Monoferric: Uses, Side Effects and Dosage

What is MONOFERRIC used for?

MONOFERRIC is used to treat adults with iron deficiency anemia. This condition happens when the body doesn´t have enough iron. MONOFERRIC is given when:

• you cannot tolerate iron that is taken by mouth (oral), or
• oral iron therapies do not work for you.

How does MONOFERRIC work?

MONOFERRIC is used to replenish your body’s iron stores. Iron is needed to make haemoglobin, which allows red blood cells to carry oxygen throughout your body.

What are the ingredients in MONOFERRIC?

Medicinal ingredient: ferric derisomaltose (also known as iron isomaltoside 1000)

Non-medicinal ingredients: hydrochloric acid, sodium hydroxide, water for injection

MONOFERRIC comes in the following dosage forms:

Solution: 100 mg / mL elemental iron (as ferric derisomaltose)

Do not use MONOFERRIC if:

• You are allergic to ferric derisomaltose or any of the ingredients in this medicine or components of the container
• You have a history of serious allergies to other injectable iron medications
• You have anemia not caused by iron deficiency (hemolytic anemia)
• You have too much iron (iron overload) or a problem in the way your body uses iron

Serious Warnings and Precautions

Do not use MONOFERRIC if you:

• are allergic to this drug, or
• are allergic to other injectable iron products.

Injectable iron products including MONOFERRIC can cause serious allergic reactions, including fatal anaphylaxis or anaphylactoid reactions. MONOFERRIC can cause serious cases of hypotension (low blood pressure).

Only use MONOFERRIC if personnel are 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 MONOFERRIC.

Ask your healthcare professional who can give you an information booklet about MONOFERRIC regarding precautions and adverse events.

• You have liver problems (cirrhosis, hepatitis)

To help avoid side effects and ensure proper use, talk to your healthcare professional before you take MONOFERRIC. Talk about any health conditions or problems you may have, including if you:

• Have a history of drug allergies
• Have lupus (an immune system disease where the body’s own defence system attacks normal tissue)
• Have rheumatoid arthritis (joint swelling)
• Have severe asthma, eczema (itchy, red skin) or other allergies
• Have low blood pressure (hypotension)
• Have a severe infection
• Are older than 65 years of age

Other warnings you should know about:

• Low levels of phosphate in the blood (hypophosphatemia)

  • Taking MONOFERRIC may cause low levels of phosphate in the blood (hypophosphatemia). This hypophosphatemia may not be permanent. You may not know you have hypophosphatemia as you may not have any symptoms or complications.

• Injection site

  • Incorrect administration of MONOFERRIC may cause leakage at the injection site. This may irritate the skin. As well, it is possible that the colour of your skin at the site and on other areas of your body may become brown. This may be long-lasting.
  • Tell your doctor or nurse immediately if you notice any leakage. They will need to stop the administration.

• Check-ups and testing

  • Before and during your treatment with MONOFERRIC, you will have blood tests done to check the level of iron in your blood.
  • Your healthcare professional will also measure your blood pressure and heart rate before, during and 30 minutes after each MONOFERRIC administration.

• Driving and using machinery

  • Give yourself time after taking MONOFERRIC to see how you feel before driving a vehicle or using machinery.

• Female patients

  Pregnancy:

  • Tell your healthcare professional right away if you are pregnant, become pregnant, think you are pregnant or are planning on becoming pregnant. There are specific risks you should discuss with your healthcare professional.
  • You can have a serious allergic reaction while receiving MONOFERRIC, 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.

Breastfeeding:

• MONOFERRIC passes into breast milk. If you are breastfeeding or are planning to breastfeed, talk to your healthcare professional.

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 MONOFERRIC:

• Oral iron.

How to take MONOFERRIC:

Your healthcare professional will give MONOFERRIC to you. It may be given only once or once per week until your condition is treated. MONOFERRIC will be given to you either:

• through a vein in your arm. This is called an intravenous (IV) infusion or IV injection. An IV infusion will be done over a minimum of 20-30 minutes. An IV injection will be done over about 2 minutes; or
• directly into the dialyzer during a hemodialysis session.

MONOFERRIC will be given in a location where any allergic events can be treated immediately.

A healthcare professional will monitor you carefully during your MONOFERRIC treatment and for at least 30 minutes afterwards. If you have any of the following symptoms of an allergic reaction or begin to feel unwell while receiving MONOFERRIC, tell your healthcare professional right away:

• Dizzy or light-headed
• Swelling of your face, tongue or throat
• Difficulty swallowing
• Itching, rash or hives
• Difficulty breathing
• Nausea or abdominal pain

About 4 weeks after your MONOFERRIC treatment is complete, your healthcare professional will assess you. This is to check whether you need more treatment.

Usual dose:

The usual dose of MONOFERRIC is different for everyone. Your healthcare professional will determine how much MONOFERRIC to give you. Your exact dose will depend on your weight, your blood hemoglobin levels and the amount of iron you need.

Overdose:

What are possible side effects from using MONOFERRIC?

These are not all the possible side effects you may feel when taking MONOFERRIC. If you experience any side effects not listed here, contact your healthcare professional.

• abdominal pain
• back pain
• chest pain
• constipation
• diarrhea
• discoloured stool
• dizziness
• fatigue
• fever
• flu-like illness may occur a few hours to several days after injection and is typically characterised by symptoms such as high temperature, and aches and pains in the muscles and joints
• flushing
• headache
• indigestion
• joint pain
• muscle pain
• muscle spasms
• nausea
• vomiting
• skin exfoliation
• itchy skin
• skin discolouration
• sore throat
• cough
• inflammation of nose and throat
• swelling of hands and feet
• taste disturbance
• tingling sensation

MONOFERRIC can cause abnormal blood test results including low levels of phosphate. Your healthcare professional will decide when to do blood tests and will interpret the results.

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

Storage:

MONOFERRIC will be stored and managed by your healthcare professional.

Store between 15-30 °C. Do Not Freeze.

If you want more information about MONOFERRIC:

• 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; the manufacturer’s website www.pfizer.ca, or by calling 1-800-463-6001.

MONOFERRIC is imported/distributed by Pfizer Canada ULC

Last Revised: JAN 29, 2025