Dimethyl Fumarate

Dimethyl Fumarate is a prescription medication used to treat relapsing Multiple Sclerosis.

• Dimethyl Fumarate is available under the following different brand names: Tecfidera, BG-12

Adult dosage

Capsule, delayed-release

• 120 mg
• 240 mg

Multiple Sclerosis

Adult dosage

120 mg orally twice a day initially; after 7 days, increase to a maintenance dose of 240 mg twice a day

Consider temporary dose reductions to 120 mg twice a day for individuals who do not tolerate the maintenance dose

Within 4 weeks, resume the recommended dose of 240 mg twice a day

Consider discontinuation in patients who are unable to tolerate the recommended maintenance dose

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

Common side effects of Dimethyl Fumarate include:

• flushing,
• abdominal pain,
• diarrhea,
• nausea,
• vomiting,
• rash,
• itching,
• redness, and
• indigestion.

Serious side effects of Dimethyl Fumarate include:

• hives,
• difficulty breathing,
• swelling of the face, lips, tongue, or throat,
• chills,
• cough,
• the feeling of warmth,
• fever,
• hoarseness,
• lower back or side pain,
• painful or difficult urination,
• redness of the face, neck, arms, and upper chest,
• black or tarry stools,
• chest pain,
• difficulty with swallowing,
• dizziness,
• fast heartbeat,
• itching,
• skin rash,
• blisters on the trunk of the body,
• swelling of the eyelids or around the eyes, face, lips, or tongue,
• sore throat,
• white spots on the lips or in the mouth,
• sore throat,
• swollen glands,
• tightness in the chest,
• unusual bleeding or bruising,
• weakness, and
• unusual tiredness

Rare side effects of Dimethyl Fumarate include:

• none 

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors;
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
• Serious heart symptoms such as fast, irregular, or pounding heartbeats; fluttering in your chest; shortness of breath; and sudden dizziness, lightheartedness, or passing out.

This is not a complete list of side effects and other serious side effects or health problems that may occur as a result of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Dimethyl Fumarate has no noted severe interactions with any other drugs
• Dimethyl Fumarate has no noted serious interactions with any other drugs
• Dimethyl Fumarate has no noted moderate interactions with any other drugs
• Dimethyl Fumarate has no noted minor interactions with any other drugs

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all your products. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your health care professional or doctor for additional medical advice, or if you have health questions or concerns.

Contraindications

• Hypersensitivity to drugs or components

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Dimethyl Fumarate?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Dimethyl Fumarate?”

Cautions

• May cause lymphopenia; obtain a CBC including lymphocyte count before initiating therapy, after 6 months, and an every6-12 month thereafter, and as clinically indicated; consider treatment interruption with lymphocyte counts below 0.5 x 10^9/L persisting for above 6 months; continue to obtain lymphocyte counts until their recovery if the drug is discontinued or interrupted due to lymphopenia; consider withholding treatment from patients with serious infections until resolution; decisions about whether or not to restart dimethyl Fumarate should be individualized based on clinical circumstances
• Flushing (.g, warmth, redness, itching, and/or burning sensation) may occur; flushing symptoms generally may happen soon after initiating treatment and improve or resolve over time; in the majority of patients experiencing flushing, it is mild or moderate in severity
• Progressive multifocal leukoencephalopathy (PML) resulting in death, in the post-marketing setting, has occurred; withhold therapy at the first sign or symptom suggestive of PML; perform appropriate diagnostic evaluation; cases have occurred predominantly in patients with lymphocyte counts below 0.8x10^9/L persisting for more than 6 months; the role of lymphopenia in PML cases uncertain
• Do not restart therapy if anaphylaxis or angioedema occur
• Clinically significant cases of liver injury were reported; onset ranged from a few days to several months after treatment initiation; elevated hepatic transaminases (most not above 3 into ULN) were observed during controlled trials and resolved upon treatment discontinuation; discontinue drug if clinically significant signs and symptoms of liver injury occur; obtain serum aminotransferase, alkaline phosphatase (ALP), and total bilirubin levels before treatment and during treatment, as clinically indicated; discontinue treatment if clinically significant liver injury induced by drug suspected
• Opportunistic infections
  • Serious cases of herpes zoster have occurred, including disseminated herpes zoster, herpes zoster ophthalmicus, herpes zoster meningoencephalitis, and herpes zoster meningomyelitis
  • Monitor patients for signs and symptoms of herpes zoster; if herpes zoster occurs, appropriate treatment should be administered; consider withholding treatment in patients with herpes zoster or other serious infections until the infection has resolved
  • Other serious opportunistic infections have occurred, including cases of serious viral (herpes simplex virus, West Nile virus, cytomegalovirus), fungal (Candida and Aspergillus), and bacterial (Nocardia, Listeria monocytogenes, Mycobacterium tuberculosis) infections; these infections have been reported in patients with reduced absolute lymphocyte counts (ALC) as well as in patients with normal ALC; these infections have affected the brain, meninges, spinal cord, gastrointestinal tract, lungs, skin, eye, and ear
  • Patients with symptoms and signs consistent with any of these infections should undergo prompt diagnostic evaluation and receive appropriate treatment
• Lymphopenia
  • Drug may decrease lymphocyte counts; the drug has not been studied in patients with pre-existing low lymphocyte counts
  • Obtain a CBC, including lymphocyte count, before initiating treatment with the drug, 6 months after starting treatment, and then every 6 to 12 months thereafter, and as clinically indicated
  • Consider interruption of the drug in patients with lymphocyte counts less than 0.5 x 109/L persisting for more than six months; given the potential for delayed recovery of lymphocyte counts, continue to obtain lymphocyte counts until their recovery if the drug is discontinued or interrupted due to lymphopenia
  • Consider withholding treatment from patients with serious infections until resolution; decisions about whether or not to restart therapy should be individualized based on clinical circumstances

Pregnancy & Lactation

• There are no adequate data on the developmental risk associated with use in pregnant women; in animals, adverse effects on offspring survival, growth, sexual maturation, and neurobehavioral function were observed when dimethyl Fumarate (DMF) was administered during pregnancy and lactation at clinically relevant doses
• Pregnancy registry
  • Monitors pregnancy outcomes in women exposed to dimethyl Fumarate during pregnancy; encourage patients to enroll by calling 1-866-810-1462 or visiting www.tecfiderapregnancyregistry.com
• Lactation
  • There are no data on the presence of DMF or MMF in human milk; effects on the breastfed infant and milk production are unknown
  • The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for drugs and any potential adverse effects on the breastfed infant from drugs or an underlying maternal condition.