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Alemtuzumab is a recombinant DNA-derived monoclonal antibody directed against the glycoprotein CD52 present on the surface of 21-28 kD cells, for immunomodulatory effects through depletion and replication lymphocyte production.
1. What is Alemtuzumab?
Alemtuzumab contains the active ingredient Alemtuzumab is made in the form of an intravenous solution (10 mg/mL or 30 mg/mL), which is an active ingredient in the CD52 monoclonal antibody group. It is used to treat B-cell chronic lymphocytic leukemia and relapsing forms of multiple sclerosis in adults (including active secondary progressive disease). Alemtuzumab is given after at least 2 other medicines have not worked or have stopped working.
Alemtuzumab will not cure MS, but it can make relapses less likely, and Alemtuzumab is not used to treat clinically isolated syndromes. In addition, Alemtuzumab may also be used for purposes not listed in this medication guide but as prescribed by the treating physician.
2. Caution when using Alemtuzumab
Alemtuzumab can cause life-threatening side effects, including serious medical problems that can occur months to years after taking Alemtuzumab.
Call your doctor at once if you are taking Alemtuzumab if you have unusual bleeding or bruising, swelling in your legs or feet, decreased urine output, blood in your urine or stools, coughing up blood, a tumor or swelling in the neck, hoarse voice, trouble swallowing or breathing, sudden weakness on one side of the body, or problems with vision, voice, or balance.
Do not use Alemtuzumab if the patient is allergic to Alemtuzumab or if you have:
Existing infection; HIV (human immunodeficiency virus). Tell your doctor before taking Alemtuzumab if you have ever:
Have tuberculosis or other infections; Thyroid disorders; Kidney disease; Bleeding or if you receive a blood transfusion; Have had any vaccines in the past 6 weeks; Tell your doctor if you have never had chickenpox or if you have never had the chickenpox vaccine (Varivax), you may need to get the vaccine and then wait 6 weeks before using Alemtuzumab; Alemtuzumab may increase your risk of developing other types of cancer, such as melanoma, thyroid cancer, lymphoma, or leukemia; You need to have a negative pregnancy test before you start treatment with Alemtuzumab. Alemtuzumab can harm an unborn baby, so it's important that you use effective birth control to prevent pregnancy while taking this medicine and for at least 3 - 4 months after your last dose of Alemtuzumab. If you use Alemtuzumab while you are pregnant, make sure your obstetrician knows that you have used it during pregnancy, as exposure to Alemtuzumab in the womb can affect the vaccination schedule. baby's. Alemtuzumab medicine may affect fertility (ability to have children) in both men and women. However, women should still use birth control to prevent pregnancy, as alemtuzumab can harm an unborn baby. It may not be safe to breast-feed while using alemtuzumab. You should not breast-feed while using it and for at least 3 months after the last dose.
3. How is the drug Alemtuzumab used?
Alemtuzumab is given intravenously over approximately 4 hours and needs to be diluted prior to infusion. For B-cell leukemia, Alemtuzumab can be injected subcutaneously.
Adults with chronic B-cell leukemia: Initially 3 mg Alemtuzumab IV infusion on day 1, increase to 10 mg Alemtuzumab daily, if tolerance is maintained, 30 mg Alemtuzumab intravenous infusion 3 times/week (every day), The total duration of treatment (including initial dose of Alemtuzumab and dose escalation) was 12 weeks. Multiple Sclerosis: Therapy 1: 12 mg Alemtuzumab infusion per day for 5 consecutive days (total 60mg Alemtuzumab). Course 2 (12 months after course 1): 12 mg of Alemtuzumab infusion per day for 3 consecutive days (total 36 mg of Alemtuzumab). Add-on therapy (consider Alemtuzumab up to 2 additional courses, starting at least 12 months after the previous course of Alemtuzumab): 12 mg of Alemtuzumab IV per day for 3 consecutive days (36 mg total). The safety and efficacy of Alemtuzumab have not been established in patients with multiple sclerosis 0-18 years of age, therefore the use of Alemtuzumab in subjects <10 years of age with MS is not recommended.
