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Lemtrada

Generic Name: Alemtuzumab (Lemtrada) (ay lem TU zoo mab)
Brand Name: Lemtrada

  • This medicine may cause very bad and sometimes life-threatening infusion reactions. You will be closely watched during the infusion and for some time after. Very bad infusion reactions may also happen up to 24 hours or longer after you get Lemtrada (alemtuzumab (lemtrada)). Tell your doctor right away if you have chest pain; passing out; fast or slow heartbeat; a heartbeat that does not feel normal; fever; hives; itching; rash; very bad headache or dizziness; shortness of breath or trouble breathing; swelling of the mouth, face, lips, throat, or tongue; tightness in the chest or throat; hoarseness that is not normal; or wheezing.
  • Other infusion reactions include change in taste, chills, dizziness, flushing, upset stomach, pain, feeling tired, or not able to sleep. Talk with the doctor.
  • This medicine may cause very bad and sometimes deadly autoimmune problems like some blood problems. Side effects may happen while you get this medicine and for 4 years after you stop treatment. You will need to have your blood work and urine checked while getting Lemtrada and after getting it as you have been told by your doctor. Talk with your doctor.
  • Very bad and sometimes deadly infections have happened in patients who take this medicine. If you have any infection, are taking antibiotics now or in the recent past, or have had many infections, talk with your doctor.
  • This medicine may raise the chance of cancer like thyroid cancer, skin cancer, and lymphoma. Have your skin checked and other lab tests done as you have been told by your doctor. Talk with your doctor.
  • You may only get Lemtrada through a special program. Talk with your doctor.

Uses of Lemtrada:

  • It is used to treat MS (multiple sclerosis).
  • It may be given to you for other reasons. Talk with the doctor.

What do I need to tell my doctor BEFORE I take Lemtrada?

  • If you have an allergy to alemtuzumab or any other part of this medicine.
  • If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
  • If you have an infection.
  • If you have a weak immune system or a disease that may cause a weak immune system like HIV.
  • If you have ever had any of these health problems: Any type of cancer or PML.
  • If you are breast-feeding or plan to breast-feed.

This is not a list of all drugs or health problems that interact with Lemtrada.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take this medicine with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take Lemtrada?

  • Tell all of your health care providers that you take Lemtrada. This includes your doctors, nurses, pharmacists, and dentists.
  • You may have more chance of getting an infection. Wash hands often. Stay away from people with infections, colds, or flu.
  • You may bleed more easily. Be careful and avoid injury. Use a soft toothbrush and an electric razor.
  • Talk with your doctor before getting any vaccines. Use with this medicine may either raise the chance of an infection or make the vaccine not work as well.
  • Make sure you are up to date with all your vaccines at least 6 weeks before treatment with Lemtrada. Talk with your doctor.
  • Certain kidney problems have happened with this medicine. These problems can lead to kidney failure, dialysis, or transplant, and can be life-threatening. Call your doctor right away if you have signs of kidney problems like unable to pass urine, change in the amount of urine passed, blood in the urine, or a big weight gain.
  • People taking Lemtrada may have a higher chance of getting an infection caused by the listeria bacteria. Avoid foods that may be a source of listeria or make sure that the food you eat that may contain listeria is heated well. Foods that may be a source of listeria include deli meat; unpasteurized milk and cheese products; or undercooked meat, seafood, or chicken. Talk with your doctor.
  • All females taking this medicine must have an HPV screening each year. Talk with your doctor.
  • You will need a TB (tuberculosis) test before starting Lemtrada (alemtuzumab (lemtrada)).
  • Hepatitis B or C testing may be done. A hepatitis B or C infection may get worse during care. Talk with the doctor.
  • Do not give to a child younger than 17 years of age.
  • If you are a female, use birth control that you can trust to prevent pregnancy while taking this medicine and for 4 months after your last dose.
  • If you get pregnant while taking Lemtrada or within 4 months after your last dose, call your doctor right away.
  • This medicine may cause harm to the unborn baby if you take it while you are pregnant.

How is this medicine (Lemtrada) best taken?

Use this medicine as ordered by your doctor. Read all information given to you. Follow all instructions closely.

  • It is given as an infusion into a vein over a period of time.
  • Other drugs may be given to help with infusion side effects.

What do I do if I miss a dose?

  • Call your doctor to find out what to do.

See also: Dosage Information (in more detail)

What are some side effects that I need to call my doctor about right away?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

  • Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
  • Signs of infection like fever, chills, very bad sore throat, ear or sinus pain, cough, more sputum or change in color of sputum, pain with passing urine, mouth sores, or wound that will not heal.
  • Signs of bleeding like throwing up blood or throw up that looks like coffee grounds; coughing up blood; blood in the urine; black, red, or tarry stools; bleeding from the gums; vaginal bleeding that is not normal; bruises without a reason or that get bigger; or any bleeding that is very bad or that you cannot stop.
  • Chest pain or pressure or a fast heartbeat.
  • A burning, numbness, or tingling feeling that is not normal.
  • Dark urine or yellow skin or eyes.
  • Shortness of breath.
  • Feeling very tired or weak.
  • Redness or white patches in mouth or throat.
  • Swollen gland.
  • Signs of lung or breathing problems like shortness of breath or other trouble breathing, cough, or fever.
  • Signs of thyroid problems like a change in weight without trying, feeling nervous and excitable, feeling restless, feeling very weak, hair thinning, low mood (depression), neck swelling, not able to focus, not able to handle heat or cold, period (menstrual) changes, shakiness, or sweating.
  • Signs of thyroid cancer like new lump or swelling in the neck, pain in the front of the neck, cough that does not go away, change in voice that does not go away like hoarseness, or trouble swallowing or breathing.
  • Change in color or size of a mole.
  • Low mood (depression).
  • Night sweats.
  • If you are planning to harm yourself or the want to harm yourself gets worse.
  • Swelling in the arms or legs.
  • A skin lump or growth.

What are some other side effects of Lemtrada?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

  • Anxiety.
  • Back pain.
  • Headache.
  • Belly pain.
  • Upset stomach or throwing up.
  • Loose stools (diarrhea).
  • Feeling tired or weak.
  • Muscle pain.
  • Not able to sleep.
  • Pain in arms or legs.
  • Dizziness.
  • Flushing.
  • Joint pain.
  • Muscle spasm.
  • Muscle weakness.
  • Neck pain.
  • Nose and throat irritation.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

See also: Side effects (in more detail)

If OVERDOSE is suspected:

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

How do I store and/or throw out Lemtrada?

  • If you need to store Lemtrada at home, talk with your doctor, nurse, or pharmacist about how to store it.

Consumer Information Use and Disclaimer

  • If your symptoms or health problems do not get better or if they become worse, call your doctor.
  • Do not share your drugs with others and do not take anyone else's drugs.
  • Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
  • Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
  • Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
  • Check with your pharmacist about how to throw out unused drugs.
  • This medicine comes with an extra patient fact sheet called a Medication Guide. Read it with care. Read it again each time this medicine is refilled. If you have any questions about Lemtrada, please talk with the doctor, pharmacist, or other health care provider.
  • If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about Lemtrada. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using Lemtrada.

Review Date: October 4, 2017

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