Iron infusion Side Effects

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Explain possible side effects and interaction/safety considerations for iron infusion without overstating causality or efficacy.

Part of vitamins & minerals side effects.

What is iron infusion?

Iron-Infusion contains the active ingredient Ferric derisomaltose.

• Active ingredient — Ferric derisomaltose
• Registration number — 46/8.3/0166; 46/8.3/0167; 46/8.3/0168
• Registration holder — Acino Pharma (Pty) Ltd

It is approved for:

• MONOFER contains a combination of iron and derisomaltose (a chain of sugar molecules)
• MONOFER is used in the treatment of low levels of iron (sometimes called ‘iron deficiency’) when you cannot take iron treatment by mouth or if your body requires the iron very quickly

Possible side effects of iron infusion

Not everyone gets side effects. The effects below are those listed in the South African approved leaflet, grouped using the leaflet’s own frequency wording.

Common side effects

• nausea
• rash
• skin reactions at or near the injection site including redness of the skin, swelling, burning, pain, bruising, brown discolouration, leakage to the tissue around the site of infusion, irritation

Uncommon side effects

• hypersensitivity reactions with potential shortness of breath and bronchospasm
• numbness
• distortion of the sense of taste
• blurred vision
• loss of consciousness
• wheezing
• pain in and around the stomach (abdominal pain), being sick (vomiting), constipation, diarrhoea, impaired digestion
• flushing, sweating, fever, feeling cold, shivering
• dizziness
• fatigue
• increased heart rate
• Chest pain, back pain, pain in your muscles or joints, muscle spasms
• low or high blood pressure
• Itching, hives, skin inflammation
• flushing, sweating, fever, feeling cold, shivering
• headache
• unusual feeling on the surface of your body (pins and needles)
• low level of phosphate in the blood
• infection
• increased liver enzymes
• local inflammation of a vein
• skin exfoliation
• general feeling of discomfort (malaise)
• tremor
• hoarseness
• seizure
• altered mental status

Not known side effects

• Skin discoloration at other areas of the body than the injection site

Interactions and medicines to check

The approved leaflet names these interactions.

• Always tell your health care provider if you are taking any other medicine
• (This includes all complementary or traditional medicines.) In particular tell your doctor, nurse or pharmacist if you are taking iron containing medicines that you take by mouth
• You should not take iron by mouth until at least 5 days after the last injection of MONOFER
• Having blood tests done while you are receiving MONOFER: MONOFER may affect the results of some blood tests to measure bilirubin and calcium
• If you have to take a blood test, inform the doctor that you are being treated with MONOFER
• If you are not sure if the above applies to you, talk to your doctor, nurse or pharmacist before receiving MONOFER

Who should use extra caution?

The approved leaflet identifies the following cautions and factors.

Do not use it at all if

• If you are allergic (hypersensitive) to ferric derisomaltose or any of the other ingredients of MONOFER (listed in section 6)
• If you have experienced serious allergic (hypersensitive) reactions to other injectable iron products
• If you have anaemia that is not caused by low levels of iron (deficiency), such as haemolytic anaemia listed in point 6
• If you have too much iron (overload) or a problem in the way your body uses iron (e.g. haemochromatosis, haemosiderosis)
• If you have an ongoing bacterial infection in your blood

Use with care, and tell your doctor, if

• If you have known allergies to any other medicine
• If you have an illness of your immune system, such as systemic lupus erythematosus (a serious disease of the skin), or rheumatoid arthritis
• If you have severe asthma or you have a history of asthma or problems with allergies, eczema or inflammation
• If you have reduced liver function
• If you have an acute or chronic infection
• Incorrect administration of MONOFER may cause leakage of the product at the injection site, which may lead to irritation of the skin and potentially long-lasting brown discolouration at the site of injection. The administration must be stopped immediately when this occurs. Children and adolescents MONOFER is for adults only. Children and adolescents younger than 18 years of age should not be administered MONOFER. If you are not sure if any of the above applies to you, talk to your doctor or healthcare professional before being administered MONOFER

Pregnancy and breastfeeding

• If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, please consult your doctor, pharmacist or other health care provider for advice before being administered MONOFER
• If you become pregnant during treatment, you must ask your doctor for advice
• Your doctor will decide whether or not you should be given MONOFER
• If you are breastfeeding, ask your doctor for advice before you are given MONOFER

Dose, timing and other factors that can affect side effects

The approved leaflet identifies the following cautions and factors.

