Venofer iron sucrose 20 mg/mL Injection, Solution
Other active recalls for Iron Sucrose (different manufacturers) — 1 · tap to view
🆔 Identity & classification
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🏷️ RxNorm drug class
This medicine belongs to the Parenteral Iron Replacement class.
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🏭 Manufacturer & labeler
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🩺 Clinical
- Iron sucrose injection is a way to get iron directly into your bloodstream through an IV. It's used when you have iron deficiency anemia — meaning your body doesn't have enough iro...
- What exactly is iron sucrose injection and why do I need it?
- A nurse or healthcare professional will place an IV and slowly administer the medication — the infusion itself can take anywhere from a few minutes to a couple of hours depending o...
- What will happen during my infusion? How long does it take?
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🧪 Inactive Ingredients / Excipients
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UNII 059QF0KO0R
Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.
1 inactive ingredient listed in the exact product block matched to this NDC.
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ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.Inactive ingredient FAQ
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💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per mL | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | Not in the retail survey — common for institutional, discontinued, or low-volume packs. | |
| Medicaid paysCMS SDUD · 12 mo | $15.88 | $1,985.49 / 125 ml |
| Medicare drug plans payPart D · quarterly | No Part D plan price is available for this NDC in our data. | |
| Medicare Part B allowsASP · J1756 | $0.227 / J1756 unit | — |
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🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Venofer 20 mg/mL 00517-2310-05 | American | 5 vials | $12.531 | AB | FDA listed | — |
| Venofer 20 mg/mL 00517-2340-01 | American | 1 vial | — | AB | FDA listed | — |
| Iron Sucrose 100 mg/5mL 00781-3486-95 | Sandoz | 10 vials | — | AB | FDA listed | — |
| Venofer 20 mg/mLthis 49230-0534-25 | Fresenius | 25 vials | — | AB | FDA listed | — |
| Venofer (Iron Sucrose) 20 mg/mL 51662-1568-01 | HF | 5 ml | — | AB | FDA listed | — |
| Iron Sucrose 100 mg/5mL 67457-0638-10 | Mylan | 10 vials | — | AB | FDA listed | — |
| Iron Sucrose 20 mg/mL 76329-9201-01 | International | 10 vials | — | AB | FDA listed | — |
| Venofer 20 mg/mL 49230-0530-10 | Fresenius | 10 vials | — | AB | FDA listed | — |
| Iron Sucrose 20 mg/mL 76329-9202-05 | International | 5 vials | — | AB | FDA listed | — |
| Iron Sucrose 20 mg/mL 76329-9200-01 | International | 10 vials | — | AB | FDA listed | — |
| Venofer 20 mg/mL 00517-2325-10 | American | 10 vials | — | AB | FDA listed | — |
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⏳ Availability & generic status
The FDA lists approved generic versions of this medicine, but that does not always mean a pharmacy can get one today. Patent rules, launch agreements, supply and pricing can affect when generics actually arrive.
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🗺️ Medicaid utilization & spend
💊 Medicaid utilization by pack size
🔬 Reported adverse events (FAERS)
Top reported reactions
Age at onset
Reporter sex
Serious outcomes
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📦 Packaging — all sizes for this product
| Package NDC | Description | Per unit | Per pack | Marketing start | Status |
|---|---|---|---|---|---|
| 49230-0534-10 | 10 VIAL, SINGLE-DOSE in 1 BOX (49230-534-10) / 5 mL in 1 VIAL, SINGLE-DOSE (49230-534-01) | $12.21 / mL | $610.34 | 2008-11-04 | Active |
| 49230-0534-25 You're viewing this | 25 VIAL, SINGLE-DOSE in 1 TRAY (49230-534-25) / 5 mL in 1 VIAL, SINGLE-DOSE (49230-534-01) | — | — | 2008-11-04 | Active |
In Medicaid, this is the most-dispensed pack of this product — about 67% of fills over the last four reported quarters. See all packs ↓
Pack size FAQ
What quantity is in NDC 49230-0534-25?
What NDC number is used to bill for this package of Venofer iron sucrose 20 mg/mL Injection, Solution?
Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.
🧭 About this NDC listing & data coverage
What data is (and isn’t) available for this NDC — tap to expand
| NDC identity (package / product / labeler codes) | ✓ Available |
| Labeler | ✓ Available |
| Product & package description | ✓ Available |
| Marketing category & status | ✓ Available |
| Active ingredient / dosage form / route | ✓ Available |
| FDA label (SPL via DailyMed) | ✓ Available |
| Package photos | ✓ Available |
| Inactive ingredients (structured) | ✓ Available |
| NADAC pharmacy acquisition price (CMS) | — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey. |
| Orange Book / therapeutic-equivalence data | ✓ Available |
| HCPCS J-code billing crosswalk | ✓ Available |
| Medicaid utilization (CMS SDUD) | ✓ Available |
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📄 Full prescribing information FDA SPL
🎯 Indications and Usage ▾
1 INDICATIONS AND USAGE Venofer is indicated for the treatment of iron deficiency anemia (IDA) in patients with chronic kidney disease (CKD). Venofer is an iron replacement product indicated for the treatment of iron deficiency anemia (IDA) in patients with chronic kidney disease (CKD). ( 1 )
⏱️ Dosage and Administration ▾
2 DOSAGE AND ADMINISTRATION Venofer must only be administered intravenously either by slow injection or by infusion. The dosage of Venofer is expressed in mg of elemental iron. Each mL contains 20 mg of elemental iron.
Population Dose Adult patients Hemodialysis Dependent-Chronic Kidney Disease (HDD-CKD) ( 2.2 ) 100 mg slow intravenous injection or infusion Non-Dialysis Dependent-Chronic Kidney Disease (NDD-CKD) ( 2.3 ) 200 mg slow intravenous injection or infusion Peritoneal Dialysis Dependent-Chronic Kidney Disease (PDD-CKD) ( 2.4 ) 300 mg or 400 mg intravenous infusion Pediatric patients HDD-CKD ( 2.5 ), PDD-CKD or NDD-CKD ( 2.6 ) 0.5 mg/kg slow intravenous injection or infusion
2.1Mode of Administration Administer Venofer only intravenously by slow injection or by infusion. The dosage of Venofer is expressed in mg of elemental iron. Each mL contains 20 mg of elemental iron.
2.2Adult Patients with Hemodialysis Dependent-Chronic Kidney Disease (HDD-CKD) Administer Venofer 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 [see How Supplied/Storage and Handling ( 16.2 )]. Administer Venofer early during the dialysis session (generally within the first hour). The usual total treatment course of Venofer is 1000 mg.
Venofer treatment may be repeated if iron deficiency reoccurs.
2.3Adult Patients with Non-Dialysis Dependent-Chronic Kidney Disease (NDD-CKD) Administer Venofer 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 Venofer, 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 [see How Supplied/Storage and Handling ( 16.2 )].
Venofer treatment may be repeated if iron deficiency reoccurs.
2.4Adult Patients with Peritoneal Dialysis Dependent-Chronic Kidney Disease (PDD-CKD) Administer Venofer 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 Venofer in a maximum of 250 mL of 0.9% NaCl [see How Supplied/Storage and Handling ( 16.2 )]. Venofer treatment may be repeated if iron deficiency reoccurs.
2.5Pediatric Patients (2 Years of Age and Older) with HDD-CKD for Iron Maintenance Treatment For iron maintenance treatment: Administer Venofer 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 0.9% NaCl at a concentration of 1 to 2 mg/mL and administered over 5 to 60 minutes. Do not dilute to concentrations below 1 mg/mL [see How Supplied/Storage and Handling ( 16.2 )]. Venofer treatment may be repeated if necessary.
The dosing for iron replacement treatment in pediatric patients with HDD-CKD has not been established.
2.6Pediatric Patients (2 Years of Age and Older) with NDD-CKD or PDD-CKD who are on Erythropoietin Therapy for Iron Maintenance Treatment For iron maintenance treatment: Administer Venofer 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 0.9% NaCl at a concentration of 1 to 2 mg/mL and administered over 5 to 60 minutes. Do not dilute to concentrations below 1 mg/mL [see How Supplied/Storage and Handling ( 16.2 )].
