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For US Healthcare Professionals Sanofi

LEMTRADA is administered by intravenous (IV) infusion through 2 initial treatment courses given over 8 days1:

Course 1

5 days of infusion treatment

Infusion
Treatment
Days

1 YEAR LATER

Course 2

3 days of infusion treatment

Infusion
Treatment
Days

If needed ≥1 year
after
last treatment
course

Additional courses as needed*

3 days of infusion treatment

Infusion
Treatment
Days

12 mg/1.2 mL per treatment

LEMTRADA is supplied in a single-dose vial and is a clear and colorless to slightly yellow solution that requires dilution prior to intravenous infusion.1

Half of LEMTRADA patients from CARE-MS II received only 2 courses through year 62

Patients Who Received LEMTRADA Courses Through Years 3-6 (n=387)

50%
did not receive
additional
courses of
LEMTRADA
or other DMT
(n=192)

No. of
patients

192

29%
received
1 additional
course (n=114)

114

13%
received
2 additional
courses (n=50)

50

2%
received
3 additional
courses(n=9)

9

1%
received
4 additional
courses (n=4)

4

5%
received
other DMT only (n=18)

18

  • Data beyond 3 courses are limited2
  • Initiate monitoring at baseline and at periodic intervals until 48 months after the last course of LEMTRADA, or longer, if clinically indicated, in order to monitor for early signs of potentially serious adverse events2

CARE-MS II Core Study:

A 2-year, randomized, open-label, rater-blinded, phase III study that included RMS patients (N=628) with Expanded Disability Status Scale (EDSS) scores of ≤5.0, who had experienced ≥2 relapses in the previous 2 years, with at least 1 relapse in the prior year and at least 1 relapse while on interferon beta or glatiramer acetate therapy after at least 6 months of treatment. Patients received LEMTRADA (12 mg intravenous infusion once daily for 5 days at month 0 and then once daily for 3 days at month 12; n=426) or Rebif (subcutaneous interferon beta-1a 44 µg, 3 times per week for 2 years; n=202).1,3


CARE-MS II Extension Study:

If eligible, LEMTRADA-treated patients from the core study were given the option to remain in the ongoing open-label extension study through 6 years and could receive additional LEMTRADA courses (12 mg dose on 3 consecutive days) at least 12 months after their previous course or other disease-modifying therapy (DMT) if they had evidence of MS disease activity based on clinical or MRI findings.2,4*

*Extension study criteria for initiating additional courses or other DMT: ≥1 protocol-defined relapse and/or ≤2 new or enlarging T2-hyperintense and/or new Gd-enhancing T1 lesions.4

The LEMTRADA Infusion Process

Watch as LEMTRADA patients share treatment tips they learned from their infusion day experiences.

Logo: Lemtrada 12mg

Title: Patient Perspectives

Title: The LEMTRADA infusion process

KATY: So one of the things about LEMTRADA is the fact that you don’t have to think about giving yourself a shot. You have five days of treatment in one year. You wait a year. You have three days of treatment the next year. You’re followed after you receive your dosage. You have regular visits with your doctor. Everybody is very, um, very actively watching you and just to make sure that you’re healthy and doing, um, doing well.

RACHEL: When you arrive at the infusion center you check in. And, uh, I recommend wearing comfortable clothing, because you’re going to be there for a little while. You get to sit there and read a book, watch TV, and the time goes really quickly, more quickly than you would think it would.

TERESA: So when we were going through the process of the LEMTRADA infusions, the staff at my neurologist’s office at the Infusion Center, they were wonderful. The nurse is there with you constantly. They had cozy pillows, cozy blankets, anything they could do to help you be more comfortable throughout the infusion process. And they really wanted to make it as pleasant as possible. I took a book, I took my favorite candy, which I’m a big chocolate lover, you know, so I had to have that. I took pictures of my grandchildren. That’s one reason I fight so hard to be okay. And I think the things that make you happy. Bring some things that make you happy when you’re going to be going through your infusion.

Title: To learn more about LEMTRADA, ask your doctor or attend a live event.

Title: LEMTRADA logo

INDICATION

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.

