Generic Medicine Info
As 12 mg/1.2 mL solution used in relapsing-remitting multiple sclerosis (RRMS): HIV infection, severe active infection (until complete resolution), other autoimmune diseases, coagulopathy, uncontrolled hypertension; history of stroke, angina pectoris, MI or arterial dissection of the cervicocephalic arteries. Concurrent antiplatelet or anticoagulant therapy.
Special Precautions
Patient with hepatitis B or C; latent TB, pre-existing or ongoing malignancies. Concomitant administration with live vaccines. Not recommended for use in multiple sclerosis (MS) patients with inactive disease or those who are stable on other treatment. Treatment guidelines may vary among individual products (refer to product-specific recommendations). Pregnancy and lactation. Monitoring Parameters Monitor patients closely for signs of infection, infusion-related reactions, vital signs, depression, and suicidal behaviour or ideation. For RRMS: Obtain CBC with differential, serum creatinine, urinalysis with urine cell counts, serum ALT/AST, and total bilirubin prior to treatment initiation and monthly thereafter until ≥48 months after the last infusion; thyroid function test before initiation and every 3 months thereafter until 48 months after the last infusion. Perform skin exams at baseline then yearly for melanoma; TB screening according to local guidelines; human papilloma virus (HPV) screening annually in females. Evaluate patient for history of varicella or vaccination for VZV; if none, test for VZV antibodies and consider vaccinations for antibody-negative patients; complete necessary immunisations at least 6 weeks prior to treatment initiation. For B-CLL: Monitor CBC with differential and platelets weekly or as clinically indicated; CD4+ lymphocyte counts following treatment until recovery; CMV antigen during and for at least 2 months after therapy.
Adverse Reactions
Significant: Hepatic injury, including acute liver failure; malignancies (e.g. thyroid cancer, melanoma, lymphoproliferative disorders, lymphoma), pneumonitis, emesis, suicidal ideation; CHF, cardiomyopathy, decreased ejection fraction, severe bleeding reactions; other infections (e.g. cervical HPV infection, nasopharyngitis, upper respiratory tract infection, pneumonia, sinusitis, herpes viral infections, influenza, bronchitis, appendicitis, gastroenteritis, tooth infection, UTI, oral or vaginal candidiasis). Blood and lymphatic system disorders: Lymphadenopathy, leukocytosis, leucopenia. Cardiac disorders: Tachycardia, bradycardia, palpitations, chest pain or discomfort. Ear and labyrinth disorders: Ear infection, vertigo. Eye disorders: Conjunctivitis, endocrine ophthalmopathy, blurred vision. Gastrointestinal disorders: Abdominal pain, nausea, diarrhoea, dyspepsia, oropharyngeal pain, dysgeusia, stomatitis. General disorders and administration site conditions: Pyrexia, fatigue, peripheral oedema, asthenia, influenza-like illness, malaise, infusion site pain. Immune system disorders: Cytokine release syndrome. Injury, poisoning and procedural complications: Contusion. Investigations: Decreased haematocrit, increased AST/ALT, increased blood creatinine. Musculoskeletal and connective tissue disorders: Myalgia, arthralgia, chills, muscle weakness, back or neck pain, pain in extremity, muscle spasms, musculoskeletal pain. Nervous system disorders: Headache, dizziness, hypoaesthesia, paraesthesia, tremor, migraine, MS relapse. Psychiatric disorders: Anxiety, depression, insomnia. Renal and urinary disorders: Haematuria, proteinuria. Reproductive system and breast disorders: Menorrhagia, irregular menstruation. Respiratory, thoracic and mediastinal disorders: Lower respiratory tract infections, epistaxis, hiccups, cough, asthma, dyspnoea. Skin and subcutaneous tissue disorders: Urticaria, rash, pruritus, erythema, ecchymosis, alopecia, hyperhidrosis, acne, skin lesion, dermatitis. Vascular disorders: Flushing, hypotension or hypertension.
Potentially Fatal: Autoimmune conditions [e.g. immune thrombocytopenic purpura (ITP), haemolytic anaemia, thrombocytopenia, bone marrow hypoplasia, neutropenia, pancytopenia, lymphopenia, thyroid disorders, glomerular nephropathies including anti-glomerular basement membrane (anti-GBM) disease, autoimmune hepatitis (AIH), acquired haemophilia A], haemophagocytic lymphohistiocytosis (HLH), progressive multifocal leukoencephalopathy (PML), acute acalculous cholecystitis; ischaemic or haemorrhagic stroke, cervicocephalic arterial dissection, serious infusion-related reactions (e.g. syncope, pulmonary infiltrates, pulmonary alveolar haemorrhage, acute respiratory distress syndrome, respiratory arrest, cardiac arrhythmias, MI, myocardial ischaemia, pericarditis, acute cardiac insufficiency, cardiac arrest, anaphylaxis, angioedema, anaphylactic shock); serious bacterial (e.g. TB, listeriosis/listeria meningitis), viral [e.g. varicella-zoster virus (VZV), cytomegalovirus (CMV), Epstein-Barr virus (EBV) reactivation], fungal and protozoan infections; severe EBV-associated hepatitis.
Drug Interactions
Increased risk of immunosuppression with concurrent antineoplastic or immunosuppressive therapies.
ATC Classification
L04AA34 - alemtuzumab ; Belongs to the class of selective immunosuppressive agents. Used to induce immunosuppression.
Disclaimer: This information is independently developed by CIMS based on alemtuzumab from various references and is provided for your reference only. Therapeutic uses, prescribing information and product availability may vary between countries. Please refer to CIMS Product Monographs for specific and locally approved prescribing information. Although great effort has been made to ensure content accuracy, CIMS shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise. Copyright © 2021 CIMS. All rights reserved. Powered by
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