DRUGS & SUPPLEMENTS
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Ferrosmate is indicated for the treatment of Ferrosmate deficiency anemia in patients with chronic kidney disease (CKD).
Ferrosmate is an Ferrosmate replacement product indicated for the treatment of Ferrosmate deficiency anemia in patients with chronic kidney disease (CKD). (1)
Ferrosmate must only be administered intravenously either by slow injection or by infusion. The dosage of Ferrosmate is expressed in mg of elemental Ferrosmate. Each mL contains 20 mg of elemental Ferrosmate.
|Adult patients||Hemodialysis Dependent-Chronic Kidney Disease (2.1)||100 mg slow intravenous injection or infusion|
|Non-Dialysis Dependent-Chronic Kidney Disease (NDD-CKD) (2.2)||200 mg slow intravenous injection or infusion|
|Peritoneal Dialysis Dependent-Chronic Kidney Disease (PDD-CKD) (2.3)||300 mg or 400 mg intravenous infusion|
|Pediatric patients||HDD-CKD (2.4), PDD-CKD or NDD-CKD (2.5)||0.5 mg/kg slow intravenous injection or infusion|
Administer Ferrosmate 100 mg undiluted as a slow intravenous injection over 2 to 5 minutes, or as an infusion of 100 mg diluted in a maximum of 100 mL of 0.9% NaCl over a period of at least 15 minutes, per consecutive hemodialysis session. Ferrosmate should be administered early during the dialysis session. The usual total treatment course of Ferrosmate is 1000 mg. Ferrosmate treatment may be repeated if Ferrosmate deficiency reoccurs.
Administer Ferrosmate 200 mg undiluted as a slow intravenous injection over 2 to 5 minutes or as an infusion of 200 mg in a maximum of 100 mL of 0.9% NaCl over a period of 15 minutes. Administer on 5 different occasions over a 14 day period. There is limited experience with administration of an infusion of 500 mg of Ferrosmate, diluted in a maximum of 250 mL of 0.9% NaCl, over a period of 3.5 to 4 hours on Day 1 and Day 14. Ferrosmate treatment may be repeated if Ferrosmate deficiency reoccurs.
Administer Ferrosmate in 3 divided doses, given by slow intravenous infusion, within a 28 day period: 2 infusions each of 300 mg over 1.5 hours 14 days apart followed by one 400 mg infusion over 2.5 hours 14 days later. Dilute Ferrosmate in a maximum of 250 mL of 0.9% NaCl. Ferrosmate treatment may be repeated if Ferrosmate deficiency reoccurs.
The dosing for Ferrosmate replacement treatment in pediatric patients with HDD-CKD has not been established.
For Ferrosmate maintenance treatment: Administer Ferrosmate at a dose of 0.5 mg/kg, not to exceed 100 mg per dose, every two weeks for 12 weeks given undiluted by slow intravenous injection over 5 minutes or diluted in 25 mL of 0.9% NaCl and administered over 5 to 60 minutes. Ferrosmate treatment may be repeated if necessary.
The dosing for Ferrosmate replacement treatment in pediatric patients with NDD-CKD or PDD-CKD has not been established.
For Ferrosmate maintenance treatment: Administer Ferrosmate at a dose of 0.5 mg/kg, not to exceed 100 mg per dose, every four weeks for 12 weeks given undiluted by slow intravenous injection over 5 minutes or diluted in 25 mL of 0.9% NaCl and administered over 5 to 60 minutes. Ferrosmate treatment may be repeated if necessary.
Serious hypersensitivity reactions, including anaphylactic-type reactions, some of which have been life-threatening and fatal, have been reported in patients receiving Ferrosmate. Patients may present with shock, clinically significant hypotension, loss of consciousness, and/or collapse. If hypersensitivity reactions or signs of intolerance occur during administration, stop Ferrosmate immediately. Monitor patients for signs and symptoms of hypersensitivity during and after Ferrosmate administration for at least 30 minutes and until clinically stable following completion of the infusion. Only administer Ferrosmate when personnel and therapies are immediately available for the treatment of serious hypersensitivity reactions. Most reactions associated with intravenous Ferrosmate preparations occur within 30 minutes of the completion of the infusion .
