What is Lemtrada and how does it work?
Lemtrada is a prescription medicine used to treat relapsing forms of multiple sclerosis (MS), including relapsing-remitting disease and active secondary progressive disease, in adults.
Since treatment with Lemtrada can increase your risk of getting certain conditions and diseases, Lemtrada is generally prescribed for people who have tried 2 or more MS medicines that have not worked well enough. Lemtrada is not recommended for use in patients with the clinically isolated syndrome (CIS).
It is not known if Lemtrada is safe and effective for use in children under 17 years of age.
What are the side effects of Lemtrada?
Lemtrada may cause serious side effects including:
- thyroid problems. Some people who receive Lemtrada may get thyroid problems including overactive thyroid (hyperthyroidism) or an underactive thyroid (hypothyroidism). Your healthcare provider will do blood tests to check how your thyroid is working. Call your healthcare provider if you have any of the symptoms of thyroid problems.
- Symptoms of hyperthyroidism may include:
- excessive sweating
- eye swelling
- unexplained weight loss
- nervousness
- fast heartbeat
- Symptoms of hypothyroidism may include:
- unexplained weight gain
- worsening tiredness
- feeling cold
- constipation
- low blood counts (cytopenias). Lemtrada may cause a decrease in some types of blood cells. Some people with these low blood counts have increased infections. Symptoms of cytopenias may include:
- weakness
- dark urine
- chest pain
- fast heartbeat
- yellowing of the skin or whites of eyes (jaundice)
Your healthcare provider will do blood tests to check for cytopenias. Call your healthcare provider right away if you have the symptoms listed above.
- inflammation of the liver. Call your healthcare provider right away if you have symptoms such as unexplained nausea, stomach pain, tiredness, loss of appetite, yellowing of skin or whites of eyes, or bleeding or bruising more easily than normal.
- hemophagocytic lymphohistiocytosis (HLH). Lemtrada may increase the risk of a type of overactivity of the immune system (hemophagocytic lymphohistiocytosis) that can be fatal, especially if not diagnosed and treated early. Call your healthcare provider right away if you have symptoms such as fever, swollen glands, skin rash, or new nervous system problems, such as seizures, changes in your thinking or level of alertness, or new or worsening unsteadiness or trouble walking. These symptoms have happened in people taking Lemtrada about 13 months to 33 months after they started taking Lemtrada.
- serious infections. Lemtrada may cause you to have serious infections while you receive and after receiving a treatment course. Serious infections may include:
- Listeria. People who receive Lemtrada have an increased chance of getting an infection caused by the bacteria, Listeria, which can lead to significant complications or death. Avoid foods that may be a source of Listeria (for example, deli meat, unpasteurized milk and cheese products, soft cheeses, or undercooked meat, seafood, or poultry), or make sure that the food you eat which may contain Listeria is heated well if you receive treatment with Lemtrada.
- herpes viral infections. Some people taking Lemtrada have an increased chance of getting herpes viral infections. Your healthcare provider will prescribe medicines to reduce your chances of getting these infections. Take these medicines exactly as your healthcare provider tells you to.
- human papilloma virus (HPV). Females have an increased chance of getting a cervical HPV infection. If you are a female, you should have an HPV screening each year.
- tuberculosis. Your healthcare provider should check you for tuberculosis before you receive Lemtrada.
- fungal infections.
Call your healthcare provider right away if you have symptoms of a serious infection, such as fever or swollen glands. You may need to go to the hospital for treatment if you get a serious infection. It is important to tell the healthcare providers that you have received Lemtrada.
Talk to your healthcare provider before you get vaccinations after receiving Lemtrada. Certain vaccinations may increase your chances of getting infections.
