Tolerability Of Ferric Carboxymaltose Research Articles

Safety and tolerability of intravenous ferric carboxymaltose in the oldest old patients: a prospective cohort study in a University Italian Geriatrics Department

Background & aims. Anemia is common in older adults and it is associated with relevant complications. Although anemia is often multifactorial in origin and iron deficiency is considered a key relevant causative factor. The first therapeutic option is oral iron supplementation, but it is frequently characterized by adverse effects and overall poor efficacy. So far, intravenous (i.v.) iron formulations may serve as alternative treatment options and, in particular, Ferric carboxymaltose (FCM), showed to be safe and effective in older patients. We aimed to assess the safety and tolerability of FCM in real world hospitalized frail oldest old patients. Methods.This is an observational prospective study on 25 old age patients with iron deficiency anemia (IDA), admitted between July 2019 and November 2019 to the Geriatric Clinical ward of the IRCCS Policlinico San Martino, Genoa, Italy and treated with i.v. FCM. The incidence, probability and severity of adverse drug reactions (ADR) were reported along with the clinical response in term of mean Haemoglobin (Hb) increase after one week from the drug administration. Results. 72% of patients were oldest old with IDA and the clinical phenotype was characterized by multimorbidity and disability. The mean dose of i.v. FCM was 1160.0 ± 313.6 mg. FCM resulted safe therapeutic option with overall good tolerability. Additionally, a significant clinical improvement in the mean Hb level was observed. Conclusions. These findings moved a step in the recommendation of i.v. iron supplementation as a preferable route in oldest old, serving as a potential platform for future randomized clinical studies.

Effectiveness and safety of ferric carboxymaltose to treat iron deficiency anemia in cancer patients.

e23153 Background: Most cancer patients are faced with anemia during the disease course. Iron deficiency (ID) is one of the major causes of anemia in cancer patients.Bleeding, malabsorption and organ dysfunction may cause iron deficiency in cancer patients. Anemia may result in a decrease in the patient's performance and delayed chemotherapy. Administration of intravenous (IV) iron is a therapeutic option in cancer patients with iron-deficiency related anemia. In this study we analyzed effectiveness and tolerability of ferric carboxymaltose in cancer patients with iron deficiency anemia Methods: This is a retrospective analysis of 603 cancer patients who were treated with ferric carboxymaltose for anemia and iron-deficiency between October 2014 and April 2017 in a tertiary cancer clinic. Demographic data, cancer diagnoses, pre- and post-treatment hemoglobin levels, pre-treatment ferritin, serum iron, and transferrin saturation (TSA) levels were recorded. Results: The median age of the population was 55 (22-90) years, and 52% were male. Of 603 patients, 47.9% (n = 289) had gastrointestinal malignancies and 17% (n = 103) had breast cancer. A total of 331 patients (55%) received cytotoxic chemotherapy and 272 patients (45%) were not on anti-cancer treatment. Median dose of the ferric carboxymaltose is 1000 mg (500-2000). The median baseline hemoglobin, ferritin and TSA were 10.7 (7-13) g/dl, 28 (2.9-2200) ng/ml and 9.3 (1-19) %, respectively. The median hemoglobin level at the 12th week of treatment was 12.7 g/dl. The median increase in hemoglobin was 2.9 (-0.10-6.9) g/dl in patients whom received cytotoxic chemotherapy. Only 2 patients had allergic reaction during IV ferric carboxymaltose administration and treatment was discontinued. Conclusions: Intravenous-iron improved hemoglobin levels both in actively treated and not-actively treated cancer patients. The effect has been shown in the first 3 months after injection. This approach is safe and tolerable. However, the impact of tumor progression on IV iron replacement is unclear, further studies are required.

Pharmacokinetics, pharmacodynamics, safety, and tolerability of intravenous ferric carboxymaltose: a dose-escalation study in Japanese volunteers with iron-deficiency anemia.

