INDICATION
LEMTRADA® (alemtuzumab) 12mg IV is a prescription medicine used to treat adults with relapsing forms of multiple sclerosis (MS).
Because of its risks, LEMTRADA is generally used in people who have tried 2 or more MS medicines that have not worked well enough.
It is not known if LEMTRADA is safe and effective for use in children under 17 years of age.
SELECTED IMPORTANT SAFETY INFORMATION
LEMTRADA can cause serious side effects including autoimmune problems, infusion reactions, some kinds of cancers, thyroid
problems, low blood counts (cytopenias), serious infections, inflammation of the gallbladder without gallstones (acalculous cholecystitis),
and swelling of lung tissue (pneumonitis). Because of these risks, LEMTRADA is only available through a restricted program called the Risk Evaluation and Mitigation Strategy (REMS) Program.
Please see additional Important Safety Information below and full Prescribing Information/Medication Guide, including serious side effects.
Sponsored by LEMTRADA / Sanofi Genzyme.
Six months into their marriage, Megan and her husband, Corey, were finally finding their footing in the whirlwind that is post-grad and newlywed life. They had just graduated from VanderCook College of Music in Chicago, where they played in the band together; Megan the flute and Corey the clarinet. They had found jobs in music and a place to live, and they were ready to start this exciting new chapter of their lives together.
Then Megan, 23 years old at the time, began to develop a vision problem. On their first Valentine’s Day as a married couple, a doctor diagnosed Megan with relapsing multiple sclerosis (RMS).
Adjusting to the diagnosis
"It was a lot to take on, and I am so glad that Corey came into my life when he did because he no doubt helped me deal with something so serious at a young age," Megan said. "What 23-year-old really worries about their health? Not many."
Issues with vision are among the most common symptoms reported in patients with multiple sclerosis (MS) – other symptoms may include, but are not limited to, fatigue, numbness, stiffness and cognitive changes — according to the National MS Society. During college, Megan experienced what she described as "awkward sensory issues," like her arm falling asleep.
"I didn’t know at the time, being young, that it is just not necessarily normal when your arm feels asleep for a week," she said. "I didn’t have that life experience of realizing that is not OK."
When it comes to MS, women are affected two to three times more than men, and most are diagnosed between the ages of 20 and 50, according to the National MS Society.
Valentine’s Day now holds a different meaning for Megan and Corey. Following Megan’s diagnosis, she had to adjust to differences in her day-to-day life from what she had come to know as normal.
"All of a sudden, in a way, your norm changes," Megan said. "You’re kind of stuck in this life you thought you had with the stuff you thought you knew, because that is still there and every single day is still very consistent. But then at the same time you’re struggling with this idea of ‘I’m being told something different’ or ‘I’m experiencing something different.’ And you start to ask yourself, ‘How do I all of a sudden start to bridge my two realities or build off the reality that I know?’"
Finding an outlet in music
For Megan, the only way to go was forward. She had to take action in order to build that bridge between her two realities and to feel grounded in her life again, but she also had to find solace in the people and things she loved most.
Like Corey, music came into Megan’s life at the perfect moment. When she was 9 years old, Megan decided she wanted to take up piano, but on the day that was supposed to be her first lesson, her dad died of cancer.
"We knew that this day would come eventually, but it was still difficult. Music came into my life at exactly the right time, and I started taking lessons once things settled down. Since then piano — music, period — has become my time to work through things."
"When I am creating music, no one is looking at me with pity," Megan said. "My hour every day that I am sitting there playing is my time. From a very early age, I started to understand the value of having something you can use to express yourself."
Megan’s journey with music helped her learn and understand the power of hard work, perseverance and resilience.
And so, years later, when she was faced with her diagnosis of RMS, Megan turned to music as a way to cope, while also taking action to try to help manage the disease.
Treating RMS
"The worst action is inaction. I’ve always lived with that," Megan said. "That is why I made sure early on in my RMS journey to bring together the right care team for my disease."
