Lemtrada

Lemtrada

alemtuzumab

Manufacturer:

sanofi-aventis

Distributor:

DKSH
Concise Prescribing Info
Contents
Alemtuzumab
Indications/Uses
As a single disease modifying therapy in adults w/ highly active relapsing remitting multiple sclerosis (RRMS) for patients with highly active disease despite a full & adequate course of treatment w/ at least 1 disease modifying therapy (DMT); or w/ rapidly evolving severe relapsing remitting multiple sclerosis (MS) defined by ≥2 disabling relapses in 1 year, & w/ ≥1 gadolinium-enhancing lesions on brain MRI or a significant increase in T2 lesion load as compared to a previous recent MRI.
Dosage/Direction for Use
IV infusion Adult Recommended dose: 12 mg/day for 2 initial treatment courses. 1st treatment course: 12 mg/day on 5 consecutive days (60 mg total dose). 2nd treatment course: 12 mg/day on 3 consecutive days (36 mg total dose) administered 12 mth after the 1st treatment course. May consider up to 2 additional treatment courses if needed: 3rd or 4th course: 12 mg/day on 3 consecutive days (36 mg total dose) administered at least 12 mth after the prior treatment course. Pre-treatment: Immediately administer corticosteroids prior to Lemtrada administration on each of the 1st 3 days of any treatment course. Additionally, may consider pretreatment w/ antihistamines &/or antipyretics prior to administration. Administer oral prophylaxis for herpes infection on the 1st day of each treatment course & continuing for a min of 1 mth following Lemtrada.
Contraindications
Hypersensitivity. HIV infection. Patients w/ severe active infection until complete resolution; uncontrolled hypertension; history of arterial dissection of the cervicocephalic arteries, stroke & angina pectoris or MI; known coagulopathy, on anti-platelet or anti-coagulant therapy; other concomitant autoimmune diseases (besides MS).
Special Precautions
Not recommended in patients w/ inactive disease or those stable on current therapy. Patients who develop autoimmunity should be assessed for other autoimmune mediated conditions. Acquired haemophilia A (anti-factor VIII Ab). Serious events of immune thrombocytopenic purpura. Obtain complete blood count (CBC) w/ differential, serum creatinine & urinalysis w/ microscopy prior to initiation of treatment & at mthly intervals thereafter, until 48 mth after the last infusion; thyroid function tests prior to initiation of treatment & every 3 mth thereafter until 48 mth following the last infusion. Perform CBC to monitor for cytopenias. Perform liver function tests before initial treatment & at mthly intervals until at least 48 mth after the last infusion. Premedicate patients to ameliorate the effects of infusion reactions. Observe for infusion reactions during & for 2 hr after infusion. Discontinue treatment if severe infusions reactions occur. Monitor vital signs including BP before & periodically during infusion. Evaluate patients who develop early manifestations of pathologic immune activation; consider diagnosis of haemophagocytic lymphohistiocytosis. Haemorrhagic stroke; myocardial ischaemia & infarction; dissection of the cervicocephalic arteries; pulmonary alveolar haemorrhage; thrombocytopenia. Perform annual HPV screenings for female patients. Evaluate for immune serostatus; active & inactive TB infection prior to initiation of therapy. Avoid ingestion of uncooked or undercooked meats, soft cheeses & unpasteurized dairy products 2 wk prior to or during & for at least 1 mth after infusion to reduce risk of infection. Pneumonitis. Delay initiation of treatment in patients w/ severe active infection until resolution. Risk of immunosuppression in concomitant use w/ other immunomodulating therapies. Screen patients w/ high risk of HBV &/or HCV before initiation of treatment; patients who are HBV &/or HCV carriers. Epstein-Barr virus (EBV) reactivation, including severe EBV hepatitis cases. May increase risk of acute acalculous cholecystitis. Preexisting &/or ongoing malignancy. Complete local immunisation requirements at least 6 wk prior to treatment. Test for varicella zoster virus (VZV) Ab in patients w/o a history of chickenpox or w/o vaccination against VZV. Consider VZV vaccination in Ab negative patients prior to initiation of Lemtrada. Minor influence on the ability to drive & use machines. Women of childbearing potential should use effective contraception during treatment & up to 4 mth after each course of treatment. Pregnancy & lactation. Childn 0-18 yr.
Adverse Reactions
Upper resp tract infection, UTI, herpes virus infection; lymphopenia, leukopenia including neutropenia; Basedow's disease, hyperthyroidism, hypothyroidism; headache; tachycardia; flushing; nausea; urticaria, rash, pruritus, generalised rash; pyrexia, fatigue, chills. Herpes zoster infections, lower resp tract infections, gastroenteritis, oral & vulvovag candidiasis, influenza, ear infection, pneumonia, vag & tooth infection; skin papilloma; lymphadenopathy, immune thrombocytopenic purpura, thrombocytopenia, decreased anaemia haematocrit, leukocytosis; cytokine release syndrome, hypersensitivity including anaphylaxis; autoimmune thyroiditis including subacute thyroiditis, goiter, anti-thyroid Ab positive; insomnia, anxiety, depression; MS relapse, dizziness, hypoaesthesia, 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 AST & ALT; erythema, ecchymosis, alopecia, hyperhidrosis, acne, skin lesion, dermatitis; myalgia, muscle weakness, arthralgia, back pain, pain in extremity, muscle spasms, neck pain, musculoskeletal pain; proteinuria, haematuria; menorrhagia, irregular menstruation; chest discomfort, pain, peripheral oedema, asthenia, influenza-like illness, malaise, infusion site pain; increased blood creatinine; contusion, infusion-related reaction.
Drug Interactions
β-interferon & glatiramer acetate.
ATC Classification
L04AA34 - alemtuzumab ; Belongs to the class of selective immunosuppressive agents. Used to induce immunosuppression.
Presentation/Packing
Form
Lemtrada infusion conc 12 mg/1.2 mL
Packing/Price
2 mL x 1's
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