- Making A Choice
QUESTIONS FOR AN MS ONE TO ONE® CASE MANAGER ABOUT LEMTRADA
It is normal for people to feel anxious when they have questions, but they don’t have answers. So, I’d like to help address some of those concerns…
MAKING A CHOICE: Making The Decision To Start LEMTRADA Treatment
QUESTIONS FOR AN MS ONE TO ONE® CASE MANAGER ABOUT LEMTRADA
By MS One to One
Hello, my name is Brenda. My job is to answer your questions about LEMTRADA and offer support and resources that can help you from the time that you’re considering your treatment options, all the way through the infusion courses and monitoring in the years that follow.
It is perfectly normal for people who are considering a treatment to feel anxious or concerned when they have questions, but they don’t have answers. So, I’d like to help address some of those concerns, provide answers, and point you toward some resources that I think can help you find the information you are looking for.
Just remember, your healthcare provider is always your primary source for information and specific questions about your health. They know much more about you than a nurse on a website ever could (even one as friendly and helpful as yours truly!).
Below are some of the most common questions I hear from people who are considering LEMTRADA, along with brief answers and resources where you can find additional information.
Q: CAN LEMTRADA HELP WITH MY RELAPSING MS?
A: There are many factors that must be considered before starting treatment. While only your healthcare provider can tell you if LEMTRADA is right for you, I can tell you that LEMTRADA has been studied in 2 Phase III clinical trials over 2 years, with 1,191 participants who had relapsing MS. Understanding the results of these studies may inspire you to have a discussion with your healthcare provider about LEMTRADA.
Q: HOW DOES LEMTRADA WORK?
A: Like most MS medications, it’s not known exactly how LEMTRADA works in relapsing MS, but we do know that LEMTRADA is thought to work by recognizing certain types of immune cells, including those that are believed to cause MS, and removing many of those cells from the body. After treatment, your immune system begins to replace many of the cells that were removed with new cells. For some people, certain cell types remained below normal levels when they were measured 1 year after treatment. You can watch this explanation about LEMTRADA in the body, or a Case Manager can tell you more about it during a call to MS One to One.
Q: HOW CAN I GET STARTED ON LEMTRADA?
A: Begin by having a discussion with your healthcare provider about how you are doing on your current relapsing MS medication, and if switching to LEMTRADA may be right for you.
For your safety, LEMTRADA can only be prescribed by a LEMTRADA-certified healthcare provider and can only be given at a LEMTRADA-certified infusion site.
You can find LEMTRADA-certified healthcare providers and treatment centers here or ask an MS One to One Case Manager to help you find one near you.
Q: HOW IS LEMTRADA GIVEN?
A: A topic that people often want to discuss is the LEMTRADA infusion schedule, and how it may differ from treatments they’ve used before.
LEMTRADA is an infusion therapy that is given in your vein (IV) in two treatment courses. There are 5 infusion days in a row in year 1, and 3 infusion days in a row in year 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. Any additional rounds would consist of one infusion a day on 3 consecutive days.
After your first treatment, you’ll start monthly monitoring, including monthly blood and urine tests, self-checks and annual skin exams, to detect potential side effects. Monitoring will continue until 4 years, or longer, after your last treatment course.
You can get more information when you watch a video about the infusion process here.
Q: WHAT DO I HAVE TO DO BEFORE LEMTRADA TREATMENT BEGINS?
A: Before starting LEMTRADA treatment, there are certain steps you must take. Your healthcare provider will instruct you to complete pretreatment blood and urine tests and a skin check. You may also be asked to get vaccinations at least 6 weeks before treatment. You should avoid foods that are potential sources of listeria prior to your treatment, and continue to do so until your healthcare provider confirms that it is safe for you to eat those foods again.
Additionally, you should use birth control while receiving LEMTRADA and for four months after the treatment course.
Q: WHAT CAN I EXPECT DURING LEMTRADA TREATMENT?
A: When you are ready to begin, you will receive your infusion at a healthcare facility with equipment and staff certified to administer LEMTRADA.
On the first three days during treatment, you'll receive intravenous steroids to help prevent infusion reactions, followed by the LEMTRADA infusions. Your LEMTRADA infusion will last for at least 4 hours, plus at least 2 hours for observation afterward.
In those hours, you can read, watch TV, talk on the phone, eat, or take a nap. You can get up to stretch or use the bathroom at any time. If something doesn’t feel quite right, just tell your infusion nurse. They are there to help.
An infusion nurse will be checking on you often to look for signs of infusion reactions including serious allergic reactions and urgent heart or breathing problems. In clinical studies, 92% of LEMTRADA-treated patients experienced infusion reactions. Serious infusion reactions did occur in 3% of patients. Serious infusion reactions may happen while you receive, or up to 24 hours or longer after you receive LEMTRADA.
Q: WHAT HAPPENS AFTER INFUSION?
A: Side effects may happen while you receive LEMTRADA and for 4 years after you stop receiving LEMTRADA. That's why you will need to monitor every month until 4 years, or longer, after you receive your last LEMTRADA infusion. You may need to continue these blood and urine tests after 4 years if you have any autoimmune signs or symptoms. The blood and urine tests will help your healthcare provider watch for signs and symptoms of serious autoimmune problems.