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 (HCP) 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 HCP 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 HCP 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 HCP 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 HCP 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, trouble swallowing or breathing, hoarseness or other voice changes that do not go away, 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 allergic to alemtuzumab or to any of the inactive ingredients in LEMTRADA
  • are infected with human immunodeficiency virus (HIV)
  • have an active infection

Thyroid problems: Some patients taking LEMTRADA may get an overactive thyroid (hyperthyroidism) or an underactive thyroid (hypothyroidism). Call your HCP if you have: excessive sweating, unexplained weight loss, unexplained weight gain, fast heartbeat, eye swelling, nervousness, 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 HCP 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 HCP right away.

Thrombotic thrombocytopenic purpura (TTP): LEMTRADA may cause blood clotting problems that can be fatal. Call your HCP right away if you experience symptoms such as: purplish spots on skin or in mouth due to bleeding under skin, yellowing of skin or whites of eyes (jaundice), feel tired or weak, very pale skin, fever, fast heart rate or short of breath, headache, speech changes, confusion, vision changes, seizure, low amount of urine or dark or bloody urine, stomach pain, nausea, vomiting, or diarrhea.

Autoimmune encephalitis (AIE): LEMTRADA may cause AIE, a brain disorder which may include symptoms that seem like an MS relapse. Call your HCP right away if you have any of the following symptoms: personality changes, mood changes, seeing things that are not there (hallucinations), agitation, short term memory loss, confusion, movement disorders, or seizures.

Bleeding disorder (acquired hemophilia A): LEMTRADA may cause acquired hemophilia A. Call your HCP right away if you have any of the following symptoms: bruising, nose bleeds, bleeding from a cut that may take longer than usual to stop, painful or swollen joints, blood in urine, dark or bloody stools.

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 HCP to reduce your chances of getting these infections.
  • tuberculosis. Your HCP 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 HCP right away if you have symptoms of a serious infection such as fever or swollen glands. Talk to your HCP 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 one 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 HCP right away if you have stomach pain or discomfort, fever, nausea, or are vomiting.

Swelling of lung tissue (pneumonitis): Some people have had swelling of the lung tissue while receiving LEMTRADA. Call your HCP right away if you have shortness of breath, cough, wheezing, chest pain or tightness, or are coughing up blood.

Before receiving LEMTRADA, tell your HCP 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 HCP 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 HCP should decide if you should receive LEMTRADA or breastfeed.

Tell your HCP 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 HCP 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 HCP 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.

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

Prior to Treatment1

  • Complete any necessary immunizations at least 6 weeks prior to treatment
  • Determine whether patients have a history of varicella or have been vaccinated for varicella zoster virus (VZV). If not, test the patient for antibodies to VZV and consider vaccination for those who are antibody-negative. Postpone treatment with LEMTRADA until 6 weeks after VZV vaccination
  • Perform tuberculosis screening according to local guidelines
  • Advise patients to avoid or adequately heat foods that are potential sources of Listeria moncytogenes prior to and throughout their treatment
  • Consider delaying LEMTRADA administration in patients with active infection until the infection is fully controlled

Prior to administration, protect diluted LEMTRADA solution from light and store for as long as 8 hours either at room temperature 15°C to 25°C (59°F to 77°F) or keep refrigerated at conditions 2°C to 8°C (36°F to 46°F).

Infusion Considerations1

  • Infuse LEMTRADA over 4 hours starting within 8 hours after dilution. Extend the duration of the infusion if clinically indicated.
  • Administer LEMTRADA in a setting where appropriate equipment and personnel are available to manage anaphylaxis or serious infusion reactions (including cardiac and respiratory emergencies).

Do not

  • Add or simultaneously infuse other drug substances through the same IV line.
  • Administer as an IV push or bolus.

The Infusion Process

What to expect before, during, and after treatment.

DR. HEIDI CRAYTON: So, the dosing of LEMTRADA sometimes a little difficult for people to really kind of wrap their head around. People are used to doing regimens daily, several times a week, monthly

DR. RANY ABURASHED: You take this drug eight days over a two-year period. So, patients will come in in year one, we give them five days of an infusion. So, Monday through Friday, they will be infused. The following year, exactly one year later, we bring them back in again. We do three days of the, of the LEMTRADA infusion. After a patient is infused with LEMTRADA, it’s very important for us to monitor them monthly and we need to do this for 48 months after the last infusion. In doing so we can help catch any potential side effect very early and if it happens we can then treat it

DR. HEIDI CRAYTON: You know I think it would be a good idea for people to go and see the infusion suite where they are going to spend an entire week and see if they can bring a loved one with. See what its, what their space is gonna look like, how much stuff can they bring with them. I think that’s an important part of being able to just kind of put yourself at ease and not be faced with all this unknown on the very first day.

