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What is Lemtrada?

Lemtrada is a prescription intravenous medication to treat multiple sclerosis (MS) in adults. It’s generally only recommended for people who’ve attempted other forms of treatment and have not obtained any relief. This is because the medication could increase the risk of contracting other autoimmune disorders or cancer. Due to the risk of developing life-threatening illnesses as a result of treatment, Lemtrada is only available through a restricted program.

What are the most important things I should know about Lemtrada?

Before starting treatment with Lemtrada, tell your doctor if you have a history of any of the following:

  • Thyroid issues
  • Kidney problems
  • History of infection
  • Taking a medication called Campath (alemtuzumab)
  • Have received a live vaccine in the past six weeks or plan to receive live vaccines
  • Are pregnant or plan to become pregnant — LEMTRADA may harm your unborn baby.
  • Are breastfeeding or planning to breastfeed

Lemtrada can cause severe, life-threatening reactions. Tell your doctor right away if you experience any of the following:

  • Swelling of the mouth or throat
  • Breathing difficulties
  • Irregular heartbeat
  • Chest pain
  • Rash
  • Weakness

Due to these risks, you will be closely monitored by healthcare providers while you receive your infusions. If you do experience any of the above-listed complications, the infusion will be stopped. To lower the risk, your healthcare provider will give you an additional medication called corticosteroids at the beginning of treatment.

Do not receive Lemtrada if you are infected with human immunodeficiency virus (HIV).

Stroke and arterial tears. Lemtrada may also cause stroke and tears in the arteries that supply blood to the brain. Signs that the medication may be affecting these blood vessels include:

  • Drooping in parts of your face
  • Weakness on one side of the face or body
  • Severe headache
  • Difficulties speaking
  • Neck pain

Cancer. In addition, Lemtrada may increase the risk of certain types of cancer — such as thyroid, skin, and blood cancer. Notify your doctor immediately if you notice any of the following:

  • Lumps
  • Swelling in your neck
  • Breathing difficulties
  • Trouble swallowing
  • Cough that is not caused by a cold
  • Pain in the front of your neck
  • Voice changes

Thyroid problems. Lemtrada may cause hyperthyroidism (an overactive thyroid) or hypothyroidism (an underactive thyroid). Let your provider know right away if you experience any of the following:

  • Fast heartbeat
  • Feeling cold
  • Excessive sweating
  • Constipation
  • Unexplained weight gain or weight loss
  • Eye swelling
  • Nervousness
  • Worsening tiredness

Low blood counts. Lemtrada may cause a decrease in certain types of blood cells — which may result in infection. Let your healthcare provider know immediately if you experience any of the following symptoms:

  • Chest pain
  • Fast heartbeat
  • Yellowing of the skin or whites of the eyes
  • Dark urine
  • Weakness

Inflammation of the liver. When taking Lemtrada, it’s possible to experience inflammation in the liver. Let your doctor know right away if you experience any of the following symptoms:

  • Nausea
  • Stomach pain
  • Yellowing of the skin or whites of eyes
  • Tiredness
  • Loss of appetite
  • Bruising or bleeding more than usual

Serious infections. Lemtrada may increase the risk of serious infections — including listeria, herpes, and/or tuberculosis. Patients who are carriers of hepatitis B or C may also be at risk of irreversible liver damage.

Progressive multifocal leukoencephalopathy (PML). PML is a rare brain infection that could lead to severe disability — or even death. Such infection has been reported with the use of Lemtrada. Let your doctor know immediately if you experience problems with any of the following:

  • Thinking
  • Eyesight
  • Strength
  • Using your limbs
  • Strength
  • Weakness on one side of your body

Inflammation of the gallbladder. Lemtrada may increase the risk of inflammation of the gallbladder without gallstones, which can be life-threatening. Seek emergency medical attention if you experience any of the following:

  • Stomach pain
  • Fever
  • Nausea
  • Vomiting

Swelling of lung tissue (pneumonitis). Lemtrada may also increase the risk of pneumonitis. Let your healthcare provider know if you experience any of the following symptoms:

  • Shortness of breath
  • Wheezing
  • Chest pain or tightness
  • Cough
  • Coughing up blood

What are the common side effects of Lemtrada?

The most common side effects of Lemtrada include:

  • Rash
  • Headache
  • Thyroid problems
  • Fever
  • Swelling of the nose and throat
  • Nausea
  • Urinary tract infection
  • Tiredness
  • Trouble sleeping
  • Upper respiratory infection
  • Herpes viral infection
  • Hives
  • Itching
  • Fungal infection
  • Joint pain
  • Pain in your arms or legs
  • Back pain
  • Diarrhea
  • Sinus infection
  • Mouth pain
  • Sore throat
  • Tingling sensation
  • Dizziness
  • Stomach pain
  • Sudden redness in face, neck, or chest
  • Vomiting

These are not all of the possible side effects of Lemtrada. Talk to your doctor about any side effects that you experience. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.