Cost-effectiveness analysis of ferric carboxymaltose for treating iron deficiency anemia in adult Chinese patients / 中国药房

OBJECTIVE To evaluate the cost-effectiveness of Ferric carboxymaltose injection in the treatment of iron deficiency anemia in adult Chinese patients. METHODS From the perspective of China’s health system， the partitioned survival model was constructed to simulate the treatment process and outcome of patients with iron deficiency anemia using ferric carboxymaltose and iron sucrose based on the ferric carboxymaltose phase Ⅲ clinical trial in China （NCT03591406）. The study period was 1 year. Total costs and quality-adjusted life years （QALYs） were calculated for both treatment regimens， and incremental cost-effectiveness ratios were calculated. Scenario analysis was performed with different assumptions for efficacy parameters between 9th week and the end of 1 year， and from the perspective of China’s health system and the entire society. The sensitivity analysis was also performed. RESULTS In the basic analysis， compared with iron sucrose， incremental effectiveness of ferric carboxymaltose therapy was 0.007 QALYs， with an additional savings of 1 038 yuan per patient. Ferric carboxymaltose therapy was more effective and less costly， presenting an absolute advantage. The results of the scenario analysis and single-factor sensitivity analysis were consistent with the basic analysis. Probability sensitivity analysis showed that when the willingness-to-pay threshold was 1， 2， 3 times gross domestic product per capita in 2022， the probability of ferric carboxymaltose with a cost- effectiveness advantage was 88.2%，94.5% and 97.6%，respectively. CONCLUSIONS For Chinese adults with iron deficiency anemia， ferric carboxymaltose is a cost-effective treatment for iron deficiency anemia， compared with iron sucrose.

Efficacy and safety of intravenous ferric carboxymaltose in moderate to severe postpartum iron deficiency anemia

Background: PPA affects 50–75% of women. Traditional treatments such as oral iron therapy and blood transfusion have significant disadvantages. Oral iron is not usually absorbed or well-tolerated because of gastrointestinal disturbances and requires long time (months) to reach target of hemoglobin (Hb). Due to limitations of prior parenteral iron preparation, search of novel drug resulted in iron sucrose and latest is Ferric carboxymaltose (FCM). Intravenous FCM has a neutral pH and physiological osmolarity allowing for higher single doses over a shorter time periods. It also does not cause dextran- associated immunogenic reactions. Aims and Objectives: Aims and objectives of the study is to evaluate the safety and efficacy of IV FCM in treatment of postpartum iron deficiency anemia. Materials and Methods: It was prospective intervention study conducted at the tertiary care center from January 2019 to June 2019. Total 151 postnatal women aged 18–45 years with moderate and severe anemia were included in the study. FCM was administered as an intravenous infusion of 500–1000 mg dose based on requirement in 100 ml of 0.9% normal saline solution over 15 min. Hb and serum ferritin were recorded at baseline and at the end of 6 weeks. Safety and tolerability were assessed by recording the adverse events during the study period. Results: Mean age of the study participants was 26.4 ± 4.54 years. Total 112 women (74.1%) had moderate anemia and 39 women (25.8%) had severe anemia. Average baseline Hb was 7.82 ± 0.84 g/dl which was significantly increased up to 12.4 ± 1.33 g/dl at 6 weeks (P < 0.05). Serum ferritin was also significantly improved from 16.22 ± 7.54 baseline to 136.21 ± 66.12 at 6 weeks (Difference 115.12 ± 53.21, P < 0.05). No any serious adverse events were reported. Only minor adverse events such as mild itching at injection site (5, 3.3%) palpitation (2, 1.3%) and nausea (1, 0.6%) were reported. Conclusion: Intravenous FCM therapy was well-tolerated and effective for management of moderate?to?severe anemia among postpartum women. It improved Hb and iron stores in the form of serum ferritin with a very few side effects such as mild itching at injection site, palpitation, and nausea.

