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How LEMTRADA Works

Proposed Mechanism of Action

LEMTRADA depletes T and B cells, two key drivers thought to cause MS inflammation. The exact mechanism by which LEMTRADA exerts its therapeutic effects in MS is unknown.

LEMTRADA is a monoclonal antibody that selectively binds to CD52, highly expressed on lymphocytes (T and B cells), depleting these cells from circulation in the periphery. Other immune cells in the periphery have lower CD52 expression and are minimally affected.1,3,4

LEMTRADA depletes T and B cells, 2 key drivers thought to cause relapsing MS inflammation.

After Treatment With LEMTRADA

Repopulation of T and B cells occurs over time with innate immune cells remaining within normal ranges.1,4,5

Immune Cell Counts Following LEMTRADA4,6
Mean Cell Counts (109/L)
  • 5.0
  • 4.5
  • 4.0
  • 2.0
  • 1.5
  • 1.0
  • 0.5
  • 0.0
  • Months
  • 0 Course 1
  • 1
  • 3
  • 6
  • 9
  • 12 Course 2
  • 15
  • 18
  • 21
  • 24
Neutrophils T and B cells Monocytes Eosinophils Basophils

Innate immune cells remained
within normal ranges4

  • After initial depletion of CD52-expressing
    T and B cells, these cells slowly repopulate
    over time.
  • Innate immune cells (eosinophils,
    neutrophils, basophils, and monocytes)
    all remained in normal ranges.
T and B Cell Depletion and Repopulation44
Mean Cell Counts (109/L)
  • 1.0
  • 0.8
  • 0.6
  • 0.4
  • 0.2
  • 0.0
  • Months
  • 0 Course 1
  • 1
  • 3
  • 6
  • 9
  • 12 Course 2
  • 13
  • 15
  • 18
  • 21
  • 24
CD4+ T cells CD19+ B cells
CD4+ LLN6 CD19+ LLN6

~40%

of patients had total lymphocyte counts reach normal levels 6 months after each course.1

~80%

of patients reached normal
levels after 12 months.1

  • B cells usually reach baseline levels by 6 months; T cells generally do not reach baseline levels by 12 months.1
  • The proportion of regulatory T cells was elevated following LEMTRADA treatment, gradually returned toward baseline levels, but remained elevated at month 12.4

Serum concentrations of LEMTRADA were generally undetectable within approximately 30 days following each treatment course.1

Choosing LEMTRADA

Healthcare professionals share perspectives on LEMTRADA and what makes it an appropriate choice for some.

DR. RANY ABURASHED: So when I think about the ideal LEMTRADA patient, typically there’s a patient who we’ve had on at least two drugs and whose disease has shown that it’s being stubborn and it wants to keep fighting.

DR. HEIDI CRAYTON: It can be people who are having relapses despite being on whatever therapy they’re on.

DR. RANY ABURASHED: And it’s typically a patient whose physical attacks are pretty clear. And that’s kind of the target that I choose for my LEMTRADA cases.

DR. RANY ABURASHED: So the idea with LEMTRADA and what we’re trying to do with LEMTRADA, is we’re trying to take a group of cells that we think are attacking the brain and we’re trying to essentially destroy them. And then we’re going to allow your body to regrow those cells under the hope that they will not attack the brain again. What you see is, approximately six months after we give this drug, you start to see the B cells start to come back at a slow rate and then approximately a year after, you start to see T cells start to come back. We monitor this very carefully because it gives us a little bit of an idea of what risk they may be at for infection.

DR. HEIDI CRAYTON: So, the dosing of LEMTRADA sometimes a little difficult for people to 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.

CARRIE BLIZZARD: LEMTRADA can cause serious side effects during infusion or up to 24 hours longer after you received LEMTRADA. Tell your healthcare provider immediately if you experience any discomfort during or after your infusion. You may also be given other medications before or after the infusion to try and reduce your chances of getting these reactions or to treat them after they happen.

DR. RANY ABURASHED: After a patient is infused with LEMTRADA, one of the most important things we do is to monitor patients’ blood and urine every month.

CARRIE BLIZZARD: You will need monthly blood and urine tests, self-checks, and yearly skin exams. These help to monitor possible side effects that can show up months or even years after your last infusion, including autoimmune side effects and some kinds of cancers, including skin cancer melanoma. It is important to have your blood and urine tested even if you’re feeling well and do not have any symptoms from LEMTRADA or your MS. This may help your healthcare provider find side effects early.

