Alemtuzumab - injection
Alemtuzumab - injection
This medication may cause very serious (rarely fatal) blood disorders (decreased bone marrow function leading to low number of blood cells such as red cells, white cells, and platelets). This effect can cause anemia, decrease your body's ability to fight an infection, or cause your body to bruise or bleed more easily. Tell your doctor right away if you develop any of the following symptoms: signs of infection (such as fever, persistent sore throat), easy bruising/bleeding, coughing up blood, unusual tiredness, fast/pounding heartbeat, dark urine.
This medication may also cause very serious (rarely fatal) infusion-related reactions. (See also Side Effects section.)
This medication may increase your risk of developing certain types of cancer (such as thyroid, skin). Tell your doctor right away if you notice symptoms such as unusual growth or lump in the neck, difficulty swallowing, shortness of breath, unusual/lasting hoarseness.
This medication may also cause very serious kidney problems. Tell your doctor right away if you notice symptoms such as change in the amount of urine, painful urination, pink/bloody urine, or swelling ankles/feet.
This medication may also cause stroke or tears in the blood vessels in the head and neck, especially within the first 3 days after receiving treatment. Get medical help right away if you notice symptoms such as weakness on one side of the body, drooping of the face, neck pain, sudden severe headache, trouble speaking, sudden vision changes, or confusion.
Your doctor will monitor you closely to decrease the risk of these serious side effects.
To receive this medication, all doctors, pharmacists, and patients must understand, agree to, and carefully follow the requirements of the Lemtrada REMS Program. These requirements apply in the United States. If you live in Canada or any other country, consult your doctor and pharmacist for your country's regulations.
Alemtuzumab is used to treat a certain type of leukemia (B-cell chronic lymphocytic leukemia, also known as B-CLL). This medication works by stopping the growth of cancer cells.
Alemtuzumab is also used to treat a certain type of multiple sclerosis (relapsing multiple sclerosis-MS). It is not a cure for MS but it is thought to help by preventing immune system cells (lymphocytes) from attacking the nerves in your brain and spinal cord. It helps decrease the number of episodes of worsening and may prevent or delay disability.
Read the Medication Guide, Patient Safety Information Card, and, if available, the Patient Information Leaflet provided by your pharmacist before you start using alemtuzumab and each time you receive treatment with this drug. Carry the Patient Safety Information Card with you at all times. If you have any questions, ask your doctor or pharmacist.
This medication is given by slow injection into a vein by a health care professional. The dosage and treatment schedule is based on your medical condition and response to treatment. If you are using this medication to treat B-cell chronic lymphocytic leukemia, your doctor will increase your dose slowly to decrease the risk of side effects.
Before you receive this medication, your doctor will direct you to take other medications (such as acetaminophen, diphenhydramine) to help prevent side effects. Your doctor should also prescribe other medications (such as antibiotics, antiviral medications) to help prevent infection in your body. Use these additional medications exactly as prescribed by your doctor.
See also Warning section.
Fever, chills, dizziness, muscle stiffness, nausea, vomiting, headache, diarrhea, mild rash/itching, tiredness, flushing, or trouble breathing may occur during or after the infusion. These reactions occur more often during the first week of treatment. Tell your doctor or pharmacist right away if any of these effects occur, persist, or worsen. Your doctor may prescribe additional medications to help control these symptoms. Mouth sores, loss of appetite, shaking (tremor), stomach/abdominal pain, constipation, feeling cold, drowsiness, cough, increased sweating, or trouble sleeping may also occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.
People using this medication may have serious side effects. However, your doctor has prescribed this drug because he or she has judged that the benefit to you is greater than the risk of side effects. Careful monitoring by your doctor may decrease your risk.
Tell your doctor right away if you have any serious side effects, including:
This medication may increase your risk of getting a rare but very serious (sometimes fatal) brain infection (progressive multifocal leukoencephalopathy-PML). Get medical help right away if any of these rare but very serious side effects occur: clumsiness, loss of coordination, weakness, sudden change in your thinking (such as confusion, difficulty concentrating), difficulty moving your muscles, problems with speech, seizure, vision changes.
Get medical help right away if you have any very serious side effects, including:
A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including:
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
In the US -
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Before receiving this medication, tell your doctor or pharmacist if you are allergic to it; or if you have ever had a severe reaction to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
Before using this medication, tell your doctor or pharmacist your medical history, especially of:
This drug may make you dizzy or drowsy. Alcohol or marijuana (cannabis) can make you more dizzy or drowsy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).
Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).
Before receiving a blood transfusion, tell your doctor that you are using this medication.
Do not have immunizations/vaccinations without the consent of your doctor, and avoid contact with people who have recently received oral polio vaccine or flu vaccine inhaled through the nose.
Wash your hands well to prevent the spread of infections.
This medication also increases your risk of getting a very serious infection caused by a bacteria called listeria. Avoid or make sure you heat well food that may contain listeria (such as deli meat, unpasteurized milk and cheese products, soft cheeses, undercooked meat/seafood/poultry) during and for a long time after treatment with this medication. Ask your doctor for more details.
To lower your risk of getting cut, bruised, or injured, use caution with sharp objects like razors and nail cutters, and avoid activities such as contact sports.
During pregnancy, this medication should be used only when clearly needed. It may harm an unborn baby. If you become pregnant or think you may be pregnant, tell your doctor right away. Women of child-bearing age should use reliable forms of birth control (such as condoms, birth control pills) during and after treatment with this medication. Talk with your doctor for more details and to discuss the risks and benefits of treatment with this medication.
It is unknown if this drug passes into breast milk. Because of the possible risk to the infant, breast-feeding is not recommended during treatment and for at least 3 to 4 months after treatment with this drug. Consult your doctor before breast-feeding.
Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.
Some products that may interact with this drug include:
If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: trouble breathing, change in the amount of urine.
Laboratory and/or medical tests (such as complete blood count, kidney/liver/thyroid function, blood pressure, skin exams, tuberculosis testing, urine tests) should be performed before treatment and periodically during and after treatment is completed to monitor your progress or check for side effects. Consult your doctor for more details.
For the best possible benefit, it is important to receive each scheduled dose of this medication as directed. If you miss a dose, contact your doctor right away to establish a new dosing schedule.
Not applicable. This medication is given in a hospital or clinic and will not be stored at home.
Your condition can cause complications in a medical emergency. For information about enrolling in MedicAlert, call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).
HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.
Information last revised January 2019.
Copyright(c) 2019 First Databank, Inc.
Selected from NATIONAL DRUG DATA FILE (NDDF) data included with permission and copyrighted by First Databank, Inc., 2019. This copyrighted material has been downloaded from a licensed data provider.
The above information is intended to supplement, not substitute for, the expertise and judgment of your health care professional. You should consult your health care professional before taking any drug, changing your diet, or commencing or discontinuing any course of treatment.