiac arrest / Early / 0-5.0
    arrhythmia exacerbation / Early / 0-5.0
    myocardial infarction / Delayed / 0-5.0
    renal failure (unspecified) / Delayed / 0-5.0
    seizures / Delayed / 0-5.0
    hepatic necrosis / Delayed / Incidence not known
    toxic epidermal necrolysis / Delayed / Incidence not known
    Stevens-Johnson syndrome / Delayed / Incidence not known
    angioedema / Rapid / Incidence not known
    exfoliative dermatitis / Delayed / Incidence not known
    anaphylactoid reactions / Rapid / Incidence not known
    erythema multiforme / Delayed / Incidence not known
    bronchospasm / Rapid / Incidence not known
    pulmonary edema / Early / Incidence not known
    pancreatitis / Delayed / Incidence not known

    Moderate

    hypotension / Rapid / 3.0-20.0
    phlebitis / Rapid / 0-18.0
    elevated hepatic enzymes / Delayed / 4.0-13.0
    hyperbilirubinemia / Delayed / 6.0-13.0
    peripheral edema / Delayed / 6.0-11.0
    anemia / Delayed / 2.0-11.0
    sinus tachycardia / Rapid / 4.0-11.0
    hypertension / Early / 5.0-10.0
    erythema / Early / 4.0-9.0
    dyspnea / Early / 0-9.0
    hypokalemia / Delayed / 5.0-8.0
    jaundice / Delayed / 0-5.0
    hepatomegaly / Delayed / 0-5.0
    skin ulcer / Delayed / 3.0-5.0
    hypoxia / Early / 0-5.0
    hyperglycemia / Delayed / 0-5.0
    hypomagnesemia / Delayed / 0-5.0
    hypercalcemia / Delayed / 0-5.0
    neutropenia / Delayed / 0-5.0
    thrombocytopenia / Delayed / 0-5.0
    constipation / Delayed / 0-5.0
    fluid retention / Delayed / 0-5.0
    hematuria / Delayed / 0-5.0
    confusion / Early / 0-5.0
    depression / Delayed / 0-5.0
    edema / Delayed / 3.0-4.0
    tachypnea / Early / 1.0-1.0
    hepatitis / Delayed / Incidence not known

    Mild

    fever / Early / 6.0-30.0
    diarrhea / Early / 6.0-27.0
    rash (unspecified) / Early / 4.0-23.0
    chills / Rapid / 9.0-23.0
    headache / Early / 5.0-15.0
    infection / Delayed / 0-14.0
    cough / Delayed / 6.0-11.0
    nausea / Early / 9.0-9.0
    abdominal pain / Early / 4.0-9.0
    vomiting / Early / 8.0-8.0
    pruritus / Rapid / 6.0-7.0
    urticaria / Rapid / 0-5.0
    petechiae / Delayed / 0-5.0
    flushing / Rapid / 0-5.0
    epistaxis / Delayed / 0-5.0
    injection site reaction / Rapid / 0-5.0
    dyspepsia / Early / 0-5.0
    anorexia / Delayed / 0-5.0
    arthralgia / Delayed / 0-5.0
    fatigue / Early / 0-5.0
    asthenia / Delayed / 0-5.0
    tremor / Early / 0-5.0
    dizziness / Early / 0-5.0
    drowsiness / Early / 0-5.0
    anxiety / Delayed / 0-5.0
    insomnia / Early / 0-5.0
    back pain / Delayed / 4.0-4.0

