VENOFER (IRON SUCROSE) 20 mg/mL
VENOFER (IRON SUCROSE) · INJECTION, SOLUTION · HF Acquisition Co LLC, DBA HealthFirst
VENOFER (IRON SUCROSE) is a prescription injection, solution containing venofer (iron sucrose) at 20 mg/mL, taken intravenous. Manufactured by HF Acquisition Co LLC, DBA HealthFirst.
Key Facts
- Brand Name
- VENOFER (IRON SUCROSE)
- Generic Name
- VENOFER (IRON SUCROSE)
- NDC Code (Product)
51662-1568- Manufacturer
- HF Acquisition Co LLC, DBA HealthFirst
- Strength
- 20 mg/mL
- Dosage Form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Marketing Status
- HUMAN PRESCRIPTION DRUG
- Application #
- NDA021135
- Drug Class
- Iron [CS]; Parenteral Iron Replacement [EPC]
- Marketing Start
- 06/25/2021
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.
Full Prescribing Information
Indications & Usage
1 INDICATIONS & USAGE Venofer is indicated for the treatment of iron deficiency anemia (IDA) in patients with chronic kidney disease (CKD).
Dosage & Administration
2 DOSAGE & 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. 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 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. 2.3 Adult 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 …
Contraindications
4 CONTRAINDICATIONS Known hypersensitivity to Venofer.
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 )] 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 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 …
Frequently Asked Questions
What is VENOFER (IRON SUCROSE) used for?
VENOFER (IRON SUCROSE) contains VENOFER (IRON SUCROSE). It is a injection, solution taken intravenous. Consult your doctor for specific uses.
Is VENOFER (IRON SUCROSE) a controlled substance?
VENOFER (IRON SUCROSE) is not classified as a controlled substance by the DEA.
What is the generic name for VENOFER (IRON SUCROSE)?
The generic name for VENOFER (IRON SUCROSE) is VENOFER (IRON SUCROSE). There are no other listed brand versions of VENOFER (IRON SUCROSE).
What is the NDC code for VENOFER (IRON SUCROSE) 20 mg/mL?
The NDC (National Drug Code) for VENOFER (IRON SUCROSE) 20 mg/mL is 51662-1568, listed by HF Acquisition Co LLC, DBA HealthFirst.
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)