Abstract
Therapeutic drug monitoring is used to prevent or decrease the risk associated with the toxic effects of medication. This study aims to evaluate the potential advantages of Therapeutic Drug Monitoring (TDM) of subcutaneous Deferoxamine injection and prevention of clinical problems in β-thalassaemia major patients. Patients & Methods: Fifty-four thalassemia patients were allocated into two groups; missing, and not missing deferoxamine dose. TDM of Deferoxamine injection and it clinical outcomes was critically studied under the following subheadings: assessment of the adequacy of Deferoxamine usage, serum peak and trough concentrations of Deferoxamine and ferroxamine with needed pharmacokinetics, cardiac parameters and biomarkers, biochemical and hematological indices, adverse effects/toxicity, urinary assessment of Fe, Zn, selenium, and copper levels, compliance to treatment, dose adjustment in correlation to therapeutic index and life style. Results: Demographic data showed no significant difference. Peak plasma concentrations were 144.83±69 and 43.54±39.16 μg/L, while trough concentrations were 33±26.32 and 31.13±21.58 μg/L of Deferoxamine and ferroxamine, respectively. The elimination rate constant was 0.0237±0.00029 min-1, half-life was 34 min, and distribution volume was 0.93±0.078. Although cardiac parameters showed no significant differences, there were significant differences in CK-MB, and hsCRP levels; troponin I value could not be detected. Biochemical and hematological studies showed significant differences in Ferritin B, urea, SGPT, SGOT, alkaline phosphatase, serum albumin and serum calcium. Assessment of adverse effects/toxicity showed significant differences. The correlation of serum ferritin to therapeutic index, and the life style including Vitamin C and/or E administration were assessed for the compliance to treatment. Conclusion: Therapeutic monitoring of chelation therapy by Deferoxamine in β-thalassemia patients is necessary to ensure effective treatment, compliance, and to avoid adverse side effects and toxicity.
Highlights
Therapeutic drug monitoring involves measuring drug concentrations, and the clinical interpretation of the result
This study aims to evaluate the potential advantages of Therapeutic Drug Monitoring (TDM) of subcutaneous Deferoxamine injection and prevention of clinical problems in β-thalassaemia major patients
TDM of Deferoxamine injection and its clinical outcomes were critically studied under the following subheadings: assessment of the adequacy of Deferoxamine usage, serum peak and trough concentrations of Deferoxamine and ferroxamine with needed pharmacokinetics, cardiac parameters and biomarkers, biochemical and hematological indices, adverse effects/ toxicity, urinary assessment of Fe, Zn, selenium, and copper levels, compliance to treatment, dose adjustment in correlation to therapeutic index and life style
Summary
Therapeutic drug monitoring involves measuring drug concentrations, and the clinical interpretation of the result. This requires knowledge of the pharmacokinetics, sampling time, drug history and the patient’s clinical condition [1]. Thalassemia major patients come to medical attention within the first 2 years and require regular blood transfusion to survive. Iron overload occurs when the intake of iron is increased over a prolonged period of time and is commonly seen in patients with beta-thalassaemia major, who receive frequent blood transfusions. The iron excess is initially stored in thereticuloendothelial system (which has a capacity of about 10 - 15 g), and in all parenchymas [3], resulting in life-threatening complications, namely cardiopathy, liver and endocrine dysfunction and reduced patient’s survival. Without adequate iron chelation therapy, almost all patients with beta-thalassemia will accumulate potentially fatal iron levels [4]
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