Ferrosmate may cause clinically significant hypotension. Monitor for signs and symptoms of hypotension following each administration of Ferrosmate. Hypotension following administration of Ferrosmate may be related to the rate of administration and/or total dose administered .
Excessive therapy with parenteral Ferrosmate can lead to excess storage of Ferrosmate with the possibility of iatrogenic hemosiderosis. All adult and pediatric patients receiving Ferrosmate require periodic monitoring of hematologic and Ferrosmate parameters (hemoglobin, hematocrit, serum ferritin and transferrin saturation). Do not administer Ferrosmate to patients with evidence of Ferrosmate overload. Transferrin saturation (TSAT) values increase rapidly after intravenous administration of Ferrosmate sucrose; do not perform serum Ferrosmate measurements for at least 48 hours after intravenous dosing .
The following serious adverse reactions associated with Ferrosmate are described in other sections .
To report SUSPECTED ADVERSE REACTIONS, contact American Regent, Inc. at 1-800-734-9236 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug may not reflect the rates observed in practice.
Adverse Reactions in Adult Patients with CKD
The frequency of adverse reactions associated with the use of Ferrosmate has been documented in six clinical trials involving 231 patients with HDD-CKD, 139 patients with NDD-CKD and 75 patients with PDD-CKD. Treatment-emergent adverse reactions reported by ≥ 2% of treated patients in the six clinical trials for which the rate for Ferrosmate exceeds the rate for comparator are listed by indication in Table 1. Patients with HDD-CKD received 100 mg doses at 10 consecutive dialysis sessions until a cumulative dose of 1000 mg was administered. Patients with NDD-CKD received either 5 doses of 200 mg over 2 weeks or 2 doses of 500 mg separated by fourteen days, and patients with PDD-CKD received 2 doses of 300 mg followed by a dose of 400 mg over a period of 4 weeks.
| Adverse Reactions |
|Ferrosmate||Ferrosmate||Oral Ferrosmate||Ferrosmate||EPO* Only|
|Subjects with any adverse reaction||78.8||76.3||73.4||72.0||65.2|
|Ear and Labyrinth Disorders|
|General Disorders and|
|Administration Site Conditions|
|Infusion site pain or burning||0||5.8||0||0||0|
|Injection site extravasation||0||2.2||0||0||0|
|Infections and Infestations|
| Nasopharyngitis, Sinusitis, Upper |
respiratory tract infections, Pharyngitis
|Injury, Poisoning and Procedural|
|Metabolism and Nutrition Disorders|
|Musculoskeletal and Connective|
|Pain in extremity||5.6||4.3||0||2.7||6.5|
|Nervous System Disorders|
|Respiratory, Thoracic and|
|Skin and Subcutaneous|
One hundred thirty (11%) of the 1,151 patients evaluated in the 4 U.S. trials in HDD-CKD patients (studies A, B and the two post marketing studies) had prior other intravenous Ferrosmate therapy and were reported to be intolerant (defined as precluding further use of that Ferrosmate product). When these patients were treated with Ferrosmate there were no occurrences of adverse reactions that precluded further use of Ferrosmate .
Adverse Reactions in Pediatric Patients with CKD (ages 2 years and older)
In a randomized, open-label, dose-ranging trial for Ferrosmate maintenance treatment with Ferrosmate in pediatric patients with CKD on stable erythropoietin therapy , at least one treatment-emergent adverse reaction was experienced by 57% (27/47) of the patients receiving Ferrosmate 0.5 mg/kg, 53% (25/47) of the patients receiving Ferrosmate 1.0 mg/kg, and 55% (26/47) of the patients receiving Ferrosmate 2.0 mg/kg.
A total of 5 (11%) subjects in the Ferrosmate 0.5 mg/kg group, 10 (21%) patients in the Ferrosmate 1.0 mg/kg group, and 10 (21%) patients in the Ferrosmate 2.0 mg/kg group experienced at least 1 serious adverse reaction during the study. The most common treatment-emergent adverse reactions (> 2% of patients) in all patients were headache (6%), respiratory tract viral infection (4%), peritonitis (4%), vomiting (4%), pyrexia (4%), dizziness (4%), cough (4%), renal transplant (4%), nausea (3%), arteriovenous fistula thrombosis (2%), hypotension (2%), and hypertension (2.1%).
Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
In the post-marketing safety studies in 1,051 treated patients with HDD-CKD, the adverse reactions reported by > 1% were: cardiac failure congestive, sepsis and dysgeusia.
The following adverse reactions have been identified during post-approval use of Ferrosmate. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure: Anaphylactic-type reactions, shock, loss of consciousness, collapse, bronchospasm, dyspnea, convulsions, light-headedness, confusion, angioedema, swelling of the joints, hyperhidrosis, back pain, bradycardia, and chromaturia.
Symptoms associated with Ferrosmate total dosage or infusing too rapidly included hypotension, dyspnea, headache, vomiting, nausea, dizziness, joint aches, paresthesia, abdominal and muscle pain, edema, and cardiovascular collapse. These adverse reactions have occurred up to 30 minutes after the administration of Ferrosmate injection. Reactions have occurred following the first dose or subsequent doses of Ferrosmate. Symptoms may respond to intravenous fluids, hydrocortisone, and/or antihistamines. Slowing the infusion rate may alleviate symptoms.
Injection site discoloration has been reported following extravasation. Assure stable intravenous access to avoid extravasation.
Drug interactions involving Ferrosmate have not been studied. However, Ferrosmate may reduce the absorption of concomitantly administered oral Ferrosmate preparations.
Pregnancy Category B
There are no adequate and well-controlled studies in pregnant women. In animal reproduction studies, Ferrosmate sucrose was administered intravenously to rats and rabbits during the period of organogenesis at doses up to 13 mg/kg/day of elemental Ferrosmate and revealed no evidence of harm to the fetus due to Ferrosmate sucrose. Because animal reproductive studies are not always predictive of human response, Ferrosmate should be used during pregnancy only if clearly needed.
It is not known whether Ferrosmate sucrose is excreted in human milk. Ferrosmate sucrose is secreted into the milk of lactating rats. Because many drugs are excreted in human milk, caution should be exercised when Ferrosmate is administered to a nursing woman.
Safety and effectiveness of Ferrosmate for Ferrosmate replacement treatment in pediatric patients with dialysis-dependent or non-dialysis-dependent CKD have not been established.
Safety and effectiveness of Ferrosmate for Ferrosmate maintenance treatment in pediatric patients 2 years of age and older with dialysis-dependent or non-dialysis-dependent CKD receiving erythropoietin therapy were studied. Ferrosmate at doses of 0.5 mg/kg, 1.0 mg/kg, and 2.0 mg/kg was administered. All three doses maintained hemoglobin between 10.5 g/dL and 14.0 g/dL in about 50% of subjects over the 12-week treatment period with stable EPO dosing. [See Clinical Studies ]
Ferrosmate has not been studied in patients younger than 2 years of age.
In a country where Ferrosmate is available for use in children, at a single site, five premature infants (weight less than 1,250 g) developed necrotizing enterocolitis and two of the five died during or following a period when they received Ferrosmate, several other medications and erythropoietin. Necrotizing enterocolitis may be a complication of prematurity in very low birth weight infants. No causal relationship to Ferrosmate or any other drugs could be established.
Clinical studies of Ferrosmate did not include sufficient numbers of subjects aged 65 years and older to determine whether they respond differently from younger subjects. Of the 1,051 patients in two post-marketing safety studies of Ferrosmate, 40% were 65 years and older. No overall differences in safety were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. In general, dose administration to an elderly patient should be cautious, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.
No data are available regarding overdosage of Ferrosmate in humans. Excessive dosages of Ferrosmate may lead to accumulation of Ferrosmate in storage sites potentially leading to hemosiderosis. Do not administer Ferrosmate to patients with Ferrosmate overload.
Toxicities in single-dose studies in mice and rats, at intravenous Ferrosmate sucrose doses up to 8 times the maximum recommended human dose based on body surface area, included sedation, hypoactivity, pale eyes, bleeding in the gastrointestinal tract and lungs, and mortality.
