[Posted 11/25/2014] ISSUE: FDA is warning that a patient with multiple sclerosis (MS) who was being treated with dimethyl fumarate (Tecfidera) developed a rare and serious brain infection called progressive multifocal leukoencephalopathy (PML), and later died. The patient who died was not taking any other drugs that affect the immune system or drugs that are thought to be associated with PML. As a result, information describing this case of PML is being added to the dimethyl fumarate drug label.
PML is a rare and serious brain infection caused by the John Cunningham (JC) virus. The JC virus is a common virus that is harmless in most people but can cause PML in some patients who have weakened immune systems.
See the FDA Drug Safety Communication at http://www.fda.gov/Drugs/DrugSafety/ucm424625.htm for additional clinical information about this case.
BACKGROUND: Dimethyl fumarate is a drug used to treat relapsing forms of multiple sclerosis (MS), a brain and spinal cord disease in which patients experience multiple episodes of weakness, numbness, and other nervous system signs and symptoms that partially or completely resolve overs weeks or months. Patients may develop persistent symptoms and disability over time.
RECOMMENDATION: Healthcare professionals should:
Tell patients taking dimethyl fumarate to contact you if they develop any symptoms that may be suggestive of progressive multifocal leukoencephalopathy (PML). Symptoms of PML are diverse, progress over days to weeks, and include the following: progressive weakness on one side of the body or clumsiness of limbs; disturbance of vision; and changes in thinking, memory and orientation, leading to confusion and personality changes. The progression of deficits can lead to severe disability or death.
Stop dimethyl fumarate immediately at the first sign or symptom suggestive of PML and perform an appropriate diagnostic evaluation.
Monitor lymphocyte counts in dimethyl fumarate-treated patients according to approved labeling.
For more information visit the FDA website at: http://www.fda.gov/Safety/MedWatch/SafetyInformation and http://www.fda.gov/Drugs/DrugSafety.
Dimethyl fumarate is used to treat relapsing forms (course of disease where symptoms flare up from time to time) of multiple sclerosis (MS; a condition in which the nerves do not function properly and people may experience weakness, numbness, loss of muscle coordination, and problems with vision, speech, and bladder control). Dimethyl fumarate is in a class of medications called Nrf2 activators. It may work by decreasing inflammation and preventing nerve damage that may cause symptoms of multiple sclerosis.
Dimethyl fumarate comes as a capsule to take by mouth. It is usually taken twice a day. Take dimethyl fumarate at around the same times every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take dimethyl fumarate exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.
Dimethyl fumarate may be taken with or without food. However, if you take dimethyl fumarate with food there is less chance that you will experience flushing during your treatment.
Swallow the capsules whole; do not chew, or crush them. Do not open the capsules or sprinkle the contents on food.
Your doctor will probably start you on a low dose of dimethyl fumarate and increase your dose after 7 days.
Dimethyl fumarate may help control your symptoms but will not cure your condition. Continue to take dimethyl fumarate even if you feel well. Do not stop taking dimethyl fumarate without talking to your doctor.
Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient.
Dimethyl fumarate is also sometimes used to treat psoriasis (a skin disease in which red, scaly patches form on some areas of the body). Talk to your doctor about the risks of using this medication for your condition.
This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.
tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking dimethyl fumarate, call your doctor.
Unless your doctor tells you otherwise, continue your normal diet.
Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.
warmth, redness, itching or burning of the skin
sore throat, fever, chills, and other signs of infection
Dimethyl fumarate may cause other side effects. Call your doctor if you have any unusual problems while you are taking this medication.
If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online [at http://www.fda.gov/Safety/MedWatch] or by phone [1-800-332-1088].
Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from light, excess heat and moisture (not in the bathroom). Throw away any medication that is outdated or no longer needed, and any medication that is left in the container 90 days after you open it. Talk to your pharmacist about the proper disposal of your medication.
In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.
Keep all appointments with your doctor and the laboratory. Your doctor may order a blood test before you begin your treatment and may order certain lab tests during your treatment to check your body's response to dimethyl fumarate.
Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.
It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.
Last Revised - 11/25/2014
AHFS® Consumer Medication Information. © Copyright, 2015. The American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland. All Rights Reserved. Duplication for commercial use must be authorized by ASHP.