Lemtrada
Generic name: alemtuzumab [ AL-em-TOOZ-ue-mab ]
Other brand names of alemtuzumab include Campath, Lemtrada
Drug class: CD52 monoclonal antibodies
What is Lemtrada?
Campath is used to treat B-cell chronic lymphocytic leukemia in adults.
Lemtrada is used to treat relapsing forms of multiple sclerosis in people 17 years and older (including active secondary progressive disease), after at least two other medicines did not work or have stopped working.
Lemtrada will not cure multiple sclerosis, but it can make relapses occur less often. Lemtrada is not for use in treating clinically isolated syndrome.
Lemtrada is available only from a certified pharmacy under a special program. You must be registered in the program and understand the risks and benefits of Lemtrada.
Lemtrada may also be used for purposes not listed in this medication guide.
Lemtrada side effects
Get emergency medical help if you have signs of an allergic reaction: hives, difficult breathing, swelling of your face, lips, tongue, or throat.
Get emergency medical help if you have symptoms of thrombotic thrombocytopenic purpura: purple spots on the skin or in the mouth, jaundice (yellowing of the skin or eyes), tiredness, fever, feeling short of breath, fast heart rate, speech or vision changes, confusion, seizure, dark or blood in your urine, stomach pain, nausea, vomiting, or diarrhea.
Lemtrada may cause a brain infection that can lead to disability or death. Tell your doctor if you have problems with speech, thought, vision, or muscle movement. These symptoms can get worse quickly.
Some side effects may occur during or shortly after the injection. Tell your caregiver if you feel weak, feverish, chilled, dizzy, nauseated, light-headed, or have a rash, wheezing, chest pain, trouble breathing, swelling in your mouth or throat, or fast, slow, or irregular heartbeats.
Lemtrada can cause your immune system to attack cells and organs in your body. This can lead to serious side effects that may occur months to years after you receive this medicine. Call your doctor at once if you have:
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unusual bleeding or bruising, nosebleeds, bleeding gums, irregular menstrual periods, blood in your urine or stools, coughing up blood, problems with speech, weakness on one side, neck pain, severe headache;
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a mole that has changed in size or color, cough, wheezing, chest pain, feeling short of breath, coughing up blood;
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an overactive immune system--fever, swollen glands, rash, feeling unsteady or less alert, trouble waking, seizure;
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liver problems--loss of appetite, nausea, vomiting, stomach pain (upper right side), tiredness, itching, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
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kidney problems--swelling, urinating less, feeling tired or short of breath;
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signs of infection--fever, chills, sore throat, body aches, unusual tiredness, loss of appetite, bruising or bleeding;
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signs of tuberculosis--cough, night sweats, loss of appetite, weight loss, and feeling very tired;
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signs of a stroke--sudden numbness or weakness (especially on one side of the body), severe headache, slurred speech, problems with vision or balance;
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gallbladder problem--chalky-colored stools, stomach pain after eating, nausea, heartburn, bloating, and severe upper stomach pain that may spread to your back;
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symptoms of Autoimmune encephalitis--personality or mood changes, hallucinations, agitation, confusion, short term memory loss, movement disorders;
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symptoms of Adult onset Still's disease--high fever, pain, stiffness with or without swelling in multiple joints, rash;
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thyroid problems--sweating, feeling cold, fast heartbeats, feeling nervous or tired, eye swelling, weight gain or loss, constipation; or
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symptoms of thyroid cancer--a lump or swelling in your neck or throat, trouble swallowing, hoarse voice, or a new cough (not caused by a cold).
Common side effects of Lemtrada may include:
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reactions to the injection, rash, itching, tingling, hives;
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stomach pain, nausea, vomiting, diarrhea;
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infections (fever, chills, runny or stuffy nose, mouth or throat pain, painful urination);
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chest pain or tightness, coughing up blood;
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dizziness, tiredness, trouble sleeping;
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headache, joint pain, back pain, pain in your arms or legs; or
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thyroid problems, flushing (sudden warmth, redness, or tingly feeling).