Venofer treatment may be repeated if necessary. The dosing for iron replacement treatment in pediatric patients with NDD-CKD or PDD-CKD has not been established.
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS Injection: 50 mg/2.5 mL or 100 mg/5 mL (20 mg/mL) in single-dose vials. Injection: 50 mg/2.5 mL or 100 mg/5 mL (20 mg/mL) in single-dose vials. ( 3 )
⛔ Contraindications ▾
4 CONTRAINDICATIONS Known hypersensitivity to Venofer Known hypersensitivity to Venofer ( 4 )
⚠️ Warnings and Cautions ▾
5 WARNINGS AND PRECAUTIONS Hypersensitivity Reactions: Observe for signs and symptoms of hypersensitivity during and after Venofer administration for at least 30 minutes and until clinically stable following completion of each administration. Only administer Venofer when personnel and therapies are immediately available for the treatment of serious hypersensitivity reactions. ( 5.1 ) Hypotension: Venofer may cause hypotension.
Monitor for signs and symptoms of hypotension during and following each administration of Venofer. ( 5.2 ) Iron Overload: Regularly monitor hematologic responses during Venofer therapy. Do not administer Venofer to patients with iron overload.
( 5.3 )
5.1Hypersensitivity Reactions Serious hypersensitivity reactions, including anaphylactic-type reactions, some of which have been life-threatening and fatal, have been reported in patients receiving Venofer. 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 Venofer immediately.
Monitor patients for signs and symptoms of hypersensitivity during and after Venofer administration for at least 30 minutes and until clinically stable following completion of the infusion. Only administer Venofer when personnel and therapies are immediately available for the treatment of serious hypersensitivity reactions. Most reactions associated with intravenous iron preparations occur within 30 minutes of the completion of the infusion [see Adverse Reactions ( 6.1 and 6.2 )].
5.2Hypotension Venofer may cause clinically significant hypotension. Monitor for signs and symptoms of hypotension following each administration of Venofer. Hypotension following administration of Venofer may be related to the rate of administration and/or total dose administered [see Dosage and Administration ( 2 ), Warnings and Precautions ( 5.1 ), and Adverse Reactions ( 6.2 )].
5.3Iron Overload Excessive therapy with parenteral iron can lead to excess storage of iron with the possibility of iatrogenic hemosiderosis. All adult and pediatric patients receiving Venofer require periodic monitoring of hematologic and iron parameters (hemoglobin, hematocrit, serum ferritin and transferrin saturation). Do not administer Venofer to patients with evidence of iron overload.
Transferrin saturation (TSAT) values increase rapidly after intravenous administration of iron sucrose; do not perform serum iron measurements for at least 48 hours after intravenous dosing [see Dosage and Administration ( 2 ) and Overdosage ( 10 )].
🤒 Adverse Reactions ▾
6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: • Hypersensitivity Reactions [see Warnings and Precautions ( 5.1 )] • Hypotension [see Warnings and Precautions ( 5.2 )] • Iron Overload [see Warnings and Precautions ( 5.3 )] Adult patients: The most common adverse reactions (≥2%) are diarrhea, nausea, vomiting, headache, dizziness, hypotension, pruritus, pain in extremity, arthralgia, back pain, muscle cramp, injection site reactions, chest pain, and peripheral edema.
( 6.1 ) Pediatric patients: The most common adverse reactions (≥2%) are headache, respiratory tract viral infection, peritonitis, vomiting, pyrexia, dizziness, cough, nausea, arteriovenous fistula thrombosis, hypotension, and hypertension. ( 6.1 ) 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 .
6.1Adverse Reactions in Clinical Trials 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 Venofer has been documented in six clinical trials involving 231 patients with HDD-CKD, 139 patients with NDD-CKD and 75 patients with PDD-CKD. Adverse reactions reported by ≥ 2% of treated patients in the six clinical trials for which the rate for Venofer 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. Table 1.
