Alemtuzumab (Intravenous route)
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 .
Uses of This Medicine:
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.
Before Using This Medicine:
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 not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.
- Measles Virus Vaccine, Live
- Mumps Virus Vaccine, Live
- Rotavirus Vaccine, Live
- Rubella Virus Vaccine, Live
- Varicella Virus Vaccine
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.
- Adenovirus Vaccine
- Bacillus of Calmette and Guerin Vaccine, Live
- Cholera Vaccine, Live
- Influenza Virus Vaccine, Live
- Poliovirus Vaccine, Live
- Smallpox Vaccine
- Typhoid Vaccine
- Yellow Fever Vaccine
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:
- Autoimmune diseases (eg, Guillain-Barré syndrome, hemolytic anemia, pancytopenia, rheumatoid arthritis) or
- Bleeding problems or
- Kidney disease or
- Lung disease (eg, pneumonitis) or
- Thyroid disease—Use with caution. May make these conditions worse.
- Human immunodeficiency virus (HIV) infection—Should not be used in patients with this condition.
- Infection—May decrease your body's ability to fight infection.
Proper Use of This Medicine:
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.
Precautions While Using This Medicine:
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:
- If you can, avoid people with infections. Check with your doctor immediately if you think you are getting an infection or if you get a fever or chills, cough or hoarseness, lower back or side pain, or painful or difficult urination.
- Check with your doctor immediately if you notice any unusual bleeding or bruising, black, tarry stools, blood in the urine or stools, or pinpoint red spots on your skin.
- Be careful when using a regular toothbrush, dental floss, or toothpick. Your medical doctor, dentist, or nurse may recommend other ways to clean your teeth and gums. Check with your medical doctor before having any dental work done.
- Do not touch your eyes or the inside of your nose unless you have just washed your hands and have not touched anything else in the meantime.
- Be careful not to cut yourself when you are using sharp objects such as a safety razor or fingernail or toenail cutters.
- Avoid contact sports or other situations where bruising or injury could occur.
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.
Side Effects of This Medicine:
- More common
- Black, tarry stools
- blood in the urine
- faintness, or lightheadedness when getting up suddenly from a lying or sitting position
- fast heartbeat
- itching, hives, or rash
- nausea and vomiting
- painful or difficult urination
- pale skin
- sore throat
- sores, ulcers, or white spots on the lips or in the mouth
- swollen glands
- tightness in the chest
- troubled breathing, exertional
- unusual bleeding or bruising
- unusual tiredness or weakness
- Less common
- Bloating or swelling of the face, hands, lower legs, or feet
- chest pain
- lower back or side pain
- muscle weakness
- pounding, or irregular heartbeat or pulse
- rapid weight gain
- red or purple spots on the skin, varying in size and remaining after pushing the skin surface
- Flushing of the face or neck
- swelling of the eyelids, face, or lips
- white patches on the tongue, in the mouth, or in folds of the skin, including the genitals
- Incidence not known
- Back pain
- blurred vision
- chest discomfort
- decreased urine output
- decreased vision
- dilated neck veins
- extreme fatigue
- eye pain
- feeling of discomfort
- inability to move the arms and legs
- inflammation of the joints
- irregular breathing
- joint pain, stiffness, or swelling
- muscle aches or pain
- numbness, pain, tingling, or weakness
- painful glands
- spitting up blood
- sudden numbness and weakness in the arms and legs
- swelling of the face, fingers, feet, or lower legs
- More common
- Fear or nervousness
- trouble sleeping
- Less common
- Acid or sour stomach
- bone pain
- burning, crawling, itching, numbness, prickling, “pins and needles”, or tingling feelings
- lack or loss of strength
- loss of appetite
- painful cold sores or blisters on the lips, nose, eyes, or genitals
- stomach discomfort, upset, or pain
- swelling or inflammation of the mouth
- weight loss
- Bloody nose
- sensation of temperature change
- stuffy nose
- unexplained nosebleeds
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.
Last Updated: 9/4/2017