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Lemtrada (alemtuzumab) - patient safety update

Lemtrada, for Multiple sclerosis from Genzyme Therapeutics

The Medicines and Healthcare products Regulatory Agency (MHRA) have published further information on restrictions regarding Genzyme's relapsing remitting multiple sclerosis (RRMS) treatment alemtuzumab, brand name Lemtrada.

The MHRA have stated that serious cardiovascular and immune-mediated adverse reactions are being investigated in patients taking Lemtrada.

While an urgent EU safety review evaluates reports of serious cardiovascular events and immune-mediated reactions, including autoimmune hepatitis, the use of alemtuzumab (Lemtrada) has been restricted and strengthened requirements have been introduced to monitor vital signs and liver function before and during treatment. All patients on alemtuzumab for multiple sclerosis should be alerted to these risks and what to do if symptoms occur.

Advice for patients highlights being aware of the symptoms of:
  • pulmonary haemorrhage, myocardial infarction, stroke, and arterial dissection within days of infusion – patients should seek urgent medical attention if they develop any symptoms of these disorders (see below), which may occur within a few days of treatment
  • hepatic injury – patients should seek urgent medical help if they develop any symptoms of liver injury including abdominal pain, jaundice, dark urine, and unexplained nausea or vomiting
  • haemophagocytic lymphohistiocytosis – patients should seek immediate medical attention if they develop unexplained fever, lymphadenopathy, bruising or rash, including if these symptoms occur several years after treatment
  • patients should speak to their doctor if they have any questions about alemtuzumab for multiple sclerosis
For more information and symptoms of side effects see full article.

Pulmonary haemorrhage
5 patients developed pulmonary alveolar haemorrhage within a day of their last infusion of alemtuzumab. Reported symptoms or signs included:
  • cough
  • haemoptysis - the coughing of blood
  • hypoxia - is a low amount of oxygen reaching the tissues of the body with resulting:
    ataxia (poor balance and speech), confusion / disorientation / hallucinations / behavioral change, severe headaches / reduced level of consciousness, papilloedema (affects eye sight), breathlessness, pallor, tachycardia (fast heart rate)
  • dyspnoea - difficulty breathing
Myocardial infarction
Symptoms of a heart attack can include:
  • chest pain – the chest can feel like it's being pressed or squeezed by a heavy object, and pain can radiate from the chest to the jaw, neck, arms and back
  • shortness of breath
  • feeling weak and/or lightheaded
  • overwhelming feeling of anxiety
It's important to stress that not everyone experiences severe chest pain; the pain can often be mild and mistaken for indigestion.

Stroke
Some patients had significant increases in their blood pressure during treatment with alemtuzumab. This is a major factor in the cause of stroke.

The main symptoms of stroke can be remembered with the word F.A.S.T.:
  • Face – the face may have dropped on 1 side, the person may not be able to smile, or their mouth or eye may have dropped.
  • Arms – the person with suspected stroke may not be able to lift both arms and keep them there because of weakness or numbness in 1 arm.
  • Speech – their speech may be slurred or garbled, or the person may not be able to talk at all despite appearing to be awake; they may also have problems understanding what you're saying to them.
  • Time – it's time to dial 999 immediately if you see any of these signs or symptoms.

The immune-mediated reactions described below generally occurred around 6 months after alemtuzumab exposure so may represent secondary autoimmune mechanisms.

Autoimmune hepatitis
Short-term (acute) hepatitis often has no noticeable symptoms, so you may not realise you have it.

If symptoms do develop, they can include:
  • muscle and joint pain
  • a high temperature
  • feeling and being sick
  • feeling unusually tired all the time
  • a general sense of feeling unwell
  • loss of appetite
  • tummy pain
  • dark urine
  • pale, grey-coloured poo
  • itchy skin
  • yellowing of the eyes and skin (jaundice)
See your GP if you have any persistent or troublesome symptoms that you think could be caused by hepatitis.

Haemophagocytic lymphohistiocytosis
This is a condition in which the body makes too many activated immune cells. Symptoms may include:
  • fever
  • enlarged liver or spleen
  • cytopenia (decreased number of blood cells)
  • neurological abnormalities
Lemtrada was first made available in the EU in 2013. It is manufactured by Genzyme Therapeutics.

Sources
MHRA
European Medicines Agency website page for Lemtrada
NHS website
Merck Manual
Contains public sector information licensed under the Open Government Licence v3.0.
Accessed 22/05/19
Links available in full article

MHRA information on Lemtrada

Reporting of suspected adverse reactions

Reporting suspected adverse reactions (side effects) after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals or patients are asked to report any suspected adverse reactions via the Yellow Card Scheme at yellowcard.mhra.gov.uk or search for MHRA Yellow Card in the Google Play or Apple App Store.


Disclaimer: This site is designed to offer information for general educational purposes only. The health information furnished on this site and the interactive responses are not intended to be professional advice and are not intended to replace personal consultation with a qualified physician, pharmacist, or other healthcare professional. We cannot provide individual medical advice. You must always seek the advice of a professional for questions related to a disease, disease symptoms, and appropriate therapeutic treatments.


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