CASPOFUNGIN ZENTIVA

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. 2). 2).

Paediatric population (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, Mosteller1 Formula). 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.

Caution is advised when treating this age group. 2). 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 neutropenia (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 neutropenia and clinical symptoms are resolved. Duration of treatment of invasive candidiasis should be based upon the patient's clinical and microbiological response.

After signs and symptoms of invasive candidiasis have improved and cultures have become negative, a switch to oral antifungal therapy may be considered. In general, antifungal therapy should continue for at least 14 days after the last positive culture.

4). Also reported in patients with invasive aspergillosis were pulmonary oedema, adult respiratory distress syndrome (ARDS), and radiographic infiltrates. Adult patients In clinical studies, 1,865 adult individuals received single or multiple doses of caspofungin: 564 febrile neutropenic patients (empirical therapy study), 382 patients with invasive candidiasis, 228 patients with invasive aspergillosis, 297 patients with localised Candida infections, and 394 individuals enrolled in Phase I studies.

In the empirical therapy study patients had received chemotherapy for malignancy or had undergone haematopoietic stem-cell transplantation (including 39 allogeneic transplantations). g. haematologic or other malignancy, recent major surgery, HIV) requiring multiple concomitant medications.

g. bone marrow or peripheral stem cell transplants, haematologic malignancy, solid tumours or organ transplants) requiring multiple concomitant medications. Phlebitis was a commonly reported local injection-site adverse reaction in all patient populations.

Other local reactions included erythema, pain/tenderness, itching, discharge, and a burning sensation. Reported clinical and laboratory abnormalities among all adults treated with caspofungin (total 1,780) were typically mild and rarely led to discontinuation.

4) Musculoskeletal and connective tissue disorders arthralgia back pain, pain in extremity, bone pain, muscular weakness, myalgia Renal and urinary disorders renal failure, renal failure acute General disorders and administration site conditions pyrexia, chills, infusion-site pruritus pain, catheter site pain, fatigue, feeling cold, feeling hot, infusion site erythema, infusion site induration, infusion site pain, infusion site swelling, injection site phlebitis, oedema peripheral, tenderness, chest discomfort, chest pain, face oedema, feeling of body temperature change, induration, infusion site extravasation, infusion site irritation, infusion site phlebitis, infusion site rash, infusion site urticaria, injection site erythema, injection site oedema, injection site pain, injection site swelling, malaise, oedema Investigations blood potassium decreased, blood albumin decreased blood creatinine increased, red blood cells urine positive, protein total decreased, protein urine present, prothrombin time prolonged, prothrombin time shortened, blood sodium decreased, blood sodium increased, blood calcium decreased, blood calcium increased, blood chloride decreased, blood glucose increased, blood magnesium decreased, blood phosphorus decreased, blood phosphorus increased, blood urea increased, activated partial thromboplastin time prolonged, blood bicarbonate decreased, blood chloride increased, blood potassium increased, blood pressure increased, blood uric acid decreased, blood urine present, breath sounds abnormal, carbon dioxide decreased, immunosuppressant drug level increased, international normalised ratio increased, urinary casts, white blood cells urine positive, and pH urine increased.

Anaphylaxis has been reported during administration of caspofungin. If this occurs, caspofungin should be discontinued and appropriate treatment administered. Possibly histamine-mediated adverse reactions, including rash, facial swelling, angioedema, pruritus, sensation of warmth, or bronchospasm have been reported and may require discontinuation and/or administration of appropriate treatment.

Limited data suggest that less common non-Candida yeasts and non-Aspergillus moulds are not covered by caspofungin. The efficacy of caspofungin against these fungal pathogens has not been established. Concomitant use of caspofungin with cyclosporin has been evaluated in healthy adult volunteers and in adult patients.

Some healthy adult volunteers who received two 3 mg/kg doses of cyclosporin with caspofungin showed transient increases in alanine transaminase (ALT) and aspartate transaminase (AST) of less than or equal to 3-fold the upper limit of normal (ULN) that resolved with discontinuation of the treatment.

5 days), no serious hepatic adverse reactions were noted. These data suggest that caspofungin can be used in patients receiving cyclosporin when the potential benefit outweighs the potential risk. Close monitoring of liver enzymes should be considered if caspofungin and cyclosporin are used concomitantly.

In adult patients with mild and moderate hepatic impairment, the AUC is increased about 20% and 75%, respectively. A reduction of the daily dose to 35 mg is recommended for adults with moderate hepatic impairment. There is no clinical experience in adults with severe hepatic impairment or in paediatric patients with any degree of hepatic impairment.

2). Laboratory abnormalities in liver function tests have been seen in healthy volunteers and adult and paediatric patients treated with caspofungin. In some adult and paediatric patients with serious underlying conditions who were receiving multiple concomitant medications with caspofungin, cases of clinically significant hepatic dysfunction, hepatitis and hepatic failure have been reported; a causal relationship to caspofungin has not been established.

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