Caspofungin Acetate for Injection 50mg

• Dossier: Ctd, Actd
• GMP: Chinese GMP
• Packing: Accoring to Client Requiremen
• Payment: Tt
• Transport Package: Free
• Specification: 50mg
• Model NO.: Powder Injection
• Trademark: Sinolead
• Origin: China

Product Description

Basic Info.

 

Generic Name	Caspofungin Acetate for Injection
Strength	50mg
Packing	1vial/box
Origin	China

Component:
Caspofungin Acetate

Character:

This product is white or white freeze-dried lump.

Indications:

This product is suitable for adult patients and children patients (3 months and above) :

Empire-based treatment of suspected fungal infection in patients with neutropenia and fever

Treatment of invasive aspergillosis that does not respond to or is not tolerated by other treatments.

 

Usage and dosage:

General recommendations for adult patients

For the treatment of adult patients (18 years of age and older), the infusion solution must be slowly infused intravenously over a period of approximately 1 hour.

Empirical treatment

A single load dose of 70mg on the first day, followed by a single daily dose of 50mg. The course of treatment depends on the patient's clinical response. Empirical treatment should be continued until the patient's neutrophils return to normal. Patients with confirmed fungal infection need a course of treatment of at least 14 days; Treatment should continue for at least 7 days after neutrophils return to normal and clinical symptoms resolve. If the 50mg dose is well tolerated but lacks an effective clinical response, the daily dose may be increased to 70mg. Although there is no evidence that a daily dose of 70mg improves efficacy, the limited safety data available suggest that increasing the daily dose to 70mg is well tolerated.

Invasive aspergillosis

A single load dose of 70mg of carpofungin acetate for injection was given on the first day, followed by a daily dose of 50mg. The course of treatment depends on the severity of the patient's disease, the recovery of suppressed immune function, and the clinical response to treatment. Although there is no evidence that higher doses improve efficacy, available safety data suggest that consideration should be given to increasing the daily dose to 70mg in patients who are not clinically responsive to treatment and are well tolerated.

Dose adjustment is not required for elderly patients (65 years or older). (See Medication for Elderly patients)

There is no need to adjust the dose based on gender, race, or kidney damage.

Adult patients: A daily dose of 70mg should be considered when this product is used in conjunction with metabolically inducing drugs such as efavirenz, nevirapine, rifampicin, dexamethasone, phenytoin, or carbamazepine.

Patients with liver dysfunction

Dose adjustment is not required in adult patients with mild liver dysfunction (Child-Pugh score 5 to 6). However, in adult patients with moderate hepatic dysfunction (Child-Pugh score 7 to 9), it is recommended to adjust the daily dose to 35mg based on pharmacokinetic data after the initial 70mg loading dose. There is currently no clinical experience in treating adult patients with severe liver insufficiency (Child-Pugh score greater than 9) and children with any degree of liver insufficiency.

Matters needing attention:

In clinical studies, 1,865 adults have received single or multiple doses of carpofungin acetate for injection: 564 patients with febrile neutropenia (empirical treatment study), 382 patients with invasive candidiasis, 297 patients with esophageal candidiasis and/or oropharyngeal candidiasis, 228 patients with invasive aspergillosis, and 394 participants in Phase I clinical trials. In the empirical study, all patients had received chemotherapy for malignant tumors or had undergone hematopoietic stem cell transplantation. In studies of patients with a definite diagnosis of candida infection, most patients had very severe disease (e.g. hematological malignancies or other tumors, recent major surgery, AIDS) that required multiple treatments at the same time. In uncontrolled studies of aspergillosis, patients with severe disease and complex pre-existing disease (such as bone marrow or peripheral blood stem cell transplantation, hematologic malignancies, solid tumors, or organ transplantation) require multiple treatments at the same time.