Safety of RAPid INJECTion of Undiluted Ferric Carboxymaltose to Patients with Iron Deficiency Anaemia (RAPINJECT): A Phase II Single Arm study

2021 ◽  
Author(s):  
Sant‐Rayn Pasricha ◽  
Michael Gilbertson ◽  
Tishya Indran ◽  
Ashwini Bennett ◽  
Matthew Dam ◽  
...  
Keyword(s):  
Iron Deficiency ◽  
Phase Ii ◽  
Iron Deficiency Anaemia ◽  
Ferric Carboxymaltose ◽  
Deficiency Anaemia ◽  
Rapid Injection

scholarly journals Safety and Efficacy of Intravenous Ferric Carboxymaltose for Treatment of Iron Deficiency Anaemia in Pregnancy - An Intervention Study Done in a Tertiary Care Hospital of Pune

2021 ◽  
Vol 8 (22) ◽  
pp. 1803-1807
Author(s):  
Anish Kumar Vishal ◽  
Dinesh Bhasin ◽  
Vidhu Dhar Dangwal ◽  
Anurakshat Bhasin
Keyword(s):  
Iron Deficiency ◽  
Blood Transfusion ◽  
Serum Ferritin ◽  
Iron Deficiency Anaemia ◽  
Tertiary Care ◽  
Ferric Carboxymaltose ◽  
Third Trimester ◽  
Deficiency Anaemia ◽  
Anaemia In Pregnancy ◽  
In Pregnancy

BACKGROUND Anaemia is one of the major public health problems in developing nations. Iron deficiency anaemia (IDA) is the commonest type of anaemia in pregnancy. Parenteral iron therapy is a recommended modality of treatment of IDA. Inj. Ferric Carboxymaltose (FCM) is a dextran free preparation which is safe, easy to deliver and better tolerated. A maximum of 1000 mg can be infused at a time. The present study was intended to assess the efficacy and safety of Inj. FCM in the treatment of iron deficiency anaemia in the second and third trimester. METHODS This prospective study was conducted at a tertiary care centre at Pune. Pregnant women with iron deficiency anaemia of moderate and severe grade were infused 1000 mg of Inj. FCM by longer infusion protocol. A total of 165 pregnant women were included in the study. The efficacy of Inj. FCM was monitored by the rise in the haemoglobin level at 03-, 06- and 08-weeks post infusion of FCM injection and serum Ferritin levels. The safety was assessed by analysing the adverse reactions. RESULTS No serious adverse reaction was recorded in any of the patients. The rise in haemoglobin (Hb) in second and third trimester of moderate and severe grade of anaemia was significant (P < 0.001). The target level of 10 g / dl was achieved in every patient. Only 03 patients received blood transfusion and that was for obstetric indications. No blood transfusion was because of anaemia per se. The rise in serum ferritin level was also statistically significant (P < 0.001). CONCLUSIONS Inj. FCM is an excellent modality to treat iron deficiency anaemia in pregnancy. It is safe and the rise of haemoglobin with correction of anaemia is satisfactory in a short span of time. In our country where only a handful of patients had regular antenatal check-up and non-compliancy and refractory anaemia is rampant, Inj. FCM is a big boon. KEYWORDS Iron Deficiency Anaemia, Inj. Ferric Carboxymaltose, Serum Ferritin, Blood Transfusion

scholarly journals Comparative study of efficacy and safety of parenteral iron sucrose versus ferric carboxymaltose in treatment of postpartum iron deficiency anaemia

2021 ◽  
Vol 11 (1) ◽  
pp. 100
Author(s):  
Ganesh N. Dakhle ◽  
Mrunalini V. Kalikar ◽  
Rujuta P. Fuke ◽  
Anisha S. Parmarthi ◽  
Mrunalini K. Chokhandre
Keyword(s):  
Iron Deficiency ◽  
Serum Ferritin ◽  
Iron Deficiency Anaemia ◽  
Maximum Dose ◽  
Iron Sucrose ◽  
Ferric Carboxymaltose ◽  
Care Hospital ◽  
Deficiency Anaemia ◽  
Iron Stores ◽  
Parenteral Iron

