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Related Concept Videos

Dosage Regimens: Partial Pharmacokinetic Parameters01:01

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It is not uncommon for complete drug pharmacokinetic profiles to remain elusive in pharmacokinetics. This necessitates certain educated assumptions by pharmacokineticists to determine appropriate dosage regimens without comprehensive pharmacokinetic data from animal or human studies. One prevalent assumption is setting the bioavailability factor, denoted as F, to 1 or 100%. This assumption caters to the scenario where a drug doesn't achieve full systemic absorption, resulting in the patient...
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Drug Dosing in Renal Diseases: Dose Adjustments Based on Drug Clearance and Elimination Rate Constant01:25

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In patients with renal disease, dosage adjustments are necessary to maintain therapeutic plasma drug concentrations and prevent toxicity or subtherapeutic exposure. Renal impairment alters drug pharmacokinetics, especially in conditions like uremia, where changes such as prolonged elimination half-life and altered apparent volume of distribution can significantly affect drug disposition. These changes require careful modification of the dosing regimen to achieve the desired clinical...
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Dosage Regimen: Individualization01:24

Dosage Regimen: Individualization

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Individualization in dosing regimens is the customization of medication doses for individual patients. Its necessity arises from the goal of maximizing therapeutic benefits while minimizing risks. This approach is pivotal because human responses to drugs can vary widely; what is effective for one person may be inadequate or excessive for another. Interpatient (intersubject) variability refers to differences in drug responses between individuals, while intrapatient (intrasubject) variability...
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In the United States, obesity is a prominent concern. It is linked to heightened mortality rates due to increased occurrences of conditions such as hypertension, atherosclerosis, coronary artery disease, and diabetes compared to nonobese individuals. A patient is classified as obese if their actual body weight surpasses the ideal or desirable body weight by 20%, based on Metropolitan Life Insurance Company data. Ideal body weights consider average weights and heights for males and females...
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A rational dosage regimen considers a drug's pharmacokinetics, including its absorption, distribution, metabolism, and elimination from the body. By understanding these factors, the appropriate dosage can be determined, and the dosing schedule can be designed to achieve and maintain the desired therapeutic effect while minimizing adverse effects.
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A drug dosage regimen describes the specific instructions and schedule for administering a drug to a patient. It considers factors such as drug dosage, frequency, route of administration, and duration of treatment. Designing an appropriate dosage regimen for a patient aims to achieve a target drug concentration at the site of action.
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Quantification of the Immunosuppressant Tacrolimus on Dried Blood Spots Using LC-MS/MS
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Improved LCP Tacrolimus XR Dosing and Monitoring Outcomes With a Genotype-Based Dosing Algorithm Versus Weight Based

Christine S Wolesensky1, Neha Patel1, Santosh Nagaraju2

  • 1Department of Pharmacy, Medical University of South Carolina, Charleston, South Carolina, USA.

Clinical Transplantation
|October 31, 2025
PubMed
Summary
This summary is machine-generated.

CYP3A5 genotype-based tacrolimus extended-release (XR) dosing in kidney transplant patients improved efficiency. Patients required fewer dose adjustments and spent more time within the therapeutic range, reducing time in concerning ranges.

Keywords:
kidney transplantmedication dosingmedication safetypharmacogenomicstacrolimus dosing

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Area of Science:

  • Nephrology
  • Pharmacogenomics
  • Transplantation

Background:

  • Tacrolimus (tac) is a crucial immunosuppressant post-kidney transplant.
  • Optimizing tacrolimus dosing is vital to balance efficacy and toxicity.
  • CYP3A5 genotype influences tacrolimus metabolism and dosing requirements.

Purpose of the Study:

  • To compare the efficacy of CYP3A5 genotype-based tacrolimus extended-release (XR) dosing versus standard weight-based dosing.
  • To assess the impact of genotype-guided dosing on tacrolimus dose adjustments and time in therapeutic range.
  • To evaluate clinical outcomes such as acute rejection and renal function.

Main Methods:

  • Retrospective longitudinal matched cohort analysis of adult kidney transplant recipients.
  • Comparison of standard weight-based tacrolimus XR dosing with CYP3A5 genotype-guided dosing.
  • Analysis of tacrolimus dose adjustments, time in therapeutic and concerning ranges, acute rejection, and estimated glomerular filtration rate (eGFR) at 90 days post-transplant.

Main Results:

  • The genotype-guided cohort required an average of two fewer tacrolimus dose adjustments (4 vs. 6, p < 0.0001).
  • Patients in the genotype-guided group spent significantly more time within the therapeutic tacrolimus range (59% vs. 47%, p = 0.004).
  • The genotype-guided cohort experienced significantly less time in concerning tacrolimus ranges (9% vs. 18%, p < 0.0001), with similar rates of acute rejection and eGFR.

Conclusions:

  • CYP3A5 genotype-based tacrolimus XR dosing improves dosing efficiency in kidney transplant recipients.
  • Genotype-guided dosing leads to fewer dose adjustments and better achievement of therapeutic drug levels.
  • This pharmacogenomic approach offers a more precise method for optimizing tacrolimus therapy, potentially improving patient outcomes.