Related Experiment Video
Updated: Mar 31, 2026
08:38
Quantification of the Immunosuppressant Tacrolimus on Dried Blood Spots Using LC-MS/MS
Published on: November 8, 2015
17.6K
Transition from brand to generic tacrolimus is associated with a decrease in trough blood concentration in pediatric
Son Q Duong1, Ashwin K Lal2, Rujuta Joshi3
1Pediatric Cardiology, Children's Hospital of Pittsburgh of UPMC, Pittsburgh, PA, USA.
Pediatric Transplantation
|October 27, 2015
Summary
Switching from brand-name to generic tacrolimus in pediatric transplant patients may lower drug levels, potentially impacting outcomes. Close monitoring during transitions is recommended to ensure patient safety and treatment efficacy.
Area of Science:
- Pharmacology
- Transplantation Medicine
- Pediatric Care
Background:
- Limited data exists on the bioequivalence of generic versus brand-name tacrolimus in pediatric heart transplant recipients.
- Tacrolimus is a critical immunosuppressant medication in organ transplantation.
Purpose of the Study:
- To assess changes in tacrolimus trough concentrations and clinical outcomes after switching from brand-name to generic formulations in pediatric thoracic organ transplant recipients.
- To compare outcomes between patients who switched formulations and a matched control group.
Main Methods:
- Retrospective study identifying pediatric patients with confirmed switch dates between brand and generic tacrolimus.
- Matched control group of patients who did not switch formulations.
- Analysis of 12-hour trough concentrations, dosage, renal and liver function, and rejection events pre- and post-switch.
Main Results:
- In patients who switched and maintained the same dose, tacrolimus trough concentrations were 14% lower on the generic formulation (p=0.037).
- The average change in trough concentration was -1.15 ± 1.76 ng/mL (p=0.045).
- No significant differences were observed in dosage adjustments, kidney, or liver function between groups; however, a trend towards more rejection events was noted in the switched group (24% vs 18%).
Conclusions:
- Transitioning from brand-name to generic tacrolimus in pediatric transplant patients may lead to decreased drug exposure.
- A proactive monitoring strategy around formulation transition is advised.
- Patient and family education on reporting formulation changes is crucial for managing immunosuppression.
More Related Videos
Related Concept Videos
01:22Pharmaceutical Alternatives: Stability-Related Therapeutic Nonequivalence
243
Generic intravenous (IV) drugs are considered bioequivalent to their branded counterparts due to their 100% bioavailability upon administration. However, variations in stability among different drug products can significantly influence their therapeutic performance, even if they are pharmaceutically equivalent.Cefuroxime, a prophylactic antimicrobial, is often used as a single-dose IV injection for patients undergoing coronary artery bypass grafting surgery. A 3 g dose typically provides...
243
01:26Pharmacokinetics in Pediatric Patients: Drug Excretion
374
In pediatric medicine, understanding the renal function and drug elimination nuances is crucial for administering safe and effective treatments. Newborns, in particular, display markedly slower renal functions than adults, profoundly affecting how drugs are cleared from their bodies. This slower drug clearance requires clinicians to extend the dosing intervals for many medications to prevent drug accumulation and toxicity while ensuring therapeutic efficacy.One key area where these adjustments...
374
01:23Pharmacokinetics in Pediatric Patients: Overview and Drug Absorption
732
Understanding the physiological differences in the pediatric population is crucial for effective pharmacotherapy. Neonates, infants, and children exhibit significant variations in gastric pH, gastric emptying time, intestinal transit time, and biliary function. These variations profoundly affect oral drug absorption, necessitating a nuanced approach to pediatric dosing.Neonates present with a unique physiological profile, having a gastric pH greater than 4 and faster and more irregular gastric...
732
01:28Kidney Transplant I: Introduction
702
A kidney transplant is a surgical approach that involves replacing a non-functioning kidney with a healthy one from a donor. This procedure is often a treatment option for end-stage renal disease (ESRD) patients. The method requires careful recipient selection, including evaluating various medical and psychosocial factors. These criteria vary between transplant centers but generally include assessments of the patient's overall health, adherence to medical recommendations, and lifestyle...
702
01:24Pharmacokinetics in Pediatric Patients: Drug Metabolism
332
In pediatric care, understanding the nuances of hepatic drug metabolism is crucial, as it significantly differs from that of adults. This divergence is primarily due to the developmental stage of drug-metabolizing enzymes, which affects how medications are processed in the body. In neonates, for instance, the activity of Phase I enzymes—critical for the initial breakdown of drugs—is markedly reduced, functioning at just 20–40% of the levels seen in adults. This reduction poses...
332
01:17Pharmacokinetics in Pediatric Patients: Drug Distribution
464
Drug distribution in the pediatric population exhibits unique challenges and considerations due to the physiological differences between children, particularly neonates and infants, and adults. A crucial aspect of pediatric pharmacology is understanding how these differences impact the pharmacokinetics of various drugs, necessitating age-specific dosing strategies to ensure efficacy and safety.Neonates and infants have a higher total body water content, ~75%–90% of their body weight,...
464