You must not receive Rienso:

• if you are allergic (hypersensitive) to the product or any of the other ingredients of this medicine (listed in section 6).
• if you have a history of medicine allergy or have experienced serious allergic (hypersensitive) reactions to other injectable iron preparations.
• if you have iron overload (too much iron in your body).
• if your anaemia is not caused by iron deficiency.

Warnings and precautions

Talk to your doctor, pharmacist or nurse before receiving Rienso:

• if you have a history of medicine allergy.
• if you have systemic lupus erythematosus.
• if you have rheumatoid arthritis.
• if you have severe asthma, eczema or other allergies.
• if you have a problem with your liver.
• if you have problems with your immune system.
• if you have any infections, including infections which have spread to your blood stream.
• if you are scheduled for magnetic resonance imaging (an MRI scan) shortly after receiving Rienso, as this medicine may interfere with the interpretation of the scan.

Rienso can affect the interpretation of your blood iron test results.

Children and adolescents

Rienso should not be given to children and adolescents under 18 years old.

Other medicines and Rienso

Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might take any other medicines.

Pregnancy

Rienso has not been tested in pregnant women. Studies in animals have shown reproductive toxicity. If you are pregnant, you should not receive Rienso.

It is important to tell your doctor if you are pregnant, think you may be pregnant, or are planning to have a baby.

If you are able to become pregnant, you must use birth control during treatment.

If you become pregnant during treatment, you must ask your doctor for advice.

Your doctor will decide whether or not you should be given this medicine.

Breast-feeding

It is not known whether the active substance in this medicine can pass into breast milk. If you are breast-feeding, ask your doctor for advice before you are given Rienso.

Driving and using machines

Some people may feel dizzy, confused or lightheaded after receiving treatment. If this happens to you, do not drive or use any tools or machinery.

Rienso contains ethanol and sodium

This medicine contains small amounts of ethanol (alcohol), less than 100 mg per 17 ml vial.

This medicine contains less than 23 mg sodium per 17 ml vial, i.e., it is essentially “sodium free”.

If you receive more Rienso than you should

Overdose can cause accumulation of iron in your body. Your doctor will monitor iron levels to avoid iron accumulation.

Serious side effects:

Tell your doctor or nurse immediately if you experience any of the following signs and symptoms indicating serious side effects during or shortly after treatment:

rash, itching, (sudden) dizziness, light-headedness, (increasing) swelling, difficulty breathing, wheezing or any other problems you may have.

In some patients these allergic reactions can become severe or life-threatening (known as anaphylactic reactions). These reactions can be associated with heart and circulation complications, loss of consciousness and may result in death.

Doctors are aware of these possible side effects and will monitor you during the infusion and for at least 30 minutes after the infusion, and also have emergency treatment available if required.

Other side effects that you should tell your doctor, pharmacist or nurse about if they become serious:

Common side effects (may affect up to 1 in 10 people):

• bleeding, swelling, bruising, pain, rash, irritation or warmth at infusion/injection site

Uncommon side effects (may affect up to 1 in 100 people):

• dizziness
• low blood pressure
• feeling weak or tired
• feeling drowsy or sleepy
• flushing, hot flush
• feeling hot, fever
• sweating (including night sweats)
• chills
• high blood pressure (sudden increase in blood pressure)
• skin rash, itching, darkening of an area of skin or nails, bruising, hives
• burning sensation of skin
• shortness of breath
• diarrhoea
• constipation
• stomach pain/discomfort
• stomach distension or bloating
• nausea, vomiting
• discoloured stools
• changes in taste
• increased or decreased appetite
• muscle/joint pain, weakness or stiffness, muscle spasms
• headache
• chest pain/discomfort
• back pain
• changes in blood test results (e.g. iron parameters)
• allergic reaction including severe allergic reaction (see paragraph "serious side effects")

Rare side effects (may affect up to 1 in 1,000 people):

• burning, prickling, numbness or tingling sensation of skin
• dehydration
• upset stomach/indigestion
• nose bleed
• dry mouth
• burning or tingling sensation of tongue/mouth
• increased tearing
• blurred vision
• gout
• abnormal blood tests (decreased glucose, elevated potassium, abnormal liver function, elevated type of white blood cell i.e. eosinophilia)

Side effects of unknown frequency (frequency cannot be estimated from the available data)

The following serious side effects have been reported shortly after receiving Rienso:

• life-threatening and fatal allergic reactions (anaphylactic/anaphylactoid hypersensitivity)
• cardiovascular complications (affecting the heart and blood vessels) including heart attack, congestive heart failure, palpitations, blood vessel dilation, changes in your pulse rate including weak/absent pulse, heart stops beating, heart and breathing stop, blue discolouration of skin and/or mucous membranes due to lack of oxygen in the blood (cyanosis)
• fainting/loss of consciousness/unresponsiveness
• sudden swelling up of skin or mucous membranes (angioedema), skin rash
• wheezing (bronchospasm), cough, upper airway swelling, difficulty breathing (change to breathing rate), inability to breathe
• throat irritation, throat tightness, lip swelling, tongue swelling
• injection site discolouration, injection site itching and discolouration

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via

By reporting side effects you can help provide more information on the safety of this medicine.

What Rienso contains

• The active substance is iron as ferumoxytol 30 mg/ml.
• 1 ml solution for infusion contains 30 mg of iron as ferumoxytol.
• 17 ml solution for infusion contains 510 mg of iron as ferumoxytol.
•  The other ingredients are mannitol, Polyglucose-sorbitol carboxymethylether (PSC), Sodium hydroxide (for pH adjustment, Hydrochloric acid (for pH adjustment) and water for injections.