- Progressive multifocal leukoencephalopathy (PML). A rare brain infection that usually leads to death or severe disability has been reported with Lemtrada. Symptoms of PML get worse over days to weeks. You must call your doctor right away if you have any new or worsening medical problems that have lasted several days, including problems with:
- thinking
- eyesight
- strength
- balance
- weakness on 1 side of your body
- using your arms or legs
- Inflammation of the gallbladder without gallstones (acalculous cholecystitis). Lemtrada may increase your chance of getting inflammation of the gallbladder without gallstones, a serious medical condition that can be life-threatening. Call your healthcare provider right away if you have any of the following symptoms of acalculous cholecystitis, which may include:
- swelling of lung tissue (pneumonitis). Some people have had swelling of the lung tissue while receiving Lemtrada. Call your healthcare provider right away if you have the following symptoms:
- shortness of breath
- chest pain or tightness
- cough
- coughing up blood
- wheezing
The most common side effects of Lemtrada include:
- rash
- fungal infection
- headache
- joint pain
- thyroid problems
- pain in your arms or legs
- fever
- back pain
- swelling of your nose and throat (nasopharyngitis)
- diarrhea
- nausea
- sinus infection
- urinary tract infection
- mouth pain or sore throat
- feeling tired
- tingling sensation
- trouble sleeping
- dizziness
- upper respiratory tract infection
- stomach pain
- herpes viral infection
- sudden redness in the face, neck, or chest
- hives
- vomiting
- itching
Tell your healthcare provider if you have any side effect that bothers you or that does not go away.
These are not all the possible side effects of Lemtrada. For more information, ask your healthcare provider or pharmacist.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
Lemtrada (alemtuzumab) is a recombinant humanized IgG1 kappa monoclonal antibody used to treat patients with relapsing forms of multiple sclerosis (MS). Because of its safety profile, the use of Lemtrada should generally be reserved for patients who have had an inadequate response to two or more drugs indicated for the treatment of MS. Common side effects of Lemtrada include:
- rash,
- headache,
- fever,
- runny nose,
- sore throat,
- nasal congestion,
- nausea,
- urinary tract infection,
- fatigue,
- insomnia,
- upper respiratory tract infection,
- herpes viral infection,
- hives,
- itching,
- thyroid gland disorders,
- fungal infection,
- joint pain,
- pain in extremity,
- back pain,
- diarrhea,
- sinus infection,
- mouth and throat pain,
- numbness or tingling, dizziness,
- abdominal pain,
- flushing of the face/neck/chest,
- vomiting,
- cough,
- chills,
- changes in sense of taste,
- flu symptoms,
- skin swelling,
- indigestion,
- blood in the urine,
- shortness of breath,
- fast heartbeat,
- anxiety,
- weakness, or
- muscle pain
The recommended dosage of Lemtrada is 12 mg/day administered by intravenous infusion for 2 treatment courses:
- First Treatment Course: 12 mg/day on 5 consecutive days (60 mg total dose;
- Second Treatment Course: 12 mg/day on 3 consecutive days (36 mg total dose) administered 12 months after the first treatment course.
Lemtrada may interact with other drugs. Tell your doctor about all medications and supplements you use. During pregnancy, Lemtrada should be used only if prescribed. It is unknown if this drug passes into breast milk. Consult your doctor before breastfeeding.
WARNING
AUTOIMMUNITY, INFUSION REACTIONS, STROKE, AND MALIGNANCIES
- Lemtrada causes serious, sometimes fatal, autoimmune conditions such as immune thrombocytopenia and anti-glomerular basement membrane disease. Monitor complete blood counts with differential, serum creatinine levels, and urinalysis with urine cell counts at periodic intervals for 48 months after the last dose of Lemtrada.
- Lemtrada causes serious and life-threatening infusion reactions. Lemtrada must be administered in a setting with appropriate equipment and personnel to manage anaphylaxis or serious infusion reactions. Monitor patients for two hours after each infusion. Make patients aware that serious infusion reactions can also occur after the 2-hour monitoring period.
- Serious and life-threatening stroke (including ischemic and hemorrhagic stroke) has been reported within 3 days of Lemtrada administration. Instruct patients to seek immediate medical attention if symptoms of stroke occur.
- Lemtrada may cause an increased risk of malignancies, including thyroid cancer, melanoma, and lymphoproliferative disorders. Perform baseline and yearly skin exams.
- Because of the risk of autoimmunity, infusion reactions, and malignancies, Lemtrada is available only through restricted distribution under a Risk Evaluation Mitigation Strategy (REMS) Program. Call 1-855-676-6326 to enroll in the Lemtrada REMS program.
What is the dosage for Lemtrada?
