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Lemtrada is a medicine used to treat people with relapsing forms of multiple sclerosis. Because of its risks, Lemtrada is generally used in people who have tried 2 or more MS medicines that have not worked well enough. Lemtrada is given intravenously (through a needle placed in your vein).
Because of your risk of autoimmunity, infusion reactions and the risk of some kinds of cancers, Lemtrada is only available through a restricted program called the Lemtrada Risk Evaluation and Mitigation Strategy (REMS) Program. You and your healthcare provider must be enrolled in the Lemtrada REMS Program. Lemtrada can only be given at a certified healthcare facility that participates in the Lemtrada REMS Program. Your healthcare provider can give you information on how to find a certified healthcare facility. Carry your Lemtrada REMS Patient Safety Information Card with you in case of an emergency.
How does this medication work?
Lemtrada is thought to work by stopping the activity of the cells that cause inflammation in the central nervous system (CNS) and produce the symptoms of multiple sclerosis.
What are the beneficial effects of this medication and when should I begin to have results?
What: Studies show that people who received Lemtrada had fewer relapses than people who received another treatment for their multiple sclerosis.
When: Everyone responds differently to treatment, so try to be patient and follow your healthcare provider's directions.
How do I know it is working?
You may experience less relapses once you begin receiving Lemtrada. Your healthcare provider will ask you questions from time to time to check if your multiple sclerosis is under control.
The following is not a full list of side effects. Side effects cannot be anticipated. If any develop or change in intensity, tell your healthcare provider as soon as possible. Only your healthcare provider can determine if it is safe for you to continue taking this medication.
Some people receiving Lemtrada develop serious and possibly life-threatening autoimmune problems (condition where the immune cells in the body attack other cells or organs in the body). Serious autoimmune problems may include immune thrombocytopenia (when reduced platelet counts in your blood cause severe bleeding) and certain kidney problems. Call your healthcare provider right away if you experience 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; blood in your urine (red or tea-colored urine); swelling in your legs or feet; or coughing up blood.
Lemtrada may cause serious and potentially life-threatening infusion reactions. 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. You will be watched while you receive and for 2 hours after you receive Lemtrada. Tell your healthcare provider right away if you experience swelling in your mouth or throat, trouble breathing, weakness, changes in your heartbeat, chest pain, or rash during the infusion, and after you have left the healthcare facility.
Receiving Lemtrada may increase your chance of getting some kinds of cancers, including thyroid cancer, skin cancer, and blood cancers called lymphoproliferative disorders and lymphoma. Call your healthcare provider if you develop a new lump, swelling in your neck, pain in the front of your neck, hoarseness or other voice changes that do not go away, trouble swallowing or breathing, or cough that is not caused be a cold as these could be signs of thyroid cancer.
More common side effects may include: rash; headache; fever; common cold; nausea; urinary tract infection; tiredness; trouble sleeping; upper respiratory tract infection; hives; itching; joint pain; pain in your arms or legs; back pain; diarrhea; sinus infection; mouth pain or sore throat; tingling sensation; dizziness; abdominal (stomach area) pain; sudden redness in face, neck, or chest; vomiting.
Less common side effects may include:
Thyroid problems, including an overactive thyroid or an underactive thyroid. Symptoms of an overactive thyroid include excessive sweating, unexplained weight loss, eye swelling, nervousness, or fast heartbeat. Symptoms of an underactive thyroid include unexplained weight gain, feeling cold, worsening tiredness, or constipation.
Decreased blood cell counts with symptoms such as weakness, chest pain, yellowing of your skin or the whites of your eyes, dark urine, or fast heartbeat.
Swelling of the lung tissue, with symptoms such as shortness of breath, coughing, wheezing, chest pain or tightness, or coughing up blood.
Increased risk of serious infections including herpes viral infections, human papillmona virus (HPV), tuberculosis, fungal infections, and listeria, with symptoms such as fever or swollen glands.
Your healthcare provider will not administer Lemtrada to you if you are allergic to it or any of its ingredients.
Your healthcare provider will not administer Lemtrada to you if you are infected with human immunodeficiency virus (HIV).
Tell your healthcare provider about all prescription, over-the-counter, and herbal medications you are taking before beginning treatment with Lemtrada. Also, talk to your healthcare provider about your complete medical history, especially if you have bleeding, thyroid, or kidney problems; HIV; a recent history of infection; are receiving cancer treatment with a medicine called Campath; have received a live vaccine in the past 6 weeks before receiving Lemtrada or plan to receive any live vaccines; or if you are pregnant, plan to become pregnant, or are breastfeeding.
The information below is based on the dosage guidelines your healthcare provider uses. Depending on your condition and medical history, your healthcare provider may prescribe a different regimen. Do not change the dosage or stop taking your medication without your healthcare provider's approval.
Adults ≥17 years: Your healthcare provider will prescribe the appropriate dose for you.
Your healthcare provider will administer Lemtrada to you.
It takes about 4 hours to receive a full dose of Lemtrada each day.
You will receive Lemtrada over 2 treatment courses. You will receive Lemtrada for 5 days in a row for the first treatment course and then for 3 days in a row about 1 year later for your second treatment course.
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 reduce your chances of these reactions or to treat them after they happen.
Do not miss any scheduled follow-up appointments with your healthcare provider.
Do not receive any live vaccines during treatment with Lemtrada. Talk to your healthcare provider about what vaccines to avoid.
Do not eat foods that may be a source for listeria (such as deli meat, unpasteurized milk and cheese products, or undercooked meat, seafood or poultry) or make sure that the food you eat which may contain listeria is heated well.
No significant interactions have been reported with Lemtrada at this time. However, always tell your healthcare provider about any medicines you take, including over-the-counter medications, vitamins, and herbal supplements.
The effects of Lemtrada during pregnancy and breastfeeding are unknown. Do not breastfeed while you are receiving Lemtrada. Tell your healthcare provider immediately if you are pregnant, plant to become pregnant, or are breastfeeding.
Lemtrada should be given under special circumstances determined by your healthcare provider. If you miss your scheduled dose, contact your healthcare provider or pharmacist for advice.
Your healthcare provider will store this medication for you.
In the event of a medical emergency call your doctor or 9-1-1 immediately. In the event of overdose, call your doctor or poison control for further instructions.
National Poison Control#: Call 1-800-222-1222
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