Caspofungin

Caspofungin is an echinocandin antifungal drug [see Microbiology ( 12.4 )].

• Caspofungin acetate for injection 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.

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

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 caspofungin acetate for injection 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 Inducers of Hepatic CYP Enzymes ( 2.5 ): Use 70 mg once daily dose for adult patients on rifampin. Consider dose increase to 70 mg once daily for adult patients on nevirapine, efavirenz, carbamazepine, dexamethasone, or phenytoin. Pediatric patients receiving these same concomitant medications may also require an increase in dose to 70 mg/m 2 once daily (maximum daily dose not to exceed 70 mg).

Hypersensitivity : Anaphylaxis, possible histamine-mediated adverse reactions, including rash, facial swelling, angioedema, pruritus, sensation of warmth or bronchospasm, and cases of Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) have been reported with use of caspofungin. Discontinue caspofungin at the first sign or symptom of a hypersensitivity reaction and administer appropriate treatment. ( 5.1 ) Hepatic Effects : Can cause abnormalities in liver enzymes. Isolated cases of hepatic dysfunction, hepatitis, or hepatic failure have been reported. Monitor patients who develop abnormal liver enzymes for evidence of worsening hepatic function, and evaluate risk/benefit of continuing caspofungin. ( 5.2 ) Elevated Liver Enzymes During Concomitant Use with Cyclosporine : Limit use to patients for whom potential benefit outweighs potential risk. Monitor patients who develop abnormal liver function tests (LFTs) during concomitant use with caspofungin. ( 5.3 ) 5.1 Hypersensitivity Anaphylaxis and other hypersensitivity reactions have been reported during administration of caspofungin. Possible histamine-mediated adverse reactions, including rash, facial swelling, angioedema, pruritus, sensation of warmth or bronchospasm have been reported. Cases of Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), some with a fatal outcome, have been reported with use of caspofungin [see Adverse Reactions ( 6.2 )] . Discontinue caspofungin at the first sign or symptom of a hypersensitivity reaction and administer appropriate treatment.

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 Sagent Pharmaceuticals at 1-866-625-1618 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 caspofungin cannot be directly compared to rates in clinical trials of another drug and may not reflect the rates observed in practice.

Pregnancy: Based on animal data, may cause fetal harm. ( 8.1 ) Pediatric Use: Safety and efficacy in neonates and infants less than 3 months old have not been established. ( 8.4 ) Hepatic Impairment: Reduce dose for adult patients with moderate hepatic impairment (35 mg once daily, with a 70 mg loading dose on Day 1 where appropriate). No data are available in adults with severe impairment or in pediatric patients with any degree of hepatic impairment. ( 2.4 , 8.6 , 12.3 ) 8.1 Pregnancy Risk Summary Based on animal data, caspofungin may cause fetal harm (see Data ) . There are insufficient human data to establish whether there is a drug-associated risk for major birth defects, miscarriage, or adverse maternal or fetal outcomes with caspofungin use in pregnant women. In animal studies, caspofungin caused embryofetal toxicity, including increased resorptions, increased peri-implantation loss, and incomplete ossification at multiple fetal sites when administered intravenously to pregnant rats and rabbits during organogenesis at doses up to 0.8 and 2 times the clinical dose, respectively ( see Data ). Advise patients of the potential risk to the fetus. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S.

Metabolism

Adult and pediatric pharmacokinetic parameters are presented in Table 8 . Distribution Plasma concentrations of caspofungin decline in a polyphasic manner following single 1-hour IV infusions.

In 6 healthy subjects who received a single 210 mg dose, no significant adverse reactions were reported. Multiple doses above 150 mg daily have not been studied. Caspofungin is not dialyzable. In clinical trials, one pediatric patient (16 years of age) unintentionally received a single dose of caspofungin of 113 mg (on Day 1), followed by 80 mg daily for an additional 7 days. No clinically significant adverse reactions were reported.

• Jan 26, 2001NDANDA021227Merck
• Dec 30, 2016NDANDA206110Fresenius Kabi Usa
• Sep 29, 2017ANDAANDA207092Gland
• Jun 28, 2018ANDAANDA200833Hengrui Pharma
• Jul 18, 2025ANDAANDA216506Hangzhou Zhongmei

1. 1Drug Ineffective65714%
2. 2Off Label Use2385.1%
3. 3Death2234.8%
4. 4Product Use In Unapproved Indication2074.5%
5. 5Pneumonia2024.3%
6. 6Pyrexia1964.2%
7. 7Sepsis1924.1%
8. 8Septic Shock1854.0%
9. 9Febrile Neutropenia1663.6%
10. 10Multiple Organ Dysfunction Syndrome1393.0%
11. 11Respiratory Failure1322.8%
12. 12Drug Interaction1222.6%
13. 13Renal Failure1192.6%
14. 14Fungal Infection1182.5%
15. 15Thrombocytopenia1162.5%

Recent PubMed references pinned to Caspofungin as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

