As a highly effective targeted therapy drug, gireltinib has brought hope to many patients. However, did you know that in order for gilitinib to work optimally, doctors often need to perform a job called "blood concentration monitoring"? Today, let's walk into the world of the "Invisible Guardian" and understand its importance.
Girelitinib: the right-hand man in the fight against cancer
Gilteritinib (Silteritinib) is an oral small molecule inhibitor targeting FLT3 gene mutations, mainly used for the treatment of hematological malignancies such as acute myeloid leukemia (AML). It inhibits the growth and spread of cancer cells by specifically blocking the FLT3 signaling pathway, giving patients valuable treatment time.
On January 31, 2021, gilitinib was approved for the first time in China for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) with FLT3 mutations;
【Dosage】:
Take 120 mg orally once a day.
Take gilitinib approximately 1 time a day at the same time. Swallow the gilitinib tablet whole with a glass of water.
Do not crush, crush or chew gilitinib tablets.
If you miss a dose of gilitinib, take your next planned dose as soon as possible and within at least 12 hours of the day. Return to your normal dosing time the next day. Do not take 2 doses within 12 hours.
Astellas Pharma Giritinib Fumarate Tablets
Why do I need to monitor my blood levels?
Monitoring principle
First, let's take a look at Therapeutic Drug Monitoring (TDM). To put it simply, blood concentration monitoring is to evaluate the absorption, distribution, metabolism and excretion of the drug in the body by measuring the concentration of gilitinib in the patient's blood, so as to evaluate the efficacy or determine the dosing regimen. This monitoring method is based on the principle of pharmacokinetics, and aims to make the dosing regimen more individualized, so as to improve the level of drug treatment and ensure the safety, effectiveness and rationality of clinical medication.
Monitoring implications
(1) Ensure efficacy: The efficacy of gilitinib is closely related to its effective concentration in the body. By monitoring blood drug levels, doctors can ensure that drug levels in the patient's body are maintained within the effective range, thereby improving the effectiveness of treatment.
(2) Prevention of adverse reactions: too high drug concentrations may lead to adverse reactions in patients, such as nausea, vomiting, diarrhea, etc. Monitoring of blood drug levels can help doctors detect and adjust the drug dose in time to reduce the risk of adverse reactions.
(3) Personalized treatment: Factors such as constitution, condition, and drug history of different patients may lead to differences in the metabolic process of drugs in vivo. Through the monitoring of blood drug concentration, doctors can formulate personalized treatment plans according to the specific conditions of patients, improving the pertinence and effectiveness of treatment.
(4) Blood drug concentration monitoring can also help doctors find abnormal drug metabolism in patients in time, so as to take corresponding interventions. For example, patients with liver and kidney insufficiency may have a weak ability to metabolize drugs, which can easily lead to drug accumulation in the body. Through blood concentration monitoring, doctors can detect such conditions in time and adjust the dosing regimen to avoid serious consequences such as drug poisoning.
How is blood concentration monitored?
How do I do it?
Plasma concentrations are usually monitored by taking a sample of the patient's venous blood and using modern analytical techniques such as high-performance liquid chromatography-mass spectrometry (HPLC-MS). The procedure is quick and easy and non-invasive for the patient. The doctor will formulate a corresponding treatment plan based on the test results and the actual situation of the patient. Liquid chromatography analysis was performed on an Acquity BEH C18 Column (50 mm × 2.1 mm, 1.7 μm) using a gradient elution of 0.1% formic acid in water (A) and acetonitrile (B). Detection was performed using Shimadzu tandem mass spectrometry by multi-reaction monitoring in positive ion mode.
Outcome:
The developed method was able to quantify gilitinib within 4 minutes and was assessed by assessing selectivity, calibration curve (10-1000 ng/mL, r 2 > 0.99), lower limit of quantification (LLOQ), accuracy (overall bias -4.2% to 1.9%), precision (intraday CV ≤ 7.9%; Day CV ≤ 13.6%), carryover, recovery, matrix effect, dilution integrity, and stability (according to U.S. Food and Drug Administration (FDA) guidelines). This method has been successfully applied to the trough concentration of gilitinib TDM in 3 patients with AML.
Conclusion:
The method developed meets FDA guidelines and can be easily implemented to facilitate TDM in patients receiving gilitinib in a clinical setting. Therapeutic drug monitoring (TDM) with gitertinib is important to improve clinical outcomes and ensure safety.
How Long After Taking Giritinib Can I Have Blood Levels Monitored?
After taking gilitinib, blood levels can generally be monitored 2 hours after oral administration, as the maximum plasma concentration of gilitinib can be observed at this time. However, this is only a preliminary monitoring time point.
In practical clinical application, in order to more accurately assess the absorption and metabolism of giritinib in the body, doctors may recommend multiple blood concentration monitoring at different time points after administration, such as 4 hours, 6 hours, 8 hours, etc., in order to have a more comprehensive understanding of the dynamic changes of the drug in the body. In addition, steady-state plasma levels may be reached within 15 days of administration, at which point blood concentration monitoring can also be performed to assess the accumulation of the drug in the body.
In conclusion, as a new antineoplastic drug, it is of great significance to monitor blood drug concentrations during the treatment of gilitinib. By monitoring the concentration of giritinib in patients in real time, doctors can formulate more accurate dosing regimens, improve treatment effects, reduce adverse reactions, and bring patients a better treatment experience.
Everyone is welcome to pay attention to the Pocket Pharmacy APP, join the relevant patient groups to exchange treatment experience and interpret test reports with each other.
Tips: The medical content involved in this article is a general application suggestion, which is for learning and reference only, and the final opinion is subject to the diagnosis of the clinician.