This site is intended for UK healthcare professionals
Medscape UK Univadis Logo
Medscape UK Univadis Logo

Alemtuzumab parenteral


Infusions containing alemtuzumab.

Drugs List

  • alemtuzumab 12mg/1.2ml concentrate for solution for infusion
  • LEMTRADA 12mg/1.2ml concentrate for solution for infusion
  • Therapeutic Indications


    Treatment of relapsing-remitting multiple sclerosis

    Treatment of adult patients with relapsing remitting multiple sclerosis (RRMS) with highly active disease despite a full and adequate course of treatment with at least 1 other disease-modifying treatment or in patients with rapidly worsening disease with at least 2 disabling relapses in a year and with one or more gadolinium enhancing lesions on brain MRI or a significant increase in T2-lesion load compared to a recent MRI scan.


    Whilst the doses stated below are those recommended by the manufacturer, local protocols for the relevant indication should be consulted.


    Initial course: 12mg/day for 5 consecutive days (60mg total).
    Second course: 12mg/day for 3 consecutive days (36mg total), administered 12 months after the initial treatment course.
    Third or fourth course: 12mg/day on 3 consecutive days (36mg total), administered at least 12 months after the previous treatment course.

    Additional Dosage Information

    Safety follow-up of patients is recommended from the beginning of the first treatment course until 48 months after the final infusion administered to the patient.


    For intravenous infusion.

    Administered by intravenous infusion over approximately 4 hours. If acute infusion reaction persist, the administration time may be extended.


    Autoimmune disease
    Children under 18 years
    Severe infection
    History of angina
    History of arterial dissection
    History of cerebrovascular accident
    History of myocardial infarction
    Positive HIV status
    Uncontrolled hypertension

    Precautions and Warnings

    History of autoimmune disorder
    Patients over 55 years
    Hepatic impairment
    Hepatitis B
    Hepatitis C
    History of thyroid disorder
    Malignant neoplasm
    Renal impairment

    Administration of live vaccines is not recommended
    Antibodies may develop and increase risk of autoimmune mediated disorders
    Consider screening at risk patients for hepatitis B and/or C virus
    If ITP is suspected perform complete blood count immediately
    ITP and/or nephropathies require prompt treatment
    Advise ability to drive/operate machinery may be affected by side effects
    Consider pre-medication with antihistamines and/or antipyretics
    Ensure relevant vaccinations administered at least 6 weeks before treatment
    Monitor patient during and for 2 hours post administration
    Premedicate for herpes infection from day 1 until, 1 month after treatment
    Premedicate with corticosteroids prior to admin on 1st 3 days of course
    Prior to starting therapy rule out active tuberculosis
    Prior to starting therapy screen for latent tuberculosis
    Treatment to be initiated and supervised by a specialist
    Varicella vaccination recommended for antibody-negative patients
    Administration carried out in centres with intensive care facilities
    Dilute and use as an infusion
    Reducing the infusion rate may minimise severity of infusion reactions
    Resuscitation facilities must be immediately available
    Monitor blood pressure pre-treatment and periodically thereafter
    Monitor CBC with differential prior to & monthly until 4 years after
    Monitor creatinine prior to & monthly until 4 years after treatment
    Monitor hepatic function before treatment and regularly during treatment
    Monitor thyroid function prior to & 3 monthly until 4 years after treatment
    Perform liver function tests prior to and monthly until 4 years after
    Perform urinalysis with microscopy prior to & monthly until 4 years after
    Autoimmune disorders can occur many months after initiation of treatment
    Consider additional monitoring if significant changes in vital signs occur
    Human papilloma virus (HPV) screening recommended annually
    If hepatic impairment symptoms occur monitor LFT & consider discontinuation
    Monitor coagulation values
    Monitor for acquired haemophilia
    Monitor patient for infusion-associated reactions (IARs)
    Monitor patients for signs of adverse cardiovascular effects
    Monitor platelet count immediately after dose on days 3+5 of 1st cycle
    Monitor vital signs and ECG every day during infusion
    Advise on the need to report unusual bleeding
    Advise patient to consult Doctor if spontaneous bruising occurs
    Advise patient to report any chest pain
    Advise patient to report breathlessness or cough immediately
    Advise patient to report signs and symptoms of nephropathy
    Advise patient to report signs of haemophagocytic lymphohistiocytosis (HLH)
    Advise patient to report symptoms of cholelithiasis and cholecystitis
    Advise patient to report unexplained fever, sore throat, bruising, bleeding
    Advise patients to report signs of hepatic damage (malaise, jaundice etc.)
    Consider discontinuing therapy if significant changes in vital signs occur
    Risk of developing opportunistic infections
    Consider discontinuing if severe infusion reactions occur
    Discontinue if headache assoc with weakness/numbness one side/part occurs
    Discontinue if Progressive multifocal leukoencephalopathy (PML) develops
    Female: Contraception required during and for 4 months after treatment
    Breastfeeding: Do not breastfeed during & for 4 months after treatment
    Advise patient to seek medical advice if delayed adverse event(s) occurs
    Avoid foods w/ high risk of listeria 2 weeks prior to 1 mth post treatment
    Remind patient of importance of carrying Alert Card with them at all times

    Complete blood count (CBC) results should be monitored for cytopenias. If a cytopenia is confirmed, appropriate medical intervention should be promptly initiated, including referral to a specialist.