Intravenous ferric carboxymaltose for anaemia in pregnancy

Background: Anaemia in pregnancy is associated with unfavourable consequences both for the mother and the fetus and is a major cause of maternal and perinatal mortality and morbidity.Methods: The study was conducted over a period of one year in which 100 pregnant females who met the inclusion criteria were administered ferric carboxymaltose (FCM) preparation.Results: There was significant rise in mean haemoglobin and serum ferritin after transfusion of ferric maltose in the patients with very less adverse effects.Conclusions: FCM, because of its high efficacy and safety can revolutionize the management of iron deficiency anaemia (IDA) in pregnancy.

Evaluation of efficacy of injection ferric carboxymaltose in pregnant women

Background: Iron deficiency anaemia (IDA) continues to be a very common problem in developing countries leading to a spectrum of adverse events in pregnant women. The objective of this study was to determine the efficacy, side effects and tolerance of ferric carboxymaltose as compared to available iron preparations for the prophylaxis and treatment of mild to moderate iron deficiency anaemia during pregnancy.Methods: One-year clinical study (from June 2017 to May 2018). A total 100 patients were enrolled after matching inclusion and exclusion criteria. The efficacy assessment was performed during 4, 8, and 12 weeks of starting therapy. If the patient is not responding to therapy in either arm as documented by no rise or fall in haemoglobin levels patients may be removed from study for other therapy. Treatment duration up to 12 weeks. Safety and efficacy follow-up visit at 4, 8 and 12 weeks. Institutional ethics committee permission was taken.Results: On intra-group comparisons there was significant increase in haemoglobin levels at 8 and 12 weeks in oral iron group as compared to day 1 haemoglobin levels while there was significant increase in haemoglobin levels at 4, 8 and 12 weeks in IV iron group as compared to day 1 haemoglobin levels. On intergroup comparisons between oral and IV iron group, there was significant increase in haemoglobin levels at 4, 8 and 12 weeks in IV iron group as compared oral iron group haemoglobin levels.Conclusions: Intravenous iron therapy with ferric carboxymaltose causes significant improvement in haemoglobin more quickly and more effective in correcting iron deficiency anaemia in pregnancy compared to oral treatment in terms of increase in haemoglobin levels at 4, 8 and 12 weeks. Intravenous ferric carboxymaltose is safe and effective option for pregnant women with iron deficiency anaemia.

A comparative study of ferric carboxymaltose and iron sucrose as a parenteral iron treatment in iron deficiency anaemia during pregnancy

Background: Iron deficiency anemia during pregnancy is a serious global concern specially in developing country, which is preventable with effective measures. In women who cannot tolerate oral iron or have moderate to severe anemia, parenteral iron in the form of iron sucrose or ferric carboxymaltose can be very much useful. This study aimed to compare efficacy and safety of iron sucrose and ferric carboxymaltose in iron deficiency anemia during pregnancy.Methods: This prospective interventional comparative study was conducted during May 2016 to April 2018 at tertiary care hospital and total 100 antenatal women from 28 to 34 weeks of gestation having moderate to severe anemia were included in this study and all women were divided in to 2 groups randomly and were given either iron sucrose or ferric carboxymaltose according to iron requirement. Rise in haemoglobin and serum ferritin were noted and data analysed statistically.Results: The mean rise of haemoglobin with iron sucrose was 1.8 gm% and with ferric carboxymaltose was 2.6 gm%. The mean rise of serum ferritin with iron sucrose was 82.4 ng/ml and with ferric carboxymaltose was 100.9 ng/ml. Other than minimal local reaction one woman had developed severe anaphylactic reaction after receiving iron sucrose.Conclusions: Intravenous ferric carboxymaltose is better and safe molecule than iron sucrose and it has advantage of ability to administer large dose in single sitting which reduce overall cost of therapy.  Hence ferric carboxymaltose is a drug of choice as parenteral iron therapy in iron deficiency anemia during second trimester of pregnancy.