• Synergistic activity of caspofungin and posaconazole against Candida (Candidozyma) auris biofilms based on phenotypic, transcriptomic, and in vivo insights.
  Microbiology spectrum · 2026 · Kovács F, Harmath A, Balázsi D, et al.
  PMID 41817193DOI 10.1128/spectrum.02686-25
• Candidozyma auris: Identification, antifungal susceptibility, and caspofungin-induced paradoxical growth.
  Indian journal of medical microbiology · 2026 · Özmerdiven GE, İrvem A
  PMID 41577033DOI 10.1016/j.ijmmb.2026.101065
• In vitro Susceptibilities to caspofungin of Candida spp. isolated from the Polyvalent Intensive Care Unit of Fattouma Bourguiba University Hospital: First report of resistant mutants in Tunisia.
  Journal de mycologie medicale · 2026 · Belgacem S, Chebil W, Ferjani I, et al.
  PMID 41558214DOI 10.1016/j.mycmed.2026.101601
• Butyrolactol A enhances caspofungin efficacy via flippase inhibition in drug-resistant fungi.
  Cell · 2026 · Chen X, Duan HD, Hoy MJ, et al.
  PMID 41478284DOI 10.1016/j.cell.2025.11.036
• Population pharmacokinetics of caspofungin in critically ill Chinese children: a prospective observational study.
  Antimicrobial agents and chemotherapy · 2026 · Xu N, Shi Y, Ju G, et al.
  PMID 41468548DOI 10.1128/aac.01277-25
• Caspofungin-loaded dissolving microneedles for transcorneal delivery in fungal keratitis.
  Experimental eye research · 2026 · Aghaei B, Jafari M, Abolmaali SS, et al.
  PMID 41420888DOI 10.1016/j.exer.2025.110812
• Microfluidic live-cell imaging of Aspergillus fumigatus and Candida albicans hyphal growth treated with AmBisome and Caspofungin.
  Journal of microscopy · 2026 · Thomson DD, Inman R, Nye S, et al.
  PMID 41410147DOI 10.1111/jmi.70053
• Comparative efficacy and safety of topical caspofungin 0.5% and voriconazole 1% for fungal keratitis: a pilot clinical trial.
  Scientific reports · 2025 · Atighehchian M, Latifi G, Bardan AS, et al.
  PMID 41198723DOI 10.1038/s41598-025-22615-w

The 10 most recently updated of 89 ClinicalTrials.gov registrations naming Caspofungin as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• A Phase 3 Efficacy and Safety Study of Fosmanogepix for the Treatment of Adult Participants With Candidemia and/or Invasive Candidiasis.
  Recruiting · Phase 3 · Interventional · 450 enrolled · Basilea Pharmaceutica
  NCT05421858updated 2026-05-20
• Study of Rezafungin Compared to Standard Antimicrobial Regimen for Prevention of Invasive Fungal Diseases in Adults Undergoing Allogeneic Blood and Marrow Transplantation
  Completed · Phase 3 · Interventional · 602 enrolled · Mundipharma Research Limited
  NCT04368559updated 2026-04-13
• Pharmacokinetics of Caspofungin in Burn Patients
  Completed · Phase 2 · Phase 3 · Interventional · 2 enrolled · Assistance Publique - Hôpitaux de Paris
  NCT00748345updated 2026-03-04
• PK/PD of Caspofungin in Children Severe Infection
  Recruiting · Observational · 60 enrolled · Children's Hospital of Fudan University
  NCT04961593updated 2026-02-17
• A Phase 3, Randomized, Double-blind Study for Patients With Invasive Candidiasis Treated With IV Echinocandin Followed by Either Oral Ibrexafungerp or Oral Fluconazole
  Terminated · Phase 3 · Interventional · 68 enrolled · Scynexis, Inc.
  NCT05178862updated 2025-12-19
• Pharmacokinetic Study on Echinocandins for Patients With Septic Shock Following Secondary Peritonitis (EPI Study)
  Completed · Phase 4 · Interventional · 24 enrolled · Centre Hospitalier Universitaire de Nīmes
  NCT02805049updated 2025-12-10
• Voriconazole and Caspofungin Acetate in Treating Invasive Fungal Infections in Patients With Weakened Immune Systems
  Terminated · Phase 2 · Interventional · 13 enrolled · OHSU Knight Cancer Institute
  NCT00238355updated 2025-04-27
• A Study Comparing Short-course Antifungal Therapy (SCAT) 7 Day vs Standard 14 Day Antifungal Therapy for Uncomplicated Candidemia
  Not yet recruiting · Observational · 150 enrolled · Augusta University
  NCT06907992updated 2025-04-04
• CaspoNEB: Efficacy and Safety of Caspofungin Aerosols for the Curative Treatment of Pneumocystis Pneumonia
  Not yet recruiting · Phase 1 · Phase 2 · Interventional · 100 enrolled · University Hospital, Tours
  NCT06892951updated 2025-03-25
• Isavuconazole (BAL8557) in the Treatment of Candidemia and Other Invasive Candida Infections
  Completed · Phase 3 · Interventional · 450 enrolled · Astellas Pharma Inc
  NCT00413218updated 2024-12-10

Frequently asked questions

How does Caspofungin work?

Caspofungin is an echinocandin antifungal drug [see Microbiology ( 12.4 )].

What is Caspofungin used for?

According to FDA labeling, Caspofungin carries indications including: Caspofungin acetate for injection 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.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Caspofungin?

Caspofungin is classified as Other antimycotics for systemic use, Echinocandin Antifungal, Glucan Synthase Inhibitors, Decreased Cell Wall Integrity.

What are the brand names for Caspofungin?

Caspofungin is marketed under brand names including Cancidas.

What are the contraindications for Caspofungin?

Caspofungin labeling lists contraindications including: Caspofungin is contraindicated in patients with known hypersensitivity (e.g., anaphylaxis) to any component of this product [see Adverse Reactions ( 6 )]. Caspofungin is contraindicated in patients with known hypersensitivity to any component of this product.. Always consult the full prescribing information and a clinician.