LEMTRADA® (alemtuzumab) 12mg IV is a prescription drugs used to deal with adults with relapsing types of a number of sclerosis (MS). Because of its dangers, LEMTRADA is usually utilized in individuals who have tried 2 or extra MS medicines that haven’t labored nicely sufficient. It just isn’t identified if LEMTRADA is secure and efficient to be used in kids below 17 years of age.
SELECTED IMPORTANT SAFETY INFORMATION
LEMTRADA may cause critical unwanted side effects together with autoimmune issues, infusion reactions, some sorts of cancers, thyroid issues, low blood counts (cytopenias), critical infections, irritation of the gallbladder with out gallstones (acalculous cholecystitis), and swelling of lung tissue (pneumonitis). Because of those dangers, LEMTRADA is just obtainable by way of a restricted program referred to as the Risk Evaluation and Mitigation Strategy (REMS) Program.
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 faculty, Megan skilled 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 mentioned. “I didn’t have that life experience of realizing that is not OK.”
When it involves MS, girls are affected 2 to a few occasions greater than males, and most are identified between the ages of 20 and 50, in response to the National MS Society.
Valentine’s Day now holds a distinct which means for Megan and Corey. Following Megan’s analysis, she needed to alter to variations in her day-to-day life from what she had come to know as regular.
“All of a sudden, in a way, your norm changes,” Megan mentioned. “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 one method to go was ahead. She needed to take motion with a purpose to construct that bridge between her 2 realities and to really feel grounded in her life once more, however she additionally needed to discover solace within the individuals and issues she cherished most.
Like Corey, music got here into Megan’s life on the excellent second. When she was 9 years previous, Megan determined she needed to take up piano, however on the day that was alleged to be her first lesson, her dad died of most cancers.
“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 mentioned. “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 study and perceive the ability of laborious work, perseverance and resilience.
And so, years later, when she was confronted together with her analysis of RMS, Megan turned to music as a method to cope, whereas additionally taking motion to attempt to assist handle the illness.
“The worst action is inaction. I’ve always lived with that,” Megan mentioned. “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 trustworthy and trusting relationship with my neurologist, so when he talked about LEMTRADA® throughout considered one of my appointments, I needed to listen to extra.” After weighing the potential dangers and advantages, Megan and Corey determined collectively that LEMTRADA was an acceptable therapy selection for Megan. However, she recommends “people bring all options and all knowledge to the table when speaking with their neurologist,” and, in the end, select what is correct for them.
“RMS is unique to each individual,” she mentioned. “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 different main advocacy organizations present a wide range of providers and on-line assets for individuals dwelling with RMS. People can even look to web sites such because the LEMTRADA Voices of Determination weblog for views from others dwelling with RMS.
Living with the illness right now
Megan and Corey lately purchased a brand new home and are elevating their daughter, Brennan. Music continues to be a staple of their life collectively — in actual fact, Megan has been at her present job as a band director for practically 12 years.
“Despite living with this disease, I realized that life goes on,” she mentioned. “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 may cause critical unwanted side effects together with:
Serious autoimmune issues: Some individuals receiving LEMTRADA develop a situation the place the immune cells in your physique assault different cells or organs within the physique (autoimmunity), which may be critical and should trigger loss of life. Serious autoimmune issues might embody:
- Immune thrombocytopenia, which is when diminished platelet counts in your blood trigger extreme bleeding that, if not handled, might trigger life-threatening issues. Call your healthcare supplier straight away when you’ve got any of the next signs: simple bruising; bleeding from a minimize that’s laborious to cease; heavier menstrual intervals than regular; bleeding out of your gums or nostril that’s new or takes longer than normal to cease; small, scattered spots in your pores and skin which might be purple, pink, or purple
- Kidney issues referred to as anti-glomerular basement membrane illness, which might, if untreated, result in extreme kidney injury, kidney failure that wants dialysis, a kidney transplant, or loss of life. Call your healthcare supplier straight away when you’ve got any of the next signs: blood within the urine (purple or tea-colored urine); swelling of legs or ft; coughing up blood
It is vital so that you can have blood and urine assessments earlier than you obtain, if you are receiving and each month, for 4 years or longer, after you obtain your final LEMTRADA infusion.
Serious infusion reactions: LEMTRADA may cause critical infusion reactions that will trigger loss of life. Serious infusion reactions might occur when you obtain, or as much as 24 hours or longer after you obtain LEMTRADA.
- You will obtain your infusion at a healthcare facility with gear and employees educated to handle infusion reactions, together with critical allergic reactions, and pressing coronary heart or respiration issues. You will probably be watched when you obtain, and for two hours or longer after you obtain, LEMTRADA. If a critical infusion response occurs if you are receiving LEMTRADA, your infusion could also be stopped.
Tell your healthcare supplier straight away when you’ve got any of the next signs of a critical infusion response in the course of the infusion, and after you might have left the healthcare facility:
- swelling in your mouth or throat
- bother respiration
- weak spot
- quick, sluggish, or irregular heartbeat
- chest ache
To decrease your possibilities of getting a critical infusion response, your healthcare supplier offers you a medication referred to as corticosteroids earlier than your first 3 infusions of a therapy course. You may additionally be given different medicines earlier than or after the infusion to attempt to scale back your possibilities of having these reactions or to deal with them after they occur.
