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Overview: Lemtrada is used to treat relapsing forms of multiple sclerosis. Common side effects include nausea and diarrhea. Call your health care provider right away if you get a fever, feel very weak or tired, or have any unusual bleeding or bruising. Get emergency help if you have sudden weakness on one side of your body, sudden and severe headache, slurred speech, or trouble understanding speech. Lemtrada is given as an infusion into your vein (IV) by your health care provider.

Uses

What is Lemtrada used for?

Lemtrada (alemtuzumab) is used to treat relapsing forms of multiple sclerosis.

Lemtrada may also be used for other conditions as determined by your health care provider.

How does Lemtrada work (mechanism of action)?

Lemtrada is a medicine called a monoclonal antibody. It may help with multiple sclerosis by its action on the immune system.

How is Lemtrada supplied (dosage forms)?

Brands and other names

  • Lemtrada

Dosage forms and strengths

Lemtrada is available in an injectable form that is given by a health care provider.

How should I store Lemtrada?

Lemtrada is usually given by a health care provider in a hospital or clinic. You will not store it at home.

Side Effects

What are the most common side effects of Lemtrada?

The most common side effects of Lemtrada are listed below. Tell your health care provider if you have any of these side effects that bother you.

  • Nausea and vomiting
  • Diarrhea
  • Trouble sleeping
  • Headache
  • Feeling tired
  • Rash, hives, and itching
  • Pain, such as back pain, joint pain, or stomach pain
  • Numbness, tingling, or burning in your arms, feet, or face
  • Dizziness
  • Sudden redness in your face, neck, or chest
  • Infections (see below)

There may be other side effects of Lemtrada that are not listed here. Contact your health care provider if you think you are having a side effect of a medicine. In the U.S., you can report side effects to the FDA at www.fda.gov/medwatch or by calling 800-FDA-1088 (800-332-1088). In Canada, you can report side effects to Health Canada at www.health.gc.ca/medeffect or by calling 866-234-2345.

What are the serious side effects of Lemtrada?

While less common, the most serious side effects of Lemtrada are described below, along with what to do if they happen.

Severe Allergic Reactions. Lemtrada may cause allergic reactions, which can be serious. Get help right away if you have any of the following symptoms of a serious allergic reaction.

  • Breathing problems or wheezing
  • Racing heart
  • Fever or general ill feeling
  • Swollen lymph nodes
  • Swelling of the face, lips, mouth, tongue, or throat
  • Trouble swallowing or throat tightness
  • Itching or skin rash
  • Bumps on the skin called hives that can be red, pink, white, or brown depending on your skin tone
  • Nausea or vomiting
  • Dizziness, feeling lightheaded, or fainting
  • Stomach cramps
  • Joint pain

Immune System Reactions. Lemtrada may cause your immune system to attack healthy tissues or organs, causing inflammation. When tissues or organs become inflamed, they may not work as well as they should. These side effects can lead to serious or even life-threatening problems. You may be able to prevent these problems from getting more serious if you get medical help right away. Keep all appointments to check your blood tests, even after you stop getting doses of Lemtrada. Tell your health care provider right away if you have any of the following signs or symptoms, even if you are no longer using this medicine.

  • Inflamed brain (encephalitis): Stiff neck, balance or memory problems, confusion, personality changes, seizures
  • Inflamed gallbladder (cholecystitis without gallstones): Stomach pain, fever, nausea, or vomiting
  • Inflamed lungs (pneumonitis): Chest pain, shortness of breath, or new or worsening cough
  • Inflamed intestines (colitis): Severe stomach pain, diarrhea, blood or mucus in your stool, or black, tarry stools
  • Inflamed thyroid gland (thyroiditis): Headache, fast or irregular heartbeat, sweating, tiredness, weight gain or loss, hair loss, changes in mood or behavior, peeing more than usual, feeling cold
  • Inflamed liver (hepatitis): Severe nausea or vomiting, stomach pain on your right side, yellowish eyes or skin, dark urine (pee), or easy bleeding or bruising
  • Heart or blood vessel inflammation: Chest pain, fast or irregular heartbeat
  • Inflamed joints (Still’s disease): Fever, rash, joint and muscle pain or stiffness

Thyroid Problems. Lemtrada can cause the function of your thyroid gland to change, which can lead to low or high thyroid levels or Graves’ disease. Keep all appointments to have your blood checked. Tell your health care provider if you have any of the following signs even after stopping this medicine. 

  • Weight gain or loss
  • Feeling cold or hot
  • Tiredness that does not go away or continues to worsen
  • Constipation
  • Eye pain
  • Bulging eyes
  • Vision changes

Kidney Damage. Glomerulonephritis can happen when using Lemtrada. Keep all appointments to have your blood checked. Call your health care provider right away if you have any of the following symptoms of kidney damage even after you stop this medicine.