"Over the years, I’ve developed an honest and trusting relationship with my neurologist, so when he mentioned LEMTRADA® during one of my appointments, I wanted to hear more." After weighing the potential risks and benefits, Megan and Corey decided together that LEMTRADA was an appropriate treatment choice for Megan. However, she recommends "people bring all options and all knowledge to the table when speaking with their neurologist," and, ultimately, choose what is right for them.
"RMS is unique to each individual," she said. "But it is important for everyone to be proactive with their care and their care team, like I was, and seek answers to any questions that they might have about the disease. There are many different helpful resources available to those living with this disease."
The National Multiple Sclerosis Society and other leading advocacy organizations provide a variety of services and online resources for people living with RMS. People can also look to websites such as the LEMTRADA Voices of Determination blog for perspectives from others living with RMS.
Living with the disease today
Megan and Corey recently bought a new house and are raising their daughter, Brennan. Music continues to be a staple in their life together — in fact, Megan has been at her current job as a band director for nearly 12 years.
"Despite living with this disease, I realized that life goes on," she said. "You may change jobs, you may buy houses and buy cars and you may have kids. But no matter what, I am constantly reminding myself that I am more than this disease."
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 thrombocytopenia, which is when reduced platelet counts in your blood cause severe bleeding that, if not treated, may cause life-threatening problems. Call your healthcare provider right away if you have any of the following symptoms: easy bruising; bleeding from a cut that is hard to stop; 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 can, if untreated, lead to severe kidney damage, kidney failure that needs dialysis, a kidney transplant, or death. Call your healthcare provider right away if you have any of the following symptoms: blood in the urine (red or tea-colored urine); swelling of legs or feet; coughing up blood
It is important for you to have blood and urine tests before you receive, while you are receiving and every month, for 4 years or longer, after you receive your last LEMTRADA infusion.
Serious infusion reactions: LEMTRADA can cause serious infusion reactions that may cause death. Serious infusion reactions may happen while you receive, or up to 24 hours or longer after you receive LEMTRADA.
- You will receive your infusion at a healthcare facility with equipment and staff trained to manage infusion reactions, including serious allergic reactions, and urgent heart or breathing problems. You will be watched while you receive, and for 2 hours or longer after you receive, LEMTRADA. If a serious infusion reaction happens while you are receiving LEMTRADA, your infusion may be stopped.
Tell your healthcare provider right away if you have any of the following symptoms of a serious infusion reaction during the infusion, and after you have left the healthcare facility:
- swelling in your mouth or throat
- trouble breathing
- weakness
- fast, slow, or irregular heartbeat
- chest pain
- rash
To lower your chances of getting a serious infusion reaction, your healthcare provider will give you a medicine called corticosteroids before your first 3 infusions of a treatment course. You may also be given other medicines before or after the infusion to try to reduce your chances of having these reactions or to treat them after they happen.
Certain cancers: Receiving LEMTRADA may increase your chance of getting some kinds of cancers, including thyroid cancer, skin cancer (melanoma), and blood cancers called lymphoproliferative disorders and lymphoma. Call your healthcare provider if you have the following symptoms that may be a sign of thyroid cancer:
- new lump
- swelling in your neck
- pain in front of neck
- hoarseness or other voice changes that do not go away
- trouble swallowing or breathing
- cough that is not caused by a cold
Have your skin checked before you start receiving LEMTRADA and each year while you are receiving treatment to monitor for symptoms of skin cancer.
Because of risks of autoimmunity, infusion reactions, and some kinds of cancers, LEMTRADA is only available through a restricted program called the LEMTRADA Risk Evaluation and Mitigation Strategy (REMS) Program.
Do not receive LEMTRADA if you are infected with human immunodeficiency virus (HIV).