- The recommended dosage of Lemtrada is 12 mg/day administered by intravenous infusion for 2 treatment courses: First Treatment Course: 12 mg/day on 5 consecutive days (60 mg total dose).
- Second Treatment Course: 12 mg/day on 3 consecutive days (36 mg total dose) administered 12 months after the first treatment course.
Following the second treatment course, subsequent treatment courses of 12 mg per day on 3 consecutive days (36 mg total dose) may be administered, as needed, at least 12 months after the last dose of any prior treatment courses.
Is Lemtrada safe to take when pregnant or breastfeeding?
- There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to Lemtrada during pregnancy. Physicians are encouraged to register patients by calling 1-866758-2990.
- There are no adequate data on the developmental risk associated with the use of Lemtrada in pregnant women.
- There are no data on the presence of alemtuzumab in human milk, the effects on the breastfed infant, or the effects of the drug on milk production.
- The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for Lemtrada and any potential adverse effects on the breastfed child from Lemtrada or the underlying maternal conditions.
SLIDESHOW
What Is Multiple Sclerosis? MS Symptoms, Causes, Diagnosis See SlideshowSummary
Lemtrada is used to treat relapsing forms of multiple sclerosis (MS). It is generally prescribed for people who have tried 2 or more MS medicines to no success. Check out the center below for more medical references on multiple sclerosis, including multimedia (slideshows, images, and quizzes), related disease conditions, treatment and diagnosis, medications, and prevention or wellness.
Multimedia: Slideshows, Images & Quizzes
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What Is Multiple Sclerosis? MS Symptoms, Causes, Diagnosis
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Multiple Sclerosis (MS) Quiz: Test Your Medical IQ
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Celebrities With Multiple Sclerosis (MS)
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Picture of Multiple Sclerosis Symptoms
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Multiple Sclerosis: Making an MS Friendly Home
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Related Disease Conditions
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Multiple Sclerosis (MS)
Multiple sclerosis or MS is an autoimmune disorder in which brain and spinal cord nerve cells become demyelinated. This damage results in symptoms that may include numbness, weakness, vertigo, paralysis, and involuntary muscle contractions. Different forms of MS can follow variable courses from relatively benign to life-threatening. MS is treated with disease-modifying therapies. Some MS symptoms can be treated with medications.
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MS (Multiple Sclerosis) vs. ALS (Amyotrophic Lateral Sclerosis)
ALS (amyotrophic lateral sclerosis, Lou Gehrig's disease) and MS (multiple sclerosis) are both diseases of the nervous system (neurodegenerative). ALS is a disease in which the nerve cells in the body are attacked by the immune system, although it's not considered an autoimmune disease by some scientists. MS is an autoimmune disease in which the insulated covering of the nerves (myelin sheath) in the CNS (central nervous system) degenerate, or deteriorate. Scientists don't know the exact cause of either problem. However, they have discovered that mutations in the gene that produces the SOD1 enzyme were associated with some cases of familial ALS. Scientists also theorize that multiple sclerosis may be caused by infection or vitamin D deficiency. ALS occurs between 50-70 years of age (the average age of occurrence ALS is 55), and mostly affects men. While MS occurs between 20-60 years of age, and mostly affects women. About 30,000 people in the US have ALS, and an average of 5,000 new diagnoses per year (that's about 15 new cases per week). Worldwide, MS affects more than 2.3 million people, with about 10,000 new cases diagnosed each year (that's about 200 new diagnoses per week).Some of the signs and symptoms of both diseases include muscle weakness, muscle spasms, problems walking, fatigue, slurred speech, and problems swallowing. ALS signs and symptoms that are different from MS include problems holding the head upright, clumsiness, muscle cramps and twitches, problems holding objects, and uncontrollable periods of laughing or crying. MS signs and symptoms that are different from ALS include vision problems, vertigo and balance problems, sexual problems, memory problems, depression, mood swings, and digestive problems. There is no cure for either disease, however the prognosis and life expectancy are different. Multiple sclerosis is not a fatal condition, while ALS progresses rapidly and leads to death.
