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Primary immune thrombocytopenia (ITP) is a common bleeding disorder in children, and China is a country with a high incidence of ITP
.
As the world's first oral thrombopoietin receptor agonist (TPO-RA), Eltroipopag has been clinically used abroad for more than ten years.
After many large-scale clinical trials, it has accumulated rich experience and data
.
In China, Eltrombopag has been widely used in patients with chronic ITP who have not been treated well in the past, but the clinical experience of treating children with ITP is still being accumulated and summarized
.
Yimaitong invited Professor Cheng Xiaoling from the Department of Pharmacy, Beijing Children's Hospital Affiliated to Capital Medical University to be interviewed to share the precautions for children with ITP during the use of Eltroipopag
.
Yimaitong: As a small molecule TPO-RA with chronic pediatric ITP indications in China, what is the status of Eltrombopag in the treatment of pediatric ITP patients? What are the advantages in the treatment of children with ITP? Cheng Xiaoling’s chief pharmacist currently targets the two major pathogenesis of ITP: increased peripheral platelet destruction and insufficient bone marrow platelet production.
There are different drugs.
Among them, Eltroipopag, as a TPO receptor agonist, is the only one with the highest grade in the Chinese ITP treatment guidelines.
(Ia) Evidence, drugs that have received A-level recommendations
.
Since Eltrodopax acts on the transmembrane region, it will not compete with endogenous TPO and will not induce the production of TPO antibodies.
Therefore, the production-promoting effect of Eltrodopag is irreplaceable
.
In the United States and the European Union, Eltrodopax has been approved for use in children over one year old and adults with ITP.
In the process of real-world research in China, Eltrodopapa has also shown very good efficacy and safety
.
In 2019, in China's pediatric ITP specialist diagnosis and treatment specifications, Eltroipopag was used as the second-line recommended medication for ITP patients over one year old
.
The clinical benefits of Eltrobopar in the treatment of children's ITP are already obvious: First, it has a significant effect, which can increase the number of platelets in a short period of time and reduce clinical bleeding, thereby improving the quality of life of children and reducing parents' anxiety, or Combination medication can help children with refractory ITP to gain remission time; second, it has good safety and has been fully verified in long-term clinical use at home and abroad; third, it has a good economic benefit ratio and reduces facial changes and body changes caused by hormones.
Relevant adverse reactions such as changes in shape, significantly reduce the economic burden of patients
.
Yimaitong: In order to bring better treatment effects to children, what advice do you have regarding the usage, dosage and dosage adjustment of Eltroipopag? Cheng Xiaoling's pharmacist in charge of children is not a reduced adult, and cannot copy the dosage of an adult.
The drug should be individualized and accurately administered according to age, weight, and tolerance of the drug
.
In addition to strictly complying with the precautions in the instructions, the patient's clinical hematology and liver function-related indicators should be regularly evaluated during the treatment process, and the dosage regimen should be adjusted according to the efficacy and patient tolerance
.
Usually the starting dose for patients 5 years old or younger is 1.
5 mg/kg per day, and the starting dose for patients 6 to 11 years old (body weight ≥27 kg) is 37.
5 mg per day.
Patients 12 years of age or older are similar to adults.
The starting dose is 50 mg per day, and the maximum daily dose for children generally does not exceed 75 mg
.
At the same time, closely monitor the platelet count during the application process and observe the clinical bleeding of children
.
In addition, when the platelet count is in the ramp-up phase of the dose, the monitoring frequency should be increased, at least once a week for 2 weeks, and then every two weeks, and can be monitored once a month after it is stable
.
This individualized dosing regimen based on the patient’s platelet count and bleeding symptoms aims to apply the lowest dose that can maintain the platelet count to avoid or reduce bleeding
.
Yimaitong: In the treatment of ITP, is there any difference in the dosage between East Asian pediatric patients and European and American pediatric patients? Cheng Xiaoling is in charge of pharmacist patients and doctors who are very concerned about whether there is a difference in the dosage of medicine between East Asian children and European and American children
.
According to the results of our real-world study that included 116 Chinese children with ITP [1], the effective dose of Eltrombopag in the treatment of ITP is not significantly different between East Asian children and European and American children
.