DON JORDAN: The first thing that we talk about is pre-medication which is over the counter. I explain what it’s for, that the drugs help to minimize the infusion reactions, and I talk about the prescription medication that’s required.

CARRIE BLIZZARD: The infusion process itself is a 7 to 8 hour day. It’s very important that they plan in advance for this week when they’re coming for their infusion. You know, if they have dogs they need to be walked, they need to have someone do that. If children need to be picked up, if things need to be taken care of, plants need to be watered, whatever. They need to make sure that they have someone to do that.

CARRIE BLIZZARD: We really kind of encourage patients to bring entertainment for themselves. Stuff to do, books to read. They need to have food that they bring with them or snacks.

CARRIE BLIZZARD: So, they come in and we get them settled into the room. If they have someone with them we let them, help them get everything situated and and then we just kind of sit down and talk, you know. It’s, you need to let them know what you’re going to be doing throughout the day. So, once you’ve gotten your consents signed, you get a good idea on them and then you start with the corticosteroids. High-dose corticosteroid goes in over an hour and then we do the LEMTRADA, which is a 4-hour infusion process and then there’s a 2-hour post-observation period. With the infusion week as it goes, usually on day 1 is the longest and it’s the most involved because it’s the element of the unknown. We’re constantly talking with the patient, saying “How are you feeling?”, “Is everything ok?”. As the day progresses and they realize, you know, how they’re feeling we um, when the infusion is done, we talk to them a little about what to expect when they go home, what they should be looking for. And then the next day when they come back the process starts again and hopefully this day is a little easier than it was before and that’s the progression during the week.

CARRIE BLIZZARD: If a patient has any type of reaction, and once we identify exactly what kind of reaction they’re having, then it’s a matter of just mediating the process. Whether it’s something oral that we might start off with, like if they have an elevated temp, we may give them Tylenol or alternate it with ibuprofen. Or if it’s some type of rash that they’re having, maybe an antihistamine. And you just make sure that you have a plan of action available for when something like that occurs.

DON JORDAN: Sometimes it’s just those physical signs, or they got their arms clinched and they’re kind of like this, and “Are you cold?”. And sure enough, they’re cold; well, we give them a blanket and you check their temperature, they’re starting to run fever, so they’re getting chills. So this is some of the things you just look for, ‘cause sometimes they won’t tell you even though you say “Come on, let me know.”

CARRIE BLIZZARD: People that are, um, having LEMTRADA and that are going through the infusion process should really have a sense of security and trust with their healthcare provider and there should be an open line of communication between the infusion nurse, between the physician, and and and anyone else involved, whether it be a family member, whether it be other physicians that, um, are seeing the patient as well, like a primary care physician.

CARRIE BLIZZARD: On the last day of discharge, we do have a little sit-down discussion with the patient and we talk about different things. We talk about, you know, handwashing and how basic it is, but how important it is because people around you don’t know that you’ve just gone through this process and so they’re not thinking about when they sneeze or when they’re coughing; and so I tell them don’t, don’t go on the hugging babies and, you know, going to the nursery tour, and and if you’re gonna shake someone’s hand—fist bump. “Hey, how’s it going?” you know? I just want you to be hypervigilant in your thought-process as far as protecting yourself.

INDICATION

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.

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 (HCP) 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 HCP 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 HCP 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 HCP 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 HCP 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, trouble swallowing or breathing, hoarseness or other voice changes that do not go away, 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 allergic to alemtuzumab or to any of the inactive ingredients in LEMTRADA
  • are infected with human immunodeficiency virus (HIV)
  • have an active infection

Thyroid problems: Some patients taking LEMTRADA may get an overactive thyroid (hyperthyroidism) or an underactive thyroid (hypothyroidism). Call your HCP if you have: excessive sweating, unexplained weight loss, unexplained weight gain, fast heartbeat, eye swelling, nervousness, 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 HCP 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 HCP right away.