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Multiple Sclerosis (MS) Symptoms and Treatments
Multiple sclerosis (MS) symptoms vary from person to person and can last for days to months without periods of remission. Symptoms of MS include sexual problems and problems with the bowel, bladder, eyes, muscles, speech, swallowing, brain, and nervous system. The early symptoms and signs of multiple sclerosis usually start between ages 20-40. MS in children, teens, and those over age 40 is rare. Treatment options for multiple sclerosis vary depending on the type and severity of symptoms. Medications may be prescribed to manage MS symptoms.
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Is Multiple Sclerosis (MS) Contagious?
Multiple sclerosis, or MS, is a degenerative disease of the covering around the nerves in the central nervous system (CNS). Researchers and doctors don't know the exact cause, but many theorize that it may be due to environmental triggers, an autoimmune disease, and viruses (infections). Symptoms and signs of MS include vision changes, paralysis, vertigo, heat intolerance, slurred speech, sexual dysfunction, and urinary incontinence (the inability to urinate). There's no vaccine or cure for MS, but the progression and symptoms of the disease can be treated.
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Multiple Sclerosis (MS) and Pregnancy
Multiple sclerosis or MS is a central nervous system disease in which the immune system attacks the myelin sheath (the protective coating around nerves). Symptoms of MS include pain, sexual problems, fatigue, numbness and tingling, emotional changes, and depression.Women who are pregnant and have multiple sclerosis may have more difficulty carrying a pregnancy. Multiple sclerosis does not affect ability to conceive, and does not seem to affect fertility. MS symptoms during pregnancy may stay the same or get better; however, they may worsen after giving birth. Pregnancy decreases the number of relapses, but flares increase in the first 3-6 months after delivery. Pregnant women with MS may carrying a pregnancy more difficult to tell when labor starts, and there is an increased need to use forceps or vacuum to assist with delivery or b7 C-section (Cesarean birth) increases. Some treatment MS drugs may be safe to use during pregnancy; however, some drugs should not be taken, for example, baclofen (Gablofen, Lioresal), fluoxetine (Prozac, Sarafem), or solifenacin succinate (VESIcare), and most disease-modifying therapies (DMTs). Talk with your healthcare team about vitamins, supplements, and medications that you are taking if you are pregnant and have MS.
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Multiple Sclerosis (MS) Early Warning Signs and Types
Multiple sclerosis (MS) can be thought of as an immune-mediated inflammatory process involving different areas of the central nervous system (CNS) at various points in time. Early warning signs and symptoms of MS in children, teens, and adults are similar; however, children and teens with pediatric also may have seizures and a complete lack of energy. Adults with MS do not have these signs and symptoms. Other signs and symptoms of MS include inflammation of the optic nerve (optic neuritis), changes in vision, Wiping or having tissues around the eye and moving the eye may be painful, and double vision. There are four types of MS, relapsing-remitting MS (RRMS), secondary progressive MS (SPMS), primary progressive MS (PPMS), and progressive relapsing MD (PRMS).
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Alternative Treatment (CAM) for MS
The term alternative therapy, in general, is used to describe any medical treatment or intervention that has not been scientifically documented or identified as safe or effective for a specific condition. Alternative therapy encompasses a variety of disciplines that range from diet and exercise to mental conditioning to lifestyle changes.
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Can Stress Cause Multiple Sclerosis (MS)?
Multiple sclerosis (MS) results when your immune system attacks the cells of the brain and spinal cord. It is an autoimmune disease, a condition in which the body's immune system is misdirected and attacks its own cells. Stress can make it difficult for a person to manage MS symptoms. Regular exercise and mindful eating have been found to control the stress levels and overall health of people with MS.
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What Are the Early Signs of Multiple Sclerosis?
Multiple sclerosis is an autoimmune disease in which the immune system attacks the central nervous system (spinal cord and brain) by damaging and destroying the protective myelin sheath around the nerve fibers. Someone with multiple sclerosis might develop problems with muscle control, vision, bladder control and other body functions.
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What Are the Very First Signs of Multiple Sclerosis?
Multiple sclerosis (MS) is an inflammatory, neurodegenerative autoimmune disease that affects the brain and spinal cord of the central nervous system (CNS). MS is one of the most common causes of non-injurious disability in young and middle-aged adults.
Treatment & Diagnosis
Medications & Supplements
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.