For children over 6 years of age, the starting dose or effective dose of Eltrombopag may need to be increased to 50 mg, so that the patient can reach a relatively safe platelet level, control bleeding as soon as possible, and minimize the number of dose adjustments
.
Yimaitong: During the course of treatment, it is necessary to evaluate the liver function of the patient regularly.
For children with ITP who have abnormal liver enzymes, is it necessary to adjust the dosage of Eltropopag? Cheng Xiaoling, a pharmacist in charge, of children with ITP who have abnormal liver enzymes in our center, according to the drug-induced liver injury (DILI) screening criteria, the severity is mild (1-2), and there are no significant clinical symptoms of liver damage, and Reversible
.
At this time, only the serum liver function indicators need to be monitored until the liver function indicators return to normal levels
.
If the patient's serum alanine aminotransferase (ALT) level ≥3 x normal value is online, or if clinical symptoms of liver damage occur, hepatoprotective drugs can be used in combination if necessary.
If abnormal anhydrase persists or severe liver damage occurs , If necessary, treatment with Eltroipopag should be discontinued
.
Yimaitong: In order to maximize the benefits of patients, please talk about how to improve patient compliance and achieve good management of children with ITP based on clinical experience? The pharmacist in charge of Cheng Xiaoling's management of pediatric patients should be omni-directional, should rely on the power of multidisciplinary, and require the cooperation of doctors, pharmacists and nursing staff
.
For high-value innovative drugs with a narrow treatment window and many precautions, the participation of pharmacists is particularly needed to carry out repeated knowledge education for children and parents.
For long-term chronic blood diseases such as ITP that require long-term home medication, it is best to provide hospitalization -Outpatient-home one-stop full medication guidance, and need to repeatedly strengthen patient compliance, reduce the attenuation of information transmission, not only written materials, oral guidance, but also online conferences and education, so as to conduct medication The all-round management of treatment improves the patient's medication management ability and compliance, and ultimately improves the efficacy of the drug and reduces the incidence of adverse drug reactions
.
Summary ITP is a common acquired autoimmune bleeding disease in children, and China is a country with a high incidence of ITP
.
Eltrobopar is the world's first oral TPO receptor agonist
.
In a real-world study in China, Eltrombopag showed good efficacy and safety for ITP patients aged 1 year and above, and there was no significant difference in dosage between East Asian children and European and American children
.
When using Eltrombopag, it is necessary to perform tailor-made and individualized administration according to the age and weight of the child patient, and it is necessary to regularly evaluate the clinical hematology and liver function-related indicators, and adjust the dosage regimen according to the efficacy and tolerance
.
If the patient has abnormal liver enzymes, hepatic function indicators should be closely monitored and medications should be adjusted flexibly
.
In addition, the patient’s family, doctors, pharmacists, and nursing staff should work together, cooperate with each other, and manage all aspects to improve the compliance of the patient and obtain the best balance of efficacy and safety of the drug
.
Cheng Xiaoling is in charge of pharmacist, National Children's Medical Center, Beijing Children's Hospital Affiliated Beijing Children's Hospital, Capital Medical University Clinical pharmacist, hemophilia comprehensive treatment team pharmacist, member of the clinical evaluation pharmacy group of the Rare Disease Branch of Beijing Medical Association The main research direction of backbone talents in the pharmacy discipline of Beijing Hospital Management Center: The rational use of medicines and individualized guidance for children with blood diseases have published 17 academic articles, of which 12 SCI articles presided over 4 topics, participated in 5 major topics and participated in the compilation of multidisciplinary expert consensus 3 articles and 7 books.
As a researcher, I participated in more than 30 drug clinical trials.
Won the annual outstanding pharmacist of Beijing Pharmaceutical Association, and 15 references of Beijing Children’s Hospital Medical Technology Star Award [1] Cheng X, Fu L, Ma J, et al Spotlight on eltrombopag in pediatric ITP in China: a long-term observational study in real-world practice.
Blood Advances.
2021;5(19):3799-3806.
MCC number REV21111591 is valid for 2022-11-19, the data is out of date, depending on Same as void
.
This information is for academic reference only by medical and health professionals, please do not distribute or forward it
.
This indication has not been approved in China, and the relevant content is for academic exchanges only
.
