What is the most important information I should know about alemtuzumab?
Alemtuzumab can cause life-threatening side effects. Seek emergency medical attention if you have sudden weakness on one side of your body, severe headache or neck pain, confusion, or problems with speech, vision, or balance.
Call your doctor if you have signs of other serious side effects, such as unusual bruising or bleeding, blood in your urine or vomit, swelling in your feet, fever, swollen glands, muscle aches, diarrhea, or if you feel very weak or tired.
Some side effects may occur during the injection or within 2 days afterward, including chest pain, trouble breathing, irregular heartbeats, or swelling in your mouth or throat. You will be watched closely for at least 2 hours after receiving alemtuzumab.
Alemtuzumab can have long lasting effects on your body. You may need medical tests for up to 4 years after you stop using this medicine.
What is alemtuzumab?
Alemtuzumab is used to treat chronic B-cell lymphocytic leukemia.
Alemtuzumab is also used to treat relapsing forms of multiple sclerosis in adults (including active secondary progressive disease).
Alemtuzumab will not cure MS, but it can make relapses occur less often. Alemtuzumab is not for use in treating clinically isolated syndrome.
Lemtrada is available only from a certified pharmacy under a special program.
Alemtuzumab may also be used for purposes not listed in this medication guide.
What should I discuss with my healthcare provider before receiving alemtuzumab?
You should not be treated with alemtuzumab if you are allergic to it. You should not be treated with Lemtrada if you have HIV (human immunodeficiency virus).
Tell your doctor if you have ever had:
- an active or recent infection, including tuberculosis;
- kidney disease;
- a thyroid disorder;
- a bleeding or blood clotting disorder; or
- if you have received a vaccine in the past 6 weeks.
Alemtuzumab may cause other types of cancer, such as melanoma, thyroid cancer, or blood cancers. Ask your doctor about this risk.
Alemtuzumab may harm an unborn baby. Use effective birth control to prevent pregnancy while you are using this medicine and for at least 4 months after your last dose. Tell your doctor if you become pregnant.
If you are pregnant, your name may be listed on a pregnancy registry to track the effects of alemtuzumab on the baby.
It may not be safe to breastfeed while using this medicine. Ask your doctor about any risk.
Alemtuzumab is not approved for use by anyone younger than 17 years old.
How is alemtuzumab given?
Alemtuzumab is given as an infusion into a vein. A healthcare provider will give you this injection.
Alemtuzumab is usually given in 2 or more treatment courses, separated by 1 year. Your doctor will determine the number of courses you need.
This medicine must be given slowly, and the infusion can take 2 to 4 hours to complete.
You will be watched closely for at least 2 hours after receiving alemtuzumab, to make sure you do not have a serious reaction.
You may be given other medicines to help prevent certain side effects. Take these medicines for the full prescribed length of time.
Alemtuzumab affects your immune system. You may get infections more easily, even serious or fatal infections. Your doctor will need to examine you on a regular basis.
Alemtuzumab can have long lasting effects on your body. You may need medical tests for up to 4 years after you stop using this medicine.
What happens if I miss a dose?
Call your doctor for instructions if you miss an appointment for your alemtuzumab injection.
What happens if I overdose?
Since this medicine is given by a healthcare professional in a medical setting, an overdose is unlikely to occur.
What should I avoid while receiving alemtuzumab?
Avoid foods that may be a source of Listeria infection, or heat them thoroughly before consuming. This includes deli meat, undercooked meat, seafood, poultry, unpasteurized dairy products, or soft cheeses.
Avoid being near people who are sick or have infections. Avoid activities that may increase your risk of bleeding or injury.
Do not receive a "live" vaccine while using alemtuzumab, or you could develop a serious infection. Live vaccines include measles, mumps, rubella (MMR), polio, rotavirus, typhoid, yellow fever, varicella (chickenpox), and zoster (shingles).
What are the possible side effects of alemtuzumab?
Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Some side effects may occur during the injection or shortly afterward, including chest pain, weakness, trouble breathing, irregular heartbeats, or swelling in your mouth or throat.
In rare cases, alemtuzumab may cause a stroke or blood vessel damage in the head and neck. This could lead to permanent disability or death. Seek emergency medical attention if you have a sudden onset of symptoms such as: weakness on one side of your body, severe headache or neck pain, problems with vision or balance, trouble speaking or understanding what is said to you.
Alemtuzumab can cause your immune system to attack cells and organs in your body. This can lead to life-threatening medical problems such as severe bleeding or kidney damage. Call your doctor right away if you have:
- easy bruising or bleeding (nosebleeds, bleeding gums);
- any bleeding that will not stop;
- purple or red spots under your skin;
- heavy menstrual periods;
- blood in your urine;
- swelling in your legs or feet; or
- if you cough up blood.
Also call your doctor at once if you have:
- fever, swollen glands, pale skin, tiredness, weakness;
- cough, chest pain or tightness, trouble breathing;
- pain or burning when you urinate;
- a mole that has changed in size or color;
-
gallbladder problems --nausea, vomiting, stomach pain, fever;
-
liver problems --loss of appetite, stomach pain (upper right side), tiredness, dark urine, jaundice (yellowing of the skin or eyes);
-
symptoms of herpes virus --cold sores around your mouth, skin sores or blisters, itching, tingling, burning pain in your thigh or lower back; or
-
thyroid problems --extreme tiredness, nervousness, fast or pounding heartbeats, sweating, constipation, weight gain or loss, swelling of your eyes, feeling cold, pain or swelling in your neck or throat, hoarse voice, trouble swallowing.
Common side effects may include:
- nausea, vomiting, stomach pain, diarrhea;
- fever, infections;
- thyroid problems;
- headache, joint pain, back pain, pain in your arms or legs;
- itching, tingling, hives;
- dizziness, tiredness, sleep problems (insomnia);
- vaginal itching or discharge;
- stuffy nose, mouth or throat pain; or
- flushing (warmth, redness, or tingly feeling).
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What other drugs will affect alemtuzumab?
Tell your doctor about all your other medicines, especially:
- drugs that weaken the immune system such as cancer medicine, or medicines to prevent organ transplant rejection.
This list is not complete. Other drugs may affect alemtuzumab, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.
Where can I get more information?
Your doctor or pharmacist can provide more information about alemtuzumab.
Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.
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