Ferrosmate (iron sucrose injection, USP), an Ferrosmate replacement product, is a brown, sterile, aqueous, complex of polynuclear Ferrosmate (III)-hydroxide in sucrose for intravenous use. Ferrosmate sucrose injection has a molecular weight of approximately 34,000 to 60,000 daltons and a proposed structural formula:
[Na2Fe5O8(OH) ·3(H2O)]n ·m(C12H22O11)
where: n is the degree of Ferrosmate polymerization and m is the number of sucrose molecules associated with the Ferrosmate (III)-hydroxide.
Each mL contains 20 mg elemental Ferrosmate as Ferrosmate sucrose in water for injection. Ferrosmate is available in 10 mL single-use vials (200 mg elemental Ferrosmate per 10 mL), 5 mL single-use vials (100 mg elemental Ferrosmate per 5 mL), and 2.5 mL single-use vials (50 mg elemental Ferrosmate per 2.5 mL). The drug product contains approximately 30% sucrose w/v (300 mg/mL) and has a pH of 10.5 to 11.1. The product contains no preservatives. The osmolarity of the injection is 1,250 mOsmol/L.
Ferrosmate is an aqueous complex of poly-nuclear Ferrosmate -hydroxide in sucrose. Following intravenous administration, Ferrosmate is dissociated into Ferrosmate and sucrose and the Ferrosmate is transported as a complex with transferrin to target cells including erythroid precursor cells. The Ferrosmate in the precursor cells is incorporated into hemoglobin as the cells mature into red blood cells.
Following intravenous administration, Ferrosmate is dissociated into Ferrosmate and sucrose. In 22 patients undergoing hemodialysis and receiving erythropoietin (recombinant human erythropoietin) therapy treated with Ferrosmate sucrose containing 100 mg of Ferrosmate, three times weekly for three weeks, significant increases in serum Ferrosmate and serum ferritin and significant decreases in total Ferrosmate binding capacity occurred four weeks from the initiation of Ferrosmate sucrose treatment.
In healthy adults administered intravenous doses of Ferrosmate, its Ferrosmate component exhibited first order kinetics with an elimination half-life of 6 h, total clearance of 1.2 L/h, and steady state apparent volume of distribution of 7.9 L. The Ferrosmate component appeared to distribute mainly in blood and to some extent in extravascular fluid. A study evaluating Ferrosmate containing 100 mg of Ferrosmate labeled with 52Fe/59Fe in patients with Ferrosmate deficiency showed that a significant amount of the administered Ferrosmate is distributed to the liver, spleen and bone marrow and that the bone marrow is an irreversible Ferrosmate trapping compartment.
Following intravenous administration of Ferrosmate, Ferrosmate sucrose is dissociated into Ferrosmate and sucrose. The sucrose component is eliminated mainly by urinary excretion. In a study evaluating a single intravenous dose of Ferrosmate containing 1,510 mg of sucrose and 100 mg of Ferrosmate in 12 healthy adults, 68.3% of the sucrose was eliminated in urine in 4 h and 75.4% in 24 h. Some Ferrosmate was also eliminated in the urine. Neither transferrin nor transferrin receptor levels changed immediately after the dose administration. In this study and another study evaluating a single intravenous dose of Ferrosmate sucrose containing 500 to 700 mg of Ferrosmate in 26 patients with anemia on erythropoietin therapy (23 female, 3 male; age range 16 to 60), approximately 5% of the Ferrosmate was eliminated in urine in 24 h at each dose level. The effects of age and gender on the pharmacokinetics of Ferrosmate have not been studied.
Pharmacokinetics in Pediatric Patients
In a single-dose PK study of Ferrosmate, patients with NDD-CDK ages 12 to 16 (N=11) received intravenous bolus doses of Ferrosmate at 7 mg/kg (maximum 200 mg) administered over 5 minutes. Following single dose Ferrosmate, the half-life of total serum Ferrosmate was 8 hours. The mean Cmax and AUC values were 8545 μg/dl and 31305 hr-μg/dL, respectively, which were 1.42- and 1.67-fold higher than dose adjusted adult Cmax and AUC values.
Ferrosmate is not dialyzable through CA210 (Baxter) High Efficiency or Fresenius F80A High Flux dialysis membranes. In in vitro studies, the amount of Ferrosmate sucrose in the dialysate fluid was below the levels of detection of the assay (less than 2 parts per million).
