Drug reference
Treatment of adults with relapsing-remitting multiple sclerosis with active disease defined by clinical or imaging features ▶BY INTRAVENOUS INFUSION ▶Adult: (consult product literature) l UNLICENSED USE Although no longer licensed for oncological and transplant indications, alemtuzumab is Immune system and malignant disease also available through a patient access programme for these indications.
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Angina (past history). autoimmune diseases (excluding multiple sclerosis). cervicocephalic arterial dissection (past history). clotting abnormalities (including patients on anticoagulant therapy). human immunodeficiency virus. hypertension (uncontrolled). myocardial infarction (past history). severe active infection (until complete resolution). stroke (past history)
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Hepatitis B carriers. hepatitis C carriers. not recommended for inactive disease. not recommended for stable disease. patients should receive oral prophylaxis for herpes infection starting on the first day of treatment and continuing for at least a month following each treatment course. pretreatment before administration is required (consult product literature) CAUTIONS, FURTHER INFORMATION For full details of cautions, consult product literature. ▶Autoimmune mediated conditions The risk of autoimmune mediated conditions may increase during treatment, including immune thrombocytopenic purpura, thyroid disorders, nephropathies, and cytopenias, and should be monitored for throughout the course of treatment (consult product literature).
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Screening patients at high risk of hepatitis B or C is recommended before treatment. All patients should be evaluated for active or latent tuberculosis before starting treatment.
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All patients should receive oral prophylaxis for herpes infection starting on the first day of treatment and continuing for at least a month following each treatment course.
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NICE decisions ▶Alemtuzumab for treating relapsing-remitting multiple sclerosis (May 2014) NICE TA312 Alemtuzumab (Lemtrada ®) is recommended as an option, within its marketing authorisation, for treating adults with active relapsing-remitting multiple sclerosis. www.nice.org.uk/guidance/ta312
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MHRA/CHM ADVICE (UPDATED FEBRUARY 2020): LEMTRADA ® (ALEMTUZUMAB): UPDATED RESTRICTIONS AND STRENGTHENED
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FOLLOWING REVIEW OF SERIOUS CARDIOVASCULAR AND IMMUNE-MEDIATED REACTIONS Following a review of alemtuzumab by the European Medicines Agency, a revised indication, additional contra-indications (see Contra-indications), and strengthened monitoring requirements before, during, and after treatment have been recommended. Healthcare professionals are advised that alemtuzumab should only be used for the treatment of patients with relapsing-remitting multiple sclerosis (RRMS) that is highly active despite a full and adequate course of treatment with at least one disease-modifying agent, or in patients with rapidly evolving severe RRMS. Healthcare professionals should monitor patients before, during, and after treatment for cardiovascular reactions and non-immune thrombocytopenia (see Monitoring requirements). Patients should be informed of serious cardiovascular symptoms that can occur within a few days of treatment, signs of autoimmune disorders that can occur 48 months or more after treatment, and symptoms of hepatic injury; immediate medical attention should be sought by patients if they experience any of these symptoms. ▶The MHRA advises to check liver, thyroid, and kidney function, urinalysis with microscopy, blood counts, and vital signs (including blood pressure, heart rate, and ECG) before infusions. ▶The MHRA advises monitor blood pressure and heart rate continuously or at least once every hour during infusions—discontinue infusion if severe adverse reactions occur. ▶The MHRA advises monitor patients for infusion-related reactions for at least 2 hours after infusions; patients should be informed of the risk of delayed infusion-related reactions and to seek immediate medical attention if these occur. ▶The MHRA advises monitor platelet counts after treatment—consult product literature. ▶For further information on monitoring, see Important safety information. ▶HPV screening should be carried out annually in female patients.
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→Appendix 1: monoclonal antibodies
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▶Common or very common Abdominal pain. anxiety. asthma. cytokine release syndrome. endocrine ophthalmopathy. goitre. haemorrhage. hiccups. hyperhidrosis. hyperthyroidism. hypothyroidism. influenza like illness. leucocytosis. lymphadenopathy. lymphopenia. malaise. meningitis. menstrual cycle irregularities. multiple sclerosis exacerbated. muscle complaints. muscle weakness. neoplasms. nephropathy. oropharyngeal pain. peripheral oedema. sensation abnormal. skin reactions. stomatitis. thyroiditis. tremor. urine abnormalities. vertigo. vision disorders ▶Uncommon Acquired haemophilia. appetite decreased. cervical dysplasia. dry mouth. dysphagia. ear pain. facial swelling. gallbladder disorders. gastrointestinal disorders . Goodpasture’s syndrome. limb discomfort. musculoskeletal stiffness. nephrolithiasis. pancytopenia. pneumonitis. tension headache. throat irritation. weight changes ▶Rare or very rare Haemophagocytic lymphohistiocytosis Immune system and malignant disease ▶Frequency not known Artery dissection. cerebrovascular insufficiency. hepatitis autoimmune (including fatal cases). liver injury. myocardial ischaemia. reactivation of infections. thyroid disorder autoimmune
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Women of childbearing potential should use effective contraception during and for 4 months after treatment.
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Manufacturer advises avoid unless potential benefit outweighs risk—toxicity in animal studies. Autoimmune thyroid disease during treatment may affect fetus (consult product literature).
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Manufacturer advises avoid during and for 4 months after each treatment course unless potential benefit outweighs risk.
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There can be variation in the licensing of different medicines containing the same drug. Solution for infusion ▶Lemtrada (Genzyme Therapeutics Ltd) A Alemtuzumab 10 mg per 1 ml Lemtrada 12mg/1.2ml concentrate for solution for infusion vials | 1 vial P £7,045.00 (Hospital only) ▶MabCampath (Genzyme Therapeutics Ltd) Alemtuzumab 30 mg per 1 ml MabCampath 30mg/1ml concentrate for solution for infusion vials | 3 vial P £792.34 (Hospital only) eiiii F 903
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Patients should be provided with a patient alert card and patient guide.
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(consult product literature)
First-line fragment. Read the complete Indications and Dose section above.
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