Generic Name: alemtuzumab (AL-em-TOOZ-ue-mab)
Brand Name: Lemtrada
Alemtuzumab may cause serious and sometimes fatal autoimmune problems (eg, blood problems). Side effects may happen while you receive alemtuzumab and for 4 years after you stop treatment. You will need to have your blood work and urine checked while getting alemtuzumab and after getting it as you have been told by your doctor. Talk with your doctor.
Alemtuzumab may cause serious and sometimes life-threatening infusion reactions. You will be closely monitored during the infusion and for 2 hours after. Serious infusion reactions may also happen up to 24 hours or longer after you receive alemtuzumab. Tell your doctor right away if you have chest pain; fainting; fast, slow, or irregular heartbeat; fever; hives; itching; rash; severe headache or dizziness; shortness of breath or trouble breathing; swelling of the mouth, face, lips, throat, or tongue; tightness in the chest or throat; unusual hoarseness; or wheezing. Other infusion reactions include change in taste, chills, dizziness, flushing, nausea, pain, tiredness, trouble sleeping, or upset stomach. Talk with your doctor.
Alemtuzumab may increase the risk of cancer (eg, thyroid cancer, skin cancer, lymphoma). Have your skin checked and other lab tests done as you have been told by your doctor. Discuss any questions or concerns with your doctor.
You can only get alemtuzumab through the Lemtrada REMS program. Discuss any questions or concerns with your doctor.
Alemtuzumab is used for:
Treating multiple sclerosis (MS). It may also be used for other conditions as determined by your doctor.
Alemtuzumab is a monoclonal antibody. Exactly how it works to treat MS is not known.
Do NOT use alemtuzumab if:
- you are allergic to any ingredient in alemtuzumab
- you have HIV
Contact your doctor or health care provider right away if any of these apply to you.
Before using alemtuzumab:
Some medical conditions may interact with alemtuzumab. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
- if you are pregnant, planning to become pregnant, or are breast-feeding
- if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
- if you have allergies to medicines, foods, or other substances
- if you have kidney problems, bleeding problems, blood or bone marrow problems, thyroid problems, an infection, or immune system problems
- if you have a history of tuberculosis (TB), hepatitis, mental or mood problems (eg, depression, suicidal thoughts or actions), a long-term infection, or an infection that goes away and keeps coming back
- if you have never had chickenpox or the chickenpox (varicella zoster virus) vaccine
- if you have received a vaccine in the past 6 weeks or are scheduled to have a vaccine
- if you have or have ever had any type of cancer or a serious brain problem called progressive multifocal leukoencephalopathy (PML)
- if you have ever used a medicine with alemtuzumab in it before
Some MEDICINES MAY INTERACT with alemtuzumab. Tell your health care provider if you are taking any other medicines, especially any of the following:
- Medicines used to treat cancer or suppress the immune system because the risk of immune system problems may be increased
This may not be a complete list of all interactions that may occur. Ask your health care provider if alemtuzumab may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.
How to use alemtuzumab:
Use alemtuzumab as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- Alemtuzumab comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get alemtuzumab refilled.
- Alemtuzumab is given as an injection at your doctor's office, hospital, or clinic. Contact your health care provider if you have any questions.
- Your doctor may give you other medicines before you receive alemtuzumab to help reduce the risk of an infusion reaction. Talk with your doctor.
- If you miss a dose of alemtuzumab, call your doctor to find out what to do.
Ask your health care provider any questions you may have about how to use alemtuzumab.
Important safety information:
- Tell your doctor or dentist that you take alemtuzumab before you receive any medical or dental care, emergency care, or surgery.
- Alemtuzumab may reduce the number of clot-forming cells (platelets) in your blood. Avoid activities that may cause bruising or injury. Tell your doctor if you have unusual bruising or bleeding. Tell your doctor if you have dark, tarry, or bloody stools.
- Make sure you are up to date with all your vaccines at least 6 weeks before treatment with alemtuzumab. If you are not sure if you are up to date with all your vaccines, talk with your doctor.
- Do not receive a live vaccine (eg, measles, mumps) while you are taking alemtuzumab. Talk with your doctor before you receive any vaccine.
