Cancidas Side Effects

Hypersensitivity reactions have been reported (see Precautions).
Adult Patients: In clinical studies, 1865 adult individuals received single or multiple doses of CANCIDAS: 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. In the studies involving patients with documented Candida infections, the majority of the patients had serious underlying medical conditions (e.g., hematologic or other malignancy, recent major surgery, HIV) requiring multiple concomitant medications. Patients in the noncomparative Aspergillus study often had serious predisposing medical conditions (e.g., bone marrow or peripheral stem cell transplants, hematologic malignancy, solid tumors 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 drug-related clinical and laboratory abnormalities among all adults treated with CANCIDAS (total 1780) were typically mild and rarely led to discontinuation.
The following adverse reactions were reported: [Very common (≥1/10), Common (≥1/100, <1/10), Uncommon (>1/1,000, <1/100)].
Blood and lymphatic system disorders: Common: haemoglobin decreased, haematocrit decreased, white blood cell count decreased.
Uncommon: anaemia, thrombocytopaenia, coagulopathy, leukopaenia, eosinophil count increased, platelet count decreased, platelet count increased, lymphocyte count decreased, white blood cell count increased, neutrophil count decreased.
Metabolism and nutrition disorders: Common: hypokalemia.
Uncommon: fluid overload, hypomagnesaemia, anorexia, electrolyte imbalance, hyperglycaemia, hypocalcaemia, metabolic acidosis.
Psychiatric disorders: Uncommon: anxiety, disorientation, insomnia.
Nervous system disorders: Common: headache.
Uncommon: dizziness, dysgeusia, paraesthesia, somnolence, tremor, hypoaesthesia.
Eye disorders: Uncommon: ocular icterus, vision blurred, eyelid oedema, lacrimation increased.
Cardiac disorders: Uncommon: palpitations, tachycardia, arrhythmia, atrial fibrillation, cardiac failure congestive.
Vascular disorders: Common: phlebitis.
Uncommon: thrombophlebitis, flushing, hot flush, hypertension, hypotension.
Respiratory, thoracic and mediastinal disorders: Common: dyspnoea.
Uncommon: nasal congestion, pharyngolaryngeal pain, tachypnoea, bronchospasm, cough, dyspnoea paroxysmal nocturnal, hypoxia, rales, wheezing.
Gastrointestinal disorders: Common: nausea, diarrhoea, vomiting.
Uncommon: abdominal pain, abdominal pain upper, dry mouth, dyspepsia, stomach discomfort, abdominal distension, ascites, constipation, dysphagia, flatulence.
Hepatobiliary disorders: Common: elevated liver values (alanine aminotransferase, aspartate aminotransferase, blood alkaline phosphatase, bilirubin conjugated, blood bilirubin).
Uncommon: cholestasis, hepatomegaly, hyperbilirubinaemia, jaundice, hepatic function abnormal, hepatotoxicity, liver disorder.
Skin and subcutaneous tissue disorders: Common: rash, pruritus, erythema, hyperhidrosis.
Uncommon: erythema multiforme, rash macular, rash maculo-papular, rash pruritic, urticaria, dermatitis allergic, pruritus generalised, rash erythematous, rash generalised, rash morbilliform, skin lesion.
Musculoskeletal and connective tissue disorders: Common: arthralgia.
Uncommon: back pain, pain in extremity, bone pain, muscular weakness, myalgia.
Renal and urinary disorders: Uncommon: renal failure, renal failure acute.
General disorders and administration site conditions: Common: pyrexia, chills, infusion-site pruritus.
Uncommon: 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: Common: blood potassium decreased, blood albumin decreased.
Uncommon: 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, gamma-glutamyltransferase 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.
Also reported in patients with invasive aspergillosis were pulmonary oedema, adult respiratory distress syndrome (ARDS), and radiographic infiltrates.
Pediatric Patients: In clinical studies, 171 pediatric patients received single or multiple doses of CANCIDAS: 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 CANCIDAS in pediatric patients is comparable to that in adult patients.
The following adverse reactions were reported: [Very common (≥1/10), Common (≥1/100, <1/10)].
Blood and lymphatic system disorders: Common: eosinophil count increased.
Nervous system disorders: Common: headache.
Cardiac disorders: Common: tachycardia.
Vascular disorders: Common: flushing, hypotension.
Hepatobiliary disorders: Common: elevated liver enzyme levels (AST, ALT).
Skin and subcutaneous tissue disorders: Common: rash, pruritus.
General disorders and administration site conditions: Very common: fever.
Common: chills, catheter site pain.
Investigations: Common: decreased potassium, hypomagnesemia, increased glucose, decreased phosphorus, and increased phosphorus.
Post-marketing experience: The following additional adverse reactions have been identified during the post-approval use of caspofungin. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Gastrointestinal disorders: pancreatitis.
Hepatobiliary: rare cases of hepatic dysfunction.
Skin and subcutaneous tissue disorders: erythema multiforme, toxic epidermal necrolysis, Stevens-Johnson syndrome, skin exfoliation.
Renal and urinary disorders: clinically significant renal dysfunction.
Laboratory abnormalities: hypercalcemia, gamma-glutamyltransferase increased.
General disorders and administration site condition: swelling and peripheral edema.