Venofer 20 mg/mL
iron sucrose · INJECTION, SOLUTION · American Regent, Inc.
Venofer is a injection, solution containing iron sucrose at 20 mg/mL, taken intravenous. Manufactured by American Regent, Inc..
Key Facts
- Brand Name
- Venofer
- Generic Name
- iron sucrose
- NDC Code (Product)
0517-2310- Manufacturer
- American Regent, Inc.
- Strength
- 20 mg/mL
- Dosage Form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Marketing Status
- Application #
- NDA021135
- Drug Class
- Parenteral Iron Replacement [EPC]
- Marketing Start
- 06/12/2007
Recall History
American Regent, Inc.
Presence of Particulate Matter: Potential for glass delamination from the vials.
American Regent, Inc.
Presence of Particulate Matter: Potential for glass delamination from the vials.
American Regent, Inc.
Presence of Particulate Matter: Potential for glass delamination from the vials.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & 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 & 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 2.1 Mode 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. 2.2 Adult 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 …
Contraindications
4 CONTRAINDICATIONS Known hypersensitivity to Venofer. Known hypersensitivity to Venofer ( 4 )
Drug Interactions
7 DRUG INTERACTIONS Venofer may reduce the absorption of concomitantly administered oral iron preparations.
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 . 6.1 Adverse 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 Adults Patients with CKD The frequ…
Frequently Asked Questions
What is Venofer used for?
Venofer contains iron sucrose. It is a injection, solution taken intravenous. Consult your doctor for specific uses.
Is Venofer a controlled substance?
Venofer is not classified as a controlled substance by the DEA.
What is the generic name for Venofer?
The generic name for Venofer is iron sucrose. There are 8 other brand versions of iron sucrose.
What is the NDC code for Venofer 20 mg/mL?
The NDC (National Drug Code) for Venofer 20 mg/mL is 0517-2310, listed by American Regent, Inc..