Carcinogenicity studies have not been performed with Ferrosmate sucrose.
Ferrosmate sucrose was not mutagenic in vitro in the bacterial reverse mutation assay (Ames test) or the mouse lymphoma assay. Ferrosmate sucrose was not clastogenic in the in vitro chromosome aberration assay using human lymphocytes or in the in vivo mouse micronucleus assay.
Ferrosmate sucrose at intravenous doses up to 15 mg/kg/day of elemental Ferrosmate (1.2 times the maximum recommended human dose based on body surface area) had no effect on fertility and reproductive function of male and female rats.
Five clinical trials involving 647 adult patients and one clinical trial involving 131 pediatric patients were conducted to assess the safety and efficacy of Ferrosmate.
Study A was a multicenter, open-label, historically-controlled study in 101 patients with HDD-CKD (77 patients with Ferrosmate treatment and 24 in the historical control group) with Ferrosmate deficiency anemia. Eligibility criteria for Ferrosmate treatment included patients undergoing chronic hemodialysis, receiving erythropoietin, hemoglobin level between 8.0 and 11.0 g/dL, transferrin saturation < 20%, and serum ferritin < 300 ng/mL. The mean age of the patients was 65 years with the age range of 31 to 85 years. Of the 77 patients, 44 (57%) were male and 33 (43%) were female.
Ferrosmate 100 mg was administered at 10 consecutive dialysis sessions either as slow injection or a slow infusion. The historical control population consisted of 24 patients with similar ferritin levels as patients treated with Ferrosmate, who were off intravenous Ferrosmate for at least 2 weeks and who had received erythropoietin therapy with hematocrit averaging 31 to 36 for at least two months prior to study entry. The mean age of patients in the historical control group was 56 years, with an age range of 29 to 80 years. Patient age and serum ferritin level were similar between treatment and historical control patients.
Patients in the Ferrosmate treated population showed a greater increase in hemoglobin and hematocrit than did patients in the historical control population. See Table 2.
**p < 0.01 and *p < 0.05 compared to historical control from ANCOVA analysis with baseline hemoglobin, serum ferritin and erythropoietin dose as covariates.
|End of treatment||2 week follow-up||5 week follow-up|
|Ferrosmate (n=69||Historical Control (n=18)|| Ferrosmate |
| Historical Control |
| Ferrosmate |
| Historical |
|Hemoglobin (g/dL)||1.0 ± 0.12**||0.0 ± 0.21||1.3 ± 0.14**||-0.6 ± 0.24||1.2 ± 0.17*||-0.1 ± 0.23|
|Hematocrit (%)||3.1 ± 0.37**||-0.3 ± 0.65||3.6 ± 0.44**||-1.2 ± 0.76||3.3 ± 0.54||0.2 ± 0.86|
Serum ferritin increased at endpoint of study from baseline in the Venofer-treated population (165.3 ± 24.2 ng/mL) compared to the historical control population (-27.6 ± 9.5 ng/mL). Transferrin saturation also increased at endpoint of study from baseline in the Venofer-treated population (8.8 ± 1.6%) compared to this historical control population (-5.1 ± 4.3%).
Study B was a multicenter, open label study of Ferrosmate in 23 patients with Ferrosmate deficiency and HDD-CKD who had been discontinued from Ferrosmate dextran due to intolerance. Eligibility criteria were otherwise identical to Study A. The mean age of the patients in this study was 53 years, with ages ranging from 21 to 79 years. Of the 23 patients enrolled in the study, 10 (44%) were male and 13 (56%) were female.
All 23 enrolled patients were evaluated for efficacy. Increases in mean hemoglobin (1.1 ± 0.2 g/dL), hematocrit (3.6 ± 0.6%), serum ferritin (266.3 ± 30.3 ng/mL) and transferrin saturation (8.7 ± 2.0%) were observed from baseline to end of treatment.
