LEMTRADA® (Alemtuzumab)

LEMTRADA®

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Important Safety Information

LEMTRADA® (alemtuzumab) is an infusion medication used to treat relapsing multiple sclerosis (MS) in adults. It is prescribed to patients who have tried two or more oral medications and have failed to obtain relief. It is unknown whether LEMTRADA® would be safe to use in patients under 17 years of age.

LEMTRADA® may increase the risk of developing serious autoimmune conditions, including anti-glomerular basement membrane disease — which could result in life-threatening kidney damage.

LEMTRADA® could also cause patients to develop immune thrombocytopenic purpura (ITP). This ailment reduces the platelet counts in the blood. Tell your doctor immediately if you experience fatigue, blood in your urine, decreased urine, coughing up blood, and/or swelling of your legs or feet.

Prior to starting treatment, tell your doctor about your medical history, especially if you have thyroid or kidney problems, a recent infection, or are taking a medication called Campath. Also, tell your healthcare provider about all drugs you are currently taking — whether they’re prescription, over-the-counter, herbal supplements, or vitamins. This should be done to prevent harmful effects from these medications interacting with each other. In addition, tell your doctor if you have received a live vaccine in the past six weeks or have plans to receive one in the future.

LEMTRADA® may harm your unborn child. Tell your doctor if you’re pregnant or there’s a possibility you may be pregnant. It is recommended you use birth control while undergoing infusion treatment with LEMTRADA®. Also, tell your doctor if you’re breastfeeding or planning on doing so.

What is the most important information I should know about LEMTRADA®?

LEMTRADA® could increase the risk of serious infections. These include herpes viral infections, tuberculosis, hepatitis, and listeria. Your healthcare provider should monitor you for signs of infection — including tiredness, bleeding, bruising easily or more than usual, yellowing of the skin or whites of eyes, stomach pain, and/or fatigue. Do not use LEMTRADA® if you are infected with the human immunodeficiency virus (HIV).

Due to the increased risk of autoimmunity and certain types of cancer, LEMTRADA® is only available through a restricted program called the LEMTRADA® Risk Evaluation and Mitigation Strategy Program. Talk to your doctor if you are interested in this program.

Side Effects of LEMTRADA®

As with any prescription medication, LEMTRADA® carries the risk of side effects. The most common ones include:

  • Headaches
  • Dizziness
  • Fever
  • Redness in the face, neck, and/or chest
  • Joint pain
  • Fungal infections
  • Back pain
  • Skin rash
  • Nausea
  • Vomiting
  • Urinary tract infection
  • Sleeping difficulties
  • Diarrhea, sinus infections
  • Abdominal pain
  • Upper respiratory infections
  • Tingling sensations

LEMTRADA® could also result in developing additional health ailments. In rare instances, these could include:

Progressive multifocal leukoencephalopathy (PML)

PML is a rare brain infection that usually leads to severe disability or death. Seek emergency medical care immediately if you experience difficulties with balance, coordination, using your limbs, thinking, or eyesight, and/or if you feel weak — especially on one side of your body.

Certain Cancers

LEMTRADA® may increase the risk of certain types of cancer, including skin, blood, and thyroid cancers. Tell your doctor immediately if you experience pain or swelling in your neck, breathing or swallowing difficulties, voice hoarseness that won’t go away, a cough that’s not caused by a cold, or if you notice any lumps.

Stroke and Tears in the Arteries that Supply Blood to the Brain

Some individuals have experienced tears in their carotid or vertebral arteries within three days of starting treatment with LEMTRADA®. Seek emergency care immediately if you experience a sudden and severe headache, drooping of parts of your face, weakness on one side of the body, speech difficulties, and/or neck pain.

Inflammation of the Liver

Tell your healthcare provider immediately if you experience yellowing of the skin or whites of eyes, loss of appetite, bleeding or bruising easily, stomach pain, and/or nausea. This could be a sign of liver failure or liver disease.

Hyperthyroidism or Hypothyroidism

Tell your doctor right away if you experience signs of these conditions. Symptoms include eye swelling, nervousness, constipation, unexplained weight loss or weight gain, feeling constantly cold or excessive sweating, eye swelling, and/or a fast heartbeat.

Cytopenia

Tell your doctor immediately if you experience chest pain, dark urine, fast heartbeat, weakness, or yellowing of the skin or whites of the eyes. These could be signs of a decrease in certain types of blood cells.

Acalculous Cholecystitis

Tell your doctor immediately if you experience a fever, stomach pain or discomfort, nausea, and/or vomiting. These may be signs of inflammation of the gallbladder without gallstones — which could be life-threatening.

Pneumonitis

Tell your doctor immediately if you experience shortness of breath, chest pain or tightness, coughing up blood, and/or wheezing. These could be signs of swelling of lung tissue.

Serious Infusion Reactions

LEMTRADA®may cause life-threatening infusion reactions, and they may occur during treatment or up to 24 hours after an infusion. Seek emergency medical care right away if you experience chest pain, breathing difficulties, swelling in the mouth or throat, irregular heartbeat, skin rash, and/or weakness.

Tell your doctor if you experience any negative side effects. You are also encouraged to report such side effects to the Food and Drug Administration (FDA) by visiting www.fda.gov/medwatch, or by calling 1-800-FDA-1088.

Indications

LEMTRADA® is used to treat relapsing multiple sclerosis in adults. It is not recommended for patients with clinically isolated syndrome (CIS). Administer LEMTRADA® for a period of four hours for two or more treatment courses.

Please refer to the full prescribing information.