    DRUG INTERACTIONS

    Carbamazepine: (Major) Data suggest that coadministration of inducers or mixed inducers/inhibitors of hepatic drug clearance along with caspofungin may result in reduced caspofungin blood concentrations. The reductions may be clinically significant. According to the manufacturer, drugs that may lead to reductions in caspofungin concentrations include carbamazepine. For adult patients receiving carbamazepine, an increase in the caspofungin dose to 70 mg/day should be considered. For pediatric patients receiving carbamazepine, a daily dosage of 70 mg/m2, not to exceed 70 mg, should be considered.
    Cyclosporine: (Major) In two clinical studies, cyclosporine increased the systemic exposure (AUC) of caspofungin by approximately 35%. Cyclosporine concentrations are not altered by coadministration with caspofungin. Seven of 20 healthy subjects who received caspofungin (35 mg or 70 mg) in combination with cyclosporine (3 mg/kg or 4 mg/kg) developed transient elevations in alanine transaminase (ALT) up to 3 times the upper limit of normal. Elevations in aspartate transaminase (AST) paralleled ALT elevations but were of lesser magnitude. As determined retrospectively, 14 of 40 patients who received caspofungin and cyclosporine (1 to 290 days, median 17.5 days) had an ALT concentration elevation greater than 5 times the upper limit of normal or greater than 3 times the baseline value during concurrent therapy or the following 14 days. Five of the 14 cases and one case of elevated bilirubin were considered possibly related to concomitant therapy; no clinical evidence of hepatotoxicity or serious hepatic events occurred. The manufacturer recommends against the concomitant use of caspofungin with cyclosporine unless the potential benefit outweighs the risk. Monitor patients who develop abnormal liver enzyme concentrations; a risk versus benefit decision for therapy continuation is recommended.
    Dexamethasone: (Major) Data suggest that coadministration of inducers or mixed inducers/inhibitors of hepatic drug clearance along with caspofungin may result in reduced caspofungin blood concentrations. The reductions may be clinically significant. It is not known how caspofungin drug clearance is induced. Drugs that may lead to reductions in caspofungin concentrations include dexamethasone. For adult patients receiving dexamethasone, an increase in the caspofungin dose to 70 mg/day should be considered. For pediatric patients receiving dexamethasone, a daily dosage of 70 mg/m2, not to exceed 70 mg, should be considered.
    Dichlorphenamide: (Moderate) Use dichlorphenamide and caspofungin together with caution. Dichlorphenamide increases potassium excretion and can cause hypokalemia and should be used cautiously with other drugs that may cause hypokalemia including antifungals. Measure potassium concentrations at baseline and periodically during dichlorphenamide treatment. If hypokalemia occurs or persists, consider reducing the dichlorphenamide dose or discontinuing dichlorphenamide therapy.
    Efavirenz: (Major) Consider dosing caspofungin as 70 mg IV once daily in adult patients and 70 mg/m2 IV once daily (Max: 70 mg/day) in pediatric patients receiving efavirenz. Administering inducers of hepatic cytochrome P450, such as efavirenz, concurrently with caspofungin may reduce the plasma concentrations of caspofungin.
    Efavirenz; Emtricitabine; Tenofovir: (Major) Consider dosing caspofungin as 70 mg IV once daily in adult patients and 70 mg/m2 IV once daily (Max: 70 mg/day) in pediatric patients receiving efavirenz. Administering inducers of hepatic cytochrome P450, such as efavirenz, concurrently with caspofungin may reduce the plasma concentrations of caspofungin.
    Ethotoin: (Major) Consider dosing caspofungin as 70 mg IV once daily in adult patients and 70 mg/m2 IV once daily (Max: 70 mg/day) in pediatric patients receiving ethotoin. Administering inducers of hepatic cytochrome P450, such as ethotoin, concurrently with caspofungin may reduce the plasma concentrations of caspofungin.
    Fosphenytoin: (Major) Consider dosing caspofungin as 70 mg IV once daily in adult patients and 70 mg/m2 IV once daily (Max: 70 mg/day) in pediatric patients receiving fosphenytoin. Administering inducers of hepatic cytochrome P450, such as fosphenytoin, concurrently with caspofungin may reduce the plasma concentrations of caspofungin.
    Nevirapine: (Major) Consider dosing caspofungin as 70 mg IV once daily in adult patients and 70 mg/m2 IV once daily (Max: 70 mg/day) in pediatric patients receiving nevirapine. Administering inducers of hepatic cytochrome P450, such as nevirapine, concurrently with caspofungin may reduce the plasma concentrations of caspofungin.
    Phenytoin: (Major) Consider dosing caspofungin as 70 mg IV once daily in adult patients and 70 mg/m2 IV once daily (Max: 70 mg/day) in pediatric patients receiving phenytoin. Administering inducers of hepatic cytochrome P450, such as phenytoin, concurrently with caspofungin may reduce the plasma concentrations of caspofungin.
    Rifamycins: (Major) If rifampin and caspofungin are administered together in adult patients, the manufacturer recommends increasing the dose of caspofungin to 70 mg daily. For pediatric patients, an increase in the daily caspofungin dose to 70 mg/m2 (Max: 70 mg/day) should be considered. Coadministration of caspofungin with CYP450 enzyme inducers, such as the rifamycins, results in reduced caspofungin blood concentrations. Rifampin has been shown to decrease caspofungin trough concentrations by 30%. Theoretically, rifabutin and rifapentine could also decrease caspofungin blood concentrations.
    Saccharomyces boulardii: (Major) Because Saccharomyces boulardii is an active yeast, it would be expected to be inactivated by any antifungals. The manufacturer does not recommend taking in conjunction with any antifungal agents. Patients should avoid use of this probiotic yeast until the patient's fungal or yeast infection is completely treated.
    Sirolimus: (Major) Sirolimus concentrations may be reduced approximately 25% in those patients receiving concurrent caspofungin. The mechanism of this interaction has not been identified but has been reported with tacrolimus; monitor sirolimus blood concentrations and adjust sirolimus dosage as required.
    Tacrolimus: (Major) Tacrolimus concentrations are reduced approximately 25% in those patients receiving concurrent caspofungin. The mechanism of this interaction has not been identified; monitor tacrolimus blood concentrations. Increased dosage of tacrolimus may be required. The pharmacokinetic parameters of caspofungin are not altered by tacrolimus.

