LEMTRADA contains the active ingredient alemtuzumab, a monoclonal antibody targeting CD52. It is available as an injection for intravenous infusion, with a concentration of 10 mg alemtuzumab per 1 mL of solution. The solution includes inactive ingredients such as dibasic sodium phosphate, disodium edetate dihydrate, polysorbate 80, potassium chloride, potassium dihydrogen phosphate, and sodium chloride.

How should I use this medication?

This medication is injected into a vein. It is given by your care team in a hospital or clinic setting.

A special MedGuide will be given to you by the pharmacist with each prescription and refill. Be sure to read this information carefully each time.

Talk to your care team about the use of this medication in children. Special care may be needed.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

Keep appointments for follow-up doses. It is important not to miss your dose. Call your care team if you are unable to keep an appointment.

Where should I keep my medication?

This medication is given in a hospital or clinic. It will not be stored at home.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.

What side effects may I notice from receiving this medication?

Side effects that you should report to your care team as soon as possible:

• Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
• Bleeding—bloody or black, tar-like stools, vomiting blood or brown material that looks like coffee grounds, red or dark brown urine, small red or purple spots on skin, unusual bruising or bleeding
• Dizziness, loss of balance or coordination, confusion or trouble speaking
• Dry cough, shortness of breath or trouble breathing
• Fever lasting more than 1 week, salmon-pink rash, sore throat, swollen lymph nodes, muscle or joint pain
• Fever, rash, swollen lymph nodes, confusion, trouble walking, loss of balance or coordination, seizures
• Gallbladder problems—severe stomach pain, nausea, vomiting, fever
• High thyroid levels (hyperthyroidism)—fast or irregular heartbeat, weight loss, excessive sweating or sensitivity to heat, tremors or shaking, anxiety, nervousness, irregular menstrual cycle or spotting
• Infection—fever, chills, cough, sore throat, wounds that don't heal, pain or trouble when passing urine, general feeling of discomfort or being unwell
• Infusion reactions—chest pain, shortness of breath or trouble breathing, feeling faint or lightheaded
• Kidney injury—decrease in the amount of urine, swelling of the ankles, hands, or feet
• Liver injury—right upper belly pain, loss of appetite, nausea, light-colored stool, dark yellow or brown urine, yellowing skin or eyes, unusual weakness or fatigue
• Low thyroid levels (hypothyroidism)—unusual weakness or fatigue, increased sensitivity to cold, constipation, hair loss, dry skin, weight gain, feelings of depression
• Stroke—sudden numbness or weakness of the face, arm, or leg, trouble speaking, confusion, trouble walking, loss of balance or coordination, dizziness, severe headache, change in vision
• Sudden or severe stomach pain, bloody diarrhea, fever, nausea, vomiting
• TTP—purple spots on the skin or inside the mouth, pale skin, yellowing skin or eyes, unusual weakness or fatigue, fever, fast or irregular heartbeat, confusion, change in vision, trouble speaking, trouble walking

Side effects that usually do not require medical attention (report these to your care team if they continue or are bothersome):

• Back pain
• Diarrhea
• Fatigue
• Headache
• Joint pain
• Nausea
• Trouble sleeping

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

• Bleeding disorder
• Cancer
• HIV or AIDs
• Immune system problems
• Infection
• Kidney disease
• Liver disease
• Recent or upcoming vaccine
• Skin cancer or melanoma
• Thyroid disease
• An unusual or allergic reaction to alemtuzumab, hamster proteins, other medications, foods, dyes, or preservatives
• Pregnant or trying to get pregnant
• Breast-feeding

What may interact with this medication?

• Live virus vaccines

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Your condition will be monitored carefully while you are receiving this medication.

You may need blood work while taking this medication.

This medication can cause serious infusion reactions. To reduce the risk, your care team may give you other medications to take before receiving this one. Be sure to follow the directions from your care team.

Talk to your care team if you have not had chickenpox or the vaccine for chickenpox.

This medication may increase your risk of getting an infection. Call your care team for advice if you get a fever, chills, sore throat, or other symptoms of a cold or flu. Do not treat yourself. Try to avoid being around people who are sick.

This medication may increase your risk to bruise or bleed. Call your care team if you notice any unusual bleeding.

In some patients, this medication may cause a serious brain infection that may cause death. If you have any problems seeing, thinking, speaking, walking, or standing, tell your care team right away. If you cannot reach your care team, urgently seek another source of medical care.

This medication may increase your risk of melanoma or skin cancer. Check your skin for changes to moles or for new growths while taking this medication. Call your care team if you notice any of these skin changes.

This medication can cause a blood clotting problem called thrombotic thrombocytopenic purpura (TTP). TTP is a rare but serious medical condition that can be deadly. Get medical help right away if you have purple spots on the skin or inside the mouth, pale skin, yellowing skin or eyes, unusual weakness or fatigue, fever, fast or irregular heartbeat, confusion, change in vision, trouble speaking, or trouble walking.

Talk to your care team if you wish to become pregnant or think you might be pregnant. This medication can cause serious birth defects if taken during pregnancy. Contraception is recommended while taking this medication and for 4 months after stopping it. Talk to your care team about effective forms of contraception.

What are the most serious risks of this medication?

This medicine can increase the risk of having a stroke.

This medicine should be given to you in the hospital, a clinic, or in a healthcare treatment setting.

This medicine may cause a serious and life-threatening autoimmune disease, where the immune cells in your body attack your other cells or organs. Your healthcare provider will monitor you for this during treatment and for at least 4 years after treatment.

This medicine can cause a serious, life-threatening reaction during the infusion and for at least a day after the infusion. You will be monitored carefully during and after the infusion.

Taking this medicine can increase the risk of getting some types of cancer, like thyroid cancer, skin cancer, or blood cancer. Have your skin checked before you start taking this medicine and each year during treatment.