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Sodium Ferric Gluconate Complex In Sucrose (Sodium Ferric Gluconate Complex In Sucrose)

Trade Name : Sodium Ferric Gluconate Complex in Sucrose

West-Ward Pharmaceuticals Corp

INJECTION

Strength 12.5 mg/mL

SODIUM FERRIC GLUCONATE COMPLEX Iron [CS],Parenteral Iron Replacement [EPC],Phosphate Binder [EPC],Phosphate Chelating Activity [MoA]

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GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Sodium Ferric Gluconate Complex In Sucrose (Sodium Ferric Gluconate Complex In Sucrose) which is also known as Sodium Ferric Gluconate Complex in Sucrose and Manufactured by West-Ward Pharmaceuticals Corp. It is available in strength of 12.5 mg/mL per ml. Read more

Sodium Ferric Gluconate Complex In Sucrose (Sodium Ferric Gluconate Complex In Sucrose) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials.  Click to know price.     Read less

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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  • No data
  • Sodium ferric gluconate complex in sucrose injection is indicated for the treatment of iron deficiency anemia in adult patients and in pediatric patients age 6 years and older with chronic kidney disease receiving hemodialysis who are receiving supplemental epoetin therapy.
  • Sodium ferric gluconate complex in sucrose injection is an iron replacement product for treatment of iron deficiency anemia in adult patients and in pediatric patients age 6 years and older with chronic kidney disease receiving hemodialysis who are receiving supplemental epoetin therapy. ()
  • The dosage of sodium ferric gluconate complex in sucrose injection is expressed in terms of mg of elemental iron. Each 5 mL sterile, single dose vial contains 62.5 mg of elemental iron (12.5 mg/mL).
  • Do not mix sodium ferric gluconate complex in sucrose injection with other medications, or add to parenteral nutrition solutions for intravenous infusion. The compatibility of sodium ferric gluconate complex in sucrose injection with intravenous infusion vehicles other than 0.9% sodium chloride has not been evaluated. Parenteral drug products should be inspected visually for particulate matter and discoloration before administration, whenever the solution and container permit. If diluted, use immediately.
  • Sodium ferric gluconate complex in sucrose injection treatment may be repeated if iron deficiency reoccurs.
  • Adult Patients - The recommended adult dosage is 10u00a0mL (125 mg of elemental iron) diluted in 100 mL of 0.9% sodium chloride administered by intravenous infusion over 1 hour per dialysis session or undiluted as a slow intravenous injection (at a rate of up to 12.5 mg/min) per dialysis session. ()u00a0 nn
  • Pediatric Patients - The recommended pediatric dosage is 0.12 mL/kg (1.5 mg/kg of elemental iron) diluted in 25 mL 0.9% sodium chloride and administered by intravenous infusion over 1 hour per dialysis session. () nn
  • Do not mix sodium ferric gluconate complex in sucrose injection with other medications or add to parenteral nutrition solutions for intravenous infusion. nn
  • Administer in 0.9% saline. ()
  • Sodium ferric gluconate complex in sucrose injection is available as a single dose vial, containing 62.5 mg of elemental iron in 5 mL volume.
  • Sodium ferric gluconate complex in sucrose injection is supplied in a single dose vial containing 62.5 mg of elemental iron in 5 mL. ()
  • Known hypersensitivity to sodium ferric gluconate or any of its components.
  • Known hypersensitivity to sodium ferric gluconate or any of its inactive components. ()
  • No data
  • Hypersensitivity Reactions: Monitor patients for signs and symptoms of hypersensitivity during and after sodium ferric gluconate complex in sucrose injection administration for at least 30 minutes and until clinically stable following completion of the infusion. Only administer sodium ferric gluconate complex in sucrose injection when personnel and therapies are immediately available for the treatment of anaphylaxis and other hypersensitivity reactions. () nn
