Patient Medication Information: uses, side effects, how to take - Venofer
What is VENOFER used for?
- VENOFER is used to treat iron deficiency anemia. This condition occurs when your body does not have enough iron. VENOFER is used in people with chronic kidney disease managed with or without dialysis.
How does VENOFER work?
VENOFER (iron sucrose) works by replenishing your body’s iron levels. You need iron to make hemoglobin, which allows red blood cells to carry oxygen throughout your body.
What are the ingredients in VENOFER?
Medicinal ingredients: Iron sucrose
Non-medicinal ingredients: Water for injection. May contain sodium hydroxide to adjust pH.
VENOFER comes in the following dosage forms:
Solution: 20 mg elemental iron per mL (as iron sucrose)
Do not receive VENOFER if:
you have any of these health problems:
- too much iron in your body (iron overload)
- anemia from a cause other than low iron
- you are allergic (hypersensitive) to iron sucrose or any of the other ingredients of VENOFER (See What are the ingredients in VENOFER)?
To help avoid side effects and ensure proper use, talk to your healthcare professional before you receive VENOFER. Talk about any health conditions or problems you may have, including if you:
- have had any allergy to iron medicines given through a vein like VENOFER in the past.
- are pregnant or planning to become pregnant.
- are breastfeeding or planning to breastfeed. Animal studies show that VENOFER may pass into breast milk.
Serious Warnings and Precautions
- Injectable iron products including VENOFER can cause serious allergic reactions, including fatal anaphylaxis or anaphylactoid reactions.
- You will receive VENOFER in a healthcare setting where staff is able to treat severe allergic reactions without delay. You will be monitored for signs and symptoms of an allergic reaction during and after your treatment with VENOFER.
Other warnings you should know about:
Older people: Your healthcare professional will start with a lower dose of VENOFER to prevent side effects.
Pregnancy: Tell your healthcare professional right away if you are pregnant, become pregnant, think you are pregnant or are planning on becoming pregnant. You can have a serious allergic reaction while receiving VENOFER, which can cause serious harm to your unborn baby. They may develop an unusually slow heart rate. This usually lasts for a short time. If you are receiving this medicine while pregnant, your healthcare professional should carefully monitor your unborn baby.
Monitoring, Lab and blood tests: Your healthcare professional will do blood tests before you receive VENOFER and/or during treatment to monitor your progress or check for side effects. These tests and monitoring may include:
- checking your blood iron level in order to prevent iron overload (see Overdose below for signs of too much iron in your body)
watching you closely for signs of
- serious allergic reactions.
- low blood pressure like dizziness or passing out
See the Serious side effects and what to do about them table, below
Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.
The following may interact with VENOFER:
- iron pills taken by mouth (oral iron preparations). These may not work if you take them at the same time that you receive VENOFER.
How you will receive VENOFER:
- in a healthcare setting where staff can provide emergency medical treatment for allergic reactions. Your healthcare professional will watch you carefully while you receive each dose of VENOFER and for at least 30 minutes afterwards.
- as an injection into your vein. It is usually injected over 2 to 5 minutes or may be mixed with another fluid and injected slowly (infused) over 15 minutes to 4 hours depending on your dose of medication.
Usual dose:
Your healthcare professional will work out:
- the right dose of VENOFER for you.
- how often you receive VENOFER; Your total number of doses is based on your condition and how well you respond to the medication.
Overdose:
Signs of too much iron in your body (iron overload) due to VENOFER may include:
low blood pressure, headache, vomiting, nausea, dizziness, joint aches, a burning, pricking or tingling feeling, abdominal and muscle pain, swelling, and sudden drop in blood flow through the body (cardiovascular collapse or shock).
| If you think you, or a person you are caring for, have received too much VENOFER, contact a healthcare professional, hospital emergency department, or regional poison control centre immediately, even if there are no symptoms. |
|---|
Missed Dose:
If you miss your scheduled dose, contact your healthcare professional as soon as possible to schedule your next treatment.
What are possible side effects from using VENOFER?
These are not all the possible side effects you may have when taking VENOFER. If you experience any side effects not listed here, tell your healthcare professional.
Common side effects that may occur include:
- nausea, vomiting, diarrhea, stomach pain, change in taste (everything seems sour, sweet, bitter or metallic)
- dizziness
- headache
- fever
- chest pain
- muscle cramps (especially leg cramps)
- swollen arm or leg
- general feeling of discomfort, flu-like symptoms such as: chills, headache, fatigue, muscle aches, or low-grade fever
- pain, redness or swelling at the injection site where the shot was given
- swelling of joints, bone pain
- burning or tingling sensation
- skin problems: skin rash, skin itchiness, skin discoloration
- flushing
If these become bothersome, consult your healthcare professional.
Serious side effects and what to do about them
| Symptom / effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help | |
|---|---|---|---|
| Only if severe | In all cases | ||
| COMMON | |||
| Hypotension (low blood pressure): dizziness, passing out, light-headedness, nausea, vomiting, fatigue | Y | ||
Serious side effects and what to do about them
| Symptom / effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help | |
|---|---|---|---|
| Only if severe | In all cases | ||
| Peripheral edema (swelling of the legs or hands caused by fluid retention): swollen or puffy legs or hands | Y | ||
| UNKNOWN | |||
| Hypersensitivity reactions (allergic reactions) – which is sometimes life-threatening: fever, joint pain, nausea, vomiting, chest pain, rash, hives, swelling of the face, lips, tongue or throat, difficulty swallowing or breathing | Y | ||
Breathing problems: shortness of breath, difficult to breathe on your own (respiratory failure) | Y | ||
| Circulatory collapse (problems with the circulatory system which is made up of blood vessels that carry blood away from and towards the heart): severely low blood pressure, chest pain, passing out | Y | ||
If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, tell your healthcare professional.
Reporting Side Effects
You can report any suspected side effects associated with the use of health products to Health Canada by:
NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice. |
Storage:
Store VENOFER at room temperature (15-25°C) until your appointment. Do not freeze. Discard unused portion.
Keep out of reach and sight of children.
If you want more information about VENOFER:
- Talk to your healthcare professional
- Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website: (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html; the manufacturer’s website www.americanregent.com, or by calling 1-800-1-800-645-1706.