Lemtrada 12 mg/1.2 mL Concentrate for solution for infusion

    Lemtrada 12 mg/1.2 mL Concentrate for solution for infusion

    S4
    PDF Leaflet Revision Date: 20 November 2023


    Clinical Summary

    Quick overview from the medicine insert

    Indication

    Treatment of highly active relapsing remitting multiple sclerosis (RRMS).

    Dosage (summary)

    12 mg/day IV infusion for 5 days, then 12 mg/day for 3 days after 12 months.

    Special Populations

    • Elderly
    • Renal impairment
    • Hepatic impairment
    • Paediatric population

    Pregnancy & Breastfeeding

    Not recommended during pregnancy; breastfeeding should be discontinued during treatment and for 4 months after.

    Key Drug Interactions

    • Corticosteroids
    • Beta interferon
    • Glatiramer acetate

    Contraindications

    • Hypersensitivity to alemtuzumab
    • HIV infection
    • Severe active infection
    • Uncontrolled hypertension
    • History of arterial dissection
    • History of stroke
    • History of angina or myocardial infarction
    • Coagulopathy or anticoagulant therapy

    Common side effects

    • Headache
    • Rash
    • Nausea
    • Fatigue
    • Thyroid disorders
    • Infections

    Counselling Points

    • Monitor for signs of infection and autoimmune disorders.
    • Educate on symptoms of serious adverse reactions.
    • Adhere to follow-up and monitoring requirements.

    Serious warnings

    • Autoimmunity risk
    • Infusion reactions
    • Serious infections
    • Thrombotic thrombocytopenic purpura
    • Autoimmune hepatitis
    Important Disclaimer

    The Lemtrada 12 mg/1.2 mL Concentrate for solution for infusion professional information leaflet below is the property of Sanofi-Aventis South Africa and is provided on Medinsert exactly as issued, with no.. alterations or editorial changes. We make every effort to keep content current by updating documents as soon as new versions become available. Medinsert serves as a trusted access point for healthcare professionals, but does not replace official sources or clinical judgement. For more details, please read our full disclaimer. read more>>

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