LYNN GOBEILLE: With the lab monitoring, um it’s important that patients continue to, um, have that done, regardless of how well you’re feeling. Your monitoring is going to continue for at least forty-eight months after the last infusion. So, it could be forty-eight months, it could be longer.

DR. RANY ABURASHED: It’s very important for us to monitor them monthly. In doing so, we can help catch any potential side effect very early and, if it happens, we can then treat it.

DR. RANY ABURASHED: Some patients are very very conservative in terms of their goals, and they say, “I don’t want anything that has risk.” And at that point it’s very important to give them the data on what these drugs do and give them the data on what we know. We have a lot of information of this, on these drugs. So, it’s imperative that I work with them, and I come up with the best treatment plan for them.

DR. HEIDI CRAYTON: It’s very important to explain risks and benefits. Um, I like to talk about what the medicine is proposed to do and why I want to implement that particular medication. We really talk about the fact that these are the things you’re going to read about, these are the things that are listed. So, once they get through that part then we, you know, we talk about monitoring. We’re educating them on what to look for and we’re monitoring blood and urine every month for forty-eight months after the last infusion. There are several options to do that. People can either go to their healthcare provider’s office, they can go to a freestanding LabCorp Quest. And people have to really buy into the monitoring with LEMTRADA. They have to be willing to be a partner, an ongoing partner in this relationship. Um, oftentimes people down the road will feel really good and they may not feel that they have to stay connected to the healthcare team. But I explain that some of the things we are monitoring for in terms of other autoimmunity can happen down the road, years down the road.

DR. RANY ABURASHED: I tell patients all the time that we are climbing a mountain and I’m kind of in front and I’m the guide. And it’s us moving together as a team as we try to get to the top of this mountain. Though there’s a lot that we don’t understand, there’s a ton we do.

DR. HEIDI CRAYTON: It takes a village. It definitely takes a village.

LYNN GOBEILLE: You know, partner with your healthcare provider. They are a part of your team and you’re the boss.

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.

Bleeding disorder (acquired hemophilia A): LEMTRADA may cause a bleeding disorder called 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.

Clinical Study Patient Characteristics

At entry, the average CARE-MS II patient who previously experienced disease activity while on a prior therapy is represented by the characteristics below1,2:

CARE-MS II Baseline Characteristics

Baseline Characteristics LEMTRADA
(n=426)
Rebif® (interferon beta-1a)
(n=202)
Demographics2
Mean Age 34.8 35.8
Sex - Female (%) 66 65
Disease Activity2
Mean Number of Relapses in Prior Year 1.7 1.5
Mean EDSS 2.7 2.7
Mean Number of Gd+ Lesions 2.3 2.1
Disease Duration2
Mean Disease Duration, Years 4.5 4.7
Relapsing MS Treatment History2
Duration of Prior MS Therapy, Years 2.9 3.0
Patients on 1 Prior MS Therapy (%) 70 75
Patients on ≥2 Prior MS Therapies (%) 30 25

CARE-MS II:

A 2-year, randomized, open-label, rater-blinded, phase III study that included RMS patients (N=628) with 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).1,2

CARE-MS: Comparison of Alemtuzumab and Rebif Efficacy in Multiple Sclerosis; EDSS: Expanded Disability Status Scale; Gd+: gadolinium-enhancing.

Get to Know Real Patients Taking LEMTRADA

It’s important to carefully consider many factors when choosing a treatment for your patients. Meet some real patients with relapsing MS, and learn why they decided to take an active role in their treatment.

Have patients who want to learn more about the LEMTRADA experience? Download the full patient resource.

LEMTRADA patient Kim

Kim, 44

Magnolia, TX

Kim, 44

Magnolia, TX

“I live an active life, and my disease progression made caring for my 3 children increasingly difficult.”

Diagnosed: age 19

About: married, mother, preschool teacher

RMS risk factors: African American, incomplete recovery from relapses

Treatment history: 1 injectable and 1 oral therapy

What motivated you to explore other treatment options?

I was having multiple relapses, and I was determined to find another treatment option. My HCP team agreed to discuss options and see what to do next.

Why LEMTRADA?

After reviewing both the safety and efficacy data with my doctor, my family and I felt the potential benefits outweighed the risks for me. The required monthly monitoring and self-checks would allow me and my HCP to keep an eye on my health.

LEMTRADA patient Luis

Luis, 38

El Paso, TX

Luis, 38

El Paso, TX

Diagnosed: age 29

About: married, father, volunteer volleyball coach

RMS risk factors: male, worsening disability progression

Treatment history: 2 injectables

What motivated you to explore other treatment options?

