LEMTRADA, illustration of injection vial form (not a photo of the actual pack)

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LEMTRADA

Alemtuzumab

Prescription required

$13350.00

12mg/1.2ml · 1 vial

BrandBranded medicine· By Sanofi-Aventis

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FDA boxed warningAutoimmunity, infusion reactions, stroke, and malignancies

LEMTRADA causes serious, sometimes fatal, autoimmune conditions such as immune thrombocytopenia and anti-glomerular basement membrane disease. Monitor complete blood counts with differential, serum creatinine levels, and urinalysis with urine cell counts before starting treatment and then at monthly intervals until 48 months after the last dose of LEMTRADA.

LEMTRADA causes serious and life-threatening infusion reactions. LEMTRADA must be administered in a setting with appropriate equipment and personnel to manage anaphylaxis or serious infusion reactions. Monitor patients for two hours after each infusion. Make patients aware that serious infusion reactions can also occur after the 2-hour monitoring period.

Serious and life-threatening stroke (including ischemic and hemorrhagic stroke) has been reported within 3 days of LEMTRADA administration. Instruct patients to seek immediate medical attention if symptoms of stroke occur.

LEMTRADA may cause an increased risk of malignancies, including thyroid cancer, melanoma, and lymphoproliferative disorders. Perform baseline and yearly skin exams.

Because of the risk of autoimmunity, infusion reactions, and malignancies, LEMTRADA is available only through restricted distribution under a Risk Evaluation Mitigation Strategy (REMS) Program. Call 1-855-676-6326 to enroll in the LEMTRADA REMS program.

LEMTRADA causes serious, sometimes fatal, autoimmune conditions such as immune thrombocytopenia and anti-glomerular basement membrane disease. Monitor complete blood counts with differential, serum creatinine levels, and urinalysis with urine cell counts monthly until 48 months after the last dose.

Serious and life-threatening stroke has been reported within 3 days of LEMTRADA administration. Instruct patients to seek immediate medical attention if symptoms of stroke occur.

LEMTRADA is available only through a restricted distribution program.

Read this with the rest of the clinical information

About LEMTRADA

Overview

LEMTRADA (alemtuzumab) is a prescription monoclonal antibody medicine given by intravenous infusion to treat relapsing forms of multiple sclerosis in adults, including relapsing-remitting disease and active secondary progressive disease. Because of its safety profile, it is generally reserved for people who have not responded adequately to at least two other MS medicines. It is not recommended for clinically isolated syndrome. Its exact action in MS is unknown, but it is thought to work by binding to CD52 on immune cells, leading to the destruction of T and B cells.

What it treats

- Relapsing forms of multiple sclerosis (MS) in adults, including relapsing-remitting MS and active secondary progressive MS. Because of its safety profile, LEMTRADA is generally reserved for patients who have had an inadequate response to two or more MS medicines. It is not recommended for clinically isolated syndrome (CIS).

Safety information

Side effects

Common side effects include rash, headache, fever, nose and throat inflammation, nausea, urinary tract infection, tiredness, difficulty sleeping, upper respiratory tract infection, herpes infection, hives, itching, thyroid disorders, fungal infection, joint pain, pain in the arms or legs, back pain, diarrhoea, sinusitis, throat pain, tingling or prickling sensations, dizziness, abdominal pain, flushing and vomiting. Serious side effects include infusion reactions, stroke, tears in arteries supplying the head and neck, cancers, and infections, including progressive multifocal leukoencephalopathy (PML). LEMTRADA can also cause autoimmune conditions affecting the blood, kidneys, thyroid, liver or brain. These include low platelet counts, other low blood cell counts, kidney disease, autoimmune hepatitis, autoimmune encephalitis and acquired haemophilia A. Other serious reactions include thrombotic thrombocytopenic purpura (TTP), severe inflammatory conditions such as haemophagocytic lymphohistiocytosis and adult-onset Still’s disease, immune-related inflammation of the colon, gallbladder inflammation without gallstones, and lung inflammation. Contact a doctor promptly if you develop symptoms suggesting a serious reaction. Symptoms specifically highlighted in the label include unexplained or extensive bruising, bleeding under the skin, blood in the urine, nosebleeds or other bleeding; new memory problems, changes in mental state, psychiatric symptoms, neurological changes or seizures; and new or persistent diarrhoea or other digestive symptoms. Suspected TTP or widespread inflammation requires immediate medical evaluation. Regular monitoring is required to detect some serious reactions. Blood counts and kidney tests are needed before treatment and monthly until 48 months after the last infusion. Thyroid tests are needed before treatment and every three months until 48 months after the last infusion.

