Clexane Side Effects

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Answer the side-effect intent for clexane without diagnosing; distinguish common from serious reactions and give safe next-step/reporting guidance.

What is Clexane?

Clexane contains the active ingredient ENOXAPARIN SODIUM.

• Active ingredient — ENOXAPARIN SODIUM
• Registration number — 550009; 550010; 550011; 550012
• Registration holder — ADCOCK INGRAM LIMITED

It is approved for:

• Treat blood clots that are in your blood
• Stop blood clots from forming in your blood in the following situations: o before and after an operation o when you have a short-term illness and will not be able to move around for some time
• Stop blood clots from forming when you have unstable angina (where not enough blood gets to your heart) or after a heart attack
• Stop blood clots from forming in the tubes of your dialysis machine (used for people with severe kidney problems)

Common side effects of Clexane

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.

Frequent side effects

• headache
• increases in liver enzymes
• itchy red skin
• hives, urticaria
• bruising or pain at the injection site
• you bruise more easily than usual – this could be because of a blood problem with low platelet counts
• high platelet counts in the blood
• decreased red blood cell count
• sudden severe headache – this could be a sign of bleeding in the brain
• a feeling of tenderness and swelling in your stomach – you may have bleeding in your stomach
• bleeding at wound sites
• nose bleeds
• blood in urine

Less frequent side effects

• an increase in the number of eosinophils in your blood – your doctor will be able to check this by carrying out a blood test
• yellowing of your skin or eyes and your urine becomes darker in colour – this could be a liver problem
• hair loss
• large red irregularly shaped skin lesions with or without blisters
• purplish bruises under the skin
• inflammation and tissue damage (necrosis) of blood vessel walls (lumen) and associated skin
• osteoporosis (a condition where your bones are more likely to break) after long term use
• hard mass or lump at the injection site
• skin irritation (local irritation)
• increased potassium in your blood. Your doctor will be able to check this by carrying out a blood test

Serious side effects 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

How long can side effects last?

How long a side effect lasts depends on the effect, the product, how long it has been used, and the person. Some effects ease within days as the body adjusts. Others continue for as long as the product is used. A few can persist after stopping, and some need review rather than waiting.

• Settling effects — mild effects that ease over the first days or weeks of use
• Ongoing effects — effects that continue while the product is being used and improve after stopping
• Persistent effects — effects that continue after stopping and need medical review
• Delayed effects — effects that appear after weeks or months rather than immediately

Which of these applies to a particular effect is a clinical question. If a side effect is not settling, is getting worse, or is affecting your daily life, that is worth a conversation with a pharmacist or doctor regardless of how long it has been going on.

Factors that may affect side effects

The approved leaflet identifies the following cautions and factors.

Do not use it at all if

• if you are hypersensitive (allergic) to enoxaparin sodium, or any of the other ingredients of CRUSIA (listed in section 6)
• if you are hypersensitive (allergic) to heparin or other low molecular weight heparins such as nadroparin, tinzaparin or dalteparin
• you have had a reaction to heparin that caused a severe drop in the number of your clotting cells (platelets) within the last 100 days
• you have antibodies against enoxaparin in your blood
• you are bleeding heavily or have a condition with a high risk of bleeding, such as: o stomach ulcer, recent surgery of the brain or eyes, or recent bleeding stroke
• you are using CRUSIA to treat blood clots and are going to have within 24 hours: o a spinal or lumbar puncture o an operation with epidural or spinal anaesthesia. Do not use CRUSIA if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before using CRUSIA

Use with care, and tell your doctor, if

• you have any problem with your spine, or you have had spinal surgery
• you have ever had a reaction to heparin that caused a severe drop in the number of your clotting cells (platelets)
• you have a history of gastric ulcer
• you have had a recent stroke
• you have high blood pressure
• you have diabetes or problems with blood vessels in the eye caused by diabetes (called diabetic retinopathy)
• you have had an operation recently on your eyes or brain
• you are currently using medicines which affect bleeding
• you have endocarditis (an infection of the inner lining of the heart)
• you have had a heart valve fitted
• you are elderly (over 65 years old) and especially if you are over 75 years old
• you have kidney problems
• you have liver problems
• you are underweight or overweight
• you have high levels of potassium in your blood (this may be checked with a blood test). Tests and checks You may have a blood test before you start using CRUSIA and at intervals while you are using it; this is to check the level of the clotting cells (platelets) and potassium in your blood. Children and adolescents The safety and efficacy of CRUSIA has not been evaluated in children or adolescents

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 healthcare provider for advice before using CRUSIA
• If you are pregnant and have a mechanical heart valve, you may be at an increased risk of developing blood clots
• Your doctor should discuss this with you

Interactions and medicines to check

The approved leaflet names these interactions.

• ibuprofen, diclofenac, ketorolac, or other medicines known as non-steroidal anti-inflammatory medicines which are used to treat pain and swelling in arthritis and other conditions
• warfarin – used for thinning the blood
• aspirin (also known as acetylsalicylic acid or ASA), clopidogrel or other medicines used to stop blood clots from forming
• dextran injection – used as a blood replacer
• prednisolone, dexamethasone, or other medicines used to treat asthma, rheumatoid arthritis, and other conditions
• medicines which increase potassium levels in your blood such as potassium salts, water pills, and some medicines for heart problems. Operations and anaesthetics If you are going to have a spinal or lumbar puncture, or an operation where an epidural or spinal anaesthetic is used, tell your doctor that you are using CRUSIA

What to do if you experience side effects

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.

When to seek urgent medical help

Some symptoms need medical attention straight away rather than an appointment in a few days. Do not wait to see whether they settle.

Get same-day medical advice if you have

• A high fever, or a rash together with feeling generally unwell
• Yellowing of the eyes or skin, or unusually dark urine
• Unusual bruising or bleeding that you cannot explain
• Severe or persistent vomiting or diarrhoea, especially if you cannot keep fluids down
• A sudden change in mood, or thoughts of harming yourself
• Any symptom that is rapidly getting worse

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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