Poke "read the original text", we make progress together
.
As the world's first oral thrombopoietin receptor agonist (TPO-RA), Eltroipopag has been clinically used abroad for more than ten years.
After many large-scale clinical trials, it has accumulated rich experience and data
.
In China, Eltrombopag has been widely used in patients with chronic ITP who have not been treated well in the past, but the clinical experience of treating children with ITP is still being accumulated and summarized
.
Yimaitong invited Professor Cheng Xiaoling from the Department of Pharmacy, Beijing Children's Hospital Affiliated to Capital Medical University to be interviewed to share the precautions for children with ITP during the use of Eltroipopag
.
Yimaitong: As a small molecule TPO-RA with chronic pediatric ITP indications in China, what is the status of Eltrombopag in the treatment of pediatric ITP patients? What are the advantages in the treatment of children with ITP? Cheng Xiaoling’s chief pharmacist currently targets the two major pathogenesis of ITP: increased peripheral platelet destruction and insufficient bone marrow platelet production.
There are different drugs.
Among them, Eltroipopag, as a TPO receptor agonist, is the only one with the highest grade in the Chinese ITP treatment guidelines.
(Ia) Evidence, drugs that have received A-level recommendations
.
Since Eltrodopax acts on the transmembrane region, it will not compete with endogenous TPO and will not induce the production of TPO antibodies.
Therefore, the production-promoting effect of Eltrodopag is irreplaceable
.
In the United States and the European Union, Eltrodopax has been approved for use in children over one year old and adults with ITP.
In the process of real-world research in China, Eltrodopapa has also shown very good efficacy and safety
.
In 2019, in China's pediatric ITP specialist diagnosis and treatment specifications, Eltroipopag was used as the second-line recommended medication for ITP patients over one year old
.
The clinical benefits of Eltrobopar in the treatment of children's ITP are already obvious: First, it has a significant effect, which can increase the number of platelets in a short period of time and reduce clinical bleeding, thereby improving the quality of life of children and reducing parents' anxiety, or Combination medication can help children with refractory ITP to gain remission time; second, it has good safety and has been fully verified in long-term clinical use at home and abroad; third, it has a good economic benefit ratio and reduces facial changes and body changes caused by hormones.
Relevant adverse reactions such as changes in shape, significantly reduce the economic burden of patients
.
Yimaitong: In order to bring better treatment effects to children, what advice do you have regarding the usage, dosage and dosage adjustment of Eltroipopag? Cheng Xiaoling's pharmacist in charge of children is not a reduced adult, and cannot copy the dosage of an adult.
The drug should be individualized and accurately administered according to age, weight, and tolerance of the drug
.
In addition to strictly complying with the precautions in the instructions, the patient's clinical hematology and liver function-related indicators should be regularly evaluated during the treatment process, and the dosage regimen should be adjusted according to the efficacy and patient tolerance
.
Usually the starting dose for patients 5 years old or younger is 1.
5 mg/kg per day, and the starting dose for patients 6 to 11 years old (body weight ≥27 kg) is 37.
5 mg per day.
Patients 12 years of age or older are similar to adults.
The starting dose is 50 mg per day, and the maximum daily dose for children generally does not exceed 75 mg
.
At the same time, closely monitor the platelet count during the application process and observe the clinical bleeding of children
.
In addition, when the platelet count is in the ramp-up phase of the dose, the monitoring frequency should be increased, at least once a week for 2 weeks, and then every two weeks, and can be monitored once a month after it is stable
.
This individualized dosing regimen based on the patient’s platelet count and bleeding symptoms aims to apply the lowest dose that can maintain the platelet count to avoid or reduce bleeding
.
Yimaitong: In the treatment of ITP, is there any difference in the dosage between East Asian pediatric patients and European and American pediatric patients? Cheng Xiaoling is in charge of pharmacist patients and doctors who are very concerned about whether there is a difference in the dosage of medicine between East Asian children and European and American children
.
According to the results of our real-world study that included 116 Chinese children with ITP [1], the effective dose of Eltrombopag in the treatment of ITP is not significantly different between East Asian children and European and American children
.