As a man, I know I am at risk for a worsening form of relapsing MS. Despite being on other treatments, I was experiencing multiple relapses that resulted in disability progression.

Why LEMTRADA?

Things were getting worse for me and it was important that I explored other therapy options that could possibly address my RMS. My doctor and I spent a lot of time discussing LEMTRADA pros and cons, and ultimately I felt that it was the right therapy for me given my active disease.

LEMTRADA patient Ginny

Ginny, 38

Phoenix, AZ

Ginny, 38

Phoenix, AZ

Diagnosed: age 30

About: married, mother, teacher, motorcycle enthusiast

RMS risk factors: incomplete recovery from relapses

Treatment history: 2 oral treatments, 2 injectables, and 1 other infusion therapy

What motivated you to explore other treatment options?

Despite taking multiple therapies, I was still experiencing relapses and disability progression. I wanted to find out more about the efficacy and safety of LEMTRADA, and was intrigued by the dosing schedule because it was different from what I was used to.

How did you handle any concerns about safety?

I wasn’t sure that I fully understood the full safety profile so I sought the advice of specialists who educated me about things like the potential autoimmune side effects and required monthly monitoring. After learning more, I felt comfortable moving forward with LEMTRADA.

LEMTRADA patient Charles

Charles, 23

Marshall, MN

Charles, 23

Marshall, MN

Diagnosed: age 18

About: pursuing a bachelor’s degree in management

RMS risk factors: male, African American, incomplete recovery from relapses

Treatment history: 1 injectable treatment for 1-2 years

What motivated you to explore other treatment options?

It seemed RMS was winning the war and I was having frequent relapses and not getting better. I was in college and I wasn’t willing to compromise my dreams.

How did you handle any concerns?

LEMTRADA has requirements, like the monthly labs and self-checks, so staying on top of those is critical. I was most worried about how the monitoring would impact my school schedule. After discussing every aspect of treatment with my doctor, I knew what to expect. Knowledge is power!

LEMTRADA patient Ashley

Ashley, 38

River Forest, IL

Ashley, 38

River Forest, IL

Diagnosed: age 18

About: social worker, mother of 3

RMS risk factors: incomplete recovery from relapses, worsening disability

Treatment history: 3 injectables and 1 other infusion therapy

What motivated you to explore other treatment options?

I had a relapse so bad that I couldn’t walk across the parking lot. The worsening of my disability progression was beginning to scare me and an incomplete recovery was my motivation to find another therapy.

How did you handle any concerns about safety?

My doctor and I discussed what to watch for, such as autoimmune problems, stroke, and possible infections. I was committed to the required monthly monitoring as it could help detect possible serious side effects after my last treatment course.

LEMTRADA patient Donnie

Donnie, 49

Winchester, KY

Donnie, 49

Winchester, KY

Diagnosed: age 30

About: married, father, former high school football player

RMS risk factors: male, severe disability progression

Treatment history: 1 oral therapy, 2 injectables, 1 other infusion treatment

What motivated you to explore other treatment options?

I was experiencing multiple relapses every year and my disability continued to progress. My primary concern was how my family could be affected. It was a turning point.

How did you handle any concerns about safety and support?

The monthly monitoring seemed like a big commitment, but my doctor said it was necessary to help detect serious side effects early. Overall, I felt I would be supported throughout my LEMTRADA treatment by my doctor and my healthcare team. Having a team behind me helped a lot!

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 register patients in the pregnancy exposure registry by calling 1-866-758-2990. 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. Lassmann H, Brück W, Lucchinetti CF. The immunopathology of multiple sclerosis: an overview. Brain Pathol. 2007;17(2):210 218. doi:10.1111/j.1750-3639.2007.00064.x
  3. Willis MD, Robertson NP. Alemtuzumab for multiple sclerosis. Curr Neurol Neurosci Rep. 2016;16:84. doi:10.1007/s11910-016-0685-y
  4. Freedman MS, Kaplan JM, Markovic-Plese S. Insights into the mechanisms of the therapeutic efficacy of alemtuzumab in multiple sclerosis. J Clin Cell Immunol. 2013;4(4):1000152. doi:10.4172/2155-9899.1000152
  5. Hill-Cawthorne GA, Button T, Tuohy O, et al. Long term lymphocyte reconstitution after alemtuzumab treatment of multiple sclerosis. J Neurol Neurosurg Psychiatry. 2012;83(3):298-304. doi:10.1136/jnnp-2011-300826
  6. 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;380:1829-1839

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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