Thrombotic thrombocytopenic purpura (TTP): LEMTRADA may cause blood clotting problems that can be fatal. Call your HCP right away if you experience symptoms such as: purplish spots on skin or in mouth due to bleeding under skin, yellowing of skin or whites of eyes (jaundice), feel tired or weak, very pale skin, fever, fast heart rate or short of breath, headache, speech changes, confusion, vision changes, seizure, low amount of urine or dark or bloody urine, stomach pain, nausea, vomiting, or diarrhea.

Autoimmune encephalitis (AIE): LEMTRADA may cause AIE, a brain disorder which may include symptoms that seem like an MS relapse. Call your HCP right away if you have any of the following symptoms: personality changes, mood changes, seeing things that are not there (hallucinations), agitation, short term memory loss, confusion, movement disorders, or seizures.

Bleeding disorder (acquired hemophilia A): LEMTRADA may cause acquired hemophilia A. Call your HCP right away if you have any of the following symptoms: bruising, nose bleeds, bleeding from a cut that may take longer than usual to stop, painful or swollen joints, blood in urine, dark or bloody stools.

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 HCP to reduce your chances of getting these infections.
  • tuberculosis. Your HCP 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 HCP right away if you have symptoms of a serious infection such as fever or swollen glands. Talk to your HCP 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 one 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 HCP right away if you have stomach pain or discomfort, fever, nausea, or are vomiting.

Swelling of lung tissue (pneumonitis): Some people have had swelling of the lung tissue while receiving LEMTRADA. Call your HCP right away if you have shortness of breath, cough, wheezing, chest pain or tightness, or are coughing up blood.

Before receiving LEMTRADA, tell your HCP 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 HCP 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 HCP should decide if you should receive LEMTRADA or breastfeed.

Tell your HCP 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 HCP 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 HCP 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.

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

Preparing for Infusion

To lower a patient's chances of serious side effects, certain pre-medications are indicated or recommended for consideration
before treatment.1

For Infusions:

Corticosteroids for Infusions

Corticosteroids

Premedicate patients with high-dose corticosteroids
(1000 mg methylprednisolone or equivalent) immediately
prior to LEMTRADA administration and for the first 3
days of each treatment course

Antihistamines and Antipyretics

Consider pretreatment with antihistamines and/or
antipyretics prior to LEMTRADA administration

For Herpetic Infections:

Antivirals for Herpetic Infections

Antivirals

Administer antiviral prophylaxis for herpetic viral infections
starting on the first day of each treatment course and continue
for a minimum of 2 months following treatment with LEMTRADA
or until the CD4+ lymphocyte count is at least 200 cells per
microliter, whichever occurs later

Steps for Diluted Solution Preparation1

Follow the steps below to prepare the diluted solution of LEMTRADA for intravenous infusion.

  1. Inspect LEMTRADA visually for particulate matter
    and discoloration prior to administration. Do not use
    if particulate matter is present or the solution is
    discolored. Do not freeze or shake vials prior to use.
  2. Withdraw 1.2 mL of LEMTRADA from the vial into
    a syringe using aseptic technique and inject into
    a 100 mL bag of sterile 0.9% Sodium Chloride,
    USP or 5% Dextrose in Water, USP.
  3. Gently invert the bag to mix the solution. Ensure the sterility
    of the prepared solution, because it contains no
    antimicrobial preservatives. Each vial is for single use only.

Administration Instructions1

After preparation of LEMTRADA for intravenous infusion, follow the steps below to properly administer LEMTRADA.

  1. Infuse LEMTRADA over 4 hours starting within 8 hours after dilution. Extend the duration of the infusion if clinically indicated.
  2. Administer LEMTRADA in a setting in which equipment and personnel to appropriately manage anaphylaxis, serious infusion reactions, myocardial ischemia, myocardial infarction, and cerebrovascular and respiratory adverse reactions are available.
  3. Do not add or simultaneously infuse other drug substances through the same intravenous line. Do not administer as an intravenous push or bolus.
  4. Obtain a baseline ECG. Monitor vital signs before the infusion and periodically during the infusion. Provide appropriate symptomatic treatment for infusion reactions as needed. Consider immediate discontinuation of the intravenous infusion if severe infusion reactions occur.
  5. Observe patients for infusion reactions during and for at least 2 hours after each LEMTRADA infusion. Consider longer periods of observation if clinically indicated. Inform patients that they should report symptoms that occur during and after each infusion because they may indicate a need for prompt medical intervention.

