Monofer (Ferric Derisomaltose)

Complete patient guide for uses, dosage, side effects, and safety information

Prescription Required

Quick Facts

Generic Name
ferric derisomaltose
Drug Class
intravenous iron preparation
Used For
iron deficiency in adults when oral iron is ineffective or cannot be used
How Taken
intravenous injection or infusion administered by healthcare professional

What Is Monofer Used For?

Monofer is an intravenous iron medication that helps restore iron levels in your body when you have iron deficiency.

Primary Uses

Monofer is used to treat iron deficiency in adults when oral iron preparations are ineffective or cannot be used, or when there is a need to deliver iron rapidly to your body.

How It Works

Monofer contains iron in the form of ferric derisomaltose, which is delivered directly into your bloodstream to quickly restore your body’s iron levels.

How to Take Monofer

Monofer is given by a healthcare professional in a clinical setting where allergic reactions can be properly treated if they occur.

Dosage Instructions

Your doctor will perform a blood test to determine your iron levels and calculate the exact dose you need. Monofer can be given by slow injection directly into a vein up to three times a week, by infusion over a longer period with doses split into weekly infusions, or during a hemodialysis session if you’re receiving dialysis treatment. You’ll be observed for at least 30 minutes after each administration.

Treatment Duration

Your doctor will determine how long you need treatment. You may receive a single administration or several administrations over several weeks depending on your iron levels and response to treatment.

Important: The solution may be diluted with 0.9% sodium chloride but never to concentrations less than 1 mg iron/mL and never diluted in more than 500 mL.

Available Tablet Strengths

100 mg/1 mL
100 mg/1 mL Tablet Dark brown, Vial • AUST R 280666
200 mg/2 mL
200 mg/2 mL Tablet Dark brown, Vial • AUST R 290832
500 mg/5 mL
500 mg/5 mL Tablet Dark brown, Vial • AUST R 290833
1000 mg/10 mL
1000 mg/10 mL Tablet Dark brown, Vial • AUST R 290834

Side Effects

Like all medications, this medicine can cause side effects. Most are mild and temporary, but some require medical attention.

Common Side Effects

These side effects occur relatively frequently and usually don’t require emergency care:

  • nausea or vomiting
  • rash
  • soreness and swelling near injection site
  • skin discoloration
  • stomach pain or cramps
  • indigestion, constipation or diarrhea
  • headache
  • blurred vision
  • dizziness or light-headedness
  • altered mental status
  • distorted sense of taste
  • chest and/or back pain
  • muscle or joint pain or spasms
  • tremor
  • chest tightness with shortness of breath
  • fast or irregular heartbeat
  • low or high blood pressure
  • tingling or numbness
  • itchiness or hives
  • flushing or sweating
  • feeling unwell
  • flu-like symptoms
  • fever or chills
  • infection
  • fatigue
  • hoarseness or sore throat

Seek immediate medical attention if you experience:

  • seizure
  • loss of consciousness
  • persistent low blood pressure
  • swelling of tongue/airway, difficulty swallowing
  • severe allergic reactions involving multiple body systems (heart, skin, breathing, stomach)
  • chest pain (could be sign of Kounis syndrome)

Important Warnings

There are important safety considerations before receiving Monofer treatment.

Who Should Not Take Monofer

Do not use Monofer if you are allergic to ferric derisomaltose or any ingredients, have anemia that is not caused by iron deficiency, or have too much iron (iron overload) or problems with how your body uses iron. There is not enough information to recommend use in children.

Medical Conditions to Discuss

Tell your doctor if you have liver problems, systemic lupus erythematosus (SLE) or related diseases, rheumatoid arthritis or other immune/inflammatory conditions, severe asthma, eczema or other allergies, ongoing bacterial blood infection, acute or chronic infection, are prone to allergies, or are older than 65 years of age.

Pregnancy and Breastfeeding

Check with your doctor if you are pregnant, intend to become pregnant, or become pregnant during treatment. Your doctor will evaluate the risks and benefits. Intravenous iron may slow your unborn baby’s heart rate temporarily if you have a reaction, so your doctor may monitor your baby during treatment. It’s unlikely that Monofer represents a risk if you’re breastfeeding, but discuss this with your doctor.

Severe Allergic Reactions: Intravenous iron preparations can cause severe allergic reactions. Tell your doctor or visit the Emergency Department immediately if you experience signs of a severe allergic reaction.

Drug Interactions

Some medications may interfere with how Monofer works in your body.

  • oral iron preparations (can reduce absorption of oral iron when given together with Monofer)

Alcohol & Driving

Be cautious about activities that require alertness until you know how Monofer affects you.

Driving and Operating Machinery

Be careful before you drive or use any machines or tools until you know how Monofer affects you.

Storage

Monofer should be stored below 30°C. Your doctor or hospital will handle proper disposal of any unwanted medicine. Do not use this medicine after the expiry date.

Overdose Information

Overdose may lead to iron accumulation in storage sites. Your doctor will monitor iron parameters to avoid this. The risk of accidental overdosing is minimal. If you think you’ve received too much Monofer, seek urgent medical attention by calling the Poisons Information Centre (13 11 26), contacting your doctor, or going to the nearest hospital Emergency Department, even if you feel fine.

Frequently Asked Questions

Your doctor will determine the treatment duration based on your iron levels. You may receive a single administration or several administrations over several weeks, with effects monitored through blood tests.

Monofer given together with oral iron preparations can reduce the absorption of oral iron. Always tell your doctor about any other medications or supplements you’re taking.

You’ll receive Monofer in a clinical setting by injection into a vein or by infusion. You’ll be observed for at least 30 minutes after each administration to monitor for any reactions.

Serious allergic reactions can involve persistent low blood pressure, swelling of tongue/airway, difficulty swallowing, and symptoms affecting multiple body systems including heart, skin, breathing, or stomach. Seek emergency medical attention immediately if these occur.

No, do not continue treatment if there is leakage around the injection site. The treatment must be stopped by your doctor as leakage can cause skin irritation or brown discoloration.

Your doctor will evaluate the risks and benefits of Monofer during pregnancy. The medication may temporarily slow your unborn baby’s heart rate if you have a reaction, so your doctor may monitor your baby during treatment.

Always remind any doctor, dentist, or pharmacist you visit that you are being treated with Monofer, especially before any surgery or emergency treatment.

Important Disclaimer

This information is intended for general educational purposes only and should not be considered medical advice. Always consult your healthcare provider or pharmacist before starting, stopping, or changing any medication.

If you think you may have a medical emergency, call your doctor or emergency services immediately.