- Certain kidney problems have happened with alemtuzumab. These problems can lead to kidney failure, dialysis, or transplant and can be life-threatening. Discuss any questions or concerns with your doctor.
- Alemtuzumab may lower the ability of your body to fight infection. Serious and sometimes fatal infections have happened in people taking alemtuzumab. Avoid contact with people who have colds or infections. Tell your doctor if you notice signs of infection like fever, sore throat, rash, or chills.
- People taking alemtuzumab have an increased chance of getting an infection caused by the bacteria, listeria. Avoid foods that may be a source for listeria or make sure that the food you eat that may contain listeria is heated well. Foods that may be a source of listeria include deli meat; unpasteurized milk and cheese products; or undercooked meat, seafood, or poultry. Talk with your doctor.
- All females taking alemtuzumab should have human papillomavirus (HPV) screening each year. Talk with your doctor.
- You will need a tuberculosis (TB) test before starting alemtuzumab. Talk with your doctor.
- Hepatitis B or C testing may be done. A hepatitis B or C infection may get worse during care. Talk with your doctor.
- Lab tests may be performed while you use alemtuzumab. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
- Do not give alemtuzumab to a CHILD younger than 17 years old. Talk with the doctor.
- If you may become pregnant, you must use an effective form of birth control while you take alemtuzumab and for 4 months after you stop taking it. If you have questions about effective birth control, talk with your doctor.
- PREGNANCY and BREAST-FEEDING: Alemtuzumab may cause harm to the fetus. If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using alemtuzumab while you are pregnant. It is not known if this medicine is found in breast milk. Do not breast-feed while you are using alemtuzumab.
Possible side effects of alemtuzumab:
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:
Seek medical attention right away if any of these SEVERE side effects occur:
Anxiety; arm or leg pain; back pain; diarrhea; dizziness; flushing; headache; joint pain; muscle pain, weakness, or spasms; nausea; neck pain; nose or throat irritation; stomach pain; tiredness; trouble sleeping; vomiting; weakness.
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness); burning, numbness, or tingling; change in the appearance or size of a mole; chest pain; dark urine; depression; night sweats; redness or white patches in the mouth or throat; shortness of breath; suicidal thoughts or actions; swelling of the hands, ankles, or feet; swollen glands; symptoms of bleeding (eg, vomiting blood or vomit that looks like coffee grounds; coughing up blood; blood in the urine; black, bloody, or tarry stools; bleeding from the gums; unusual vaginal bleeding; bruises without a reason or that get bigger; any severe bleeding or bleeding that you cannot stop); symptoms of infection (eg, fever, chills, sore throat, ear or sinus pain, cough, more sputum or change in color of sputum, painful urination, mouth sores, wound that will not heal); symptoms of kidney problems (eg, not able to pass urine, change in the amount of urine passed, blood in the urine, big weight gain); symptoms of lung or breathing problems (eg, shortness of breath or other trouble breathing, cough, wheezing, chest pain or tightness, coughing up blood); symptoms of thyroid cancer (eg, new lump or swelling in the neck; pain in the front of the neck; persistent cough; persistent voice changes, such as hoarseness; trouble swallowing or breathing); symptoms of thyroid problems (eg, unexplained weight loss or gain, fast or irregular heartbeat, eye swelling, constipation, feeling cold, sweating, feeling nervous); unusual skin growths or lumps; unusual tired or weakness; yellowing of the skin or eyes.
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.
If OVERDOSE is suspected:
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.Proper storage of alemtuzumab:
Alemtuzumab is handled and stored by a health care provider. You will not store it at home. Keep all medicines out of the reach of children and away from pets.
- If you have any questions about alemtuzumab, please talk with your doctor, pharmacist, or other health care provider.
- Alemtuzumab is to be used only by the patient for whom it is prescribed. Do not share it with other people.
- If your symptoms do not improve or if they become worse, check with your doctor.
- Check with your pharmacist about how to dispose of unused medicine.
This information should not be used to decide whether or not to take alemtuzumab or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about alemtuzumab. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to alemtuzumab. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your health care provider for complete information about the risks and benefits of using alemtuzumab.
Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.