Iron-deficiency anemia (IDA) is the most common form of anemia. Iron replacement therapy is an effective treatment, but oral and previously available intravenous (IV) formulations in Japan have disadvantages such as side effects, immunogenic reactions, low dose per tablet/vial, and the need for continuous administration. Ferric carboxymaltose (FCM), which overcomes these limitations, is widely used as an IV iron preparation outside of Japan. In this single-center, open-label, single-dose escalation study, we investigated the pharmacokinetics (PK), pharmacodynamics (PD), safety, and tolerability of FCM in Japanese subjects. Twenty-four Japanese IDA patients, diagnosed by hemoglobin, serum ferritin, and transferrin saturation, were assigned in equal groups to the 100, 500, 800, and 1000mg iron dose arms. All subjects completed the study without important protocol deviations. Mean total serum iron concentrations showed a rapid, dose-dependent increase after FCM injection, reaching a maximum within 1h. Mean reticulocyte counts significantly increased in all arms, suggesting improved hematopoietic function. Fourteen of 24 subjects experienced adverse events, but these were neither serious nor led to drug interruption. The PK/PD and safety profiles were similar in Japanese and European subjects. Ferric carboxymaltose is safe for administration in Japanese patients with IDA.

Clinical use of ferric carboxymaltose in patients with solid tumours or haematological malignancies in France.

This study collected data on the use of ferric carboxymaltose (FCM) in a cancer patient population in France to evaluate the feasibility and the conditions of use of FCM in routine clinical practice beyond the limiting criteria of clinical trials. This observational, prospective study of patients with a solid tumour or a haematological malignancy who have received treatment with FCM after 01 July 2011 evaluated data about the circumstances of iron administration, concomitant medication and laboratory tests in the period from 3 months prior to the first FCM administration (baseline) until 3 months post-baseline. Data from 367 FCM-treated patients were analysed. FCM was mainly given as a single dose at baseline (69.2%) and without additional erythropoiesis-stimulating agent (ESA, 64.3%). The median total iron dose was 1000 mg per patient. Median haemoglobin (Hb) levels of FCM-treated patients improved from 10.3 g/dL (interquartile range 9.5, 11.1 g/dL) at baseline to 11.8 g/dL (11.1, 13.0 g/dL) until the end of the 3-month observational period. Patients treated with FCM alone or additional ESA achieved similar median Hb increase (1.3 [0.4, 2.1] g/dL and 1.4 [0.4, 2.5] g/dL, respectively). Patients with baseline Hb up to 11.0 g/dL and serum ferritin up to 500 ng/mL and beyond achieved stable median Hb levels ≥11.0 g/dL without signs of iron overload. No severe or serious adverse reaction and no hypersensitivity reactions were reported. The results of this observational study confirm the effectiveness and tolerability of FCM when given in clinical routine practice alone or in combination with an ESA.

Clinical experience with ferric carboxymaltose in the treatment of cancer- and chemotherapy-associated anaemia

BackgroundIntravenous (i.v.) iron can improve anaemia of chronic disease and response to erythropoiesis-stimulating agents (ESAs), but data on its use in practice and without ESAs are limited. This study evaluated effectiveness and tolerability of ferric carboxymaltose (FCM) in routine treatment of anaemic cancer patients.Patients and methodsOf 639 patients enrolled in 68 haematology/oncology practices in Germany, 619 received FCM at the oncologist's discretion, 420 had eligible baseline haemoglobin (Hb) measurements, and 364 at least one follow-up Hb measurement. Data of transfused patients were censored from analysis before transfusion.ResultsThe median total iron dose was 1000 mg per patient (interquartile range 600–1500 mg). The median Hb increase was comparable in patients receiving FCM alone (1.4 g/dl [0.2–2.3 g/dl; N = 233]) or FCM + ESA (1.6 g/dl [0.7–2.4 g/dl; N = 46]). Patients with baseline Hb up to 11.0 g/dl and serum ferritin up to 500 ng/ml benefited from FCM treatment (stable Hb ≥11.0 g/dl). Also patients with ferritin >500 ng/ml but low transferrin saturation benefited from FCM treatment. FCM was well tolerated, 2.3% of patients reported putative drug-related adverse events.ConclusionsThe substantial Hb increase and stabilisation at 11–12 g/dl in FCM-treated patients suggest a role for i.v. iron alone in anaemia correction in cancer patients.

