VENOFER- iron sucrose injection, solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

IRON SUCROSE (UNII: FZ7NYF5N8L) (FERRIC CATION - UNII:91O4LML611)

Available from:

Fresenius Medical Care Holdings, Inc.

INN (International Name):

IRON SUCROSE

Composition:

FERRIC CATION 20 mg in 1 mL

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Venofer is indicated for the treatment of iron deficiency anemia (IDA) in patients with chronic kidney disease (CKD). - Known hypersensitivity to Venofer 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

Product summary:

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). 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.

Authorization status:

New Drug Application

Summary of Product characteristics

VENOFER- IRON SUCROSE INJECTION, SOLUTION
FRESENIUS MEDICAL CARE HOLDINGS, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
VENOFER SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
VENOFER.
VENOFER (IRON SUCROSE) INJECTION, FOR INTRAVENOUS USE
INITIAL U.S. APPROVAL: 2000
INDICATIONS AND USAGE
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
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
DOSAGE FORMS AND STRENGTHS
Injection: 50 mg/2.5 mL or 100 mg/5 mL (20 mg/mL) in single-dose
vials. (3)
CONTRAINDICATIONS
Known hypersensitivity to Venofer (4)
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)
ADVERSE REACTIONS
Adult patients: The most common adverse reactions (≥2%) are
diarrhea, nausea, vomiting, headache,
dizziness, hypotension, pruritus, pain in extremity, arthralgia, back
pain, muscl