FDA boxed warning

Autoimmunity, infusion reactions, stroke, and malignancies

LEMTRADA causes serious, sometimes fatal, autoimmune conditions such as immune thrombocytopenia and anti-glomerular basement membrane disease. Monitor complete blood counts with differential, serum creatinine levels, and urinalysis with urine cell counts before starting treatment and then at monthly intervals until 48 months after the last dose of LEMTRADA.

LEMTRADA causes serious and life-threatening infusion reactions. LEMTRADA must be administered in a setting with appropriate equipment and personnel to manage anaphylaxis or serious infusion reactions. Monitor patients for two hours after each infusion. Make patients aware that serious infusion reactions can also occur after the 2-hour monitoring period.

Serious and life-threatening stroke (including ischemic and hemorrhagic stroke) has been reported within 3 days of LEMTRADA administration. Instruct patients to seek immediate medical attention if symptoms of stroke occur.

LEMTRADA may cause an increased risk of malignancies, including thyroid cancer, melanoma, and lymphoproliferative disorders. Perform baseline and yearly skin exams.

Because of the risk of autoimmunity, infusion reactions, and malignancies, LEMTRADA is available only through restricted distribution under a Risk Evaluation Mitigation Strategy (REMS) Program. Call 1-855-676-6326 to enroll in the LEMTRADA REMS program.

LEMTRADA causes serious, sometimes fatal, autoimmune conditions such as immune thrombocytopenia and anti-glomerular basement membrane disease. Monitor complete blood counts with differential, serum creatinine levels, and urinalysis with urine cell counts monthly until 48 months after the last dose.

Serious and life-threatening stroke has been reported within 3 days of LEMTRADA administration. Instruct patients to seek immediate medical attention if symptoms of stroke occur.

LEMTRADA is available only through a restricted distribution program.

A boxed warning is the strongest warning the US Food and Drug Administration requires on a medicine label. Text is taken from the official label, with internal section references removed.

When to call your doctor

- Large bruises that appear without injury, extensive bruising, blood in the urine, nosebleeds or other unusual bleeding. - New memory problems, changes in thinking or behaviour, or seizures. - New or persistent diarrhea or other stomach or bowel symptoms.

If symptoms are severe or getting worse quickly, seek emergency care rather than waiting.

Before taking this medicine

Do not receive LEMTRADA if you are allergic to alemtuzumab or any of its ingredients, have previously had an anaphylactic reaction to them, have HIV infection, or have an active infection. LEMTRADA causes prolonged reductions in CD4+ lymphocytes, a type of immune cell. Important risks requiring monitoring include low platelet or other blood cell counts, kidney disease, thyroid disorders, autoimmune liver inflammation, serious inflammatory conditions, blood-clotting and bleeding disorders, autoimmune brain inflammation, and immune-related inflammation of the colon. Blood counts and kidney tests are required before treatment and monthly until 48 months after the last infusion. Thyroid tests are required before treatment and every three months until 48 months after the last infusion. Seek prompt medical assessment for unusual bruising or bleeding, new memory problems, confusion, psychiatric symptoms, seizures, or new or persistent diarrhoea or other digestive symptoms. Treatment must be withheld at the first sign or symptom suggesting progressive multifocal leukoencephalopathy (PML), a serious brain condition. Do not receive live viral vaccines after a course of LEMTRADA. LEMTRADA may harm an unborn baby. Women who could become pregnant should use effective contraception during treatment and for four months after a treatment course.

Using LEMTRADA

Dosing

Dosing is set by your prescriber. Each health care professional may prescribe medication differently according to a patient's medical history and condition, so follow the directions on your prescription label and speak to your doctor or pharmacist before changing anything.

Storage

Store in the original carton below 25°C, protected from light, unless the pack states refrigeration. Do not freeze. Keep all medicines out of the sight and reach of children.

Clinical information on this page is summarised from the US FDA label LEMTRADA (ALEMTUZUMAB) INJECTION, SOLUTION, CONCENTRATE [GENZYME CORPORATION] (DailyMed, retrieved 19 September 2026).

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