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Lemtrada

  • Generic Name: alemtuzumab injection for intravenous infusion
  • Brand Name: Lemtrada
  • Drug Class:

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    Lemtrada Patient Information Including Side Effects

    Brand Names: Campath, Lemtrada

    Generic Name: alemtuzumab (Lemtrada)

    What is alemtuzumab (Lemtrada) (Campath, Lemtrada)?

    This medication guide provides information about the Lemtrada brand of alemtuzumab. Campath is another brand of alemtuzumab that is not covered in this medication guide.

    Lemtrada is used to treat relapsing forms of multiple sclerosis in adults (including active secondary progressive disease), after at least two other medicines did not work or have stopped working.

    Lemtrada will not cure MS, 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.

    Lemtrada may also be used for purposes not listed in this medication guide.

    What are the possible side effects of Lemtrada (Campath, Lemtrada)?

    Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

    Some side effects may occur during the injection or within 24 hours afterward. Tell your caregiver if you feel weak or you have a rash, chest pain, trouble breathing, swelling in your mouth or throat, or fast, slow, or irregular heartbeats.

    Lemtrada may cause a serious brain infection that can lead to disability or death. Call your doctor right away if you have problems with speech, thought, vision, or muscle movement. These symptoms may start gradually and get worse quickly.

    Lemtrada can cause your immune system to attack cells and organs in your body. This can lead to life-threatening medical problems that may occur up to 3 years after you receive Lemtrada. Call your doctor right away if you have:

    • an overactive immune system--fever, swollen glands, rash, feeling unsteady or less alert, trouble waking, seizure;
    • unusual bleeding--bruising under your skin, nosebleeds, bleeding gums, heavy menstrual periods, bleeding that will not stop, blood in your urine or stools, coughing up blood;
    • kidney problems--swelling in your lower legs, decreased urination, urine that looks pink/brown or foamy; or
    • liver problems--loss of appetite, stomach pain (upper right side), tiredness, dark urine, jaundice (yellowing of the skin or eyes).

    Also call your doctor at once if you have:

    • pain or burning when you urinate;
    • a mole that has changed in size or color;
    • pain or swelling in your neck or throat, trouble swallowing or breathing, hoarse voice, or a new cough (not caused by a cold);
    • signs of infection--fever, chills, mouth sores, skin sores, sore throat, cough, pale or yellowed skin, dark colored urine, confusion or weakness, chest pain, fast heartbeats;
    • signs of a stroke or tear in an artery--sudden severe headache, weakness on one side of your body, drooping in your face, neck pain, slurred speech;
    • thyroid problems--sweating, feeling cold, fast heartbeats, feeling nervous or tired, eye swelling, constipation, weight gain or loss;
    • gallbladder problems--fever with nausea, vomiting, and stomach pain;
    • lung problems--cough, wheezing, chest pain, feeling short of breath, coughing up blood;
    • signs of tuberculosis: fever, cough, night sweats, loss of appetite, weight loss, and feeling very tired; or
    • symptoms of herpes virus--cold sores around your mouth, skin sores or blisters, itching, tingling, burning pain in your thigh or lower back.

    Common side effects may include:

    • stomach pain, nausea, vomiting, diarrhea;
    • fever, infections;
    • chest pain or tightness, coughing up blood;
    • runny or stuffy nose, mouth or throat pain;
    • rash, itching, tingling, hives;
    • painful urination;
    • headache, dizziness;
    • tiredness, trouble sleeping;
    • joint pain, back pain, pain in your arms or legs;
    • thyroid problems; or
    • 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.

    What is the most important information I should know about Lemtrada (Campath, Lemtrada)?

    Lemtrada can cause life-threatening side effects. Seek emergency medical attention if you have sudden weakness on one side of your body, severe headache or neck pain, or problems with speech, vision, or balance.

    Some side effects may occur during the injection or within 24 hours afterward. You will be watched closely for at least 2 hours after receiving Lemtrada.

    Lemtrada affects your immune system. You may get infections more easily, even serious or fatal infections. Call your doctor if you have symptoms such as fever, chills, sore throat, cough, pale skin, skin sores, confusion or weakness, chest pain, or trouble breathing.

    Call your doctor if you have signs of other serious side effects, such as bruising or bleeding, trouble swallowing, pain or swelling in your neck or throat, coughing up blood, swelling, decreased urination, dark urine, stomach pain, yellowing of your skin or eyes.

    Lemtrada can have long lasting effects on your body. You may need medical tests for up to 4 years after you stop using this medicine.

    Lemtrada Patient Information including How Should I Take

    What should I discuss with my healthcare provider before receiving Lemtrada (Campath, Lemtrada)?

    You should not be treated with Lemtrada if:

    Tell your doctor if you have ever had:

    • an active or recent infection, including tuberculosis;
    • kidney disease;
    • a thyroid disorder;
    • bleeding problems; or
    • if you have received any vaccine in the past 6 weeks.

    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.

    Lemtrada may harm an unborn baby. Use effective birth control to prevent pregnancy while you are using Lemtrada and for at least 4 months after your last dose. Tell your doctor if you become pregnant.

    If you are pregnant, your name may be listed on a pregnancy registry to track the effects of Lemtrada on the baby.

    It may not be safe to breastfeed while using this medicine. Ask your doctor about any risk.

    How is Lemtrada given (Campath, Lemtrada)?

    Lemtrada is given as an infusion into a vein. A healthcare provider will give you this injection.

    Lemtrada is usually given in 2 or more treatment courses, separated by 1 year. Your doctor will determine how long to treat you and the number of courses you need.

    This medicine must be given slowly, and the infusion can take 4 hours to complete.

    You will be watched closely for at least 2 hours after receiving Lemtrada, to make sure you do not have a serious reaction.

    You may be given other medicines to help prevent certain side effects or infections. Take these medicines for the full prescribed length of time.

    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.

    Lemtrada can have long lasting effects on your body. You may need medical tests for up to 4 years after you stop using this medicine. Tell any doctor or other healthcare provider who treats you that you were treated with Lemtrada.

    Lemtrada Patient Information including If I Miss a Dose

    What happens if I miss a dose (Campath, Lemtrada)?

    Call your doctor for instructions if you miss an appointment for your Lemtrada injection.

    What happens if I overdose (Campath, Lemtrada)?

    Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

    An overdose may cause a severe reaction when the medicine is injected.

    What should I avoid while receiving Lemtrada (Campath, 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.

    Do not receive a "live" vaccine while using Lemtrada, 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.

    What other drugs will affect Lemtrada (Campath, 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.

    This list is not complete. Other drugs may affect Lemtrada, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.

    Where can I get more information (Campath, Lemtrada)?

    Your doctor or pharmacist can provide more information about alemtuzumab (Lemtrada).


    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.