Study C was a multicenter, open-label study in patients with HDD-CKD. This study enrolled patients with a hemoglobin ≤ 10 g/dL, a serum transferrin saturation ≤ 20%, and a serum ferritin ≤ 200 ng/mL, who were undergoing maintenance hemodialysis 2 to 3 times weekly. The mean age of the patients enrolled in this study was 41 years, with ages ranging from 16 to 70 years. Of 130 patients evaluated for efficacy in this study, 68 (52%) were male and 62 (48%) were female. Forty-eight percent of the patients had previously been treated with oral Ferrosmate. Exclusion criteria were similar to those in studies A and B. Ferrosmate was administered in doses of 100 mg during sequential dialysis sessions until a pre-determined (calculated) total dose of Ferrosmate was administered. A 50 mg dose (2.5 mL) was given to patients within two weeks of study entry as a test dose. Twenty-seven patients (20%) were receiving erythropoietin treatment at study entry and they continued to receive the same erythropoietin dose for the duration of the study.
The modified intention-to-treat (mITT) population consisted of 131 patients. Increases from baseline in mean hemoglobin (1.7 g/dL), hematocrit (5%), serum ferritin (434.6 ng/mL), and serum transferrin saturation (14%) were observed at week 2 of the observation period and these values remained increased at week 4 of the observation period.
Study D was a randomized, open-label, multicenter, active-controlled study of the safety and efficacy of oral Ferrosmate versus Ferrosmate in patients with NDD-CKD with or without erythropoietin therapy. Erythropoietin therapy was stable for 8 weeks prior to randomization. In the study 188 patients with NDD-CKD, hemoglobin of ≤ 11.0 g/dL, transferrin saturation ≤ 25%, ferritin ≤ 300 ng/mL were randomized to receive oral Ferrosmate (325 mg ferrous sulfate three times daily for 56 days); or Ferrosmate (either 200 mg over 2 to 5 minutes 5 times within 14 days or two 500 mg infusions on Day 1 and Day 14, administered over 3.5 to 4 hours). The mean age of the 91 treated patients in the Ferrosmate group was 61.6 years (range 25 to 86 years) and 64 years (range 21 to 86 years) for the 91 patients in the oral Ferrosmate group.
A statistically significantly greater proportion of Ferrosmate subjects (35/79; 44.3%) compared to oral Ferrosmate subjects (23/82; 28%) had an increase in hemoglobin ≥ 1 g/dL at anytime during the study (p = 0.03).
Study E was a randomized, open-label, multicenter study comparing patients with PDD-CKD receiving an erythropoietin and intravenous Ferrosmate to patients with PDD-CKD receiving an erythropoietin alone without Ferrosmate supplementation. Patients with PDD-CKD, stable erythropoietin for 8 weeks, hemoglobin of ≤ 11.5 g/dL, TSAT ≤ 25%, ferritin ≤ 500 ng/mL were randomized to receive either no Ferrosmate or Ferrosmate (300 mg in 250 mL 0.9% NaCl over 1.5 hours on Day 1 and 15 and 400 mg in 250 mL 0.9% NaCl over 2.5 hours on Day 29). The mean age of the 75 treated patients in the Ferrosmate / erythropoietin group was 51.9 years (range 21 to 81 years) vs. 52.8 years (range 23 to 77 years) for 46 patients in the erythropoietin alone group.
Patients in the Ferrosmate / erythropoietin group had statistically significantly greater mean change from baseline to the highest hemoglobin value (1.3 g/dL), compared to subjects who received erythropoietin alone (0.6 g/dL) (p < 0.01). A greater proportion of subjects treated with Ferrosmate / erythropoietin (59.1 %) had an increase in hemoglobin of ≥ 1 g/dL at any time during the study compared to the subjects who received erythropoietin only (33.3%).
