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On July 3, 2020 Sanofi Genzyme was notified that our Lemtrada Home Phlebotomy Partner, Examination Management Services Inc., (EMSI) has gone out of business. Because of this, unfortunately, all future Lemtrada Home Phlebotomy (lab draw) visits from EMSI have been cancelled. Patient safety is Sanofi Genzyme’s #1 priority and we are working to provide an alternative phlebotomy solution as well as coordinate alternative testing options for your next monthly lab tests. If you have any questions related to this announcement, please contact your healthcare provider or your One to One Nurse at 1-855-557-2483.

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Medication
Guide Prescribing Information,
including serious side effects For Healthcare Professionals

LEMTRADA is a prescription medicine used to treat relapsing forms of multiple sclerosis (MS), to include relapsing-remitting disease and active secondary progressive disease, in adults. Since treatment with LEMTRADA can increase your risk of getting certain conditions and diseases, LEMTRADA is generally prescribed for people who have tried 2 or more MS medicines that have not worked well enough. LEMTRADA is not recommended for use in patients with clinically isolated syndrome (CIS). It is not known if LEMTRADA is safe and effective for use in children under 17 years of age.

LEMTRADA is a prescription medicine used to treat relapsing forms of multiple sclerosis (MS), to include relapsing-remitting disease and active secondary progressive disease, in adults. Since treatment with LEMTRADA can increase your risk of getting certain conditions and diseases, LEMTRADA is generally prescribed for people who have tried 2 or more MS medicines that have not worked well enough. LEMTRADA is not recommended for use in patients with clinically isolated syndrome (CIS). It is not known if LEMTRADA is safe and effective for use in children under 17 years of age.

PERSONAL SUPPORT

GET ANSWERS AND SUPPORT FOR LEMTRADA TREATMENT
FROM MS ONE TO ONE ®

Whether you’re considering LEMTRADA or getting started on treatment, you and your Support Partners can benefit from information and resources to help make smart decisions. That’s why LEMTRADA offers personalized support from MS One to One.

A dedicated nurse assigned to
every patient

Anyone can call and speak with an MS One to One nurse, anytime. If you have been prescribed LEMTRADA and would like to be assigned your own dedicated MS One to One nurse, you and your healthcare provider must first complete the LEMTRADA Services Form.

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1-855-676-6326 1-855-676-6326

Relapsing MS treatment questions? MS One to One can
help with:

  • Getting started on LEMTRADA
  • Understanding the potential benefits and risks of
    LEMTRADA
  • Preparing for your infusions
  • Remembering monthly monitoring
  • Providing information for financial support
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MS One to One nurse Lynn

*As a member of MS One to One, you’ll have access to an on-duty nurse 24/7. Regular MS One to One call center hours are Mon–Fri, 8:30 am–8:00 pm ET.

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LEMTRADA patient brochure

THE LEMTRADA PATIENT
BROCHURE

Get all the facts about treatment with LEMTRADA. Download now.

IMPORTANT SAFETY INFORMATION

LEMTRADA can cause serious side effects including:

Serious autoimmune problems: Some people receiving LEMTRADA develop a condition where the immune cells in your body attack other cells or organs in the body (autoimmunity), which can be serious and may cause death. Serious autoimmune problems may include:

  • Immune thrombocytopenic purpura (ITP), a condition of reduced platelet counts in your blood that can cause severe bleeding that may cause life‑threatening problems. Call your healthcare provider right away if you have any of the following symptoms: easy bruising; bleeding from a cut that is hard to stop; coughing up blood; heavier menstrual periods than normal; bleeding from your gums or nose that is new or takes longer than usual to stop; small, scattered spots on your skin that are red, pink, or purple
  • Kidney problems called anti‑glomerular basement membrane disease, which, if not treated, can lead to severe kidney damage, kidney failure that needs dialysis, a kidney transplant, or death. Call your healthcare provider right away if you have any of the following symptoms: swelling of your legs or feet; blood in the urine (red or tea‑colored urine); decrease in urine; fatigue; coughing up blood

It is important for you to have blood and urine tests before you receive, while you are receiving and every month for 4 years or longer, after you receive your last LEMTRADA infusion.

