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:

A-S Medication Solutions

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:

Product: 50090-4541 NDC: 50090-4541-0 5 mL in a VIAL, SINGLE-USE

Authorization status:

New Drug Application

Summary of Product characteristics

VENOFER- IRON SUCROSE INJECTION, SOLUTION
A-S MEDICATION SOLUTIONS
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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, 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