Concise Prescribing Info
Single disease modifying therapy (DMT) in adults w/ highly active relapsing remitting multiple sclerosis (RRMS) for patients w/ highly active disease despite full & adequate course of treatment w/ at least 1 DMT or w/ rapidly evolving severe RRMS defined by ≥2 disabling relapses in 1 yr & w/ ≥1 gadolinium-enhancing lesions on brain MRI or significant increase in T2 lesion load as compared to previous recent MRI.
Dosage/Direction for Use
12 mg IV infusion daily for 2 initial treatment courses w/ up to 2 additional courses if needed. Initial treatment course: 12 mg daily on 5 consecutive days. Total dose: 60 mg. 2nd treatment course: 12 mg daily on 3 consecutive days given 12 mth after 1st treatment course. Total dose: 36 mg. 3rd or 4th course (as needed): 12 mg daily on 3 consecutive days given at least 12 mth after prior treatment course. Total dose: 36 mg.
Hypersensitivity. HIV, severe active infection, uncontrolled HTN; history of cervicocephalic arterial dissection; stroke; angina pectoris or MI; known coagulopathy; other concomitant autoimmune diseases. Concomitant use w/ anti-platelet or anticoagulant therapy.
Special Precautions
Discontinue use if severe infusion reactions occur; adult onset still's disease. Not recommended for patients w/ inactive disease or those stable on current therapy. Previous autoimmune conditions other than multiple sclerosis (MS); thyroid disorder; acquired haemophilia A; immune thrombocytopenic purpura (ITP) & TTP; nephropathies; cytopenias; haemophagocytic lymphohistiocytosis. Haemorrhagic stroke; myocardial ischaemia & MI; cervicocephalic arterial dissection; pulmonary alveolar haemorrhage; thrombocytopenia; pericarditis; pneumonitis; autoimmune encephalitis. Infections; active & latent TB; EBV reactivation; superficial fungal infections; HBV &/or HCV carriers; acute acalculous cholecystitis; preexisting &/or ongoing malignancy. Perform CBC w/ differential, serum transaminases & creatinine, urinalysis w/ microscopy prior to & at mthly intervals thereafter until 48 mth after last infusion; thyroid function tests prior to & every 3 mth thereafter until 48 mth after last infusion. Obtain baseline ECG & vital signs including heart rate & BP measurement prior to & periodically during infusion. Perform LFTs prior to & at mthly intervals until at least 48 mth after last infusion; annual HPV screening in female patients. Evaluate for immune serostatus; MRI scan for signs of progressive multifocal leukoencephalopathy. Test for Ab to varicella-zoster virus (VZV) in patients w/o history of chickenpox or w/o VZV vaccination. Concomitant use w/ antineoplastics or immunosuppressives. Not to be administered w/ live viral vaccine immunisation. Avoid ingestion of uncooked or undercooked meats, soft cheeses & unpasteurized dairy products 2 wk prior to, during & at least 1 mth after infusion. May affect ability to drive & use machines. Autoimmune hepatitis, hepatic injury. Women of childbearing potential should use effective contraceptive during & 4 mth after treatment. Pregnancy & lactation. Childn 0-18 yr. Elderly >61 yr.
Adverse Reactions
URTI, UTI, herpes virus infection; lymphopenia, leukopenia, neutropenia; Basedow's disease, hyper- & hypothyroidism; headache; tachycardia; flushing; nausea; urticaria, rash, pruritus, generalised rash; pyrexia, fatigue, chills. Herpes zoster, lower resp tract, ear, vag & tooth infections, gastroenteritis, oral & vulvovag candidiasis, flu, pneumonia; skin papilloma; lymphadenopathy, ITP, thrombocytopenia, anaemia, decreased haematocrit, leukocytosis; cytokine release syndrome, hypersensitivity eg, anaphylaxis; autoimmune thyroiditis eg, subacute thyroiditis, goitre, +ve anti-thyroid Ab; insomnia, anxiety, depression; MS relapse, dizziness, hypo- & paraesthesia, tremor, dysgeusia, migraine; conjunctivitis, endocrine ophthalmopathy, blurred vision; vertigo; bradycardia, palpitations; hypotension, HTN; dyspnoea, cough, epistaxis, hiccups, oropharyngeal pain, asthma; abdominal pain, vomiting, diarrhoea, dyspepsia, stomatitis; increased ALT & AST; erythema, ecchymosis, alopecia, hyperhidrosis, acne, skin lesion, dermatitis; myalgia, muscle weakness & spasms, arthralgia, back, neck & musculoskeletal pain, pain in extremity; proteinuria, haematuria; menorrhagia, irregular menstruation; chest discomfort, pain, peripheral oedema, asthenia, flu-like illness, malaise, infusion site pain; increased blood creatinine; contusion, infusion-related reaction.
Drug Interactions
β-interferon, glatiramer acetate.
MIMS Class
ATC Classification
L04AA34 - alemtuzumab ; Belongs to the class of selective immunosuppressive agents. Used to induce immunosuppression.
Lemtrada infusion conc 12 mg/1.2 mL
(single-use) 2 mL x 1's
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