CASPOVITAE POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION 70MG/VIAL [SIN15976P]

Product Info

CASPOVITAE POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION 70MG/VIAL

[SIN15976P]

4.1 Therapeutic indications

• Treatment of cadidemia and the following Candida infections: intra-abdominal abcesses, peritornitis and pleural space infections in adult or paediatric patients. Caspofungin has not been studied in endocarditis, osteomyelitis, and meningitis due to Candida.

• Treatment of invasive aspergillosis in adult or paediatric patients who are refractory to or intolerant of amphotericin B, lipid formulations of amphotericin B and/or itraconazole. Refractoriness is defined as progression of infection or failure to improve after a minimum of 7 days of prior therapeutic doses of effective antifungal therapy.

• Empirical therapy for presumed fungal infections (such as Candida or Aspergillus) in febrile, neutropaenic adult or paediatric patients, whose fever has failed to respond to broadspectrum antibiotics.

4.2 Posology and method of administration
Caspofungin should be initiated by a physician experienced in the management of invasive fungal infections.

Posology
Adult patients
A single 70 mg loading dose should be administered on Day-1, followed by 50 mg daily thereafter. No dosage adjustment is necessary based on gender or race (see section 5.2 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Paediatric patients (12 months to 17 years)
In paediatric patients (12 months to 17 years of age), dosing should be based on the patient’s body surface area (see Instructions for Use in Paediatric Patients, Mosteller Formula – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). For all indications, a single 70-mg/m² loading dose (not to exceed an actual dose of 70 mg) should be administered on Day 1, followed by 50 mg/m² daily thereafter (not to exceed an actual dose of 70 mg daily). If the 50-mg/m² daily dose is well tolerated but does not provide an adequate clinical response, the daily dose can be increased to 70 mg/m² daily (not to exceed an actual daily dose of 70 mg).

The safety and efficacy of caspofungin have not been sufficiently studied in clinical trials involving neonates and infants below 12 months of age.

Duration of treatment
Duration of empirical therapy should be based on the patient’s clinical response. Therapy should be continued until up to 72 hours after resolution of neutropaenia (ANC≥500). Patients found to have a fungal infection should be treated for a minimum of 14 days and treatment should continue for at least 7 days after both neutropaenia and clinical symptoms are resolved. If the 50 mg dose is well tolerated but does not provide an adequate clinical response, the daily dose can be increased to 70 mg. Although an increase in efficacy with 70 mg daily has not been demonstrated, safety data suggest that an increase in dose to 70 mg daily is well tolerated.

Duration of treatment of candinemia and other candidiasis should be based upon the patient’s clinical and microbiological response. In general, antifungal therapy should continue for at least 14 days after the last positive culture. Patients who remain persistently neutropenic may warrant a longer course of therapy pending resolution of the neutropenia.

Duration of treatment of invasive aspergillosis is determined on a case by case basis and should be based upon the severity of the patient’s underlying disease, recovery from immunosuppression, and clinical response. The efficacy of a 70-mg dose regimen in patients who are not clinically responding to the 50-mg daily dose is not known. Safety data suggest that an increase in dose to70 mg daily is well tolerated. The efficacy of doses above 70 mg has not been adequately studied in patients with invasive aspergillosis.

The safety information on treatment durations longer than 4 weeks is limited. However, available data suggest that caspofungin continues to be well tolerated with longer courses of therapy (up to 162 days in adult patients and up to 87 days in paediatric patients).

Special populations
Elderly population
In elderly patients (65 years of age or more), the area under the curve (AUC) is increased by approximately 30 %. However, no systematic dosage adjustment is required. There is limited treatment experience in patients 65 years of age and older (see section 5.2 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Renal impairment
No dosage adjustment is necessary based on renal impairment (see section 5.2 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Hepatic impairment
For adult patients with mild hepatic impairment (Child-Pugh score 5 to 6), no dosage adjustment is needed. For adult patients with moderate hepatic impairment (Child-Pugh score 7 to 9), caspofungin 35 mg daily is recommended based upon pharmacokinetic data. An initial 70 mg loading dose should be administered on Day-1. There is no clinical experience in adult patients with severe hepatic impairment (Child-Pugh score greater than 9) and in paediatric patients with any degree of hepatic impairment (see section 4.4 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Co-administration with inducers of metabolic enzymes
Limited data suggest that an increase in the daily dose of caspofungin to 70 mg, following the 70 mg loading dose, should be considered when co-administering caspofungin in adult patients with certain inducers of metabolic enzymes (see section 4.5 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). When caspofungin is coadministered to paediatric patients (12 months to 17 years of age) with these same inducers of metabolic enzymes (see section 4.5 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information), a caspofungin dose of 70-mg/m² daily (not to exceed an actual daily dose of 70 mg) should be considered.

Method of administration
After reconstitution and dilution, the solution should be administered by slow intravenous infusion over approximately 1 hour. Reconstituted solution is clear, and should be visually inspected for particulate matter or discolouration.

For reconstitution directions see section 6.6 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.

Both 70 mg and 50 mg vials are available.
Caspofungin should be given as a single daily infusion.

4.3 Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.