Lemtrada® is a CD52-directed cytolytic monoclonal antibody indicated for the treatment of patients with relapsing forms of multiple sclerosis (MS). It is administered by intravenous infusion. Because of its safety profile, the use of Lemtrada is generally reserved for patients who have had an inadequate response to two or more drugs indicated for the treatment of MS.1
Lemtrada is available only through a restricted distribution program, Risk Evaluation and Mitigation Strategy (REMS), because of the possibility of developing autoimmunity, infusion reactions, and/or malignancies.
Lemtrada is a relapsing MS medication that is administered in 8 doses over 2 years. It comes in an injection form of 12 mg/1.2 mL (10 mg/mL) in a single-use vial that gets diluted prior to use. Before treatment, patients are given preventive medications to protect against the risk of certain side effects.1
Patients must enroll in a REMS program to receive Lemtrada and agree to ongoing monitoring requirements. Monitoring begins after the first treatment, and continues for four years or longer after the last treatment.
What are the ingredients in Lemtrada?
The active ingredient in Lemtrada is alemtuzumab, a recombinant humanized IgG1 kappa monoclonal antibody directed against the cell surface glycoprotein, CD52.1
How does Lemtrada work?
The precise mechanism by which Lemtrada works is unknown. It is presumed to involve binding to and destroying lymphocytes (white blood cells) which 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 experienced by those taking Lemtrada include:1
- Thyroid problems
- Serious infections
- Urinary tract infection
- Fungal infection
- Herpes viral infection
- Hives, itching
- Sinus infection
- Swelling of your nose and throat (nasopharyngitis)
- Joint, back or stomach pain
- Tingling sensation
- Sudden redness in face, neck, or chest
- Autoimmune conditions
- Low blood counts
- Insomnia (trouble sleeping)
This is not an exhaustive list of all potential side effects of Lemtrada. For more information, consult your doctor or healthcare provider. If you notice any new or worsening side effects when taking Lemtrada, contact your doctor or healthcare provider immediately.
There have been several cases of strokes or tears in the lining of the arteries in the head and neck (called arterial dissection) in people with MS taking Lemtrada, leading the U.S. Food and Drug Administration (FDA) to add a new warning to Lemtrada’s label. These side effects have occurred shortly after these patients received the medication (within 1-3 days). Stroke and arterial dissection are serious potential side effects and can lead to permanent disability or death.2
Anyone who is receiving Lemtrada for MS who experiences any signs of stroke or tears in the arteries of the head or neck should seek emergency treatment immediately. Common symptoms of stroke or arterial dissection include:2
- Sudden weakness or numbness in the body (face, arms, or legs), especially if it occurs only on one side of the body
- Sudden confusion, difficulty speaking, or difficulty understanding speech
- Sudden vision problems (in one or both eyes)
- Sudden difficulty with walking, balance, coordination, or dizziness
- Sudden severe headache or neck pain
Things to note about Lemtrada
Lemtrada can cause serious, sometimes fatal, autoimmune conditions such as immune thrombocytopenia and anti-glomerular basement membrane disease. Initial and ongoing monitoring will include complete blood counts with differential, serum creatinine levels, urinalysis with urine counts and thyroid function tests at periodic intervals. Baseline and annual skin exams should also be performed.1
Lemtrada may cause serious and life-threatening infusion reactions. It must be administered in a setting that can manage anaphylaxis or serious infusion reactions. Patients should be monitored for at least two hours after each infusion. It may also cause an increased risk of malignancies, including thyroid cancer, melanoma, and lymphoproliferative (excessive production of lymphocytes) disorders.1
The safety and effectiveness of Lemtrada in pediatric patients less than 17 years of age has not been established.1
Before starting Lemtrada talk with 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
- Are pregnant or plan to become pregnant.
Lemtrada may interact with other medicines causing additional side effects. Tell your healthcare provider about all medicines that you take, especially those that increase your chance of getting infections, including those to treat cancer.
Lemtrada is an IV infusion medication. It requires premedication with corticosteroids prior to Lemtrada infusion for the first 3 days of each treatment. Antiviral agents for herpetic prophylaxis are also given starting on the first day of treatment and continuing for 2 months after the completion of Lemtrada treatment.1
It is administered by IV infusion over a 4-hour period during each of 2 courses of treatment. The first treatment course is 12 mg/day on 5 consecutive days (60 mg total dose). The second treatment course is 12 mg/day on 3 consecutive days (36 mg total dose), and is administered 12 months after the first course.1
For more information, read the full prescribing information of Lemtrada.
- LEMTRADA prescribing information available at: http://products.sanofi.us/lemtrada/lemtrada.html. Accessed 4/15/18.
- FDA warns about rare but serious risks of stroke and blood vessel wall tears with multiple sclerosis drug Lemtrada (alemtuzumab). U.S. Food and Drug Administration. Available at https://www.fda.gov/Drugs/DrugSafety/ucm624247.htm. Accessed 12/11/18.