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CASPOFUNGIN FOR is a brand name for Caspofungin, supplied as a powder for solution. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: AND CLINICAL USE ............................................................................... 3 CONTRAINDICATIONS ..................................................................................................... 4 WARNINGS AND PRECAUTIONS…
Verbatim from this product's HC label. Tap a section to expand.
Hypersensitivity reactions have been reported (see WARNINGS AND PRECAUTIONS). Adverse Drug Reaction Overview Adverse Drug Reaction Overview from Clinical Trials in Adult Patients In clinical studies, 1865 adult individuals received single or multiple doses of caspofungin acetate 564 febrile, neutropenic patients (empirical therapy study), 382 patients with invasive candidiasis, 297 patients with esophageal and/or oropharyngeal candidiasis, 228 patients with invasive aspergillosis, and 394 individuals in phase I studies.
In the empirical therapy study patients had received chemotherapy for malignancy or had undergone hematopoietic stem-cell transplantation. , hematologic or other malignancy, recent major surgery, HIV [with CD4 counts less than 50/mm3]) requiring multiple concomitant medications.
, bone marrow or peripheral stem cell transplants, hematologic malignancy, solid tumors or organ transplants) requiring multiple concomitant medications. Reported drug-related clinical and laboratory abnormalities among all adults treated with caspofungin acetate (total 1780) were typically mild and rarely led to discontinuation.
Common General Fever, headache, chills, abdominal pain, pain (> 1/100) GI Nausea, diarrhea, vomiting Liver Elevated liver enzyme levels (AST, ALT, alkaline phosphatase, direct and total bilirubin) Kidney Increased serum creatinine Blood Anemia (decreased hemoglobin and hematocrit) Cardiac Tachycardia Metabolism Hypokalaemia (blood potassium decreased) Peripheral Vascular Phlebitis/thrombophlebitis, infusion-site pruritus, infused- vein complication, flushing.
Bone Arthralgia Respiratory Dyspnea Skin Rash, pruritus, sweating, erythema Adverse Drug Reaction Overview from Clinical Trials in Pediatric Patients In clinical studies, 171 pediatric patients received single or multiple doses of caspofungin acetate 104 febrile, neutropenic patients; 56 patients with invasive candidiasis; 1 patient with esophageal candidiasis; and 10 patients with invasive aspergillosis.
The overall clinical safety profile of caspofungin acetate in pediatric patients is comparable to that in adult patients. Reported drug-related clinical and laboratory abnormalities among all pediatric patients treated with caspofungin acetate (total 171) were typically mild and rarely led to discontinuation.
Caspofungin for Injection Page 8 of 50 Common General Fever, headache, chills (> 1/100) Liver Elevated liver enzyme levels (AST, ALT) Cardiac Tachycardia Peripheral Vascular Catheter site pain, flushing, hypotension Skin Rash, pruritus Clinical Trial Adverse Drug Reactions Because clinical trials are conducted under very specific conditions the adverse reaction rates observed in the clinical trials may not reflect the rates observed in practice and should not be compared to the rates in the clinical trials of another drug.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Adverse drug reaction information from clinical trials is useful for identifying drug-related adverse events and for approximating rates. 0 mg/kg/day). Drug-related clinical adverse experiences occurring in 2% of the patients in either treatment group are presented in Table 1.
3 (29) * Determined by the investigator to be possibly, probably, or definitely drug-related. ** 70 mg on Day 1, then 50 mg daily for the remainder of treatment; daily dose was increased to 70 mg for 73 patients. 0 mg/kg for 74 patients.
0%). Only rash, perspiration, and diarrhea were numerically higher in the caspofungin acetate group with the remaining adverse experiences being numerically higher in the AmBisome§ group. Numerically higher frequencies of clinical adverse experiences were observed in the caspofungin acetate group compared with the AmBisome§ group for serious rash (4 vs 0), discontinuations due to drug-related adverse experiences in the skin/skin appendages (10 vs 3), discontinuations due to drug-related hepatobiliary adverse events (4 vs 0).
Also reported was an isolated, serious adverse experience of hyperbilirubinemia considered possibly related to caspofungin acetate. 1%) than in the group treated […]