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On May 6, 2021, the U.
S.
Food and Drug Administration (FDA) approved a single injection of 1000 mg of iron carboxymaltose to treat adult patients with iron deficiency anemia.
This approval will reduce the number of injections and alleviate the suffering of patients.
This article reviews the introduction of the drug, dosage, precautions, and adverse reactions, as well as the market situation in my country for iron carboxymaltose injection.
Drug introduction Carboxymaltose iron injection is a kind of intravenous iron.
It is suitable for adult patients with chronic kidney disease and iron deficiency anemia who are intolerant or not obviously non-dialysis dependent on oral iron supplementation.
It can make up for the poor absorption, slow onset and large adverse reactions of oral iron.
Clinical trials have shown that the bioavailability of carboxymaltose iron injection is between 61% and 99%, and half of the patients have an iron utilization rate of more than 91%.
In 2013, the FDA has approved Injectafer® to treat patients with iron deficiency anemia.
For adult patients over 50kg, two injections of injectafer® are required at an interval of 7 days, each injection of 750mg, for a total of 1500mg.
If the patient's body weight is less than 50kg, the injection dose is 15mg/kg.
The single treatment approved by the FDA this time is a one-time injection of 1000 mg of iron carboxymaltose, but it is only suitable for patients weighing more than 50 kg, and patients under 50 kg still need two injections.
Precautions There are reports that carboxymaltose iron injections have the risk of hypophosphatemia.
Possible risk factors include gastrointestinal diseases related to malabsorption of fat-soluble vitamins or phosphates, drugs that affect the proximal renal tubules, and hyperparathyroidism , Lack of vitamin D and malnutrition.
Therefore, it is recommended to clinically monitor the level of serum phosphorus.
Some people will experience allergic reactions.
Severe allergies can manifest as shock, hypotension, loss of consciousness or coma.
In clinical trials, 0.
1% of patients reported severe allergic events, and 1.
5% of patients reported other possible allergic reactions, including but not limited to itching, rash, urticaria or asthma.
Some patients have experienced high blood pressure.
Therefore, it is recommended not only to test the patient's serum iron and transferrin-bound iron, but also to pay attention to the above biochemical indicators.
Adverse reactions Adverse reactions are mainly tachycardia, chest discomfort, nausea, hypertension, injection site reactions, angioedema, urticaria, arthralgia, syncope, erythema, hypophosphatemia, dizziness and vomiting.
In addition, pregnant women may experience fetal bradycardia.
my country's marketing situation In my country, carboxyl maltose iron injection has not yet been approved for marketing, but since 2016, some pharmaceutical companies are conducting corresponding clinical trials.
Therefore, domestic patients may still need to wait patiently for the approval to be completed.
In short, carboxymaltose iron injection is a noteworthy drug, and it is hoped that it can be marketed in China as soon as possible to benefit patients.
References: 1.
Wang Fanghai, Zhao Wei, Chen Jianfang, et al.
Carboxymaltose iron and its application progress in iron deficiency anemia[J].
Chinese Journal of New Drugs, 2017, 026(009):1011-1015.
2.
Daiichi Sankyo, Inc.
Injectafer® (ferric carboxymaltose injection) Receives FDA Approval for Single Dose Option for the Treatment of Adult Patients with Iron Deficiency Anemia.
Cision PR Newswire.
May 06, 2021.
3.
Carboxymaltose iron.
Drug intelligence data.
2021.
05.
13.
S.
Food and Drug Administration (FDA) approved a single injection of 1000 mg of iron carboxymaltose to treat adult patients with iron deficiency anemia.
This approval will reduce the number of injections and alleviate the suffering of patients.
This article reviews the introduction of the drug, dosage, precautions, and adverse reactions, as well as the market situation in my country for iron carboxymaltose injection.
Drug introduction Carboxymaltose iron injection is a kind of intravenous iron.
It is suitable for adult patients with chronic kidney disease and iron deficiency anemia who are intolerant or not obviously non-dialysis dependent on oral iron supplementation.
It can make up for the poor absorption, slow onset and large adverse reactions of oral iron.
Clinical trials have shown that the bioavailability of carboxymaltose iron injection is between 61% and 99%, and half of the patients have an iron utilization rate of more than 91%.
In 2013, the FDA has approved Injectafer® to treat patients with iron deficiency anemia.
For adult patients over 50kg, two injections of injectafer® are required at an interval of 7 days, each injection of 750mg, for a total of 1500mg.
If the patient's body weight is less than 50kg, the injection dose is 15mg/kg.
The single treatment approved by the FDA this time is a one-time injection of 1000 mg of iron carboxymaltose, but it is only suitable for patients weighing more than 50 kg, and patients under 50 kg still need two injections.
Precautions There are reports that carboxymaltose iron injections have the risk of hypophosphatemia.
Possible risk factors include gastrointestinal diseases related to malabsorption of fat-soluble vitamins or phosphates, drugs that affect the proximal renal tubules, and hyperparathyroidism , Lack of vitamin D and malnutrition.
Therefore, it is recommended to clinically monitor the level of serum phosphorus.
Some people will experience allergic reactions.
Severe allergies can manifest as shock, hypotension, loss of consciousness or coma.
In clinical trials, 0.
1% of patients reported severe allergic events, and 1.
5% of patients reported other possible allergic reactions, including but not limited to itching, rash, urticaria or asthma.
Some patients have experienced high blood pressure.
Therefore, it is recommended not only to test the patient's serum iron and transferrin-bound iron, but also to pay attention to the above biochemical indicators.
Adverse reactions Adverse reactions are mainly tachycardia, chest discomfort, nausea, hypertension, injection site reactions, angioedema, urticaria, arthralgia, syncope, erythema, hypophosphatemia, dizziness and vomiting.
In addition, pregnant women may experience fetal bradycardia.
my country's marketing situation In my country, carboxyl maltose iron injection has not yet been approved for marketing, but since 2016, some pharmaceutical companies are conducting corresponding clinical trials.
Therefore, domestic patients may still need to wait patiently for the approval to be completed.
In short, carboxymaltose iron injection is a noteworthy drug, and it is hoped that it can be marketed in China as soon as possible to benefit patients.
References: 1.
Wang Fanghai, Zhao Wei, Chen Jianfang, et al.
Carboxymaltose iron and its application progress in iron deficiency anemia[J].
Chinese Journal of New Drugs, 2017, 026(009):1011-1015.
2.
Daiichi Sankyo, Inc.
Injectafer® (ferric carboxymaltose injection) Receives FDA Approval for Single Dose Option for the Treatment of Adult Patients with Iron Deficiency Anemia.
Cision PR Newswire.
May 06, 2021.
3.
Carboxymaltose iron.
Drug intelligence data.
2021.
05.
13.