Ferric carboxymaltose: choice of treatment in postpartum anaemia in multispeciality zonal hospital of armed forces medical services

Background: World Health Organization has defined postpartum anemia (PPA) as hemoglobin (Hb) of < 10 gm% during the postpartum period. The objective of the present study was to compare the safety and efficacy of ferric carboxymaltose (FCM) in the treatment of post-partum anaemia (PPA).Methods: A total of 214 patients were identified in a zonal hospital of Armed Forces Medical Services, between Jan 2019 and August 2019 who found to have PPA. Patients having hemoglobin (Hb) <10 g/dl were assigned to receive Intravenous FCM, as per the calculated dose. Changes in hemoglobin (Hb) and serum ferritin levels at 2 and 6 weeks after treatment were recorded and analyzed. Adverse effects to FCM administration were also recorded.Results: Significant rises in Hb and serum ferritin levels were observed. The mean increase in Hb after 2 weeks was 3.1±0.50 g/dl and 4.0±70 g/dl at 6 weeks. The mean increase in serum ferritin levels after 2 weeks was 210.40±38.50 and 270.25±14.60 ng/ml after 6 weeks. Adverse drug reactions were significantly less (p<0.001).Conclusions: Ferric carboxymaltose increases Hb level and restores iron stores faster without any severe adverse drug reactions. Patient tolerance was good after FCM injection.

A Comparative Study of Injection Ferric Carboxymaltose and Iron Sucrose in Anaemia Complicating Pregnancy

Introduction: Anemia during pregnancy is most commonlycaused by iron deficiency anemia. It can cause severeconsequences for both the mother and developing fetus.Study aimed to compare the safety and efficacy of intravenousferric carboxy maltose (FCM) vs iron sucrose in anaemia inpregnancy.Material and Methods: This is prospective observationalstudy; all women treated with FCM and iron sucrose foranemia during pregnancy between May 2017 and April2018 at our Hospital were included. Total 110 women wereselected. Each study group contained 55 women receivingFCM which was group A and 55 in group B receivingInjection Iron Sucrose between 30 and 36 weeks of pregnancy.Treatment effectiveness was assessed by repeat Hemoglobinand Serum Ferritin level measurement after 2 weeks ofcompletion of therapy. Safety was assessed by analysis ofadverse drug reactions during infusion and 2 hours afterinfusion.Results: Intravenous ferric carboxymaltose infusionsignificantly increased Hemoglobin values compared toIntravenous ferrous sucrose. None of the women developedserious adverse reaction in FCM group.Conclusion: Ferric carboxymaltose can be used safely in Irondeficiency anemia complicating pregnancy.

A study for efficacy and safety of ferric carboxymaltose versus iron sucrose in iron deficiency anemia among pregnant women in tertiary care hospital

Background: Anemia is one of the common manageable problem among the pregnant women worldwide, which contributes to maternal and perinatal mortality. This study aims to compare the efficacy and safety of intravenous ferric carboxymaltose with intravenous iron sucrose in treating anemia during pregnancy. Objective of this study was to compare safety and efficacy of intravenous ferric carboxymaltose with intravenous ferric sucrose in iron deficiency anemia during pregnancy.Methods: It’s an interventional prospective study conducted in Department of Obstetrics and Gynecology at NIMS, Jaipur, Rajasthan, India constituting of 100 pregnant women. Group 1- 50 pregnant women were treated with intravenous ferric carboxymaltose and Group 2: 50 pregnant women were treated with intravenous iron sucrose. Hemoglobin and serum ferritin levels were measured pre and post treatment with parenteral iron therapy. The efficacy of intravenous ferric carboxymaltose in comparison to intravenous iron sucrose was assessed. The evaluation of safety and tolerance with the parenteral therapy was also performed.Results: Anemia during pregnancy was more prevalent among the reproductive age group and in multiparous women. The mean rise in the hemoglobin level with ferric carboxymaltose was 2.92 gm/dl and with that of iron, sucrose was 1.08 gm/dl. The man rise in the serum ferritin levels with ferric carboxymaltose was 64.97ng/ml and with iron sucrose was 31.64 ng/ml. Ferric carboxymaltose was observed to be safer with no adverse events in comparison to the Iron sucrose which was related with adverse events among 03 pregnant women.Conclusions: Intravenous ferric carboxymaltose was more efficacious and safer in comparison to intravenous iron sucrose among pregnant women. Hence, ferric carboxymaltose is the drug of choice in treatment of iron deficiency anemia during pregnancy.

