Serious, sometimes fatal autoimmune conditions including immune thrombocytopenia and antiglomerular basement membrane disease may occur. Complete blood counts with differential, serum creatinine levels, and urinalysis with urine cell counts should be monitored at periodic intervals for 48 months after discontinuing therapy. Serious and life-threatening infusion reactions have been reported and can occur after the 2-hour monitoring period. Administer in a setting appropriate for managing anaphylaxis or serious infusion reactions. Alemtuzumab may increase the risk of malignancies including thyroid cancer, melanoma, and lymphoproliferative disorders. Baseline and yearly skin exams are recommended. Because of the risks associated with alemtuzumab, it is only available through restricted distribution under a Risk Evaluation Mitigation Strategy (REMS) program .
Alemtuzumab injection is used to treat the relapsing forms of multiple sclerosis (MS). This medicine will not cure MS, but it may slow some of the disabling effects and decrease the number of relapses of the disease.
This medicine is only available through a restricted access program. Doctors who are enrolled in the restricted program can write a prescription for this medicine.
Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although these uses are not included in product labeling, alemtuzumab is used in certain patients with the following medical conditions:
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Appropriate studies have not been performed on the relationship of age to the effects of alemtuzumab injection in the pediatric population. Safety and efficacy have not been established.
Appropriate studies on the relationship of age to the effects of alemtuzumab injection have not been performed in the geriatric population. However, geriatric-specific problems that would limit the usefulness of alemtuzumab injection in the elderly are not expected.
|All Trimesters||C||Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.|
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are receiving this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.
Other medical problems
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
A nurse or other trained health professional will give you this medicine. This medicine is given through a needle placed into one of your veins.
This medicine is usually given for 2 treatment courses. You will receive this medicine for 5 consecutive days for the first treatment course and for 3 consecutive days about 1 year later for your second treatment course. Each treatment usually takes about 4 hours per day.
You will receive medicines to prevent allergic reactions (eg, steroids) before you start treatment with alemtuzumab.
You must enroll in a prescribing program called Lemtrada™ REMS program in order to begin receiving alemtuzumab. Your doctor will explain the program and have you sign an enrollment form. Be sure to ask your doctor if you have any questions about the Lemtrada™ REMS prescribing program. It is very important that you understand and follow all of the instructions for the program.
This medicine should come with a Medication Guide. Read and follow the instructions carefully. Ask your doctor if you have any questions.
It is very important that your doctor check you at regular visits to make sure this medicine is working properly. Blood and urine tests may be needed to check for any unwanted effects. It is important that your doctor check your skin for melanoma (tumor) yearly.
Do not use this medicine if you are also receiving Campath®.
This medicine may cause a rare but serious type of an allergic reaction called an infusion reaction. This can be life-threatening and requires immediate medical attention. Tell your doctor right away if you start to have a cough, difficulty with swallowing, dizziness, fast heartbeat, trouble breathing, chest tightness, swelling in your face or hands, fever, chills, itching or hives, or lightheadedness or faintness while you are receiving this medicine.
This medicine may increase risk of cancer, including thyroid, skin, or lymph nodes. Call your doctor right away if you have a new lump or swelling in the neck, cough, hoarseness or voice changes, neck pain, or trouble breathing or swallowing.
This medicine may cause autoimmune disorders, including immune thrombocytopenia (ITP). Tell your doctor right away if you have a bloody nose, coughing or spitting up blood, small red or purple spots on skin, or heavier than normal or irregular monthly periods.
This medicine may cause a serious kidney problem called anti-glomerular basement membrane disease. Call your doctor right away if you have blood in the urine, coughing up blood, or swelling in your legs or feet.
While you are being treated with alemtuzumab, and after you stop treatment with it, do not have any immunizations (vaccinations) without your doctor's approval. You should receive live vaccines for at least 6 weeks before starting treatment with this medicine. Alemtuzumab may lower your body's resistance and there is a chance you might get the infection the immunization is meant to prevent. In addition, other persons living in your household should not take oral polio vaccine since there is a chance they could pass the polio virus on to you. Also, avoid persons who have taken oral polio vaccine within the last several months. Do not get close to them, and do not stay in the same room with them for very long. If you cannot take these precautions, you should consider wearing a protective face mask that covers the nose and mouth.
Alemtuzumab can temporarily lower the number of white blood cells in your blood, which will increase the risk of getting an infection. It can also lower the number of platelets, which are necessary for proper blood clotting. If this occurs, these are precautions you can take, especially when your blood count is low, to reduce the risk of infection or bleeding:
This medicine may increase your risk of developing infections. Avoid being near people who are sick or have infections while you are using this medicine. Wash your hands often. Tell your doctor if you have any kind of infection before you start using this medicine. Also tell your doctor if you have ever had an infection that would not go away or an infection that kept coming back. Tell your doctor right away if you have been exposed to someone with chickenpox.
If you are a female, you should have a human papilloma virus (HPV) screening every year to avoid getting a cervical HPV infection.
You will need to have a skin test for tuberculosis (TB) before you start this medicine. Tell your doctor if you or anyone in your home has ever had a positive TB skin test or been exposed to TB.
Do not eat foods that may contain a bacteria called listeria, such as deli milk, unpasteurized milk and cheese products, or not properly cooked meat, seafood, or chicken. Make sure that the food you eat which may contain listeria is heated well when you receive this medicine.
Tell your doctor if you are pregnant, planning to become pregnant, or breastfeeding. Use an effective form of birth control to prevent from getting pregnant while you are receiving this medicine and for 4 months after your treatment ends.
Tell your doctor right away if you have unexplained weight gain or loss, constipation, fast, pounding, or uneven heartbeat, feeling cold, swelling of the eye. These may be symptoms of a thyroid problem.
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor or nurse immediately if any of the following side effects occur:
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.