Lemtrada® (alemtuzumab) is a CD52-directed cytolytic monoclonal antibody approved to treat relapsing forms of multiple sclerosis (MS) in adults, including:1
- Relapsing-remitting MS
- Active secondary progressive MS
Lemtrada is given by intravenous (IV) infusion. Because of its risk of side effects, Lemtrada is generally reserved for people who have not responded to 2 or more drugs used to treat MS.1
Lemtrada is part of the US Food and Drug Administration's (FDA) Risk Evaluation and Mitigation Strategies (REMS) program. People must enroll in the REMS program to receive Lemtrada and agree to certain requirements. This ensures people taking Lemtrada are monitored during the time when a side effect is most likely to occur so it can be detected and treated. This means Lemtrada can only be given at a REMS-certified healthcare facility. 1
What are the ingredients in Lemtrada?
The active ingredient in Lemtrada is alemtuzumab.1
How does Lemtrada work?
The exact way Lemtrada works is unknown. Researchers think it binds to and destroys white blood cells (lymphocytes) that are involved when the immune system attacks myelin.1
What are the possible side effects of Lemtrada?
Many clinical trials evaluated the safety and efficacy of Lemtrada. The most common side effects of Lemtrada include:1
- Rash
- Headache
- Thyroid problems
- Fever
- Swelling of your nose and throat (nasopharyngitis)
- Nausea
- Urinary tract infection
- Fatigue
- Insomnia (trouble sleeping)
- Fungal infection
- Herpes viral infection
- Hives, itching
- Sinus infection
- Joint, back, or stomach pain
- Diarrhea
- Tingling sensation
- Sudden redness in face, neck, or chest
- Vomiting
- Autoimmune conditions
- Low blood counts
- Dizziness
Lemtrada has a boxed warning, the strictest warning from the US Food and Drug Administration (FDA). It has this warning because it can cause:1
- Serious autoimmune conditions, including immune thrombocytopenic purpura (ITP) and a kidney condition called anti-glomerular basement membrane disease. Get medical help right away if you have symptoms like easy bruising, coughing up blood, swelling of your legs or feet, blood in the urine, and red, pink, or purple spots on your skin.
- Serious and life-threatening infusion reactions, such as swelling in your mouth or throat, trouble breathing, weakness, irregular heartbeat, chest pain, and rash. You will be monitored for 2 hours after each infusion. You may also be given other medicines before or after the infusion to reduce your chances of these reactions or treat them if they appear.
- Stroke and tears in your arteries that supply blood to your brain (carotid and vertebral arteries). Get medical help right away if you have any signs of a stroke or tears in your arteries, such as sudden severe headache, drooping of parts of your face, weakness on one side, difficulty with speech, and neck pain.
- Increased risk of certain cancers, such as thyroid cancer, skin cancer, and blood cancers. You should have your skin checked before starting Lemtrada and each year during treatment.
These are not all the possible side effects of Lemtrada. Talk to your doctor about what to expect when taking Lemtrada. You also should call your doctor if you have any changes that concern you when taking Lemtrada.
Things to know about Lemtrada
Your doctor will order blood and urine tests before, during, and after treatment with Lemtrada. You may need to continue these tests for 4 years after treatment. It is important to have your blood and urine tested even if you do not have any symptoms from Lemtrada and your MS. This can help your doctor provide any problems early.1
The safety and effectiveness of Lemtrada in children younger than 17 years old has not been established.1
Before starting Lemtrada, tell your doctor if you:1
- Take Campath®
- Have bleeding problems
- Have thyroid problems
- Have kidney problems
- Have a recent history of infection
- Have HIV
- Have received a live vaccine in the past 6 weeks
Lemtrada can harm an unborn baby. If you can become pregnant, you should use birth control during treatment and for some time after the last dose of Lemtrada. You should also not breastfeed during treatment with Lemtrada and for some time after the last dose. Talk to your doctor about your options for birth control and breastfeeding while taking Lemtrada.1
Lemtrada may interact with other medicines, causing additional side effects. Before beginning treatment for MS, tell your doctor about all your health conditions and any other drugs, vitamins, or supplements you are taking. This includes over-the-counter drugs.
For more information, read the full prescribing information of Lemtrada.