INDICATION

LEMTRADA is indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include relapsing-remitting disease and active secondary progressive disease, in adults. Because of its safety profile, the use of LEMTRADA should generally be reserved for patients who have had an inadequate response to two or more drugs indicated for the treatment of MS.

Limitations of Use: LEMTRADA is not recommended for use in patients with clinically isolated syndrome (CIS) because of its safety profile.

IMPORTANT SAFETY INFORMATION

WARNING: AUTOIMMUNITY, INFUSION REACTIONS, STROKE AND MALIGNANCIES

CONTRAINDICATIONS

LEMTRADA is contraindicated in patients:

WARNINGS AND PRECAUTIONS

Most Common Adverse Reactions

In controlled clinical trials, the most common adverse reactions (incidence ≥10% and >interferon beta-1a) with LEMTRADA vs interferon beta-1a were: rash (53% vs 6%), headache (52% vs 23%), pyrexia (29% vs 9%), nasopharyngitis (25% vs 19%), nausea (21% vs 9%), urinary tract infection (19% vs 8%), fatigue (18% vs 13%), insomnia (16% vs 15%), upper respiratory tract infection (16% vs 13%), herpes viral infection (16% vs 3%), urticaria (16% vs 2%), pruritus (14% vs 2%), thyroid gland disorders (13% vs 3%), fungal infection (13% vs 4%), arthralgia (12% vs 9%), pain in extremity (12% vs 9%), back pain (12% vs 8%), diarrhea (12% vs 6%), sinusitis (11% vs 8%), oropharyngeal pain (11% vs 5%), paresthesia (10% vs 8%), dizziness (10% vs 5%), abdominal pain (10% vs 5%), flushing (10% vs 4%), and vomiting (10% vs 3%).

Use in Specific Populations

Physicians are encouraged to report pregnancies by calling 1-800-745-4447, option 2. Antibodies, including anti-CD52 and autoantibodies, may be transferred from the mother to the fetus during pregnancy. Placental transfer of anti-thyroid antibodies resulting in neonatal Graves’ disease has been reported.

Safety and effectiveness in pediatric patients less than 17 years of age have not been established. Use of LEMTRADA is not recommended in pediatric patients due to the risks of autoimmunity and infusion reactions, stroke, and because it may increase the risk of malignancies.

Please see full Prescribing Information, including Boxed WARNING.

References:

  1. LEMTRADA [prescribing information]. Cambridge, MA: Genzyme Corporation.
  2. Data on file. Genzyme Corporation.
  3. Coles AJ, Twyman CL, Arnold DL, et al; for CARE-MS II investigators. Alemtuzumab for patients with relapsing multiple sclerosis after disease-modifying therapy: a randomised controlled phase 3 trial. Lancet. 2012;380(9856):1829-1839. doi:10.1016/S0140-6736(12)61768-1
  4. Coles AJ, Cohen JA, Fox EJ, et al; on behalf of CARE-MS II and CAMMS03409 investigators. Alemtuzumab CARE-MS II 5-year follow-up: efficacy and safety findings. Neurology. 2017;89(11):1117-1126. doi:10.1212/WNL.0000000000004354

Indication

LEMTRADA is indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include relapsing-remitting disease and active secondary progressive disease, in adults. Because of its safety profile, the use of LEMTRADA should generally be reserved for patients who have had an inadequate response to two or more drugs indicated for the treatment of MS.

Limitations of Use: LEMTRADA is not recommended for use in patients with clinically isolated syndrome (CIS) because of its safety profile.

IMPORTANT SAFETY INFORMATION

WARNING: AUTOIMMUNITY, INFUSION REACTIONS, STROKE AND MALIGNANCIES

  • LEMTRADA causes serious, sometimes fatal, autoimmune conditions such as immune thrombocytopenia and anti-glomerular basement membrane (anti-GBM) disease. Monitor complete blood counts with differential, serum
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