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
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Warnings
Alemtuzmab can increase your risk of fatal heart attack or stroke. Get emergency medical help if you have signs of a heart attack or stroke: chest pain spreading to your jaw or shoulder, sudden numbness or weakness on one side of the body, slurred speech, leg swelling, feeling short of breath.
Lemtrada could also attack healthy organs and tissues in your body. This could lead to serious or life-threatening side effects on your lungs, liver, pancreas, kidneys, intestines, thyroid, or adrenal glands.
Lemtrada can cause life-threatening side effects during administration.
Using Lemtrada may increase your risk of developing other cancers. Ask your doctor about this risk.
Before taking this medicine
You may not be able to use Lemtrada if you are allergic to it, or if you have an active infection, or HIV (human immunodeficiency virus).
Tell your doctor if you have ever had:
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tuberculosis or other infections;
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a thyroid disorder;
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bleeding problems, or if you receive blood transfusions;
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if you have received any vaccine in the past 6 weeks; or
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kidney disease.
Tell your doctor if you have never had chickenpox or if you have never received a varicella vaccine (Varivax). You may need to receive the vaccine and then wait 6 weeks before using Lemtrada.
Lemtrada may increase your risk of developing other types of cancer, such as melanoma, thyroid cancer, lymphoma, or leukemia. Ask your doctor about this risk.
You may need to have a negative pregnancy test before starting this treatment. Lemtrada may harm an unborn baby. Use effective birth control to prevent pregnancy while receiving this medicine, and for at least 3 months after your last dose of Campath and for 4 months after your last dose of Lemtrada. Tell your doctor if you become pregnant.
Do not breastfeed while using this medicine, and for at least 3 months after your last dose.
How is Lemtrada given?
Lemtrada is given as an infusion into a vein. A healthcare provider will give you this injection. You will be watched closely for up to 2 hours or longer after the infusion, to make sure you do not have a serious reaction.
Your doctor will determine how long to treat you and the number of courses you need. The infusion can take 2 to 4 hours to complete.
You may be given other medications to help prevent serious side effects or allergic reaction. Keep taking these medicines for as long as your doctor has prescribed.
Lemtrada affects your immune system. You may get infections more easily, even serious or fatal infections. You will need frequent medical tests, and your next dose may be delayed based on the results.
You should have a human papilloma virus (HPV) screening every year if you are a female.
You may need frequent medical tests while using this medicine and for a short time after your last dose.
What happens if I miss a dose?
Call your doctor for instructions if you miss an appointment for your Lemtrada.
What happens if I overdose?
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.
What should I avoid while receiving Lemtrada?
Do not receive a "live" vaccine while using Lemtrada. The vaccine may not work as well or you could develop a serious infection. Live vaccines include measles, mumps, rubella (MMR), rotavirus, typhoid, yellow fever, varicella (chickenpox), zoster (shingles), and nasal flu (influenza) vaccine.
While being treated with Lemtrada, avoid foods that may be a source of Listeria infection, or heat them thoroughly before consuming. This includes deli meat, undercooked meat, seafood, poultry, unpasteurized dairy products, or soft cheeses.
What other drugs will affect Lemtrada?
Tell your doctor about all your other medicines, especially drugs that weaken the immune system such as cancer medicine, or medicines to prevent organ transplant rejection.
Other drugs may affect Lemtrada, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all other medicines you use.
Lemtrada Biosimilars
Biosimilar and interchangeable products are biological products that are highly similar to and have no clinically meaningful differences from the reference product.
Reference products
These are biological products that have already been approved by the FDA, against which biosimilar products are compared. There are 2 for Lemtrada.
Campath (alemtuzumab) - Genzyme Corporation
Formulation type | Strength |
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Ampule | 30 mg (10 mg/mL) Discontinued |
Single-Dose Vial | 30 mg/1 mL |
View Campath information in detail.
Lemtrada (alemtuzumab) - Genzyme Corporation
Formulation type | Strength |
---|---|
Single-Dose Vial | 12 mg/1.2 mL (10 mg/mL) |
Frequently asked questions
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Further information
Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
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