    Progressive Multifocal Leukoencephalopathy Syndrome (PML)
    Progressive multifocal leukoencephalopathy syndrome (PML) has been reported in some patients treated with this agent. If patients present with symptoms indicating PML such as worsening neurological, cognitive or behavioural signs or symptoms, an MRI should be performed. If PML is diagnosed, treatment should be permanently discontinued.

    Pregnancy and Lactation


    Alemtuzumab is contraindicated during pregnancy.

    The manufacturer recommends that alemtuzumab should only be administered during pregnancy if the potential benefit justifies the potential risk to the foetus.

    There is limited data for the use of alemtuzumab in pregnant women. Human IgG is known to cross the placental barrier; alemtuzumab may cross the placental barrier and thus potentially cause foetal harm.


    Alemtuzumab is contraindicated during breastfeeding.

    The manufacturer recommends that breastfeeding should be discontinued during treatment and for at least 4 months following alemtuzumab therapy.

    It is unknown if alemtuzumab is excreted in human breast milk. However, it was detected in the milk and offspring in animals, therefore the risk to the breastfed child cannot be excluded.

    Side Effects

    Abdominal pain
    Antibody formation
    Autoimmune hepatitis
    Blood pressure changes
    Cardiac arrhythmias
    Cervicocephalic arterial dissection
    Cytokine release syndrome
    Cytomegalovirus infection
    Decrease in haematocrit
    Ear infection
    Epstein-Barr virus
    Extremity pain
    Gastroesophageal reflux disease
    Gingival bleeding
    Goodpasture's syndrome
    Graves' disease
    Haemolytic anaemia
    Haemophagocytic lymphohistiocytosis
    Herpes infections
    Hypersensitivity reactions including anaphylaxis
    Idiopathic thrombocytopenic purpura (ITP)
    Increased susceptibility to infection
    Increases in hepatic enzymes
    Influenza-like symptoms
    Infusion-related symptoms
    Muscle spasm and pain of back and chest
    Muscle weakness
    Myocardial infarction
    Night sweats
    Oropharyngeal pain
    Peripheral oedema
    Progressive multifocal leukoencephalopathy (PML)
    Psychiatric disorders
    Pulmonary alveolar haemorrhage
    Reproductive disorders
    Respiratory tract infection
    Sensory disturbances
    Serum creatinine increased
    Throat irritation
    Throat tightness
    Thyroid abnormalities
    Tooth infection
    Urinary tract infections
    Weight loss


    It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.

    The following number will direct the caller to the relevant local centre (0844) 892 0111

    Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( ) or if this is unavailable at the backup site ( ).

    Further Information

    Last Full Review Date: July 2019

    Reference Sources

    Drugs During Pregnancy and Lactation: Treatment Options and Risk Assessment, 3rd edition (2015) ed. Schaefer, C., Peters, P. and Miller, R. Elsevier, London.

    Drugs in Pregnancy and Lactation: A Reference Guide to Fetal and Neonatal Risk, 10th edition (2015) ed. Briggs, G., Freeman, R. and Yaffe, S. Lippincott Williams & Wilkins, Philadelphia.

    EMA 15 November 2019: Measures to minimise risk of serious side effects of multiple sclerosis medicine Lemtrada
    Available at:
    Last accessed: 13 January 2020

    Joint Formulary Committee. British National Formulary (online) London: BMJ Group and Pharmaceutical Press. Accessed on 15 July 2019.

    MHRA Drug Safety Update May 2019
    Available at:
    Last accessed: 19 July 2019

    MHRA Drug Safety Update February 2020
    Available at:
    Last accessed: 10 March 2020

    Summary of Product Characteristics: Lemtrada 12mg/1.2ml concentrate for solution for infusion. Sanofi Genzyme. Revised September 2020.

    The Renal Drug Handbook. 4th edition. (2014) ed. Ashley, C and Dunleavy, A. Radcliffe Publishing Ltd, London.

    Access the full UK drug database with a FREE Medscape UK Account
    It takes just a few minutes, and you’ll get unlimited access to information on over 11,000 UK drugs.
    Register for Free

    Already a member? Log in

    Medscape UK | Univadis prescription drug monographs & interactions are based on FDB Multilex Content

    FDB Logo

    FDB Disclaimer : FDB Multilex is intended for the use of healthcare professionals and is provided on the basis that the healthcare professionals will retain FULL and SOLE responsibility for deciding what treatment to prescribe or dispense for any particular patient or circumstance.