3000 POSTER DISCUSSION Effectiveness and Tolerability of Ferric Carboxymaltose in the Correction of Cancer – and Chemotherapy-associated Anaemia – a Multicenter Observational Study

3000 POSTER DISCUSSION Effectiveness and Tolerability of Ferric Carboxymaltose in the Correction of Cancer – and Chemotherapy-associated Anaemia – a Multicenter Observational Study

Safety and tolerability of ferric carboxymaltose (FCM) for treatment of iron deficiency in patients with chronic kidney disease and in kidney transplant recipients

Iron deficiency is common in patients with chronic kidney disease and in kidney transplant recipients. We analyzed the safety and tolerability of the new intravenous iron preparation ferric carboxymaltose (FCM) in these two patient groups. Adverse events after administration of the drug were assessed by using a questionnaire. Vital signs and laboratory data were collected before and after the application of FCM. A total of 46 FCM doses were applied to 44 patients (17 with chronic kidney disease and 27 kidney transplant recipients) either as single injection of 100 or 200 mg (n = 42) or as short infusion with up to 500 mg (n = 4). Mild and transient adverse events (metallic taste, headache, dizziness) occurred in six patients. The estimated glomerular filtration rate remained unchanged by the FCM administration. We conclude that safety and tolerability of FCM were excellent. Compared with other intravenous iron preparations the considerably shorter administration time of FCM allows to save time and to reduce costs.

55: Treating postpartum anemia with intravenous ferric carboxymaltose in a randomized controlled study

A RANDOMIZED CONTROLLED STUDY MELVIN H. SEID, RALPH ROGERS, QUINN DINH, Lyndhurst Gynecologic Associates, Winston Salem, North Carolina, Women’s Clinical Research, Newburgh, Indiana, American Regent/Luitpold Pharmaceuticals, Norristown, Pennsylvania OBJECTIVE: To evaluate the superiority, safety and tolerability of ferric carboxymaltose (FCM) to oral iron in postpartum women with iron deficiency anemia (IDA). FCM is a novel non-dextran iron agent given in large doses by rapid IV injection. STUDY DESIGN: In a randomized, controlled, superiority designed pivotal trial, 289 women 10 days post-delivery with hemoglobin 10g/dL were randomized and received: (a) FCM up to 1,000mg IV over 15 minutes, repeated weekly to correct anemia up to maximum total calculated dose of 2,500mg, or (b) Oral ferrous sulfate 325mg (65mg elemental iron) thrice daily for 6 weeks. RESULTS: Patients (n 142) received 293 IV doses of FCM (mean total dose 1504mg) in 1, 2, or 3 injection(s) [5%, 84%, or 11% respectively]; 147 received oral iron. FCM group compared with oral iron group was: (1) more likely to achieve hemoglobin (Hb) 12g/dL (91% vs. 67%, p .0001) in a shorter time period (14 days vs. 27 days, p .0002) with sustained success (85% vs. 58%) at Day 42, (p .0001), (2) more likely to achieve Hb rise 3.0g/dL at any time (91% vs. 65%, p .0001) in a shorter time period (15 days vs. 28 days, p .0001), and (3) more likely to attain higher transferrin saturation (TSAT) (36% vs. 28%) and ferritin (647 ng/mL vs. 12 ng/mL), p .0001. Drug-related adverse events (AEs) were lower with FCM (11%) than oral iron (22%). Urticaria (2%) was the only drug-related AE occurring in 2% of the FCM group. Constipation (11%;0%), elevated ALT (4%; 0.7%), elevated AST (2%;0.7%), and nausea (2%;1.4%) were more common with oral iron than FCM, respectively. No hypotensive or drug-related serious AEs such as hypersensitivity or anaphylactic reactions were reported in either treatment group. CONCLUSION: Ferric carboxymaltose (FCM) was safe and well-tolerated. FCM was superior to oral iron in increasing Hb 12g/dL earlier with greater sustained success. FCM was more effective in raising TSAT and ferritin. This non-dextran IV iron agent may fulfill an unmet medical need for safe, rapid administration of iron in single doses up to 1,000mg in postpartum women with IDA.