Certain cancers: Receiving LEMTRADA might enhance your probability of getting some sorts of cancers, together with thyroid most cancers, pores and skin most cancers (melanoma), and blood cancers referred to as lymphoproliferative problems and lymphoma. Call your healthcare supplier when you’ve got the next signs which may be an indication of thyroid most cancers:
- new lump
- swelling in your neck
- ache in entrance of neck
- hoarseness or different voice modifications that don’t go away
- bother swallowing or respiration
- cough that isn’t attributable to a chilly
Have your pores and skin checked earlier than you begin receiving LEMTRADA and every year if you are receiving therapy to observe for signs of pores and skin most cancers.
Because of dangers of autoimmunity, infusion reactions, and a few sorts of cancers, LEMTRADA is just obtainable by way of a restricted program referred to as the LEMTRADA Risk Evaluation and Mitigation Strategy (REMS) Program.
Do not obtain LEMTRADA in the event you are contaminated with human immunodeficiency virus (HIV).
Thyroid issues: Some sufferers taking LEMTRADA might get an overactive thyroid (hyperthyroidism) or an underactive thyroid (hypothyroidism). Call your healthcare supplier when you’ve got any of those signs:
- extreme sweating
- unexplained weight reduction
- eye swelling
- quick heartbeat
- unexplained weight achieve
- feeling chilly
- worsening tiredness
Low blood counts (cytopenias): LEMTRADA might trigger a lower in some varieties of blood cells. Some individuals with these low blood counts have elevated infections. Call your physician straight away when you’ve got signs of cytopenias reminiscent of:
- weak spot
- chest ache
- yellowing of the pores and skin or whites of the eyes (jaundice)
- darkish urine
- quick heartbeat
Serious infections: LEMTRADA might trigger you to have a critical an infection when you obtain and after receiving a course of therapy. Serious infections might embody:
- Herpes viral infections. Some individuals taking LEMTRADA have an elevated probability of getting herpes viral infections. Take any medicines as prescribed by your healthcare supplier to scale back your possibilities of getting these infections.
- Tuberculosis. Your healthcare supplier ought to test you for tuberculosis earlier than you obtain LEMTRADA.
- Hepatitis. People who’re at excessive danger of, or are carriers of, hepatitis B (HBV) or hepatitis C (HCV) could also be vulnerable to irreversible liver injury.
- Listeria. People who obtain LEMTRADA have an elevated probability of getting a bacterial an infection referred to as listeria, which might result in vital issues or loss of life. Avoid meals which may be a supply of listeria or make certain meals that will comprise listeria are heated nicely.
These are usually not all of the attainable infections that would occur whereas on LEMTRADA. Call your healthcare supplier straight away when you’ve got signs of a critical an infection reminiscent of fever or swollen glands. Talk to your healthcare supplier earlier than you get vaccinations after receiving LEMTRADA. Certain vaccinations might enhance your possibilities of getting infections.
Inflammation of the gallbladder with out gallstones (acalculous cholecystitis):
LEMTRADA might enhance your probability of getting irritation of the gallbladder with out gallstones, a critical medical situation that may be life-threatening. Call your healthcare supplier straight away when you’ve got any of the next signs:
- abdomen ache or discomfort
- nausea or vomiting
Swelling of lung tissue (pneumonitis): Some individuals have had swelling of the lung tissue whereas receiving LEMTRADA. Call your healthcare supplier straight away when you’ve got the next signs:
- shortness of breath
- chest ache or tightness
- coughing up blood
Before receiving LEMTRADA, inform your healthcare supplier in the event you:
- are taking a medication referred to as Campath® (alemtuzumab)
- have bleeding, thyroid, or kidney issues
- have HIV
- have a current historical past of an infection
- have acquired a stay vaccine up to now 6 weeks earlier than receiving LEMTRADA or plan to obtain any stay vaccines. Ask your healthcare supplier if you’re unsure in case your vaccine is a stay vaccine
- are pregnant or plan to develop into pregnant. LEMTRADA might hurt your unborn child. You ought to use contraception whereas receiving LEMTRADA and for 4 months after your course of therapy
- are breastfeeding or plan to breastfeed. You and your healthcare supplier ought to determine in the event you ought to obtain LEMTRADA or breastfeed. You mustn’t do each.
Tell your healthcare supplier about all of the medicines you’re taking, together with prescription and over-the-counter medicines, nutritional vitamins, and natural dietary supplements. LEMTRADA and different medicines might have an effect on one another, inflicting unwanted side effects. Especially inform your healthcare supplier in the event you take medicines that enhance your probability of getting infections, together with medicines used to deal with most cancers or to regulate your immune system.
The commonest unwanted side effects of LEMTRADA embody:
- thyroid issues
- swelling of your nostril and throat
- urinary tract an infection
- feeling drained
- bother sleeping
- higher respiratory an infection
- herpes viral an infection
- fungal an infection
- joint ache
- ache in your arms or legs
- again ache
- sinus an infection
- mouth ache or sore throat
- tingling sensation
- abdomen ache
- sudden redness in face, neck, or chest
Tell your healthcare supplier when you’ve got any facet impact that bothers you or that doesn’t go away. These are usually not all of the attainable unwanted side effects of LEMTRADA.
You might report unwanted side effects to the FDA at 1-800-FDA-1088.
This put up 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 up to date: 08/2018