Details for: VENOFER
Company: AMERICAN REGENT, INC
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 02243716 | VENOFER | IRON (IRON SUCROSE) | 20 MG / ML | SOLUTION | INTRAVENOUS |
Consumer Information
This information was provided by the drug’s manufacturer when this drug product was approved for sale in Canada. It is designed for consumers and care givers. It is a summary of information about the drug and will not tell you everything about the drug. Contact your doctor or pharmacist if you have any questions about the drug.
What the medication is used for
VENOFER is used in the treatment of iron deficiency anemia in dialysis dependent or non-dialysis-dependent chronic kidney disease patients.
What it does
VENOFER is used to replenish body iron stores in dialysis dependent or non-dialysis-dependent chronic kidney disease patients. Iron deficiency may be caused by blood loss during dialysis, increased production of red blood cells secondary to erythropoietin use, and insufficient absorption of iron from the gastrointestinal tract. Iron is needed to make haemoglobin, which allows red blood cells to carry oxygen throughout the body. Most dialysis patients require intravenous iron to maintain sufficient iron stores.
When it should not be used
The use of VENOFER is contraindicated in patients with too much iron (iron overload) in their body, patients with known hypersensitivity (allergy or sensitivity) to VENOFER, and patients with anemia not caused by iron deficiency.
What the medicinal ingredient is
Iron sucrose
What the non-medicinal ingredients are
For a full listing of nonmedicinal ingredients see Part I of the Product Monograph.
What dosage form it comes in
5 mL Single Dose Vials, 20 mg elemental iron/mL
Warnings and precautions
BEFORE you use VENOFER talk to your doctor or pharmacist if:
- You are hypersensitive to injectable iron products;
- You have symptoms of iron overload (see Overdose);
- You are pregnant or planning to become pregnant.
- You are breastfeeding or planning to breastfeed. Animal studies show that Venofer is excreted in breast milk.
Low blood pressure has been reported frequently in hemodialysis
patients receiving intravenous iron.
Only a qualified doctor or other healthcare professional should
administer VENOFER. VENOFER is not intended for
administration by patient.
The safety and effectiveness of VENOFER in pediatric patients
has not been established.
Caution should be used when administering VENOFER to elderly
patients, usually starting with the lowest dose.
Interactions with this medication
Drug interactions involving VENOFER have not been studied. Oral iron should not be administered together with other injectable iron preparations. Like other injectable iron preparations, VENOFER may reduce the absorption of oral iron preparations.
Proper use of this medication
Usual dose:
Only a qualified doctor or other healthcare professional should
administer VENOFER. VENOFER is not intended for
administration by patient.
Recommended Adult Dosage:
The dose of VENOFER is expressed in terms of mg of elemental
iron.
Chronic Kidney Disease Patients not on Dialysis: VENOFER is
administered as a total cumulative dose of 1000 mg over a 14 day
period, either as a 200 mg slow intravenous injection on 5
different occasions within the 14 day period, or as an infusion of
500 mg of VENOFER over a period of 4 hours on day 1 and day
14. Patients weighing less than 70 kg may require longer infusion
times.
Hemodialysis Patients: VENOFER is administered as a 100 mg
slow intravenous injection or as an infusion of 100 mg per
consecutive hemodialysis session for a total cumulative dose of
1000 mg.
Peritoneal Dialysis Patients: VENOFER is administered as a total
cumulative dose of 1000 mg in 3 divided doses within a 28 day
period: 2 infusions of 300 mg over 1.5 hours 14 days apart
followed by one 400 mg infusion over 2.5 hours 14 days later.
Overdose
Symptoms associated with overdosage or infusing VENOFER too rapidly include low blood pressure, headache, vomiting, nausea, dizziness, joint aches, a burning, pricking or tingling feeling, abdominal and muscle pain, swelling, and cardiovascular collapse (shock).
Side effects and what to do about them
Common side effects that may occur include: nausea, dizziness,
headache, vomiting, diarrhea, abdominal pain, fever, chest pain,
muscle cramps (especially leg cramps). If these become
bothersome, consult your doctor.
Very rare cases of severe, sometimes life-threatening allergic
reactions (loss of consciousness, collapse, difficulty breathing or
convulsions) and cases of severe low blood pressure (hypotension)
have been reported with the use of VENOFER. Only a qualified
doctor or other healthcare professional should administer
VENOFER. VENOFER is not intended for administration by
patient.
| Symptom / effect | Talk to your healthcare professional Only if severe | Talk to your healthcare professional In all cases | Stop taking drug and call your doctor or pharmacist |
|---|---|---|---|
| Serious Side Effects | |||
| Severe allergic reactions, sometimes life threatening with symptoms such as difficulty breathing, convulsion, collapse, itching, rash. | ✔ | ||
| Low blood pressure, with symptoms such as fainting, weakness. | ✔ | ||
This is not a complete list of side effects. For any unexpected effects while taking VENOFER, contact your doctor or pharmacist.
How to store
Store at 15-25°C. Do not freeze. Discard unused portion.
Keep out of reach of children.
Reporting side effects
You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following 3 ways:
- Report online at www.canada.ca/fr/sante-canada/services/medicaments-produits-sante/medeffet-canada.html
- Call toll-free at 1-866-234-2345
- Complete a Canada Vigilance Reporting Form and:
- Fax toll-free to 1-866-678-6789, or
- Mail to: Canada Vigilance Program
Health Canada
Postal Locator 0701E
Ottawa, Ontario
K1A 0K9
Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffectTM Canada Web site at www.healthcanada.gc.ca/medeffect.
NOTE: Should you require information related to the management of side effects, contact your health professional. The Canada Vigilance Program does not provide medical advice.
More information
Manufactured by:
AMERICAN REGENT, INC.
Shirley, New York USA 11967
Imported by:
Fresenius Medical Care Canada Inc.
Richmond Hill, Ontario
L4B 4W6
This document, plus the full product monograph prepared for
health professionals, can be found at:
www.americanregent.com
or by contacting the sponsor, American Regent, Inc., at:
1-800-645-1706
This leaflet was prepared by American Regent, Inc.
Last revised: January 23, 2019