Ferricarboxy maltose to treat iron deficiency anemia in pregnancy: is it a feasible option?

Background: Iron deficiency is a common cause of anaemia in pregnancy which influences the health of mother and developing fetus. Intravenous (IV) iron preparations are considered, when oral iron therapy is ineffective or intolerant. Ferric carboxymaltose is an IV preparation that can be given with ease of administration and better tolerated. The aim of this study was to assess the efficacy and safety of IV ferric carboxymaltose in pregnant mother with all grades of anemia in the second and third trimester.Methods: This is a prospective observational study where 44 pregnant women with iron deficiency anemia [IDA] received ferric carboxymaltose up to 15mg/kg in second and third trimester. The parameters that were taken into account, to assess the effectiveness of the treatment was repeat haemoglobin [Hb] measurements and the subjective sense of wellbeing in the patient. The safety of the drug was analysed by continuous fetal heart rate [FHR] monitoring during the infusion and observation of any adverse reactions.Results: Ferric carboxymaltose intravenous infusion significantly increased Hb levels above baseline values in all women. The Increase in Hb levels were observed at 3- and 6-weeks post infusion therapy. FHR monitoring did not show any drug related unfavourable effect on the fetus. Of the 44 women interviewed, 33 (75%) women reported sense of well-being, 7 (15.9%) women could not feel any difference after the infusion and 4 (9.1%) patients could not comment. No serious adverse effects were noticed but minor side effects occurred in 3 (6.8%) patients.Conclusions: This prospective study showed safety and efficacy of ferric carboxymaltose in pregnancy with IDA which is consistent with available observational data.

Iron Sucrose or Ferric Carboxy Maltose: Comparative Study for Treatment of Post-Partum Iron Deficiency Anemia

Background: Iron deficiency anemia (IDA) is commonlyobserved due to blood loss at the time of delivery or lack ofadequate supply during pregnancy, thus increasing the risk ofmorbidity and mortality. Iron supplementation is currently usedto treat postpartum anemia, however oral iron supplementationis associated with unwanted side effects especiallygastrointestinal. Parenteral iron therapy is effective than oraliron supplementation in replenishment of haemoglobin and ironstores (ferritin) with much better compliance. Thus, we aimedto evaluate efficacy of two commonly used parentalpreparations of iron viz sucrose and ferric carboxymaltose.Materials and Methods: This study was conducted at KatiharMedical College, katihar in the department of Obstetrics andGynaecology from november 2012 to october 2013. Weincluded 120 female with post-partum anemia. The patientswere divided into two groups name Group 1 and Group 2.Patinets in Group 1 received multiple doses of iron sucroseeach in small quantity while patients in Group 2 wereadministered single high dose of ferric carboxymaltose. Thechanges in haemoglobin and ferritin levels post therapy werenoted.Results: The level of haemoglobin post therapy increased to10.48±0.56gm% and 11.83±0.79gm% from 8.27±0.53gm%and 8.305±0.609gm% in group 1 and group 2 respectively.Similarly the level of serum ferrtin increased from 77.91±27.14ng/dl and 78.05±34.69ng/dl to 182.86±33.36ng/dl and195.39±44.6ng/dl respectively. The mean increase ofhemoglobin in group 1 was by 2.2 gm% while it was 3.53gm%in group 2.Conclusion: We found that FCM is more effective than ironsucrose for treatment of iron deficiency anemia.

