Alemtuzumab Injection (Multiple Sclerosis)

WHY is this medicine prescribed?

Alemtuzumab injection is used to treat adults with various forms of multiple sclerosis (MS; a disease in which the nerves do not function properly and people may experience weakness, numbness, loss of muscle coordination, and problems with vision, speech, and bladder control) including relapsing-remitting forms (course of disease where symptoms flare up from time to time) or secondary progressive forms (course of disease where relapses occur more often). Alemtuzumab injection is usually used by people who have not improved with at least two or more MS medications. Alemtuzumab is in a class of medications called monoclonal antibodies. It works by decreasing the action of immune cells that may cause nerve damage.

Alemtuzumab is also available as an injection (Campath) that is used to treat chronic lymphocytic leukemia (a slowly developing cancer in which too many of a certain type of white blood cell accumulates in the body). This monograph only gives information about alemtuzumab injection (Lemtrada) for multiple sclerosis. If you are receiving alemtuzumab for chronic lymphocytic leukemia, read the monograph entitled Alemtuzumab Injection (Chronic Lymphocytic Leukemia).

HOW should this medicine be used?

Alemtuzumab injection comes as a solution (liquid) to be injected intravenously (into a vein) over 4 hours by a doctor or nurse in a hospital or medical office. It is usually given once daily for 5 days for the first treatment cycle. A second treatment cycle is usually given once daily for 3 days, 12 months after the first treatment cycle. Your doctor may prescribe an additional treatment cycle for 3 days at least 12 months after the previous treatment.

Alemtuzumab injection helps to control multiple sclerosis, but does not cure it.

Are there OTHER USES for this medicine?

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

What SPECIAL PRECAUTIONS should I follow?

Before receiving alemtuzumab injection,

• tell your doctor and pharmacist if you are allergic to alemtuzumab, any other medications, or any of the ingredients in alemtuzumab injection. Ask your pharmacist or check the Medication Guide for a list of the ingredients.
• tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, you are taking or plan to take. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
• tell your doctor if you have human immunodeficiency virus (HIV) or if you have or think you have any other type of infection now. Your doctor will probably tell you not to receive alemtuzumab injection.
• tell your doctor if you have or have ever had herpes zoster (shingles; a rash that can occur in people who have had chickenpox in the past), genital herpes (a herpes virus infection that causes sores to form around the genitals and rectum from time to time), varicella (chickenpox), liver disease including hepatitis B or hepatitis C, or thyroid, heart, lung, or gallbladder disease. Also tell your doctor if you have or have ever had tuberculosis (TB; a lung infection that may not cause symptoms for many years and that may spread to other parts of the body) or if you have been around someone who has or has had tuberculosis. Your doctor may give you a skin test to see whether you are infected with tuberculosis. Tell your doctor if you have ever had a positive skin test for tuberculosis in the past.
• tell your doctor if you are pregnant, plan to become pregnant, or are breastfeeding. If you are female, you may need to take a pregnancy test before you start treatment with alemtuzumab. You should not become pregnant during your treatment with alemtuzumab injection. You should use birth control to prevent pregnancy during your treatment and for 4 months after your final dose. Talk to your doctor about types of birth control that you can use to prevent pregnancy during this time. If you become pregnant while you are receiving alemtuzumab injection, call your doctor immediately. Alemtuzumab may harm the fetus.
• check with your doctor to see if you need to receive any vaccinations before receiving alemtuzumab. Tell your doctor if you have received a vaccine within the past 6 weeks. Do not have any vaccinations without talking to your doctor during your treatment.

What SPECIAL DIETARY instructions should I follow?

Avoid the following foods that may cause infection at least 1 month before you start receiving alemtuzumab and during your treatment: deli meat, dairy products made with unpasteurized milk, soft cheeses, or undercooked meat, seafood, or poultry.

What SIDE EFFECTS can this medicine cause?

Alemtuzumab injection may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• difficulty sleeping or falling asleep
• pain in legs, arms, toes, and hands
• mouth or throat pain
• tingling, pricking, chilling, burning, or numb sensation on the skin
• red, itchy, or scaly skin
• heartburn
• dizziness
• change in sense of taste
• hair loss

Some side effects can be serious. If you experience any of these symptoms or those listed in the IMPORTANT WARNING section, call your doctor immediately or get emergency medical treatment:

• shortness of breath, chest pain or tightness, cough, coughing up blood, or wheezing
• fever, chills, or other signs of infection
• bruising or bleeding easily, blood in urine or stool, nose bleeding, bloody vomit, or painful and/or swollen joints
• diarrhea, red or black, tarry stools, or severe stomach pain
• excessive sweating, eye swelling, weight loss, nervousness, or fast heartbeat
• unexplained weight gain, tiredness, feeling cold, or constipation
• depression
• thinking about harming or killing oneself or planning or trying to do so
• genital sores, sensation of pins and needles, or rash on penis or in vaginal area
• cold sores or fever blisters on or around the mouth
• painful rash on one side of face or body, with blisters, itching, or tingling in rash area
• (in women) vaginal odor, white or yellowish vaginal discharge (may be lumpy or look like cottage cheese), or vaginal itching
• white lesions on tongue or inner cheeks
• stomach pain or tenderness, fever, nausea, or vomiting
• yellowing eyes or skin, loss of appetite, extreme tiredness, or dark urinel
• decreased strength or weakness on one side of the body that worsens over time, clumsiness of the arms or legs, new or worsening unsteadiness, or difficulty walking
• vision changes
• small purple spots on the skin, pale skin, tiredness, weakness, fast heartbeat
• agitation, confusion, memory loss, mood or personality changes, changes in thinking or alertness, or hallucinations (seeing things or hearing voices that do not exist)
• seizures
• rash
• swollen glands
• high fever that lasts for more than 1 week

Alemtuzumab injection may increase the risk of getting a cervical HPV (human papillomavirus) infection (an infection that can cause cervical cancer in women). If you are female, you should have a Pap test (cervical cancer screening to test for HPV infection) every year.

Alemtuzumab injection may cause other side effects. Call your doctor if you have any unusual problems while receiving this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (https://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

What should I do in case of OVERDOSE?

What OTHER INFORMATION should I know?

Ask your pharmacist any questions you have about alemtuzumab injection.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.

The American Society of Health-System Pharmacists, Inc. represents that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. makes no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. does not endorse or recommend the use of any drug. The information is not a substitute for medical care.

AHFS^® Patient Medication Information™. © Copyright, 2024. The American Society of Health-System Pharmacists^®, 4500 East-West Highway, Suite 900, Bethesda, Maryland. All Rights Reserved. Duplication for commercial use must be authorized by ASHP.

Selected Revisions: August 20, 2024.