Generic Name: alemtuzumab (Intravenous route)
Serious, including fatal, cytopenias, infusion reactions, and infections can occur in patients receiving alemtuzumab. Limit doses to 30 mg (single) and 90 mg (cumulative weekly); higher doses increase risk of pancytopenia. Escalate dose gradually and monitor patients during infusion. Withhold therapy for Grade 3 or 4 infusion reactions. Administer prophylaxis against Pneumocystis jiroveci pneumonia (PCP) and herpes virus infections .
Commonly used brand name(s):
In the U.S.
Available Dosage Forms:
Therapeutic Class: Immunological Agent
Pharmacologic Class: Monoclonal Antibody
Alemtuzumab is a monoclonal antibody. It is used to treat a certain type of leukemia called B-cell chronic lymphocytic leukemia (B-CLL). It is given to recently diagnosed patients and to patients whose disease has progressed despite treatment with other cancer medicines. Alemtuzumab interferes with the growth of leukemic cells, which are then destroyed by the body.
This medicine is available only with your doctor's prescription.
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 in the pediatric population. Safety and efficacy have not been established.
Appropriate studies on the relationship of age to the effects of alemtuzumab have not been performed in the geriatric population. However, geriatric-specific problems that would limit the usefulness of this medication 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.
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.
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.
You will receive a medicine to prevent allergic reactions (such as diphenhydramine, Benadryl®) before you receive this medicine.
It is very important that your doctor check you at regular visits to make sure this medication is working properly. Blood tests may be needed to check for any unwanted effects.
This medicine may cause birth defects if it is used by the mother while she is pregnant or by the father when his sexual partner becomes pregnant. Use an effective form of birth control to avoid pregnancy while you are using this medicine and for at least 6 months after your treatment ends. This is very important whether you are a man or a woman. If a pregnancy occurs while you are using this medicine, tell your doctor right away.
Alemtuzumab may cause a serious allergic reaction which can be life-threatening and requires immediate medical attention. Tell your doctor right away if you have a rash; itching; swelling of the face, tongue, and throat; trouble breathing; or chest pain after you get the injection.
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. 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:
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 immediately if any of the following side effects occur:More common
Get emergency help immediately if any of the following symptoms of overdose 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:More common
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.
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