  • Reduced need to pee
  • Blood in your pee
  • Swelling in your feet, ankles, or legs
  • Weakness or unusual tiredness
  • A hard time catching your breath, chest pain/pressure, or coughing up blood
  • Confusion
  • Nausea
  • Seizures

Hemophilia A. Lemtrada can cause a bleeding disorder called hemophilia A. This disorder keeps your blood from clotting the way that it should. Call your health care provider right away if you have any of the following symptoms.

  • Bruising
  • Nose bleeds
  • Pain or swelling in your joints
  • Blood in your pee
  • Blood in your stool or black, tarry stool
  • Bleeding that takes longer than usual to stop

Infections. Lemtrada can increase your risk of infections, including serious infections. Take any medicines that are prescribed to you to help prevent infections. Follow any instructions that your health care provider gives you to help prevent infections. Call your health care provider right away if you have an infection or any of the following symptoms even after you stop this medicine.

  • Burning or stinging when you pee
  • Cough or coughing up blood
  • Fever, sweats, chills, or muscle aches
  • Shortness of breath
  • Diarrhea or stomach pain
  • Nausea or vomiting
  • Weight loss
  • Neck stiffness, headache, confusion, or trouble walking

Blood Disorders. Lemtrada can cause blood disorders, such as lymphopenia, aplastic anemia, hemolytic anemia, neutropenia, and pancytopenia. Keep all appointments to check your blood tests, even after you stop using Lemtrada. Get help right away if you have any of the following symptoms of blood disorders.

  • Fever
  • Shortness of breath
  • Pale or yellowish skin
  • Frequent infection
  • Unusual weakness or tiredness
  • Dizziness, lightheadedness, or feeling like you are about to pass out
  • Headache
  • Fast or abnormal heartbeat
  • Chest pain

Immune Thrombocytopenic Purpura (ITP). Lemtrada can lead to a serious problem with blood clotting, called ITP. ITP is when your immune system attacks the platelets in your blood, which causes low platelet levels (thrombocytopenia) and a reduced ability of your blood to clot. ITP needs to be treated right away in the hospital or it can lead to death. Keep all appointments to check your blood tests, even after you stop using Lemtrada. Get emergency help if you have any of the following symptoms without another explanation.

  • Purplish spots (purpura) on the skin or in the mouth due to bleeding under the skin
  • Easy bruising
  • Heavier than normal periods
  • Coughing up blood
  • Bleeding that is hard to stop, such as from cuts or in the mouth or nose

Thrombotic Thrombocytopenic Purpura (TTP).Lemtrada can lead to a serious problem with blood clotting, called TTP. TTP is when blood clots form in some parts of your bloodstream, which causes a loss of platelets in the rest of the blood (thrombocytopenia). TTP needs to be treated right away in the hospital or it can lead to death. Get emergency help if you have any of the following symptoms without another explanation.

  • Fever
  • Shortness of breath
  • Pale or yellowish skin
  • Your skin or the whites of your eyes turning yellowish in color (also called jaundice)
  • Changes in your vision
  • Unusual weakness or tiredness
  • Headache, confusion, or slurred speech
  • Fast heartbeat
  • Purplish spots (purpura) on the skin or in the mouth due to bleeding under the skin
  • Less amount of pee or pee that is pink or has blood in it

Progressive Multifocal Leukoencephalopathy (PML). People using Lemtrada may get a rare brain disease called PML. It is caused by a virus called the JC virus. PML is very serious and can lead to death. Call your health care provider right away if you have any of the following symptoms of PML.

  • Clumsiness or loss of coordination
  • Difficulty walking or speaking
  • Facial drooping
  • Vision problems
  • Thinking, memory, or personality changes
  • Weakness on one side of your body that gets worse
  • Seizures

Hemophagocytic Lymphohistiocytosis (HLH). People using Lemtrada may develop a rare condition called HLH. It happens when your immune system overreacts to an infection and the cells that are meant to attack the infection attack your body. HLH is very serious and can lead to death. Keep all appointments to check your blood tests, even after you stop getting this medicine. Get emergency help if you have any of the following symptoms.

  • Fever
  • Swollen glands
  • Rash
  • Changes in mental function, such as trouble thinking or staying awake
  • Seizures
  • Feeling unsteady or trouble walking

Infusion Reactions. Lemtrada can cause reactions that can be serious when it is given to you. This may happen while you are receiving a dose or up to 24 hours or more after you receive a dose. Your infusion may need to be slowed or stopped if you have these reactions. Wait at the facility where you receive Lemtrada to be watched for as long as your health care provider recommends, usually for at least two hours after getting a dose. Tell your health care provider right away if you have any of the following symptoms during your infusion, while you are waiting, or after you leave the facility.

  • Rash
  • Trouble breathing
  • Swelling in your mouth or throat
  • Weakness
  • A heart beat that seems fast, slow, or not regular
  • Chest pain

Stroke and Blood Vessel Problems. Lemtrada can increase your risk of stroke or tears in the blood vessels that supply your brain. These events can be life-threatening and can happen within three days after receiving a dose. Get emergency help if you have any of the following symptoms of blood vessel tears or stroke.

