| Document Date: 2014-12-11 14:21:32
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City Cambridge / / Company SUSPECTED ADVERSE REACTIONS / Genzyme Corporation / / Country United States / / Event Product Issues / / Facility Laboratory Testing / / IndustryTerm certified healthcare settings / Magnetic resonance imaging / treatment for multiple sclerosis / food / final product / treatment of MS / appropriate equipment / healthcare providers / qualified healthcare facilities / monitor for melanoma / yellow solution / rubber / healthcare / Healthcare facilities / treatment of B-cell chronic lymphocytic leukemia / certified healthcare facilities / treatment of other disorders / / MedicalCondition listeria meningitis / mean disease / HIV / viral infection / MS. Listeria Infections Listeria meningitis / HBV / thyroid disease / herpes zoster / active infections / Untreated hypothyroidism / hives / sterility / Rheumatoid arthritis / anti-glomerular basement membrane disease / skin cancer / herpetic infections / anaphylaxis / neonatal Graves’ disease / Cardiac Disorders Congestive heart failure / intracerebral hemorrhage / thyroid disorder / Hepatitis B / either hypotension / thyroid gland disorders / melanoma / Infections Infections / herpes viral infection / multiple sclerosis / autoimmune pancytopenia / latent infections / disorder / bradycardia / Lymphopenia / transient neurologic symptoms / diarrhea / Graves’ disease / cardiac arrest / papilloma / tiredness / listeria infection / respiratory tract infection / pain in the front of the neck / fungal infections / upper respiratory tract infection / abdominal pain / pneumonia / pulmonary infiltrates / Autoimmune hemolytic anemia / mental retardation / cancer / cardiomyopathy / tooth infection / arthralgia / nasopharyngitis / hypothyroidism / shortness of breath / chills / immune thrombocytopenia / dysgeusia / Guillain-Barré syndrome / HPV / Carcinogenesis / chronic inflammatory demyelinating polyradiculoneuropathy / neutropenia / HCV / itching / fever / chronic infections / human papilloma virus / vomiting / especially oral and vaginal candidiasis / kidney failure / Virus-associated lymphoproliferative disorders / HCV infection / thyroid storm / lymphoproliferative disorders / persistent hoarseness / cytokine release syndrome / atrial fibrillation / infection / fungal infection / dizziness / renal failure / depression / anti-GBM disease / thrombocytopenic purpura / hypersensitivity pneumonitis / rash / joint pain / varicella / paresthesia / oral herpes / disorders / appendicitis / fibrosis / pancytopenia / Tuberculosis Tuberculosis / locally advanced disease / Muscular weakness / anaphylactic shock / chest pain / lymphoma / headache / active infection / genital herpes / chronic lymphocytic leukemia / graft-versus-host disease / bronchitis / urinary tract infection / Dermatitis / nausea / Muscle spasms / thrombocytopenia / Serious infections / herpes / pulmonary compromise / Hepatitis C / hyperthyroidism / hemoptysis / fatal autoimmune hemolytic anemia / syncope / Relapsing-Remitting Multiple Sclerosis LEMTRADA / fatigue / lung disease / miscarriage / autoimmune thyroid disorders / tachycardia / membranous glomerulonephritis / end stage renal disease / vitiligo / sinusitis / aplastic anemia / MS / constipation / pruritus / Neck Pain / undifferentiated connective tissue disorders / Pneumonitis / Infections / back pain / influenza / Fungal Infections Fungal infections / sepsis / wheezing / hypotension / I diabetes / purpura / cancers / sore throat / proteinuria / insomnia / epistaxis / herpetic viral infections / Castleman’s Disease / hemolytic anemia / hypertension / Active and latent tuberculosis / bronchospasm / petechiae / flushing / disease / CONTRAINDICATIONS Infection / gastroenteritis / dyspnea / hoarseness / persistent thyroid disorders / acute respiratory distress syndrome / sinus tachycardia / hematuria / constant cough / Malignancies Thyroid cancer LEMTRADA / unexplained hematuria / coughing / dwarfism / Erythema / acquired hemophilia A / exophthalmos / pain / Serious herpetic infections / herpes meningitis / myocardial infarction / Relapsing-Remitting Multiple Sclerosis / Thyroid Disorders / varicella zoster virus / urticaria / autoimmune disease / angioedema / eye pain / MALT lymphoma / cough / thyroid cancer / Melanoma LEMTRADA / tuberculosis / / MedicalTreatment immunosuppressive therapies / immunizations / vaccination / immunosuppression / kidney transplant / dialysis / birth control / renal transplantation / intravenous infusion / Vaccinations / / Organization LEMTRADA administration / DOSAGE AND ADMINISTRATION / FDA / U.S. Food and Drug Administration / / / Position /no head / physician / pharmacist / prescribing physician / / Product methylprednisolone / Dextrose / LEMTRADA / epinephrine / DOSAGE FORMS AND STRENGTHS Injection / CAMPATH / potassium chloride / Sodium Chloride / disodium edetate / atropine / Concomitant Medication / response / / ProvinceOrState Mississippi / Massachusetts / / Technology ALE / Magnetic resonance imaging / dialysis / antibodies / transplantation / MRI / Pharmacokinetics / Pharmacodynamics / / URL www.LemtradaREMS.com / www.fda.gov/medwatch / /
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HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use LEMTRADA safely and effectively. See full prescribing information for LEMTRADA. LEMTRADA™ (alemtuzumab) injection,