For children over 6 years of age, the starting dose or effective dose of Eltrombopag may need to be increased to 50 mg, so that the patient can reach a relatively safe platelet level, control bleeding as soon as possible, and minimize the number of dose adjustments
.
Yimaitong: During the course of treatment, it is necessary to evaluate the liver function of the patient regularly.
For children with ITP who have abnormal liver enzymes, is it necessary to adjust the dosage of Eltropopag? Cheng Xiaoling, a pharmacist in charge, of children with ITP who have abnormal liver enzymes in our center, according to the drug-induced liver injury (DILI) screening criteria, the severity is mild (1-2), and there are no significant clinical symptoms of liver damage, and Reversible
.
At this time, only the serum liver function indicators need to be monitored until the liver function indicators return to normal levels
.
If the patient's serum alanine aminotransferase (ALT) level ≥3 x normal value is online, or if clinical symptoms of liver damage occur, hepatoprotective drugs can be used in combination if necessary.
If abnormal anhydrase persists or severe liver damage occurs , If necessary, treatment with Eltroipopag should be discontinued
.
Yimaitong: In order to maximize the benefits of patients, please talk about how to improve patient compliance and achieve good management of children with ITP based on clinical experience? The pharmacist in charge of Cheng Xiaoling's management of pediatric patients should be omni-directional, should rely on the power of multidisciplinary, and require the cooperation of doctors, pharmacists and nursing staff
.
For high-value innovative drugs with a narrow treatment window and many precautions, the participation of pharmacists is particularly needed to carry out repeated knowledge education for children and parents.
For long-term chronic blood diseases such as ITP that require long-term home medication, it is best to provide hospitalization -Outpatient-home one-stop full medication guidance, and need to repeatedly strengthen patient compliance, reduce the attenuation of information transmission, not only written materials, oral guidance, but also online conferences and education, so as to conduct medication The all-round management of treatment improves the patient's medication management ability and compliance, and ultimately improves the efficacy of the drug and reduces the incidence of adverse drug reactions
.
Summary ITP is a common acquired autoimmune bleeding disease in children, and China is a country with a high incidence of ITP
.
Eltrobopar is the world's first oral TPO receptor agonist
.
In a real-world study in China, Eltrombopag showed good efficacy and safety for ITP patients aged 1 year and above, and there was no significant difference in dosage between East Asian children and European and American children
.
When using Eltrombopag, it is necessary to perform tailor-made and individualized administration according to the age and weight of the child patient, and it is necessary to regularly evaluate the clinical hematology and liver function-related indicators, and adjust the dosage regimen according to the efficacy and tolerance
.
If the patient has abnormal liver enzymes, hepatic function indicators should be closely monitored and medications should be adjusted flexibly
.
In addition, the patient’s family, doctors, pharmacists, and nursing staff should work together, cooperate with each other, and manage all aspects to improve the compliance of the patient and obtain the best balance of efficacy and safety of the drug
.
Cheng Xiaoling is in charge of pharmacist, National Children's Medical Center, Beijing Children's Hospital Affiliated Beijing Children's Hospital, Capital Medical University Clinical pharmacist, hemophilia comprehensive treatment team pharmacist, member of the clinical evaluation pharmacy group of the Rare Disease Branch of Beijing Medical Association The main research direction of backbone talents in the pharmacy discipline of Beijing Hospital Management Center: The rational use of medicines and individualized guidance for children with blood diseases have published 17 academic articles, of which 12 SCI articles presided over 4 topics, participated in 5 major topics and participated in the compilation of multidisciplinary expert consensus 3 articles and 7 books.
As a researcher, I participated in more than 30 drug clinical trials.
Won the annual outstanding pharmacist of Beijing Pharmaceutical Association, and 15 references of Beijing Children’s Hospital Medical Technology Star Award [1] Cheng X, Fu L, Ma J, et al Spotlight on eltrombopag in pediatric ITP in China: a long-term observational study in real-world practice.
Blood Advances.
2021;5(19):3799-3806.
MCC number REV21111591 is valid for 2022-11-19, the data is out of date, depending on Same as void
.
This information is for academic reference only by medical and health professionals, please do not distribute or forward it
.
This indication has not been approved in China, and the relevant content is for academic exchanges only
.
Poke "read the original text", we make progress together
