Lemtrada 12 mg/1.2 mL intravenous solution

Generic name:
Alemtuzumab (multiple sclerosis) - injection

Pronunciation
(AL-em-TOOZ-oo-mab)

Brand name(s)
Lemtrada

This medication may cause very serious (rarely fatal) blood disorders (low number of blood cells such as red cells, white cells, and platelets). This effect can cause anemia, decrease your body's ability to fight an infection, or cause easy bruising/bleeding. Tell your doctor right away if you develop any of the following symptoms: signs of infection (such as sore throat that doesn't go away, fever, swollen lymph nodes), easy bruising/bleeding, coughing up blood, shortness of breath, unusual tiredness, fast/pounding heartbeat.

This medication may also cause very serious kidney problems. Tell your doctor right away if you notice symptoms such as change in the amount of urine, painful urination, pink/bloody urine, or swelling ankles/feet.

Serious (rarely fatal) infusion reactions may happen during the infusion of this drug and for 24 hours or more afterward. Your doctor will prescribe other medications (such as acetaminophen, diphenhydramine, corticosteroids) before each treatment to help prevent these side effects. Tell your doctor right away if you have any symptoms of infusion reactions such as headache, fever, chills, flushing, mild rash/itching, nausea, vomiting, shortness of breath, tiredness, or dizziness. Your doctor may give you other medications to help with these side effects.

This medication may also cause a stroke, or tears in the blood vessels in the head and neck, especially within the first 3 days after receiving treatment. Get medical help right away if you notice symptoms such as weakness on one side of the body, drooping of the face, neck pain, sudden severe headache, trouble speaking, sudden vision changes, or confusion.

This medication may increase your risk of developing certain types of cancer (such as thyroid, skin, blood). Tell your doctor right away if you notice symptoms such as unusual growth or lump in the neck, difficulty swallowing, unusual/lasting hoarseness, unusual skin changes, change in appearance or size of moles.

Your doctor will monitor you closely to decrease the risk of these serious side effects.

To receive alemtuzumab in the United States, you must understand, agree to, and carefully follow the requirements of the REMS Program for this medication. If you live in Canada or any other country, consult your doctor and pharmacist for your country's regulations.

Alemtuzumab is used to treat multiple sclerosis (MS). It is not a cure for MS but it is thought to help by preventing immune system cells (lymphocytes) from attacking the nerves in your brain and spinal cord. It helps decrease the number of relapses and may prevent or delay disability.

Read the Medication Guide, Patient Safety Information Card, and, if available, the Patient Information Leaflet provided by your pharmacist before you start using alemtuzumab and each time you receive treatment with this drug. Carry the Patient Safety Information Card with you at all times. If you have any questions, ask your doctor or pharmacist.

This medication is given by injection into a vein over at least 4 hours by a health care professional. It should be given over 2 treatment courses. The first treatment course is usually given daily for 5 days while the second treatment course is usually given daily for 3 days. The treatment courses should be separated by 12 months. Additional treatment courses of 3 days may be given if needed, but should be separated by at least 12 months from the previous treatment.

Before you receive this medication, your doctor will direct you to take other medications (such as acetaminophen, diphenhydramine, corticosteroids, antiviral medication) to help prevent side effects and infection. Use these additional medications exactly as prescribed by your doctor.

See also Warning section.

Diarrhea, stomach/abdominal pain, cough, trouble sleeping, or mouth sores may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

People using this medication may have serious side effects. However, you have been prescribed this drug because your doctor has judged that the benefit to you is greater than the risk of side effects. Careful monitoring by your doctor may decrease your risk.

Tell your doctor right away if you have any serious side effects, including:

• diarrhea with blood/mucus
• mental/mood changes (such as depression, anxiety)
• muscle/bone/back pain
• joint pain/stiffness
• signs of thyroid disease (such as unusual weight changes, increased sweating, constipation, feeling cold, fast/slow/irregular heartbeat)
• signs of liver disease (such as nausea/vomiting that doesn't stop, loss of appetite, severe stomach/abdominal pain, yellowing eyes/skin, dark urine)

This medication may increase your risk of getting a rare but very serious (possibly fatal) brain infection (progressive multifocal leukoencephalopathy-PML). Get medical help right away if you have any of these side effects:

• clumsiness
• loss of coordination/balance
• weakness
• sudden change in your thinking (such as confusion, difficulty concentrating, memory loss)
• difficulty talking/walking
• seizure
• vision changes

Get medical help right away if you have any very serious side effects, including:

• fainting
• chest/jaw/left arm pain

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including:

• rash
• itching/swelling (especially of the face/tongue/throat)
• severe dizziness
• trouble breathing

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Before receiving alemtuzumab, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of:

• immune system problems (such as HIV)
• recent/current infections (such as tuberculosis)
• bleeding/blood problems
• high blood pressure
• stroke
• cancer
• kidney problems
• heart problems
• blood vessel problems (such as tears in arteries)
• thyroid problems

This drug may make you dizzy. Alcohol or marijuana (cannabis) can make you more dizzy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Before receiving a blood transfusion, tell your doctor that you are using this medication.

Tell your doctor your vaccine history and ask if you need to get any vaccines before starting treatment with this medication. Your doctor may direct you to have any required vaccines at least 6 weeks before starting this medication. Tell your health care professional that you are using alemtuzumab before having any immunizations/vaccinations. Avoid contact with people who have recently received live vaccines (such as flu vaccine inhaled through the nose).

Wash your hands well to prevent the spread of infections.

This medication also increases your risk of getting a very serious infection caused by a bacteria called listeria. During treatment and for some time after treatment with this medication, either avoid food that may contain listeria (such as deli meat, unpasteurized milk and cheese products, soft cheeses, undercooked meat/seafood/poultry), or make sure you heat it well. Ask your doctor for more details.

To lower the chance of getting cut, bruised, or injured, use caution with sharp objects like razors and nail cutters, and avoid activities such as contact sports.

Tell your doctor if you are pregnant or plan to become pregnant. You should not become pregnant while using alemtuzumab. Alemtuzumab may harm an unborn baby. Your doctor should order a pregnancy test before you start this medication. Ask about reliable forms of birth control while using this medication and for 4 months after the last dose. If you become pregnant, talk to your doctor right away about the risks and benefits of this medication.

It is unknown if this drug passes into breast milk. Because of the possible risk to the infant, breastfeeding is not recommended while using this drug and for at least 4 months after the last dose. Consult your doctor before breastfeeding.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Some products that may interact with this drug are:

• other drugs that weaken the immune system/increase the risk of infection (such as natalizumab, rituximab)

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call 1-800-222-1222. Canada residents can call 1-844-764-7669.

Lab and/or medical tests (such as complete blood count, EKG, kidney/liver/thyroid function, skin exams, tuberculosis testing, urine tests) should be done before treatment, while you are receiving this medication, and for some time after treatment is completed. Keep all medical and lab appointments. Consult your doctor for more details.

It is important to get each dose of this medication as scheduled. If you miss a dose, ask your doctor or pharmacist right away for a new dosing schedule.

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

Your condition can cause complications in a medical emergency. For information about enrolling in MedicAlert, call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).

HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.