Serious infusion reactions: LEMTRADA can cause serious infusion reactions that may cause death. Serious infusion reactions may happen while you receive, or up to 24 hours or longer after you receive LEMTRADA.

  • You will receive your infusion at a healthcare facility with equipment and staff trained to manage infusion reactions, including serious allergic reactions, and urgent heart or breathing problems. You will be watched while you receive, and for 2 hours or longer after you receive, LEMTRADA. If a serious infusion reaction happens while you are receiving LEMTRADA, your infusion may be stopped.

Tell your healthcare provider right away if you have any of the following symptoms of a serious infusion reaction during the infusion, and after you have left the healthcare facility:

  • swelling in your mouth or throat
  • trouble breathing
  • weakness
  • fast, slow, or irregular heartbeat
  • chest pain
  • rash

To lower your chances of getting a serious infusion reaction, your healthcare provider will give you a medicine called corticosteroids before your first 3 infusions of a treatment course. You may also be given other medicines before or after the infusion to try to reduce your chances of having these reactions or to treat them if they happen.

Stroke and tears in your arteries that supply blood to your brain (carotid and vertebral arteries): Some people have had serious and sometimes deadly strokes and tears in their carotid or vertebral arteries within 3 days of receiving LEMTRADA. Get help right away if you have any of the following symptoms that may be signs of a stroke or tears in your carotid or vertebral arteries:

  • drooping of parts of your face
  • weakness on one side
  • sudden severe headache
  • difficulty with speech
  • neck pain

Certain cancers: Receiving LEMTRADA may increase your chance of getting some kinds of cancers, including thyroid cancer, skin cancer (melanoma), and blood cancers called lymphoproliferative disorders and lymphoma. Call your healthcare provider if you have the following symptoms that may be a sign of thyroid cancer:

  • new lump
  • swelling in your neck
  • pain in front of neck
  • hoarseness or other voice changes that do not go away
  • trouble swallowing or breathing
  • cough that is not caused by a cold

Have your skin checked before you start receiving LEMTRADA and each year while you are receiving treatment to monitor for symptoms of skin cancer.

Because of risks of autoimmunity, infusion reactions, and some kinds of cancers, LEMTRADA is only available through a restricted program called the LEMTRADA Risk Evaluation and Mitigation Strategy (REMS) Program.

Do not receive LEMTRADA if you are infected with human immunodeficiency virus (HIV).

Thyroid problems: Some patients taking LEMTRADA may get an overactive thyroid (hyperthyroidism) or an underactive thyroid (hypothyroidism). Call your healthcare provider if you have any of these symptoms:

  • excessive sweating
  • unexplained weight loss
  • fast heartbeat
  • eye swelling
  • nervousness
  • unexplained weight gain
  • feeling cold
  • worsening tiredness
  • constipation

Low blood counts (cytopenias): LEMTRADA may cause a decrease in some types of blood cells. Some people with these low blood counts have increased infections. Call your doctor right away if you have symptoms of cytopenias such as:

  • weakness
  • chest pain
  • yellowing of the skin or whites of the eyes (jaundice)
  • dark urine
  • fast heartbeat

Inflammation of the liver: Call your healthcare provider right away if you have symptoms such as unexplained nausea, stomach pain, tiredness, loss of appetite, yellowing of skin or whites of eyes, or bleeding or bruising more easily than normal.

Hemophagocytic lymphohistiocytosis: LEMTRADA may increase the risk of overactivity of the immune system that can be fatal if not diagnosed and treated early. If you experience symptoms such as fever, swollen glands, or skin rash, contact your healthcare provider right away.