There is no need to adjust the dose of Alemtuzumab in patients with liver or kidney failure.
Patients will be closely monitored for up to 2 hours or longer after the Alemtuzumab infusion to ensure there are no serious reactions.
Patients may be given other medicines to help prevent side effects or infections. Accordingly, the patient needs to take these drugs for the prescribed period of time.
Alemtuzumab will affect the patient's immune system. Patients can get infections more easily, even serious infections or die, so regular medical check-ups are needed and the next dose of Alemtuzumab may be delayed depending on the test results.
Alemtuzumab may have long-lasting effects on the body. You may need medical tests for up to 2 months after you stop using Campath or 4 years after you stop using Lemtrada (2 trade names for the active ingredient Alemtuzumab).
Do not get a "live" vaccine while you are using Alemtuzumab because the vaccine may not work as well or you could get a serious infection, live vaccines include the measles, mumps, rubella (MMR) vaccine ), rotavirus, typhoid, yellow fever, chickenpox (chickenpox), zoster and flu vaccines.
4. Side effects of Alemtuzumab
Get emergency medical help if the patient has signs of an allergic reaction such as: hives; shortness of breath; swelling of the face, lips, tongue, or throat.
Some side effects may occur during or for a short time after receiving Alemtuzumab injection, tell your caregiver if you feel weak, fever, chills, dizziness, nausea, lightheadedness or rash, wheezing, chest pain, trouble breathing, swelling of the mouth or throat, fast, slow, or irregular heartbeat.
Alemtuzumab can cause your immune system to attack cells and organs in your body leading to serious medical problems months to years after using Alemtuzumab. Call your doctor right away if you have:
Unusual bleeding or bruising, nosebleeds, bleeding gums, heavy periods, blood in your urine or stools, coughing up blood; Problems with speech, thinking, vision, or muscle movements; A mole that changes size or color; Cough, wheezing, chest pain, shortness of breath, coughing up blood; an overactive immune system--fever, swollen glands, rash, feeling groggy or less alert, trouble waking up, seizures; liver problems, loss of appetite, stomach pain, dark urine, yellowing of the skin or eyes; kidney problems--edema in the legs, weight gain, loss of appetite, sudden pain in the abdomen and back, pink/brown or foamy urine; signs of infection--fever, chills, sore throat, cough, mouth sores, skin sores or blisters, tingling, burning pain, pale or yellow skin, pain or burning when urinating, dark urine, cold feeling dizzy, cold hands and feet; signs of tuberculosis: cough, night sweats, loss of appetite, weight loss and feeling very tired; signs of a stroke or torn artery--sudden severe headache, weakness on one side of the body, drooping face, slurred speech; gallbladder problems--fever, nausea, vomiting, and stomach pain; thyroid problems--sweating, feeling cold, fast heartbeat, feeling nervous or tired, swollen eyes, weight gain or loss; Symptoms of thyroid cancer--a lump or swelling in the neck or throat, trouble swallowing, hoarseness, or a new cough (not caused by a cold). Other common side effects of Alemtuzumab may include:
Reactions to the injection; Stomach pain, vomiting, diarrhea; Infection (fever, chills, runny or stuffy nose, sore mouth or throat, painful urination); Chest pain or tightness, coughing up blood; Rash, tingling; Dizziness, fatigue, trouble sleeping; headache, joint pain, back pain, arm or leg pain; Thyroid problems; Flushing (sudden heat, redness, or tingling sensation). Alemtuzumab is used to treat B-cell chronic lymphocytic leukemia and relapsing forms of multiple sclerosis in adults (including active secondary progressive disease). To ensure effective treatment and avoid side effects, patients need to strictly follow the instructions of the doctor and medical staff.
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