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:

HF Acquisition Co LLC, DBA HealthFirst

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. 8.1 Pregnancy 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 de

Product summary:

16.1 How Supplied Venofer is supplied sterile in 10 mL, 5 mL, and 2.5 mL single-dose vials. Each 10 mL vial contains 200 mg elemental iron, each 5 mL vial contains 100 mg elemental iron, and each 2.5 mL vial contains 50 mg elemental iron (20 mg/mL). 16.2 Stability 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.

Authorization status:

New Drug Application

Summary of Product characteristics

VENOFER (IRON SUCROSE)- VENOFER (IRON SUCROSE) INJECTION, SOLUTION
HF ACQUISITION CO LLC, DBA HEALTHFIRST
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VENOFER (IRON SUCROSE INJECTION,USP) 100MG ELEMENTAL IRON PER 5ML
(20MG/ML)
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
DOSAGE FORMS AND STRENGTHS
Injection: 50 mg/2.5 mL, 100 mg/5 mL, or 200 mg/10 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: May cause hypotension. Monitor for signs and symptoms of
hypotension
during and following each administration. ( 5.2)
Iron Overload: Regularly monitor hematologic responses during therapy.
Do not
administer 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, 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 Americ