Serious infections: LEMTRADA may cause you to have a serious infection while you receive and after receiving a course of treatment. Serious infections may include:

  • listeria. People who receive LEMTRADA have an increased chance of getting a bacterial infection called listeria, which can lead to significant complications or death. Avoid foods that may be a source of listeria or make sure foods are heated well.
  • herpes viral infections. Some people taking LEMTRADA have an increased chance of getting herpes viral infections. Take medicines as prescribed by your healthcare provider to reduce your chances of getting these infections.
  • tuberculosis. Your healthcare provider should check you for tuberculosis before you receive LEMTRADA.
  • hepatitis. People who are at high risk of, or are carriers of, hepatitis B (HBV) or hepatitis C (HCV) may be at risk of irreversible liver damage.

These are not all the possible infections that could happen while on LEMTRADA. Call your healthcare provider right away if you have symptoms of a serious infection such as fever or swollen glands. Talk to your healthcare provider before you get vaccinations after receiving LEMTRADA. Certain vaccinations may increase your chances of getting infections.

Progressive multifocal leukoencephalopathy (PML): A rare brain infection that usually leads to death or severe disability has been reported with LEMTRADA. Symptoms of PML get worse over days to weeks. It is important that you call your doctor right away if you have any new or worsening medical problems that have lasted several days, including problems with:

  • thinking
  • eyesight
  • strength
  • balance
  • balance
  • weakness on 1 side of your body
  • using your arms or legs

Inflammation of the gallbladder without gallstones (acalculous cholecystitis): LEMTRADA may increase your chance of getting inflammation of the gallbladder without gallstones, a serious medical condition that can be life-threatening. Call your healthcare provider right away if you have any of the following symptoms:

  • stomach pain or discomfort
  • fever
  • nausea or vomiting

Swelling of lung tissue (pneumonitis): Some people have had swelling of the lung tissue while receiving LEMTRADA. Call your healthcare provider right away if you have the following symptoms:

  • shortness of breath
  • cough
  • wheezing
  • chest pain or tightness
  • coughing up blood

Before receiving LEMTRADA, tell your healthcare provider if you:

  • have bleeding, thyroid, or kidney problems
  • have a recent history of infection
  • are taking a medicine called Campath® (alemtuzumab)
  • have received a live vaccine in the past 6 weeks before receiving LEMTRADA or plan to receive any live vaccines. Ask your healthcare provider if you are not sure if your vaccine is a live vaccine
  • are pregnant or plan to become pregnant. LEMTRADA may harm your unborn baby. You should use birth control while receiving LEMTRADA and for 4 months after your course of treatment
  • are breastfeeding or plan to breastfeed. You and your healthcare provider should decide if you should receive LEMTRADA or breastfeed.

Tell your healthcare provider about all the medicines you take, including prescription and over‑the‑counter medicines, vitamins, and herbal supplements. LEMTRADA and other medicines may affect each other, causing side effects. Especially tell your healthcare provider if you take medicines that increase your chance of getting infections, including medicines used to treat cancer or to control your immune system.

The most common side effects of LEMTRADA include:

  • rash
  • headache
  • thyroid problems
  • fever
  • swelling of your nose and throat
  • nausea
  • urinary tract infection
  • feeling tired
  • trouble sleeping
  • upper respiratory infection
  • herpes viral infection
  • hives
  • itching
  • upper respiratory infection
  • herpes viral infection
  • hives
  • itching
  • fungal infection
  • joint pain
  • pain in your arms or legs
  • back pain
  • diarrhea
  • sinus infection
  • mouth pain or sore throat
  • tingling sensation
  • dizziness
  • stomach pain
  • sudden redness in face, neck, or chest
  • vomiting
  • sinus infection
  • mouth pain or sore throat
  • tingling sensation
  • dizziness
  • stomach pain
  • sudden redness in face, neck, or chest
  • vomiting

Tell your healthcare provider if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of LEMTRADA.

You may report side effects to the FDA at 1-800-FDA-1088.

Please see full Prescribing Information/Medication Guide, including serious side effects.

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MAT-US-2002447 Last Updated: June 2020
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Important Safety Information See More

LEMTRADA can cause serious side effects including serious autoimmune problems. Some people receiving LEMTRADA develop a condition where the immune cells in your body attack other cells or organs in the body (autoimmunity), which can be serious and may cause death. Serious autoimmune problems may include: