Challenge your relapsing MS by being prepared · Challenge your relapsing MS by being prepared Get ready for treatment with this step-by-step handbook LEMTRADA is a prescription medicine

Please see Important Safety Information on pages 13-14 and full Prescribing Information/Medication Guide, including serious side effects.

Challenge your relapsing MS by being preparedGet ready for treatment with this step-by-step handbookLEMTRADA 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.

SELECTED IMPORTANT SAFETY INFORMATIONLEMTRADA can cause serious side effects including autoimmune problems, infusion reactions, stroke, tears in your arteries that supply blood to your brain (carotid and vertebral arteries), some kinds of cancers, thyroid problems, low blood counts (cytopenias), serious infections, progressive multifocal leukoencephalopathy (PML), inflammation of the gallbladder without gallstones (acalculous cholecystitis), and swelling of lung tissue (pneumonitis). Because of the risks of autoimmune problems, infusion reactions and some kinds of cancers, LEMTRADA is only available through a restricted program called the Risk Evaluation and Mitigation Strategy (REMS) Program.


It’s time to get preparedNow that you’ve enrolled in the LEMTRADA REMS Program, you’re ready to begin your LEMTRADA treatment journey. Read the information in this handbook to prepare for your next steps. This way you’ll know just what to expect before, during, and after treatment.

SUPPORT SERVICES

Your Nurse:NAME PHONE

* 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.

Support services for patientsAs a patient taking LEMTRADA, you’ll receive personalized support from MS One to One®. An MS One to One Nurse will be your contact for what you need, when you need it. You’ll get customized support each time you call. At any time, an MS One to One Nurse can help you in the following ways:

• Helping with benefits verification and other insurance questions

• Locating infusion sites

• Preparing for your days of infusion

• Helping you remember your monthly monitoring

MS One to One Nurses are available 24/7,* so even if your dedicated Nurse is not available, there is always someone to support you.

When you review and sign the LEMTRADA Services Form with your doctor, MS One to One can begin the benefits verification process. If your MS One to One Nurse has not already called, he or she will reach out to you soon to welcome you to your LEMTRADA treatment.

For any questions, contact MS One to One at 1-855-676-6326


RachelLEMTRADA Patient

2

SUPPORT SERVICES

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Support along the wayYour journey is organized into steps to help you plan your LEMTRADA treatment.

These steps include Planning, Before Treatment, Treatment, and After Treatment.

Just take it one step at a time. Don’t forget to call your MS One to One® Nurse

with any questions that you may have. Support is only a phone call away.

AFTER TREATMENT

Plan and commit to after-treatment care and monthly monitoring.

TREATMENT

Know what to expect from your days of infusion.

Handle the specific things you need to do to get ready for treatment.

BEFORE TREATMENT

Schedule appointments and get instructions from your healthcare provider.

PLANNING

YOUR TREATMENT JOURNEY

YOUR TREATMEN

T JOURN

EY


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Notes:

What tests do I need before starting treatment?• Blood and urine tests, in addition to a skin check

What other tests may be recommended?• A tuberculosis test

• A hepatitis B (HBV) and hepatitis C (HCV) test, if necessary

Do I need any vaccinations?• Ask your healthcare provider if any vaccinations are

recommended for you. If so, complete these at least 6 weeks before you begin your LEMTRADA treatment

What to ask your healthcare provider

Getting ready for treatmentAfter you sign the LEMTRADA Services Form, your MS One to One® Nurse will call you to review and start to plan for your LEMTRADA journey. Your Nurse can help you organize and prepare for your treatment, as well as what to expect after your infusion days.

What your MS One to One Nurse will do:• Review your insurance coverage and discuss available financial assistance

— Eligible LEMTRADA patients enrolled in the LEMTRADA Co-Pay Program* will receive:

• Discuss steps involved in finding an infusion site and scheduling your LEMTRADA treatment

• Help you plan for your required blood and urine tests

* Patients who have coverage or prescriptions paid for in part or in full under Medicare, Medicaid, or other state or federally funded healthcare are not eligible. The LEMTRADA Co-Pay Program is subject to termination or modification at any time. Depending on your specific situation, your MS One to One Nurse can direct you to other patient assistance programs that may offer you financial support.

† Commercially insured residents of Massachusetts, Minnesota, Michigan, and Rhode Island are not eligible for infusion-related financial assistance.

PLANNING

LEMTRADA at

$0out-of-pocket costUp to

$100 for each day of infusion toward the cost of administration†

MS One to One offers support throughout your treatment

PLANN

ING

5


1-week checklist

❑ Confirm your infusion appointments with your infusion center

❑ Pick up medications to take during the week of and weeks following treatment, as prescribed by your healthcare provider

❑ Confirm how you will get to and from your infusion appointments. It is recommended that you do not drive yourself

1 week before treatmentThis 1-week before treatment checklist allows you to follow up and confirm your plans for infusion days.


1 month before treatmentThere are ways to prepare yourself for your LEMTRADA treatment courses. It is important to remember to follow all instructions that your healthcare provider gives you. In addition, please use these checklists to help get ready for your infusions.

This 1-month checklist contains the basic elements of your treatment, including scheduling appointments and plans for family responsibilities and/or being out of work for your days of infusion. It also reminds you about instructions from your healthcare provider.

BEFORE TREATMENT

1-month checklist

❑ Schedule your LEMTRADA infusion appointments

DATES

❑ Call MS One to One® at 1-855-676-6326 and give your Nurse your appointment dates so LEMTRADA can be delivered to your treatment center

❑ Complete a blood and urine test, and a skin check

❑ Make plans for transportation, work coverage, and/or child care for days of infusion

Transportation: NAME PHONE

Work: NAME PHONE

Child care: NAME PHONE

❑ Learn about your infusion center’s policies. Call your infusion center to ask about their policies on bringing food, entertainment, visitors, etc.

❑ Follow any instructions your healthcare provider has given you (for example, completing recommended tests and vaccinations)

Getting prepared for LEMTRADA may mean reaching out to your care team for support. The enclosed guide can help you start those conversations

BEFORE TREATM

ENT

6


Questions about LEMTRADA? Contact MS One to One® at 1-855-676-6326

Specific things to bring (favorite books, music, etc.):

1 day before treatmentToday is the day to get organized and finalize all plans for your infusion days. Talk to your healthcare provider about what you will need, and use this checklist to help stay organized.

You should also call your infusion center to find out their policy on things like bringing food or having visitors.

Day-before checklist

❑ Rest!

❑ Drink water to stay hydrated

❑ Pack a travel bag for your time at the infusion center. Suggested items to bring with you could include:

❑ Water or water bottle

❑ Entertainment or activities

❑ Headphones

❑ Blanket/Sweatshirt

❑ Food/Snacks

• Ask your healthcare provider if you should avoid certain foods

• Make sure you know the infusion facility’s policy on bringing food

NAME

DIRECTIONS

PHONE

Infusion center:

BEFORE TREATMENT

Harold LEMTRADA Patient

Pack some of your favorite things so you can feel comfortable during your infusion days


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Days of infusionIt’s time to start your LEMTRADA infusions, and you’re well prepared! Here’s a checklist of things to remember for your treatment days.

Days-of-infusion checklist

❑ Bring the bag you packed

❑ Wear layered, comfortable clothing

❑ Take any pretreatment medications before you arrive at your infusion appointments, as prescribed by your healthcare provider

❑ Arrive early to your appointments

❑ Drink water to stay hydrated before, during, and after your treatments

Steps to help manage infusion reactionsLEMTRADA 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 be closely monitored during the infusion and for at least 2 hours following the completion of the infusion to watch for any infusion reactions.

Tell your healthcare provider right away if you have any of the following symptoms of a serious infusion reaction during or after treatment:

• Swelling in your mouth or throat

• Trouble breathing

• Weakness

• Fast, slow, or irregular heartbeat

• Chest pain

• Rash

• Drooping of parts of your face

• Sudden severe headache

• Neck pain

• Weakness on one side

• Difficulty with speech

Your healthcare provider may also give you other medicines before, during, or after the infusion to try to reduce your chances of these reactions or to treat them if they happen. You will be prescribed a corticosteroid, which is usually given through a vein in your arm on the first 3 days of your infusions, just before your LEMTRADA infusion. Your doctor may also give you other medications, such as anti-allergy (e.g., Benadryl®) and anti-fever medications (e.g., Tylenol®).

In addition, some people have experienced stroke and tears in their arteries that supply blood to the brain within 3 days of receiving LEMTRADA. Get help right away if you have any of the following symptoms:

TREATMENT

Rene LEMTRADA Patient

Alert a healthcare professional right away if you experience discomfort or side effects during and after your infusions

TREATMEN

T

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After treatment

• Your healthcare provider will prescribe medicines to reduce your chances of getting herpes viral infections. Take these medicines exactly as your healthcare provider tells you to

• Effective contraception should be used by women of childbearing potential during treatment and continued for 4 months after your treatment course

• Women should have an HPV screening each year


If you have questions after your treatment, call your healthcare provider or MS One to One® at 1-855-676-6326

What to expect Your risk of infection is greater following treatment. However, there are things you can do to help prevent infections. You can take care of yourself by doing things like washing your hands.

AFTER TREATMENT

Follow your healthcare provider’s instructions, and use this resource and the enclosed Medication Guide to help you take care of yourself after treatment courses of LEMTRADA.

What to do after treatment

Alert your healthcare provider immediately if anything feels out of the ordinary.

Rest and don’t overexert yourself.

Stay hydrated.

Schedule your lab- monitoring tests.

Wash your hands and use hand sanitizer. Ask adults and children around you to wash their hands, too.

Avoid situations that could expose you to germs.

Talk to your healthcare provider about any foods you should avoid.

AFTER TREATM

ENT


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Monitoring is just as important as getting treatmentEven after treatment is complete, it is important that you establish a regular monitoring routine. Your MS One to One® Nurse can help support you with reminders. Monitoring includes monthly blood and urine tests, ongoing symptom self-checks, and yearly skin checks. These can help to detect possible serious side effects that can show up months or even years after your last infusion, including autoimmune diseases, which may cause death.

These may include blood, thyroid, and kidney disorders (e.g., anti-glomerular basement membrane disease). Kidney disease can lead to kidney failure needing dialysis or transplant and can be life-threatening if untreated. LEMTRADA may also be associated with some kinds of cancers, including skin cancer (melanoma), thyroid cancer, and blood cancers (e.g., lymphoproliferative disorders and lymphoma). Monitoring may help you and your healthcare provider find any potential problems early.

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.

Tests and checksYou will need to complete certain tests until 4 years, or longer, after your last treatment course. These will include monthly blood and urine tests, symptom self-checks, and yearly skin checks. It is important that you complete these tests, even if you are feeling well.

Tip for female patients: Please be sure to schedule urine tests at a time when you are not having your period. False results can occur when a test is completed during menstruation.

Monitoring optionsMS One to One offers a range of options, which are free of charge, for monthly blood and urine testing. You can choose to be tested at home, work, or your doctor’s office. Remember, monitoring is just as important as receiving treatment, so make sure you talk to your healthcare provider about which option works best for you.

AFTER TREATMENT

Even if you feel well, it is important to watch for side effects. Monitoring may help you and your healthcare provider identify potential

problems before they become serious

* If the samples are taken at your healthcare provider’s office, you may have to pay a co-pay. However, the cost of analyzing the samples will be covered by the LEMTRADA Central Lab Program.

LorenzoLEMTRADA Patient

Call MS One to One at 1-855-676-6326 for questions about your required monthly monitoring

The following options are covered by the LEMTRADA Central Lab Program at no cost to you:

Any local LabCorp® or Quest Diagnostics® patient service center:Go to any local facility (www.labcorp.com or www.questdiagnostics.com) and provide necessary samples.

Your home or office: Have a visiting lab tech come to you to take the required samples.

Your healthcare provider’s office: Your healthcare provider can choose to perform the tests in their office if they are enrolled in the LEMTRADA Central Lab Program.*


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AFTER TREATMENT

Symptom self-checksAn important part of your monitoring routine is symptom self-checks. This is something that you can do at home by yourself, or with the help of a family member.

Performing symptom self-checks regularly will help you identify any changes in your health. This can help you detect possible serious side effects associated with LEMTRADA.

Use the guide on the following page to help you know what to look for during a symptom self-check. Be sure to check your skin, in and around your mouth, and even under your tongue. To help you examine your whole body, be sure to stand in front of a mirror. In addition, take note of any changes in your energy or mood. If something feels out of the ordinary, even if it’s small, contact your healthcare provider right away.

It’s important to do a full body check


Communicate openly with your healthcare providers, follow their instructions, and alert them right away if you experience any side effects or changes in your health

Be sure to look out for any of the following:

Skin• Easy bruising• Small, scattered spots that are red,

pink, or purple• Yellowing of the skin• Bleeding from a cut that is hard to stop• Swelling in your legs or feet• Swelling in your neck• New lump• Rash

Eyes, nose, and mouth

• Yellowing of the whites of your eyes• Eye issues, including swelling or vision

problems• Bleeding from gums or nose that is

new or takes longer to stop• Swelling in your mouth• Drooping of parts of your face

Respiratory and throat• Cough that is not caused by a cold• Coughing up blood• Trouble swallowing or breathing• Hoarseness or other voice changes

that don’t go away• Swelling in your throat• Wheezing• Shortness of breath

Pain• Chest pain or tightness• Stomach pain or discomfort• Sudden severe headache• Neck pain

Bowel and urinary issues• Constipation• Blood in the urine (red or tea-colored)• Dark urine

Other• Fast, slow, or irregular heartbeat• Excessive sweating or feeling cold• Weakness• Worsening tiredness• Nervousness• Loss of appetite• Unexplained weight loss or gain• Fever • Swollen glands• For women: heavier menstrual periods

than normal• Nausea or vomiting• Weakness on one side or both sides of

your body• Difficulty with speech• Fatigue• Impaired balance• Problems with thinking• Difficulty using your arms or legs

These are not all the possible side effects that LEMTRADA can cause.

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Frequently asked questionsWhat is LEMTRADA?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.

How do I take LEMTRADA?LEMTRADA is given through a needle placed in your vein (IV infusion). When starting LEMTRADA, you will receive 8 infusions over two years—one infusion a day on 5 consecutive days in round 1 and, one year later, on 3 consecutive days in round 2. You and your healthcare provider may decide that you need one or more additional rounds of treatment. If so, this would occur at least 1 year after your last round and would consist of 3 treatment days in a row.

How long does each infusion last?Each infusion takes approximately 4 hours. Afterward, your healthcare provider will monitor you for at least 2 hours for serious infusion reactions. The total time you spend at the infusion facility will depend on how your body reacts to the infusion. Your healthcare provider will let you know when you are ready to go home for the day. Serious infusion reactions, though, may happen up to 24 hours or longer after you receive LEMTRADA.

What kinds of side effects can happen during or after an infusion?Tell your healthcare provider right away if you have any of the following symptoms of a serious reaction during the infusion or after you have left the healthcare facility: swelling in your mouth or throat, trouble breathing, weakness, fast, slow, or irregular heartbeat, chest pain or rash.

In addition, some people have experienced serious and sometimes deadly strokes and tears in their arteries that supply blood to the brain within 3 days of receiving LEMTRADA. Get help right away if you have any of the following symptoms:

FREQUENTLY ASKED QUESTIONS

Can I eat on the days of my infusion?Yes. In fact, you should remember to bring food with you to eat normally throughout the days of your infusion. Before you start treatment, talk to your healthcare provider to see if there is anything you should avoid. Also, remember to call the infusion site to find out about its policies on bringing food.

Are there any foods I should avoid while on LEMTRADA?Avoid foods that may contain a bacteria called listeria (for example, deli meat, unpasteurized milk and cheese products, soft cheeses, or undercooked meat, seafood, or poultry), or make sure that these foods are heated well if you receive treatment with LEMTRADA. It is important to talk to your healthcare provider about any other foods you should avoid while on LEMTRADA.

Are there any medications I should avoid while on LEMTRADA?You should talk to your doctor before taking any prescription medication and over-the-counter medicines, vitamins, and herbal supplements. 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. Keep a list of all of your medications to show to your healthcare provider.

Is it okay if I get pregnant while taking LEMTRADA?You should talk to your doctor if you 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.

• Drooping of parts of your face

• Sudden severe headache

• Neck pain

• Weakness on one side

• Difficulty with speech



12

Frequently asked questions (continued)

How often should I check in with my healthcare provider after treatment?Your healthcare provider will talk to you about your individual treatment needs, and you should work together to determine how often you should check in. You’ll be getting your monthly blood and urine tests, yearly skin tests, and doing your self-checks. Learn more about monitoring on pages 9-10. Call your healthcare provider right away if you experience any side effects or changes in your health.

How do I arrange my monitoring tests?The LEMTRADA Central Lab Program offers a variety of ways you can get your blood and urine tests done generally at no cost to you. Options include going to a local LabCorp or Quest Diagnostics patient service center or having a lab technician come to your home. You can also have the tests completed at your healthcare provider’s office. If samples are taken at your healthcare provider’s office, you may have to pay a co-pay. However, the cost of analyzing the samples will still be covered by the LEMTRADA Central Lab Program. You should talk to your healthcare provider and MS One to One® Nurse about which option works best for you.

How do I perform a symptom self-check?To perform a symptom self-check, inspect your body for the symptoms listed on page 10. Be sure to check your skin, in and around your mouth, and even under your tongue. To help you examine your whole body, be sure to stand in front of a mirror. In addition, take note of any changes in your energy or mood. If something feels out of the ordinary, even if it’s small, contact your healthcare provider right away.

Is there financial assistance available?Eligible patients enrolled in the LEMTRADA Co-Pay Program receive LEMTRADA at $0 out-of-pocket cost and up to $100 for each day of infusion toward the cost of infusion administration (commercially insured residents of Massachusetts, Minnesota, Michigan, and Rhode Island are not eligible for infusion-related financial assistance). To learn more, please call your MS One to One Nurse at 1-855-676-6326.


Be sure to stick to your monthly monitoring

If you have questions, contact your healthcare provider or call MS One to One at 1-855-676-6326

HaroldLEMTRADA Patient

13

IMPORTANT SAFETY INFORMATIONLEMTRADA 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 and, if not treated, 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


IMPORTAN

T SAFETY

INFORM

ATION

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IMPORTANT SAFETY INFORMATION (continued)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

• 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• 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

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 Important Safety Information on pages 13-14 and full Prescribing Information/Medication Guide, including serious side effects.

©2019 Genzyme Corporation. All rights reserved.LEMTRADA, MS One to One, Sanofi and Genzyme registered in U.S. Patent and Trademark Office.SAUS.LEMT.19.08.4265(1) Last Updated: November 2019


Your determination helped you decide— now use it to prepareBe ready for the next steps of your treatment journeyUse this handbook to prepare for your days of infusion and monthly monitoring.


* 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.

If you have any questions about LEMTRADA, please visit www.Lemtrada.com or call MS One to One® 24 hours a day, 7 days a week at 1-855-676-6326*

ReneLEMTRADA Patient

Documents

Challenge your relapsing MS by being prepared · Challenge your relapsing MS by being prepared Get ready for treatment with this step-by-step handbook LEMTRADA is a prescription medicine