Adverse Reactions Reported in ≥ 2% of Study Populations and for which the Rate for Venofer Exceeds the Rate for Comparator * EPO=Erythropoietin Body System/Adverse Reactions HDD-CKD NDD-CKD PDD-CKD Venofer Venofer Oral Iron Venofer EPO* Only (N=231) (N=139) (N=139) (N=75) (N=46) % % % % % Subjects with any adverse reaction 78.8 76.3 73.4 72.0
65.2Ear and Labyrinth Disorders Ear Pain 0 2.2 0.7 0 0 Eye Disorders Conjunctivitis 0.4 0 0 2.7 0 Gastrointestinal Disorders Abdominal pain 3.5 1.4 2.9 4.0
6.5Diarrhea 5.2 7.2 10.1 8.0
4.3Dysgeusia 0.9 7.9 0 0 0 Nausea 14.7 8.6 12.2 5.3
4.3Vomiting 9.1 5.0 8.6 8.0
2.2General Disorders and Administration Site Conditions Asthenia 2.2 0.7 2.2 2.7 0 Chest pain 6.1 1.4 0 2.7 0 Feeling abnormal 3.0 0 0 0 0 Infusion site pain or burning 0 5.8 0 0 0 Injection site extravasation 0 2.2 0 0 0 Peripheral edema 2.6 7.2 5.0 5.3
10.9Pyrexia 3.0 0.7 0.7 1.3 0 Infections and Infestations Nasopharyngitis, Sinusitis, Upper respiratory tract infections, Pharyngitis 2.6 2.2 4.3 16.0
4.3Injury, Poisoning and Procedural Complications Graft complication 9.5 1.4 0 0 0 Metabolism and Nutrition Disorders Fluid overload 3.0 1.4 0.7 1.3 0 Gout 0 2.9 1.4 0 0 Hyperglycemia 0 2.9 0 0
2.2Hypoglycemia 0.4 0.7 0.7 4.0 0 Musculoskeletal and Connective Tissue Disorders Arthralgia 3.5 1.4 2.2 4.0
4.3Back pain 2.2 2.2 3.6 1.3
4.3Muscle cramp 29.4 0.7 0.7 2.7 0 Myalgia 0 3.6 0 1.3 0 Pain in extremity 5.6 4.3 0 2.7
6.5Nervous System Disorders Dizziness 6.5 6.5 1.4 1.3
4.3Headache 12.6 2.9 0.7 4.0 0 Respiratory, Thoracic and Mediastinal Disorders Cough 3.0 2.2 0.7 1.3 0 Dyspnea 3.5 5.8 1.4 1.3
2.2Nasal congestion 0 1.4 2.2 1.3 0 Skin and Subcutaneous Tissue Disorders Pruritus 3.9 2.2 4.3 2.7 0 Vascular Disorders Hypertension 6.5 6.5 4.3 8.0
6.5Hypotension 39.4 2.2 0.7 2.7
2.2One 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 iron therapy and were reported to be intolerant (defin…
🔄 Drug Interactions ▾
7 DRUG INTERACTIONS Venofer may reduce the absorption of concomitantly administered oral iron preparations. The most common adverse reactions (≥2%) following the administration of Venofer are diarrhea, nausea, vomiting, headache, dizziness, hypotension, pruritus, pain in extremity, arthralgia, back pain, muscle cramp, injection site reactions, chest pain, and peripheral edema. ( 6.1 )
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS
8.1Pregnancy Risk Summary Published studies on intravenous iron sucrose treatment after the first trimester of pregnancy have not shown adverse maternal or fetal outcomes (see Data) . Available reports of intravenous iron sucrose use in pregnant women during the first trimester are insufficient to assess the risk of major birth defects and miscarriage. There are risks to the mother and fetus associated with untreated IDA in pregnancy as well as risks to the fetus associated with maternal severe hypersensitivity reactions (see Clinical Considerations) .
Animal reproduction studies of iron sucrose administered to rats and rabbits during the period of organogenesis at elemental iron doses equivalent to the maximum recommended human dose based on body surface area revealed no evidence of harm to the fetus (see Data). The estimated background risk of major birth defects and miscarriage for the indicated populations is unknown. Adverse outcomes in pregnancy occur regardless of the health of the mother or the use of medications.
In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically-recognized pregnancies is 2-4% and 15-20%, respectively. Clinical Considerations Disease-associated maternal and/or embryo/fetal risk Iron deficiency anemia during pregnancy should be treated. Untreated IDA in pregnancy is associated with adverse maternal outcomes such as post-partum anemia.
Adverse pregnancy outcomes associated with IDA include increased risk for preterm delivery and low birth weight. Fetal/Neonatal adverse reactions Severe adverse reactions including circulatory failure (severe hypotension, shock including in the context of anaphylactic reaction) may occur in pregnant women with parenteral iron products (such as Venofer) which may cause fetal bradycardia, especially during the second and third trimester. Data Human Data Published data from randomized controlled studies and prospective observational studies on the use of Venofer in pregnant women have not reported an association of Venofer and adverse developmental outcomes.
However, these studies did not include women exposed during the first trimester of pregnancy and were not designed to assess the risk of major birth defects. Maternal adverse events reported in these studies are similar to those reported during clinical trials in adult males and non-pregnant females [see Adverse Reactions (6.1)] . Animal Data Iron sucrose was administered intravenously to rats and rabbits during the period of organogenesis at elemental iron doses up to 13 mg/kg/day (0.25 times or equivalent to the maximum recommended human dose based on body surface area, respectively) and revealed no evidence of harm to the fetus.
8.2Lactation Risk Summary Iron sucrose is present in human milk, and available published reports following exposure to 100-300 mg intravenous iron sucrose have not reported adverse reactions in breastfed infants (see Data) . There are no data on the effects on milk production. The developmental and health benefits of breastfeeding should be considered, along with the mother’s clinical need for Venofer and any potential adverse effects on the breastfed child from Venofer or from the underlying maternal condition.
Data A published study showed no difference in iron concentration in the colostrum of 10 iron deficient breastfeeding women who were 2 to 3 days postpartum and received a single dose of 100 mg of intravenous iron sucrose compared to 5 breastfeeding women who received no iron. These results may underestimate the amount of iron in breastmilk following the standard dose of Venofer. A published report of 78 breastfeeding women who received 300 mg of intravenous iron sucrose over 3 days (infant age not reported) did not report on the safety of iron sucrose in breastfed infants; however adverse reactions in breastfed infants were not reported.
Clinical Considerations Monitor breastfed infants for…
🤰 Pregnancy ▾
8.1Pregnancy Risk Summary Published studies on intravenous iron sucrose treatment after the first trimester of pregnancy have not shown adverse maternal or fetal outcomes (see Data) . Available reports of intravenous iron sucrose use in pregnant women during the first trimester are insufficient to assess the risk of major birth defects and miscarriage. There are risks to the mother and fetus associated with untreated IDA in pregnancy as well as risks to the fetus associated with maternal severe hypersensitivity reactions (see Clinical Considerations) .
Animal reproduction studies of iron sucrose administered to rats and rabbits during the period of organogenesis at elemental iron doses equivalent to the maximum recommended human dose based on body surface area revealed no evidence of harm to the fetus (see Data). The estimated background risk of major birth defects and miscarriage for the indicated populations is unknown. Adverse outcomes in pregnancy occur regardless of the health of the mother or the use of medications.
In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically-recognized pregnancies is 2-4% and 15-20%, respectively. Clinical Considerations Disease-associated maternal and/or embryo/fetal risk Iron deficiency anemia during pregnancy should be treated. Untreated IDA in pregnancy is associated with adverse maternal outcomes such as post-partum anemia.
Adverse pregnancy outcomes associated with IDA include increased risk for preterm delivery and low birth weight. Fetal/Neonatal adverse reactions Severe adverse reactions including circulatory failure (severe hypotension, shock including in the context of anaphylactic reaction) may occur in pregnant women with parenteral iron products (such as Venofer) which may cause fetal bradycardia, especially during the second and third trimester. Data Human Data Published data from randomized controlled studies and prospective observational studies on the use of Venofer in pregnant women have not reported an association of Venofer and adverse developmental outcomes.
However, these studies did not include women exposed during the first trimester of pregnancy and were not designed to assess the risk of major birth defects. Maternal adverse events reported in these studies are similar to those reported during clinical trials in adult males and non-pregnant females [see Adverse Reactions (6.1)] . Animal Data Iron sucrose was administered intravenously to rats and rabbits during the period of organogenesis at elemental iron doses up to 13 mg/kg/day (0.25 times or equivalent to the maximum recommended human dose based on body surface area, respectively) and revealed no evidence of harm to the fetus.
🧒 Pediatric Use ▾
8.4Pediatric Use Safety and effectiveness of Venofer for iron replacement treatment in pediatric patients with dialysis-dependent or non-dialysis-dependent CKD have not been established. Safety and effectiveness of Venofer for iron maintenance treatment in pediatric patients 2 years of age and older with dialysis-dependent or non-dialysis-dependent CKD receiving erythropoietin therapy were studied. Venofer at doses of 0.5 mg/kg, 1 mg/kg, and 2 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 ( 14.7 )]. Venofer has not been studied in patients younger than 2 years of age. In a country where Venofer 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 Venofer, several other medications and erythropoietin.
Necrotizing enterocolitis may be a complication of prematurity in very low birth weight infants. No causal relationship to Venofer or any other drugs could be established.
🧓 Geriatric Use ▾
8.5Geriatric Use Of the 1,051 patients in two post-marketing safety studies of Venofer, 40% were 65 years and older. No overall differences in safety or effectiveness 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.
🆘 Overdosage ▾
10 OVERDOSAGE No data are available regarding overdosage of Venofer in humans. Excessive dosages of Venofer may lead to accumulation of iron in storage sites potentially leading to hemosiderosis. Do not administer Venofer to patients with iron overload [see Warnings and Precautions ( 5.3 )].
Venofer is not dialyzable through CA210 (Baxter) High Efficiency or Fresenius F80A High Flux dialysis membranes. Toxicities in single-dose studies in mice and rats, at intravenous iron 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.
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY
12.1Mechanism of Action Venofer is an aqueous complex of poly-nuclear iron (III)-hydroxide in sucrose. Following intravenous administration, Venofer is dissociated into iron and sucrose and the iron is transported as a complex with transferrin to target cells including erythroid precursor cells. The iron in the precursor cells is incorporated into hemoglobin as the cells mature into red blood cells.
12.2Pharmacodynamics Following intravenous administration, Venofer is dissociated into iron and sucrose. In 22 patients undergoing hemodialysis and receiving erythropoietin (recombinant human erythropoietin) therapy treated with iron sucrose containing 100 mg of iron, three times weekly for three weeks, significant increases in serum iron and serum ferritin and significant decreases in total iron binding capacity occurred four weeks from the initiation of iron sucrose treatment.
12.3Pharmacokinetics In healthy adults administered intravenous doses of Venofer, its iron 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
7.9L. The iron component appeared to distribute mainly in blood and to some extent in extravascular fluid. A study evaluating Venofer containing 100 mg of iron labeled with 52 Fe/ 59 Fe in patients with iron deficiency showed that a significant amount of the administered iron is distributed to the liver, spleen and bone marrow and that the bone marrow is an irreversible iron trapping compartment.
Following intravenous administration of Venofer, iron sucrose is dissociated into iron and sucrose. The sucrose component is eliminated mainly by urinary excretion. In a study evaluating a single intravenous dose of Venofer containing 1,510 mg of sucrose and 100 mg of iron in 12 healthy adults (9 female, 3 male: age range 32 to 52), 68.3% of the sucrose was eliminated in urine in 4 h and 75.4% in 24 h.
Some iron 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 iron sucrose containing 500 to 700 mg of iron in 26 patients with anemia on erythropoietin therapy (23 female, 3 male; age range 16 to 60), approximately 5% of the iron was eliminated in urine in 24 h at each dose level.
The effects of age and gender on the pharmacokinetics of Venofer have not been studied. Pharmacokinetics in Pediatric Patients In a single-dose PK study of Venofer, patients with NDD-CKD ages 12 to 16 (N=11) received intravenous bolus doses of Venofer at 7 mg/kg (maximum 200 mg) administered over 5 minutes. Following a single dose of Venofer, the half-life of total serum iron 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. Venofer is not dialyzable through CA210 (Baxter) High Efficiency or Fresenius F80A High Flux dialysis membranes. In in vitro studies, the amount of iron sucrose in the dialysate fluid was below the levels of detection of the assay (less than 2 parts per million).
🧬 Mechanism of Action ▾
12.1Mechanism of Action Venofer is an aqueous complex of poly-nuclear iron (III)-hydroxide in sucrose. Following intravenous administration, Venofer is dissociated into iron and sucrose and the iron is transported as a complex with transferrin to target cells including erythroid precursor cells. The iron in the precursor cells is incorporated into hemoglobin as the cells mature into red blood cells.
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/storage and handling
16.1How Supplied Venofer is supplied sterile in 5 mL and 2.5 mL single-dose vials. Each 5 mL vial contains 100 mg elemental iron, and each 2.5 mL vial contains 50 mg elemental iron (20 mg/mL). NDC-49230-534-10 100 mg/5 mL Single-Dose Vial Packages of 10 NDC-49230-534-25 100 mg/5 mL Single-Dose Vial Packages of 25 NDC-49230-530-10 50 mg/2.5 mL Single-Dose Vial Packages of 10 NDC-49230-530-25 50 mg/2.5 mL Single-Dose Vial Packages of 25
16.2Stability and Storage 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) [see USP Controlled Room Temperature]. Do not freeze.
Syringe Stability : Venofer, when diluted with 0.9% NaCl at concentrations ranging from 2 mg to 10 mg of elemental iron per mL, or undiluted (20 mg elemental iron 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: Venofer, 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 iron 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 Venofer 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.
📦 Storage and Handling ▾
16.2Stability and Storage 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) [see USP Controlled Room Temperature]. Do not freeze.
Syringe Stability : Venofer, when diluted with 0.9% NaCl at concentrations ranging from 2 mg to 10 mg of elemental iron per mL, or undiluted (20 mg elemental iron 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: Venofer, 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 iron 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 Venofer 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.
📋 Description ▾
11 DESCRIPTION Venofer (iron sucrose injection, USP), an iron replacement product, is a brown, sterile, aqueous, complex of polynuclear iron (III)-hydroxide in sucrose for intravenous use. Iron sucrose injection has a molecular weight of approximately 34,000 to 60,000 daltons and a proposed structural formula: [Na 2 Fe 5 O 8 (OH) ·3(H 2 O)] n ·m(C 12 H 22 O 11 ) where: n is the degree of iron polymerization and m is the number of sucrose molecules associated with the iron (III)-hydroxide. Each mL contains 20 mg elemental iron as iron sucrose in water for injection.
Venofer is available in 5 mL single-dose vials (100 mg elemental iron per 5 mL), and 2.5 mL single-dose vials (50 mg elemental iron per 2.5 mL). The drug product contains approximately 30% sucrose w/v (300 mg/mL). Sodium hydroxide may be added to adjust pH to 10.5 to 11.1.
The product contains no preservatives. The osmolarity of the injection is 1,250 mOsmol/L.
💬 Information for Patients ▾
17 PATIENT COUNSELING INFORMATION Prior History of Reactions to Parenteral Iron Products Question patients regarding any prior history of reactions to parenteral iron products [see Warnings and Precautions ( 5 )]. Serious Hypersensitivity Reactions Advise patients to report any symptoms of hypersensitivity that may develop during and following Venofer administration, such as rash, itching, dizziness, light-headedness, swelling, and breathing problems [see Warnings and Precautions ( 5 )] . Distributed by: Fresenius Medical Care, NA Waltham, MA 02451 1-800-323-5188 IN534 100801.K MG # 25536 Venofer is manufactured under license from American Regent, Inc.
(Shirley, NY) and Vifor (International) Inc., Switzerland.