  • Hypotension: Sodium ferric gluconate complex in sucrose injection may cause hypotension. Monitor patients for signs and symptoms of hypotension during and following each sodium ferric gluconate complex in sucrose injection dose. () nn
  • Iron Overload: Regularly monitor hematologic responses during sodium ferric gluconate complex in sucrose injection therapy. Do not administer sodium ferric gluconate complex in sucrose injection to patients with iron overload. () nn
  • Benzyl Alcohol Toxicity: Premature and low-birthweight infants may be more likely to develop toxicity. ()
  • The following serious adverse reactions are discussed in greater detail in other sections of the labeling:
  • The most commonly reported adverse reactions (u226510%) in adult patients were nausea, vomiting and/or diarrhea, injection site reaction, hypotension, cramps, hypertension, dizziness, dyspnea, chest pain, leg cramps and pain. In patients 6 to 15 years of age the most common adverse reactions (u226510%) were hypotension, headache, hypertension, tachycardia and vomiting. ()
  • Drug-drug interactions involving sodium ferric gluconate complex in sucrose injection have not been studied. Sodium ferric gluconate complex in sucrose injection may reduce the absorption of concomitantly administered oral iron preparations.
  • No data
  • Pregnancy: Use only if clearly needed (contains benzyl alcohol). () nn
  • Nursing Mothers: Caution should be exercised when administered to a nursing woman (contains benzyl alcohol). () nn
  • Pediatric Use: Safety and effectiveness have not been established in pediatric patients <6 years of age. ()
  • The sodium ferric gluconate complex in sucrose injection iron complex is not dialyzable.
  • No data is available regarding overdose of sodium ferric gluconate complex in sucrose injection in humans. Excessive dosages of sodium ferric gluconate complex in sucrose injection may lead to accumulation of iron in storage sites potentially leading to hemosiderosis. Do not administer sodium ferric gluconate complex in sucrose injection to patients with iron overload [see n n ].
  • Individual doses exceeding 125 mg may be associated with a higher incidence and/or severity of adverse events [see n n ].
  • Sodium ferric gluconate complex in sucrose injection at elemental iron doses of 125 mg/kg, 78.8 mg/kg, 62.5 mg/kg and 250 mg/kg caused deaths in mice, rats, rabbits, and dogs respectively. The major symptoms of acute toxicity were decreased activity, staggering, ataxia, increases in the respiratory rate, tremor, and convulsions.
  • Sodium ferric gluconate complex in sucrose injection, an iron replacement product, is a stable macromolecular complex with an apparent molecular weight on gel chromatography of 289,000 u2013 440,000 daltons. The macromolecular complex is negatively charged at alkaline pH and is present in solution with sodium cations. The product has a deep red color indicative of ferric oxide linkages. The chemical name is D-Gluconic acid, iron (3+) sodium salt.
  • The structural formula is considered to be [NaFeO(CHO)(CHO)5].u00a0
  • Each sterile, single dose vial of 5 mL of sodium ferric gluconate complex in sucrose injection for intravenous injection contains 62.5 mg (12.5u00a0mg/mL) of elemental iron as the sodium salt of a ferric ion carbohydrate complex in an alkaline aqueous solution with approximately 20% sucrose w/v (195 mg/mL) in water for injection, pH 7.7 - 9.7.
  • Each mL contains 9 mg of benzyl alcohol as an inactive ingredient.
  • No data
  • Long term carcinogenicity studies of sodium ferric gluconate in animals were not performed.
  • Sodium ferric gluconate was not genotoxic in the Ames test or the rat micronucleus test. Sodium ferric gluconate produced a clastogenic effect in an chromosomal aberration assay in Chinese hamster ovary cells.
  • Studies to assess the effects of sodium ferric gluconate on fertility were not conducted.
  • Two clinical studies (Studies A and B) were conducted in adults and one clinical study was conducted in pediatric patients (Study C) to assess the efficacy and safety of sodium ferric gluconate complex in sucrose injection.
  • Study A