  • Pain in your neck
  • Sudden weakness on one side of your body
  • Sudden and severe headache
  • Slurred speech or trouble understanding speech

New Cancer. Lemtrada can cause a new cancer to develop, such as certain blood cancers, skin cancer, or thyroid cancer. Keep appointments to have your skin checked before you start treatment with Lemtrada and during your treatment. Tell your health care provider about any new symptoms, including any of the following symptoms.

  • A new lump or swelling or pain in your neck
  • Trouble breathing or swallowing
  • A voice change or cough that does not go away

Suicidal Thoughts and Actions. Lemtrada may cause suicidal thoughts or actions in a small number of people. If you are about to harm yourself, call 911 or call or text 988, the Suicide & Crisis Lifeline. Call your health care provider right away if you have any of the following symptoms.

  • New or increased thoughts of suicide or death
  • Suicide attempt

New or increased feelings of anxiety or depression or other unusual changes in mood or behavior

Warnings & Precautions

Who should not use Lemtrada?

Allergies to Ingredients. People who are allergic to any of the following should not use Lemtrada.

  • Alemtuzumab
  • Lemtrada
  • Any of the ingredients in the specific product dispensed

Your pharmacist can tell you all of the ingredients in Lemtrada.

Current Infection. Lemtrada is not to be used if you have an infection because this medicine makes it hard for you to fight infection.

HIV Infection. Lemtrada should not be used if you are infected with HIV because this medicine reduces the same blood cell counts as HIV.

What should I know about Lemtrada before using it?

Lemtrada is usually given by a health care provider in a clinic or hospital.

Your health care provider may prescribe medicines for you to take before you get doses of Lemtrada or after your treatment is finished. It is important to take these as they are meant to lower your risk of having problems, such as a reaction related to the infusion or an infection.

Lemtrada is only available through a special program called the Lemtrada Risk Evaluation and Mitigation Strategy (REMS) Program from certain health care providers and pharmacies and to certain people. It is important that you keep all of your appointments, including labs or other testing, while using Lemtrada. If you have any questions about this program, you can go to www.lemtradaREMS.com or call 855-676-6326.

Do not eat deli meat; dairy products that are made using unpasteurized milk; soft cheeses; or undercooked meat, seafood, or poultry before you start Lemtrada and while you are using it. These foods can contain a bacteria called Listeria monocytogenes, which can cause life-threatening infections.

What should I tell my health care provider before using Lemtrada?

Tell your health care provider about all of your health conditions and any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. This will help them know if Lemtrada is right for you.

In particular, make sure that you discuss any of the following.

Vaccines. Talk to your health care provider about any vaccines that you may need. You should not receive vaccines less than six weeks before or while using Lemtrada. Tell your health care provider about any vaccines you have recently received or have scheduled.

Current and Past Health Conditions. Tell your health care provider if you have any of the following.

  • Bleeding problems
  • Thyroid problems
  • Kidney problems
  • Recent infection
  • Hepatitis B or C
  • Cancer

Other Medicines and Supplements. Lemtrada may interact with other medicines and supplements. Before using Lemtrada, tell your health care provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. See the Interactions section for more details.

Pregnancy. Lemtrada may cause harm to a fetus. If you can become pregnant, you should use effective birth control while using Lemtrada and for four months after your last dose. Tell your health care provider right away if you are pregnant or plan to become pregnant.

If you become pregnant while using Lemtrada, you can sign up for a pregnancy safety surveillance program by calling 800-745-4447, option 2.

Breastfeeding. It is not known if Lemtrada passes into breast milk. Tell your health care provider if you are breastfeeding or plan to breastfeed. Your health care provider will let you know if you should stop breastfeeding or stop Lemtrada.

How can I get more information about Lemtrada?

For more information about Lemtrada, you can visit the drugmaker’s website at www.lemtrada.com or call them at 855-676-6326.

Interactions

Does Lemtrada interact with foods or drinks?

There are no known interactions between Lemtrada and foods or drinks.

 It is unknown if drinking alcohol will affect Lemtrada.

Does Lemtrada interact with other medicines (drug interactions)?

Always tell your health care provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using.

In particular, make sure that you discuss if you are using any of the following before using Lemtrada.

  • Azathioprine (Azasan, Imuran), cyclosporine (Gengraf, Neoral, Sandimmune, and others), or mycophenolate (Cellcept), which are medicines that suppress your immune system
  • Alemtuzumab (Campath), which is a medicine used to treat certain cancers

This may not be a complete list of medicines that can interact with Lemtrada. Always check with your health care provider.

Does interact with other drugs you are taking?

Enter your medication into the WebMD interaction checker

Overdose/Missed Dose

What should I do if I accidentally use too much Lemtrada?

If you or someone else has used too much Lemtrada, get medical help right away, call 911, or contact a Poison Control center at 800-222-1222.

What should I do if I miss a dose of Lemtrada?

Lemtrada is usually given by a health care provider in a clinic or hospital. Your health care provider will make sure you are receiving Lemtrada as scheduled.

If you miss an appointment to get your Lemtrada dose, call to make another appointment as soon as possible.