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 immediately 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.
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.Who should not take alemtuzumab intravenous?
Alemtuzumab is also used to treat a certain type of multiple sclerosis (relapsing-remitting 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 immediately 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, drowsiness, cough, increased sweating, or trouble sleeping may also occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.
Many people using this medication 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: shortness of breath, mental/mood changes (such as depression, anxiety), bone/joint/back pain, muscle pain/spasm, unusual weakness, swelling ankles/feet, yellowing skin/eyes, change in the amount of urine, painful urination, pink/bloody urine, numbness/tingling of arms/legs, pain/redness/swelling of arms/legs/injection site.
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.
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: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
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.
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: recent/current infections (such as tuberculosis), bleeding/blood problems, cancer, kidney problems, heart problems, immune system problems (e.g., HIV), thyroid problems.
This drug may make you dizzy or drowsy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.
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.
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 immediately. 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: other drugs that weaken the immune system/increase the risk of infection (such as natalizumab, rituximab).
If overdose is suspected, contact a poison control center or emergency room immediately. 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 function, thyroid function, blood pressure, skin exams) should be performed 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 immediately to establish a new dosing schedule.
Not applicable. This medication is given in a hospital or clinic and will not be stored at home.
MEDICAL ALERT: 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).
Information last revised March 2014. Copyright(c) 2014 First Databank, Inc.
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