  • Study A was a three-center, randomized, open-label study of the safety and efficacy of two doses of sodium ferric gluconate complex in sucrose injection administered intravenously to iron-deficient hemodialysis patients. The study included both a dose-response concurrent control and an historical control. Enrolled patients received a test dose of sodium ferric gluconate complex in sucrose injection (25u00a0mg of elemental iron) and were then randomly assigned to receive sodium ferric gluconate complex in sucrose injection at cumulative doses of either 500u00a0mg (low dose) or 1000u00a0mg (high dose) of elemental iron. Sodium ferric gluconate complex in sucrose injection was given to both dose groups in eight divided doses during sequential dialysis sessions (a period of 16 to 17 days). At each dialysis session, patients in the low-dose group received sodium ferric gluconate complex in sucrose injection 62.5u00a0mg of elemental iron over 30 minutes, and those in the high-dose group received sodium ferric gluconate complex in sucrose injection 125u00a0mg of elemental iron over 60 minutes. The primary endpoint was the change in hemoglobin from baseline to the last available observation through Day 40.
  • Eligibility for this study included chronic hemodialysis patients with a hemoglobin below 10u00a0g/dL (or hematocrit at or below 32%) and either serum ferritin below 100 ng/mL or transferrin saturation below 18%. Exclusion criteria included significant underlying disease or inflammatory conditions or an epoetin requirement of greater than 10,000 units three times per week. Parenteral iron and red cell transfusion were not allowed for two months before the study. Oral iron and red cell transfusion were not allowed during the study for sodium ferric gluconate complex in sucrose injection-treated patients.
  • The historical control population consisted of 25 chronic hemodialysis patients who received only oral iron supplementation for 14 months and did not receive red cell transfusion. All patients had stable epoetin doses and hematocrit values for at least two months before initiation of oral iron therapy.
  • The evaluated population consisted of 39 patients in the low-dose sodium ferric gluconate complex in sucrose injection group (50% female, 50% male; 74% white, 18% black, 5% Hispanic, 3% Asian; mean age 54 years, range 22-83 years), 44 patients in the high-dose sodium ferric gluconate complex in sucrose injection group (50% female, 48% male, 2% unknown; 75% white, 11% black, 5% Hispanic, 7% other, 2% unknown; mean age 56 years, range 20-87 years), and 25 historical control patients (68% female, 32% male; 40% white, 32% black, 20% Hispanic, 4% Asian, 4% unknown; mean age 52 years, range 25-84 years).
  • The mean baseline hemoglobin and hematocrit were similar between treatment and historical control patients: 9.8 g/dL and 29% and 9.6 g/dL and 29% in low- and high-dose sodium ferric gluconate complex in sucrose injection-treated patients, respectively, and 9.4 g/dL and 29% in historical control patients. Baseline serum transferrin saturation was 20% in the low-dose group, 16% in the high-dose group, and 14% in the historical control. Baseline serum ferritin was 106 ng/mL in the low-dose group, 88 ng/mL in the high-dose group, and 606 ng/mL in the historical control.
  • Patients in the high-dose sodium ferric gluconate complex in sucrose injection group achieved significantly higher increases in hemoglobin and hematocrit than patients in the low-dose sodium ferric gluconate complex in sucrose injection group. See Table 1.
  • Study B
  • Study B was a single-center, non-randomized, open-label, historically-controlled, study of the safety and efficacy of variable, cumulative doses of intravenous sodium ferric gluconate complex in sucrose injection in iron-deficient hemodialysis patients. Sodium ferric gluconate complex in sucrose injection administration was identical to Study A. The primary efficacy variable was the change in hemoglobin from baseline to the last available observation through Day 50.
  • Inclusion and exclusion criteria were identical to those of Study A as was the historical control population. Sixty-three patients were evaluated in this study: 38 in the sodium ferric gluconate complex in sucrose injection-treated group (37% female, 63% male; 95% white, 5% Asian; mean age 56 years, range 22-84 years) and 25 in the historical control group (68% female, 32% male; 40% white, 32% black, 20% Hispanic, 4% Asian, 4% unknown; mean age 52 years, range 25-84 years).