Thyroid problems: Some patients taking LEMTRADA may get an overactive thyroid (hyperthyroidism) or an underactive thyroid (hypothyroidism). Call your healthcare provider if you have any of these symptoms:
- excessive sweating
- unexplained weight loss
- eye swelling
- nervousness
- fast heartbeat
- unexplained weight gain
- feeling cold
- worsening tiredness
- constipation
Low blood counts (cytopenias): LEMTRADA may cause a decrease in some types of blood cells. Some people with these low blood counts have increased infections. Call your doctor right away if you have symptoms of cytopenias such as:
- weakness
- chest pain
- yellowing of the skin or whites of the eyes (jaundice)
- dark urine
- fast heartbeat
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:
- Herpes viral infections. Some people taking LEMTRADA have an increased chance of getting herpes viral infections. Take any medicines as prescribed by your healthcare provider to reduce your chances of getting these infections.
- Tuberculosis. Your healthcare provider should check you for tuberculosis before you receive LEMTRADA.
- Hepatitis. People who are at high risk of, or are carriers of, hepatitis B (HBV) or hepatitis C (HCV) may be at risk of irreversible liver damage.
- 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 that may contain listeria are heated well.
These are not all the possible infections that could happen while on LEMTRADA. Call your healthcare provider right away if you have symptoms of a serious infection such as fever or swollen glands. Talk to your healthcare provider before you get vaccinations after receiving LEMTRADA. Certain vaccinations may increase your chances of getting infections.
Inflammation of the gallbladder without gallstones (acalculous cholecystitis):
LEMTRADA may increase your chance of getting inflammation of the gallbladder without gallstones, a serious medical condition that can be life-threatening. Call your healthcare provider right away if you have any of the following symptoms:
- stomach pain or discomfort
- fever
- nausea or vomiting
Swelling of lung tissue (pneumonitis): Some people have had swelling of the lung tissue while receiving LEMTRADA. Call your healthcare provider right away if you have the following symptoms:
- shortness of breath
- cough
- wheezing
- chest pain or tightness
- coughing up blood
Before receiving LEMTRADA, tell your healthcare provider if you:
- are taking a medicine called Campath® (alemtuzumab)
- have bleeding, thyroid, or kidney problems
- have HIV
- have a recent history of infection
- have received a live vaccine in the past 6 weeks before receiving LEMTRADA or plan to receive any live vaccines. Ask your healthcare provider if you are not sure if your vaccine is a live vaccine
- are pregnant or plan to become pregnant. LEMTRADA may harm your unborn baby. You should use birth control while receiving LEMTRADA and for 4 months after your course of treatment
- are breastfeeding or plan to breastfeed. You and your healthcare provider should decide if you should receive LEMTRADA or breastfeed. You should not do both.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. LEMTRADA and other medicines may affect each other, causing side effects. Especially tell your healthcare provider if you take medicines that increase your chance of getting infections, including medicines used to treat cancer or to control your immune system.
The most common side effects of LEMTRADA include:
- rash
- headache
- thyroid problems
- fever
- swelling of your nose and throat
- nausea
- urinary tract infection
- feeling tired
- trouble sleeping
- upper respiratory infection
- herpes viral infection
- hives
- itching
- fungal infection
- joint pain
- pain in your arms or legs
- back pain
- diarrhea
- sinus infection
- mouth pain or sore throat
- tingling sensation
- dizziness
- stomach pain
- sudden redness in face, neck, or chest
- vomiting
Tell your healthcare provider if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of LEMTRADA.
You may report side effects to the FDA at 1-800-FDA-1088.
Please see the full Prescribing Information, including Boxed WARNING and Medication Guide, for additional Important Safety Information.
This post is sponsored by Sanofi Genzyme.
2018 Genzyme Corporation. All rights reserved. LEMTRADA, Sanofi and Genzyme registered in U.S. Patent and Trademark Office. SAUS.LEMT.18.05.3123. Last updated: 08/2018
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