Hierro carboximaltosa por vía intravenosa para tratamiento de la anemia ferropénica en pacientes con hemorragia uterina anormal / Intravenous ferric carboxymaltose injection for treatment iron deficiency anemia in abnormal uterine bleeding

Resumen OBJETIVO: Evaluar la eficacia y seguridad de la administración de altas dosis de hierro carboximaltosa en el tratamiento de pacientes con anemia ferropénica secundaria a hemorragia uterina anormal. MATERIAL Y MÉTODOS: Estudio cuasiexperimental de intervención, no controlado, con la variedad antes y después de un solo grupo (pretest-postest) efectuado en el Hospital Río de la Loza entre mayo de 2014 y septiembre de 2018. Criterios de inclusión: pacientes de 18 años o mayores con anemia y hemorragia uterina anormal severa. Criterios de exclusión: transfusión de concentrados eritrocitarios o administración de hierro parenteral en las ocho semanas previas al estudio, etc. Variables de estudio: hemoglobina, hematocrito, volumen corpuscular medio, concentración de hemoglobina corpuscular media, plaquetas y concentraciones de ferritina y plaquetas. RESULTADOS: Se analizaron los datos de 18 pacientes con anemia ferropénica secundaria a hemorragia uterina anormal 13 de 18 experimentaron un incremento de 2 g/dL o mayor de hemoglobina , 9 de 18 obtuvieron un incremento de 2.5 o mayor y solo 7 de 18 obtuvieron un incremento de 3 g/dL o mayor, los incrementos fueron dependientes de las dosis administrada. La ferritina sérica final promedio fue de 33.44 mcg/L. No hubo efectos adversos graves reportados. CONCLUSIONES: En este grupo de pacientes con anemia ferropénica, la administración de hierro carboximaltosa por vía intravenosa a dosis altas fue segura en la corrección de la carencia del mineral secundaria a hemorragia uterina anormal y en el reabastecimiento de los depósitos de hierro.

Abstract OBJECTIVE: The objective was to evaluate efficacy and safety of rapid, large-dose intravenous (IV) administration of ferric carboxymaltose in correcting iron deficiency anemia due to abnormal uterine bleeding. MATERIAL AND METHODS: Quasi-experimental study of intervention, not controlled, with the variety before and after a single group (pretest-posttest) carried out in the Hospital Río de la Loza, Mexico, between May 2014 and September 2018. Inclusion criteria: patients 18 years of age or older with anemia and severe abnormal uterine hemorrhage. Exclusion criteria: transfusion of erythrocyte concentrates or administration of parenteral iron in the eight weeks prior to the study, etc. Study variables: hemoglobin, hematocrit, mean corpuscular volume, mean corpuscular hemoglobin concentration, platelets and concentrations of ferritin and platelets. RESULTS: 13 patients of 18 obtained an increase of 2 g/dL or greater of hemoglobin, 9 of 18 obtained an increase of 2.5 or greater and only 7 of 18 obtained an increase of 3g/dL or greater, the increases were dependent on the administered dose. The average final serum ferritin was 33.44 mcg/L. There were no serious adverse effects reported. CONCLUSIONS: The use of iron carboxymaltose intravenously at high doses is a safe treatment in the correction of iron deficiency anemia secondary to abnormal uterine hemorrhage and in the replenishment of iron stores.

Hypersensitivity reactions to intravenous ferric carboxymaltose in a patient with iron deficiency anemia: a rare case report

Ferric carboxymaltose (FCM) is a non-dextran iron preparation recently approved in the United States for intravenous treatment of iron deficiency anemia (IDA) in adult patients with intolerance or poor response to oral iron therapy. Acute hypersensitivity reactions (HSRs) during iron infusions are very rare but can be life-threatening. Adverse events, including immune system disorders (0% in FCM) and skin disorders (7.3% in FCM), are less frequently observed with FCM. On treatment with FCM, the change in hemoglobin from baseline to the highest observed level is about 2.8g/dL. Treatment of IDA with FCM resulted in fewer hypersensitivity reactions. Here, authors report a case of a 23 years old female diagnosed for IDA presented with the picture of adverse drug reaction due to injection FCM given by the physician. The patient was managed with Antibiotics, Corticosteroids and Intravenous fluids and recovered well within 12 hours of admission from this adverse drug reaction. Since such cases have been rarely reported, authors are intended to notify about this potentially dangerous drug reaction due to FCM which is used extensively in the treatment of IDA. Hence management of iron infusions requires very careful and precise observation, and, in the event of an adverse reaction, prompt recognition and severity-related interventions by well-trained medical and nursing staff.