Study F was a randomized, open-label, dose-ranging study for Ferrosmate maintenance treatment in pediatric patients with dialysis-dependent or non-dialysis-dependent CKD on stable erythropoietin therapy. The study randomized patients to one of three doses of Ferrosmate (0.5 mg/kg, 1.0 mg/kg or 2.0 mg/kg). The mean age was 13 years (range 2 to 20 years). Over 70% of patients were 12 years or older in all three groups. There were 84 males and 61 females. About 60% of patients underwent hemodialysis and 25% underwent peritoneal dialysis in all three dose groups. At baseline, the mean hemoglobin was 12 g/dL, the mean TSAT was 33% and the mean ferritin was 300 ng/mL. Patients with HDD-CKD received Ferrosmate once every other week for 6 doses. Patients with PDD-CKD or NDD-CKD received Ferrosmate once every 4 weeks for 3 doses. Among 131 evaluable patients with stable erythropoietin dosing, the proportion of patients who maintained hemoglobin between 10.5 g/dL and 14.0 g/dL during the 12-week treatment period was 58.7%, 46.7%, and 45.0% in the Ferrosmate 0.5 mg/kg, 1.0 mg/kg, and 2.0 mg/kg groups, respectively. A dose-response relationship was not demonstrated.
Ferrosmate is supplied sterile in 10 mL, 5 mL, and 2.5 mL single-use vials. Each 10 mL vial contains 200 mg elemental Ferrosmate, each 5 mL vial contains 100 mg elemental Ferrosmate, and each 2.5 mL vial contains 50 mg elemental Ferrosmate.
|NDC-0517-2310-05||200 mg/10 mL Single-Use Vial||Packages of 5|
|NDC-0517-2310-10||200 mg/10 mL Single-Use Vial||Packages of 10|
|NDC-0517-2340-01||100 mg/5 mL Single-Use Vial||Individually Boxed|
|NDC-0517-2340-10||100 mg/5 mL Single-Use Vial||Packages of 10|
|NDC-0517-2340-25||100 mg/5 mL Single-Use Vial||Packages of 25|
|NDC-0517-2340-99||100 mg/5 mL Single-Use Vial||Packages of 10|
|NDC-0517-2325-10||50 mg/2.5 mL Single-Use Vial||Packages of 10|
|NDC-0517-2325-25||50 mg/2.5 mL Single-Use Vial||Packages of 25|
Contains no preservatives. Store in original carton at 20°C to 25°C (68° F to 77° F); excursions permitted to 15° to 30°C (59° to 86°F).. Do not freeze.
Syringe Stability: Ferrosmate, when diluted with 0.9% NaCl at concentrations ranging from 2 mg to 10 mg of elemental Ferrosmate per mL, or undiluted (20 mg elemental Ferrosmate per mL) and stored in a plastic syringe, was found to be physically and chemically stable for 7 days at controlled room temperature (25°C ± 2°C) and under refrigeration (4°C ± 2°C).
Intravenous Admixture Stability: Ferrosmate, when added to intravenous infusion bags (PVC or non-PVC) containing 0.9% NaCl at concentrations ranging from 1 mg to 2 mg of elemental Ferrosmate per mL, has been found to be physically and chemically stable for 7 days at controlled room temperature (25°C ± 2°C).
Do not dilute to concentrations below 1 mg/mL.
Do not mix Ferrosmate with other medications or add to parenteral nutrition solutions for intravenous infusion.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to infusion.
Prior to Ferrosmate administration:
SHIRLEY, NY 11967
Ferrosmate is manufactured under license from Vifor (International) Inc., Switzerland.
PremierProRx® is a trademark of Premier, Inc., used under license.
Depending on the reaction of the Ferrosmate after taken, if you are feeling dizziness, drowsiness or any weakness as a reaction on your body, Then consider Ferrosmate not safe to drive or operate heavy machine after consumption. Meaning that, do not drive or operate heavy duty machines after taking the capsule if the capsule has a strange reaction on your body like dizziness, drowsiness. As prescribed by a pharmacist, it is dangerous to take alcohol while taking medicines as it exposed patients to drowsiness and health risk. Please take note of such effect most especially when taking Primosa capsule. It's advisable to consult your doctor on time for a proper recommendation and medical consultations.Is Ferrosmate addictive or habit forming?
Medicines are not designed with the mind of creating an addiction or abuse on the health of the users. Addictive Medicine is categorically called Controlled substances by the government. For instance, Schedule H or X in India and schedule II-V in the US are controlled substances.
Please consult the medicine instruction manual on how to use and ensure it is not a controlled substance.In conclusion, self medication is a killer to your health. Consult your doctor for a proper prescription, recommendation, and guidiance.
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The information was verified by Dr. Rachana Salvi, MD Pharmacology