    PREGNANCY AND LACTATION

    Pregnancy

    Caspofungin is classified in FDA pregnancy risk category C. There have been no well-controlled studies in pregnant women. Animal data revealed embryotoxic effects of caspofungin including increased fetal resorptions, increased peri-implantation loss, and incomplete ossification at multiple fetal sites including incomplete ossification of the talus/calcaneus, skull, and torso. Embryotoxic effects have been observed at doses in animals that produced exposure similar to those seen in humans treated with a 70 mg dose. Caspofungin crosses the placenta in animal models and is detected in the plasma of animal fetuses. Caspofungin should be used in pregnancy only when the benefits clearly outweigh the risks.

    Data are limited regarding use of caspofungin during breast-feeding and it is not known if it is excreted into human milk. Caution is advised when administering to nursing mothers. Studies to evaluate the effects of exposure on a breast-fed infant have not been conducted; however, based on caspofungin's poor oral absorption, the risks appear to be low. Monitor potentially exposed infants for gastrointestinal adverse events and signs of histamine release. Fluconazole may be a potential alternative to consider during breast-feeding. However, site of infection, local susceptibility patterns, and specific microbial susceptibility should be assessed before choosing an alternative agent. Consider the benefits of breast-feeding, the risk of potential infant drug exposure, and the risk of an untreated or inadequately treated condition. If a breast-feeding infant experiences an adverse effect related to a maternally ingested or administered drug, health care providers are encouraged to report the adverse effect to the FDA.

    MECHANISM OF ACTION

    Caspofungin inhibits the synthesis of a major fungal cell wall component, beta (1,3)-D-glucan. Beta (1,3)-D-glucan is not present in mammalian cells and therefore is an attractive target for antifungal activity. Morphologically, fungi hyphae and yeast shapes are altered. Caspofungin is fungicidal against Candida sp., and has activity against Aspergillus sp. with hyphae undergoing active cell growth. Resistance, resulting in clinical failure, has been reported. In some cases, resistance was linked to specific mutations in the Fks subunit of glucan synthase. Although the in vivo significance has not been established, Candida sp. have also developed reduced susceptibility to caspofungin by increasing the amount of chitin in the fungal cell wall. Because of its unique mechanism of action, cross-resistance with amphotericin B and the azoles is not expected.
     