Clinical Factors Related to the Response of IV Ferric Carboxymaltose Treatment in Patients with Restless Legs Syndrome

OBJECTIVES: Significant benefit of intravenous ferric carboxymaltose (FCM) for restless legs syndrome (RLS) has been demonstrated. However, clinical indicators to expect treatment response of RLS are not clarified. The aim of this study is to find out determinant factors to predict treatment outcome of FCM. METHODS: We enrolled consecutive 108 patients with RLS who visited sleep clinic and received FCM from April 2016 to November 2017. Obtained data were detailed history including international restless legs scale (IRLS) and questionnaires, comorbid diseases, medication. Complete blood cell count, serum iron, ferritin, and total iron-binding capacity were sampled before and after treatment. Treatment response was assessed about four weeks after FCM administration. Patients with more than 40% decrease on IRLS were classified into the responders. RESULTS: 99 patients (mean 54.5 y and 79 females) were included. 58 patients (58.6%) were classified to be responders. There were substantial differences in post-treatment IRLS and symptom reduction rate between responders (7.4±6.4, 77.5±18.6%) and non-responders (29.7±8.7, 7.4±10.3%). No significant differences were found in demographics, baseline IRLS, sleep, and mood status between two groups. Serum ferritin and transferrin saturation was significantly lower in responders (37.6 ng/mL, 25.0%) than non-responders (55.1 ng/mL, p=0.014 and 36.5%, p=0.001). Patients with a history of gastrectomy (n=8) showed an excellent response to FCM (83.8% of symptom reduction). Comorbid lumbosacral radiculopathy had lower response rate (29.4%). CONCLUSIONS: Peripheral iron compromised state and gastrectomy history may indicate good response to intravenous FCM in patients with RLS. Patients with lumbosacral radiculopathy tend to be poor responders to intravenous FCM.

Postoperative Intravenous Ferric Carboxymaltose Reduces Transfusion Amounts after Orthopedic Hip Surgery

BACKGROUND: This retrospective study was performed to determine whether postoperative intravenous ferric carboxymaltose reduces transfusion amounts without influencing clinical outcomes in patients that have undergone hip surgery. METHODS: Between May 2014 and April 2016, the authors adopted a new perioperative blood management protocol involving the administration of intravenous ferric carboxymaltose after hip surgeries. One-to-one matching between the 150 patients treated during this period with 150 patients treated before initiation of the new protocol was performed by propensity scoring for age, sex, diagnosis, and type of hip surgery. Hematologic results and clinical outcomes in these two groups were compared. RESULTS: Average amounts of perioperative blood loss were not different in the two groups. Ninety-two patients (61%) were transfused in the control group and 70 patients (47%) were transfused in the intravenous ferric carboxymaltose group. The average number of transfused blood units was significantly lower in the intravenous ferric carboxymaltose group (1.7 ± 2.7 units vs. 1.0 ± 1.2 units, p = 0.002). At 6 weeks after surgery, the average hemoglobin concentration recovered to baseline in both groups, but the amount of recovered hemoglobin concentration at 6 weeks was significantly greater in the intravenous ferric carboxymaltose group than in the control group. Clinical outcomes including incidences of postsurgical complications were similar between the two groups. CONCLUSIONS: This study suggests that postoperative intravenous ferric carboxymaltose injection is associated with reduced transfusion amounts and that intravenous ferric carboxymaltose does not influence clinical outcomes after hip surgery.

Anaphylaxis to Intravenous Ferric Carboxymaltose

The efficacy and the adverse effects of intravenous iron formulas have been well established. However, there are few reports of anaphylaxis of ferric carboxymaltose (FCM). A man received intravenous FCM for the treatment of restless legs syndrome. The FCM gave rise to angioedema, urticaria, chest tightness, sinus tachycardia, and hypotension. In the end, epinephrine and dexamethasone resolved the symptoms. The findings were consistent with anaphylactic hypersensitivity reaction from FCM. We need to be careful when we administer FCM in clinics.