It is important to have your blood and urine tested, even if you are feeling well and do not have any symptoms from LEMTRADA and your multiple sclerosis. This may help your healthcare provider find any problems early.
To find out more about monitoring and to hear patients perspectives, watch a video here.
Q: HOW WILL I KNOW HOW MUCH LEMTRADA WILL COST ME?
A: MS One to One Case Managers can assist you with understanding your insurance coverage related to LEMTRADA, as well as the LEMTRADA Co-Pay Program. We can speak directly to your insurance company and get all the details and approvals and then call you back. We can also talk to you about other resources to help offset your out-of-pocket and treatment-related costs, so make sure to ask your nurse about financial assistance options.
Q: HOW CAN MY MS ONE TO ONE CASE MANAGER HELP ME PREPARE FOR TREATMENT?
A: Once you’re prescribed LEMTRADA, your MS One to One Case Manager will help you schedule your treatment. But before you start, they’ll give you some tips on what to wear, what to bring, and how to handle logistics, like getting to and from treatment or planning for childcare if necessary. They’ll also tell you about any over-the-counter medicines you may want to pick up before treatment, in case you need them before or afterwards. They’ll also suggest that you call your infusion center to find out their policies so you can get a better idea of who and what to bring with you on your treatment days.
Still have questions? We’re happy to help.
I hope the information and resources I’ve presented have helped to address some of your concerns. Your next step would be to have a discussion with your healthcare provider about your treatment options. If you still have questions about LEMTRADA, you can call MS One to One during business hours at 1-855-676-6326.
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Questions For An MS One To One® Case Manager About LEMTRADA
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Important Safety Information
LEMTRADA is a prescription medicine used to treat relapsing forms of multiple sclerosis (MS), to include relapsing-remitting disease and active secondary progressive disease, in adults. Since treatment with LEMTRADA can increase your risk of getting certain conditions and diseases, LEMTRADA is generally prescribed for people who have tried 2 or more MS medicines that have not worked well enough. LEMTRADA is not recommended for use in patients with clinically isolated syndrome (CIS). It is not known if LEMTRADA is safe and effective for use in children under 17 years of age.
LEMTRADA 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:
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|
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.
Adult Onset Still's Disease (AOSD): LEMTRADA may cause AOSD, a rare condition that can cause a high fever lasting more than 1 week, pain, stiffness with or without swelling in multiple joints, and/or a skin rash. If you experience a combination of these symptoms, contact your HCP immediately.
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.
Inflammation of the colon (colitis): Tell your HCP if you have symptoms of colitis, such as diarrhea (loose stools) or more frequent bowel movements, stools that are black, tarry or have blood or mucous, or severe stomach-area pain or tenderness.
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:
|
|
|
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. You may report side effects to FDA at 1-800-FDA-1088.
Click here for full Prescribing Information including Serious Side Effects.
Click here for medication Guide including Serious Side Effects.
Important Safety Information
LEMTRADA is a prescription medicine used to treat relapsing forms of multiple sclerosis (MS), to include relapsing-remitting disease and active secondary progressive disease, in adults. Since treatment with LEMTRADA can increase your risk of getting certain conditions and diseases, LEMTRADA is generally prescribed for people who have tried 2 or more MS medicines that have not worked well enough. LEMTRADA is not recommended for use in patients with clinically isolated syndrome (CIS). It is not known if LEMTRADA is safe and effective for use in children under 17 years of age.
LEMTRADA 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:
|
|
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.
Adult Onset Still's Disease (AOSD): LEMTRADA may cause AOSD, a rare condition that can cause a high fever lasting more than 1 week, pain, stiffness with or without swelling in multiple joints, and/or a skin rash. If you experience a combination of these symptoms, contact your HCP immediately.
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.
Inflammation of the colon (colitis): Tell your HCP if you have symptoms of colitis, such as diarrhea (loose stools) or more frequent bowel movements, stools that are black, tarry or have blood or mucous, or severe stomach-area pain or tenderness.
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:
|
|
|
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. You may report side effects to FDA at 1-800-FDA-1088.
Click here for full Prescribing Information including Serious Side Effects.
Click here for medication Guide including Serious Side Effects.
Important Safety Information
LEMTRADA is a prescription medicine used to treat relapsing forms of multiple sclerosis (MS), to include relapsing-remitting disease and active secondary progressive disease, in adults. Since treatment with LEMTRADA can increase your risk of getting certain conditions and diseases, LEMTRADA is generally prescribed for people who have tried 2 or more MS medicines that have not worked well enough. LEMTRADA is not recommended for use in patients with clinically isolated syndrome (CIS). It is not known if LEMTRADA is safe and effective for use in children under 17 years of age.
LEMTRADA 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:
|
|
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.
Adult Onset Still's Disease (AOSD): LEMTRADA may cause AOSD, a rare condition that can cause a high fever lasting more than 1 week, pain, stiffness with or without swelling in multiple joints, and/or a skin rash. If you experience a combination of these symptoms, contact your HCP immediately.
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.
Inflammation of the colon (colitis): Tell your HCP if you have symptoms of colitis, such as diarrhea (loose stools) or more frequent bowel movements, stools that are black, tarry or have blood or mucous, or severe stomach-area pain or tenderness.
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:
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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. You may report side effects to FDA at 1-800-FDA-1088.
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