    The following organisms are generally considered susceptible to caspofungin in vitro: Aspergillus sp. including: Aspergillus flavus, Aspergillus fumigatus, and Aspergillus terreus. Candida sp. including: Candida albicans, Candida glabrata, Candida guilliermondii, Candida krusei, Candida lusitaniae, Candida parapsilosis, and Candida tropicalis. Activity against Trichosporon beigelii, Fusariu sp., and Rhizopus arrhizus is limited. It has no activity against Cryptococcus neoformans, but in vitro has shown synergistic activity against C. neoformans when combined with amphotericin B or fluconazole. In murine models, caspofungin has been shown to have less activity against histoplasmosis than amphotericin B. Standardized susceptibility testing using microbroth dilution methods read at 24 hours are available for Candida sp. The Clinical and Laboratory Standards Institute (CLSI) defines minimum inhibitory concentrations (MICs) for C. albicans, C. krusei, and C. tropicalis as susceptible if 0.25 mcg/mL or less, intermediate if 0.5 mcg/mL, and resistant if 1 mcg/mL or more. For C. glabrata, the MICs for susceptible, intermediate, and resistant are 0.12 mcg/mL or less, 0.25 mcg/mL, and 0.5 mcg/mL or more, respectively. C. parapsilosis has the highest MIC break-points, susceptible if 2 mcg/mL or less, intermediate if 4 mcg/mL, and resistant if 8 mcg/mL or more. Currently, there are no established interpretive breakpoints for Aspergillus sp.

    PHARMACOKINETICS

    Caspofungin is administered by slow intravenous infusion. Distribution, the primary mechanism influencing plasma clearance, follows a three-compartment model. A short alpha-phase is followed by a beta-phase (half-life of 9—11 hours); once daily dosing is adequate. The final phase (half-life of 40—50 hours) results in significant tissue distribution. Animal studies reveal distribution primarily into the liver and kidneys. Caspofungin is 97% bound to serum proteins. Approximately 92% of a 70 mg radiolabeled dose is distributed to tissues within 36—48 hours after the dose. There is little excretion or biotransformation during the first 30 hours post-infusion. The clinical significance of the extensive tissue accumulation is unknown, but may contribute to the activity of the drug against localized tissue infections. Metabolism occurs by hydrolysis and N-acetylation. Hydrolysis results in two tyrosine amino acid by-products that are rapidly cleared by the kidneys. Chemical degradation leads to the formation of the metabolite L-747969 and very low levels of reactive intermediates. The pathway of chemical degradation is uncertain. Caspofungin does not interact substantially with the cytochrome P450 enzyme system, but does undergo significant hepatic metabolism. Single-dose IV administration resulted in excretion of 35% and 41% of the dose in the feces and urine, respectively. Approximately 1.4% of caspofungin is excreted unchanged in the urine. Metabolites are removed primarily via biliary excretion.
     
    Affected cytochrome P450 isoenzymes: none

    Oral Route

    Caspofungin has limited oral bioavailability.

    Intravenous Route

    Plasma concentrations of caspofungin decline in a polyphasic manner following single 1-hour intravenous (IV) infusions. A short alpha-phase occurs immediately postinfusion, followed by a beta-phase (half-life of 9 to 11 hours) that characterizes much of the profile and exhibits clear log-linear behavior from 6 to 48 hours postdose, during which the plasma concentration decreases 10-fold. An additional, longer half-life phase, gamma-phase, (half-life of 40 to 50 hours), also occurs. Distribution, rather than excretion or biotransformation, is the dominant mechanism influencing plasma clearance.