  • Sodium ferric gluconate complex in sucrose injection-treated patients were considered to have completed the study per protocol if they received at least eight sodium ferric gluconate complex in sucrose injection doses of either 62.5u00a0mg or 125u00a0mg of elemental iron. A total of 14 patients (37%) completed the study per protocol. Twelve (32%) sodium ferric gluconate complex in sucrose injection-treated patients received less than eight doses, and 12 (32%) patients had incomplete information on the sequence of dosing. Not all patients received sodium ferric gluconate complex in sucrose injection at consecutive dialysis sessions and many received oral iron during the study.
  • Baseline hemoglobin and hematocrit values were similar between the treatment and control groups, and were 9.1u00a0g/dL and 27.3%, respectively, for sodium ferric gluconate complex in sucrose injection-treated patients. Serum iron studies were also similar between treatment and control groups, with the exception of serum ferritin, which was 606u00a0ng/mL for historical control patients, compared to 77u00a0ng/mL for sodium ferric gluconate complex in sucrose injection-treated patients.
  • In this patient population, only the sodium ferric gluconate complex in sucrose injection-treated group achieved increase in hemoglobin and hematocrit from baseline. See Table 2.
  • Study C
  • Study C was a multicenter, randomized, open-label study of the safety and efficacy of two sodium ferric gluconate complex in sucrose injection dose regimens (1.5u00a0mg/kg or 3.0u00a0mg/kg of elemental iron) administered intravenously to 66 iron-deficient (transferrin saturation <20% and/or serum ferritin <100 ng/mL) pediatric hemodialysis patients, 6 to 15 years of age, inclusive who were receiving a stable erythropoietin dosing regimen.
  • Sodium ferric gluconate complex in sucrose injection at a dose of 1.5 mg/kg or 3.0 mg/kg (up to a maximum dose of 125 mg of elemental iron) in 25 mL 0.9% sodium chloride was infused intravenously over 1 hour during each hemodialysis session for eight sequential dialysis sessions. Thirty-two patients received the 1.5u00a0mg/kg dosing regimen (47% male, 53% female; 66% Caucasian, 25% Hispanic, and 3% Black, Asian, or Other; mean age 12.3 years). Thirty-four patients received the 3.0 mg/kg dosing regimen (56% male, 44% female; 77% Caucasian, 12% Hispanic, 9% Black, and 3% Other; mean age 12.0 years).
  • The primary endpoint was the change in hemoglobin concentration from baseline to 2 weeks after last sodium ferric gluconate complex in sucrose injection administration. There was no significant difference between the treatment groups. Improvements in hematocrit, transferrin saturation, serum ferritin, and reticulocyte hemoglobin concentrations compared to baseline values were observed 2 weeks after the last sodium ferric gluconate complex in sucrose injection infusion in both the 1.5 mg/kg and 3.0 mg/kg treatment groups (Table 3).
  • The increased hemoglobin concentrations were maintained at 4 weeks after the last sodium ferric gluconate complex in sucrose injection infusion in both the 1.5 mg/kg and the 3.0 mg/kg sodium ferric gluconate complex in sucrose injection dose treatment groups.
  • How Suppliedn
  • Storagen
  • Keep out of the reach of children.
  • Prior to sodium ferric gluconate complex in sucrose injection administration:
  • Advise patients that sodium ferric gluconate complex in sucrose injection may reduce the absorption of concomitantly administered oral iron preparations [see n n ].
  • Manufactured by
  • Distributed byn
  • NOVAPLUSu00a0is a registered trademark of Vizient, Inc.
  • NOVAPLUSu00ae
  • Issued September 2017
  • PIN473-NOV/1n n
  • NDC 0143-9298-01u00a0u00a0 5 mL Single Dose Vialu00a0u00a0u00a0 n n
  • NDC 0143-9298-10u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 PLB111-NOV/1n n 10 x 5 mL Single Dose Vialsn n n n
  • No data

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