Intravenous Iron Therapy for the Treatment of Iron Deficiency Anemia: Ferric Carboxymaltose Vs Iron Sucrose

Background: Postpartum anemia effects every fourth women in India. Parenteral iron therapy in comparison to oral is much faster in correction of Hb level, and replenishment of iron stores with much better compliance.  The two available preparations of parentral iron that is iron sucrose and ferric carboxymaltose were compared in the present study for safety and efficacy. Methods: This prospective observational study was conducted in the department of  obstetrics and gynecology (SRHU Dehradun Uttarakhand)  for a period of 18 month.  180 women of iron deficiency anemia were divided into two groups. 100 mg of IV iron sucrose was given in multiple dose of 200mg on alternate day over a period of 10 days to one group. 1000 mg of IV ferric carboxymaltose was given a single dose to the 2nd group of 90 women. side effects and reactions were noted. Results: Hb% and serum ferritin were done after 14 day of last injection the mean rise in HB in both groups were 1.71%( Group I) versus 3.20 % (Group II)     serum     ferritin     levels    was     found  significantly higher (p vol < 0.0001) in group II there were no serious adverse reactions in either group. Conclusions: FCM proved its efficacy better than iron sucrose. short stay at hospitals, large dose were given at over with very few adverse reactions were the main advantage.

Determination of Weight Average Molecular Weight and Molecular Weight Distribution of Ferric Carboxy-maltose by HPGPC / 中国药房

OBJECTIVE:To establish a method for the determination of weight average molecular weight(Mw)and molecular weight distribution (D) of ferric carboxymaltose. METHODS:HPGPC method was adopted to detect the Mw and D of 3 batches of Ferric carboxymaltose injection (imported) and its raw material (self-made). The determination was performed on TSK G4000 PWXL column with 0.1% sodium azide solution with the flow rate of 0.5 ml/min. The detector was refractive index detector;the column temperature was set at 35 ℃,and sample size was 20 μl. The results were calculated with GPC software. RESULTS:RSDs of precision,stability and reproducibility tests were all lower than 3.0%(n=6);Mw and D of 3 imported samples were 157 667 and 1.30;those of self-made samples were 162 000 and 1.42. CONCLUSIONS:The method has high precision,good stability,repeat-ability and durability. It can be used for the determination of Mw and D of ferric carboxymaltose.

Efficacy of Ferric Carboxymaltose in Anaemia of Malignancy - A Pilot Study.

Anaemia is an important problem in malignancy. It may be due to chronic causes like malnutrition, marrow infiltration, associated renal or endocrine disorders and it may be complicated with blood loss. Measures like blood transfusion, erythropoietin injections often pose a logistical problem. Parenteral iron injections have proved to be useful in fighting anaemia in some chronic conditions e.g. patients on hemodialysis. Aims and Objectives: Primarily to see the observable change in hemoglobin (Hb) level with ferric carboxymaltose (FCM) in treating patients of malignancy on anti-cancer treatment. Materials and Methods: Twenty seven patients were enrolled for this study who were suffering from various malignancies. The baseline Hb level was estimated and FCM injection was administered as per the schedule of 500 mg intravenously (IV) weekly once. The overall results of increase in Hb level was noted during the middle of the treatment (chemotherapy or radiotherapy) and later 3-4 weeks after treatment completion. The results were analysed using SPSS and the mean values of initial Hb and after treatment were analysed. Level of significance (p value) was noted using t test. Results: In 27 patients the mean initial Hb level was 8.09 g/dl before treatment which increased to 10.28 g/dl after FCM treatment (p <0.0001). Conclusion: Treatment with FCM definitely led to a significant increase in Hb level in patients of malignancy undergoing treatment. However, further detailed study is needed to establish its definite role in improving the body iron parameters.