Background: Postpartum anaemia often leads to multiple clinical complications in mother as well as infant and iron supplementation with parenteral iron is the preferred treatment modality. The present study was planned to compare the efficacy and tolerability of IV iron sucrose and IV ferric carboxymaltose in treatment of postpartum iron deficiency anaemia.Methods: This randomized, parallel, open label, prospective 4-weeks study was conducted from June 2019 to December 2020 in women with postpartum anaemia admitted to obstetrics and gynaecology inpatient department of a tertiary care hospital. Women with postpartum iron deficiency anaemia (N=60) were randomly divided into two groups; receiving Injection iron sucrose (N=30, maximum dose 500 mg) or Injection ferric carboxymaltose (N=30, maximum dose 500 mg). Change in haemoglobin and serum ferritin levels from baseline to the end of 2 and 4 weeks of treatment were evaluated.Results: The results showed early, sustained and significant increase in the haemoglobin levels in both the groups. However, the difference was not significant between groups (p=0.2). Evaluation of replenishment of iron stores (serum ferritin) showed improvement in both the groups, however in FCM group the rise was found to be significant (p<0.05).Conclusions: FCM in a lower dose of 500mg was found to be safe and effective in significantly improving haemoglobin concentration as well as in replenishing iron stores in patients with postpartum anaemia.

scholarly journals Hypophosphatemia after High Dosage Iron Substitution with Ferric Carboxymaltose (FCM) and Iron Isomaltoside (IM) — the Randomised Controlled Home Afers 1 Trial

Blood ◽  
2018 ◽  
Vol 132 (Supplement 1) ◽  
pp. 3627-3627 ◽  
Author(s):  
Insa E. Emrich ◽  
Fabio Lizzi ◽  
Seiler-Mußler Sarah ◽  
Christian Ukena ◽  
Dominic Kaddu-Mulindwa ◽  
...  
Keyword(s):  
Iron Deficiency ◽  
Board Of Directors ◽  
Interim Analysis ◽  
Research Funding ◽  
Iron Deficiency Anaemia ◽  
Ferric Carboxymaltose ◽  
Advisory Committees ◽  
Deficiency Anaemia ◽  
Iron Substitution ◽  
Plasma Phosphorus

Abstract In iron deficiency anaemia patients, intravenous administration of either ferric carboxymaltose (FCM) or iron isomaltoside (IM) both allow high dosage iron substitution within a single outpatient visit. In contrast, other iron compounds require repetitive, low dosage infusions. Recently, FCM was reported to frequently induce acute, reversible hypophosphatemia. It remains enigmatic whether these hypophosphataemic effects of FCM are substance-specific, or whether they generally occur after high dosage iron substitution. A direct comparison of phosphorus regulation after high dosage iron substitution with either FCM or IM is clinically important, as hypophosphatemia after FCM has anecdotally been associated with osteomalacia and bone fractures. In the HOMe AFers 1 (HOMburg evaluations on application of Ferrum study 1) trial, we recruited normophosphatemic women with gynaecological bleeding and subsequent iron deficiency anaemia, in whom we assessed the longitudinal biochemical response over 28 days to a single intravenous injection of equivalent doses of randomly-assigned FCM and IM (1000 mg). The primary study hypothesis was that the incidence of hypophosphatemia - defined as plasma phosphorus < 2.0 mg/dl at least out of three post-infusion study time points (day 1, day 8, and week 5) - differs between FCM and IM. HOMe AFers 1 initially planned to recruit 60 women. An interim analysis was pre-specified and scheduled in July 2018, with the option to stop further patient recruitment if the incidence of hypophosphatemia differs significantly at this interim analysis. At the time point of the interim analysis, 26 patients have been recruited. One patient withdrew her acceptance to participate after day 1, leaving 25 patients for our per protocol interim analysis. Baseline plasma phosphorus did not differ significantly between FMC (3.3 ± 0.4 mg/dl) and IM (3.6 ± 0.6 mg/dl; p = 0.135). Analysis on the primary endpoint demonstrated that significantly more women developed hypophosphatemia < 2.0 mg/dl after FMC infusion (9 out of 12 patients) than after IM infusion (1 out of 13 patient) (p=0.001). Further, the minimum plasma phosphorus during any of the three post-infusion study time points was lower after FMC (1.8 ± 0.3 mg/dl) than after IM (2.7 ± 0.6 mg/dl; p < 0.001). As expected, ferritin and haemoglobin increased in both study groups after iron infusion. No severe adverse events occurred in either group. In conclusion, while both FCM and IM provide efficient iron substitution in iron deficiency anaemia, FCM induced a substantially higher incidence of hypophosphatemia. Disclosures Emrich: Pharmacosmos: Consultancy, Honoraria, Research Funding. Stilgenbauer:Mundipharma: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding; Novartis: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding; AbbVie: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding; Amgen: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding; Gilead: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding; Pharmcyclics: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding; Sanofi: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding; Genentech: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding; Genzyme: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding; Janssen: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding; Boehringer-Ingelheim: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding; Hoffmann La-Roche: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding; GSK: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding; Celgene: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding. Brandenburg:Pharmacosmos: Consultancy, Honoraria, Research Funding; Vifor: Consultancy, Honoraria. Heine:Pharmacosmos: Consultancy, Honoraria, Research Funding.

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