Do not use it at all if

• If you are allergic (hypersensitive) to ferric derisomaltose or any of the other ingredients of MONOFER (listed in section 6)
• If you have experienced serious allergic (hypersensitive) reactions to other injectable iron products
• If you have anaemia that is not caused by low levels of iron (deficiency), such as haemolytic anaemia listed in point 6
• If you have too much iron (overload) or a problem in the way your body uses iron (e.g. haemochromatosis, haemosiderosis)
• If you have an ongoing bacterial infection in your blood

Use with care, and tell your doctor, if

• If you have known allergies to any other medicine
• If you have an illness of your immune system, such as systemic lupus erythematosus (a serious disease of the skin), or rheumatoid arthritis
• If you have severe asthma or you have a history of asthma or problems with allergies, eczema or inflammation
• If you have reduced liver function
• If you have an acute or chronic infection
• Incorrect administration of MONOFER may cause leakage of the product at the injection site, which may lead to irritation of the skin and potentially long-lasting brown discolouration at the site of injection. The administration must be stopped immediately when this occurs. Children and adolescents MONOFER is for adults only. Children and adolescents younger than 18 years of age should not be administered MONOFER. If you are not sure if any of the above applies to you, talk to your doctor or healthcare professional before being administered MONOFER

Pregnancy and breastfeeding

• If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, please consult your doctor, pharmacist or other health care provider for advice before being administered MONOFER
• If you become pregnant during treatment, you must ask your doctor for advice
• Your doctor will decide whether or not you should be given MONOFER
• If you are breastfeeding, ask your doctor for advice before you are given MONOFER

Serious symptoms and warning signs

This leaflet does not set out a separate list of serious side effects. The general warning signs below apply to any medicine.

General warning signs that apply to any medicine

What to do if side effects occur

If you think you are having a side effect, the response depends on how severe it is. Use the warning signs above first — if any of those apply, treat it as urgent.

If the symptom is severe or frightening

Get medical help immediately. Call 10177 for an ambulance, or 112 from a mobile phone, or go to the nearest emergency department. Take the product and its packaging with you if you can.

If the symptom is mild but bothering you

• Write down what the symptom is, when it started, and how it relates to when you take the product
• Check the leaflet that came with the product to see whether the symptom is listed
• Speak to your pharmacist — for many questions this is the fastest route to a useful answer
• Contact the prescriber if the symptom is affecting your daily life or is not settling

You can also report a suspected side effect in South Africa. Reporting does not replace getting medical advice, and you do not need to be certain the product was the cause.

How to report a suspected side effect in South Africa

South Africa has an official system for reporting suspected side effects, run by the South African Health Products Regulatory Authority (SAHPRA). Reports from the public and from healthcare professionals are how safety signals get detected after a product is already in use.

Who can report

Anyone can report — you do not have to be a healthcare professional, and you do not need to prove that the product caused the problem. A suspicion is enough. Patients, caregivers and family members can all submit a report.

What to have ready

• The name of the product, its strength and form, and the batch number if you have it
• Why it was being used, and when it was started and stopped
• What the suspected reaction was, when it began, and how long it lasted
• Any other medicines, supplements or remedies being used at the same time
• Basic details about the person affected — age and sex are usually enough

How to report

SAHPRA accepts adverse reaction reports through its e-Services reporting system and through the Med Safety mobile app. Healthcare professionals can also report through the same routes. Current forms and access points are published on the SAHPRA site.

• SAHPRA Health Products Vigilance — the main vigilance and reporting hub
• SAHPRA e-Services — current adverse reaction reporting access

For a fuller walkthrough see how to report an adverse drug reaction.

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