Tecfidera (Dimethyl Fumarate) - Oral

What Is Tecfidera?

Tecfidera (dimethyl fumarate) is an orally administered prescription medicine used to treat several types of relapsing forms of multiple sclerosis (MS), including clinically isolated syndrome (CIS), relapsing-remitting multiple sclerosis (RRMS), and secondary progressive multiple sclerosis (SPMS) in adults.

The goal of treatment with Tecfidera is to decrease the number of relapses or periods with worsening neurologic symptoms. Tecfidera is classified as a nuclear erythroid-related factor 2 (Nrf2) activator. These activators work by decreasing inflammation and preventing nerve damage that may contribute to MS symptoms.

Tecfidera is a prescription product, so you can’t purchase it over-the-counter (OTC). It is also considered a specialty drug, which means you’ll have to get it from a specialty pharmacy.

Tecfidera is an orally administered drug that comes in the form of a delayed-release (DR) capsule. DR capsules are medications that are designed to release the active ingredient(s) later after taking it). Under the name dimethyl fumarate, the drug is also available generically.

What Is Tecfidera Used For?

MS is an autoimmune condition. Autoimmune diseases occur when the body’s immune system, meant to protect you from foreign bodies like viruses and bacteria, attacks your cells instead.

In the case of MS, the cells being attacked are the nerve cells protecting the brain and spinal cord, called myelin. This results in symptoms such as muscle weakness, muscle spasms, pain, and cognitive issues.

Tecfidera is approved by the Food and Drug Administration (FDA) to treat the following types of MS:

• Clinically isolated syndrome (CIS) is the first episode of neurologic symptoms, which is not necessarily a diagnosis of MS but may lead to a diagnosis depending on evaluation and imaging.
• Relapsing-remitting multiple sclerosis (RRMS), the most common form of the disease, includes periods of little to no symptoms as well as periods of symptoms that worsen each time or become stable.
• Secondary progressive multiple sclerosis (SPMS) can follow RRMS for some people. This course is characterized by a steady worsening of neurologic symptoms over time. Some periods of relapse or remittance still may occur occasionally.
  

How to Take Tecfidera

Tecfidera is taken by mouth twice a day. You will start out taking Tecfidera at a lower dose for the first week you’re on it, then the dose will increase to its regular maintenance dosing after a week.

You can take Tecfidera with or without food. However, taking it with food may lower the risk for a certain side effect called flushing, reddening of the face and neck, and a warm or burning sensation. This is a common side effect, especially for people who have just started taking the drug.

It usually improves or goes away after several weeks of taking Tecfidera. Taking a dose of up to 325 milligrams of aspirin 30 minutes before your Tecfidera dose may also help with this side effect, but make sure to discuss this option with your healthcare provider first.

Swallow Tecfidera capsules whole. Do not crush, cut, chew, or open them.

Storage

Store Tecfidera capsules at room temperature (between 59 to 86 degrees F) in the original container, out of reach of children and pets and away from too much light. Avoid storing in an area with a lot of heat and moisture like a bathroom.

If you’re traveling by plane, you’ll want to keep Tecfidera in your carry-on luggage so that you aren’t separated from it in case your checked luggage goes missing. If you’re traveling by car, take care not to leave your medicine in especially hot or cold temperatures for long periods, like overnight in the car.

Off-Label Uses

Tecfidera is approved by the FDA to treat MS, but it may also be used in some cases of plaque psoriasis, an autoimmune disease that causes inflamed, scaly patches on your skin. There is a product called Skilarence that is also dimethyl fumarate, approved in Europe and the United Kingdom to treat plaque psoriasis.

What Are the Side Effects of Tecfidera?

This is not a complete list of side effects, and others may occur. A healthcare provider can advise you on side effects. If you experience other effects, contact your pharmacist or a healthcare provider. You may report side effects to the FDA at fda.gov/medwatch or 1-800-FDA-1088.

Common Side Effects

Some more common side effects that you may experience while taking Tecfidera include the following.

• Flushing, which is reddening of the face and neck and a warm or burning sensation, occurs in up to 40% of people who take Tecfidera. This may be improved by taking Tecfidera with food, or by taking a dose of up to 325 milligrams of aspirin 30 minutes before your Tecfidera dose. Be sure to check with your healthcare provider before starting to take aspirin.
• Abdominal pain
• Diarrhea
• Nausea
• Pruritus (itching)
• Rash
  

Severe Side Effects

Potential side effects of Tecfidera that may be more serious include:

• Anaphylaxis and angioedema, two serious allergic reactions, can potentially occur after your first dose or any time during treatment. Signs and symptoms may include trouble breathing, rash, and swelling of your throat and tongue. Call 911 or go to the emergency room if you experience a serious allergic reaction.
• Progressive multifocal leukoencephalopathy (PML) is a serious brain infection caused by the John Cunningham (JC) virus. The virus typically only causes problems in people who are immunocompromised. Symptoms may develop over days to weeks and include progressive weakness on one side of the body or clumsiness of limbs, vision changes, and changes in thinking or memory. Contact your healthcare provider immediately if you notice any of these. They may tell you to stop taking Tecfidera until they can evaluate your symptoms.
• Herpes zoster and other serious infections have occurred in people taking Tecfidera. They may affect the brain, spinal cord, digestive tract, lungs, skin, eyes, and ears. Be especially vigilant about watching for signs of infections and contacting your healthcare provider if you notice any.
• Lymphopenia may occur when taking Tecfidera, which is a decrease in your lymphocyte count. Lymphocytes are one type of white blood cell that helps you fight off infections. Your healthcare provider should run a certain lab test called a complete blood count (CBC) before you start taking Tecfidera to get a baseline number for your lymphocyte count. Then it should be repeated six months after starting the medicine and every six to 12 months after that.
• Hepatotoxicity is the inflammation of the liver. This side effect may be more common in older adults who experience existing liver issues before starting Tecfidera.

Call your healthcare provider right away if you feel like you are experiencing serious side effects. Call 911 if your symptoms feel life-threatening or if you think you’re having a medical emergency.

Dosage: How Much Tecfidera Should I Take?

Modifications

Users should be aware of the following before beginning Tecfidera:

In pregnancy: There is not enough conclusive data regarding the use of Tecfidera in pregnant humans to make a solid recommendation on the risk of birth defects, miscarriage, or adverse outcomes.

A Tecfidera pregnancy registry monitors outcomes in people who took Tecfidera while pregnant. Another registry called MotherToBaby is focused on establishing more actionable data surrounding drugs being used during pregnancy.

Speak with your healthcare provider about the benefits of Tecfidera and any risk it may pose to your pregnancy.

In breastfeeding: It is not known whether Tecfidera is present in human milk. As in pregnancy, the clinical benefit of Tecfidera for breastfeeding people should be weighed against any risk the drug and the person's MS may pose to a newborn.

In pediatrics: Safety and effectiveness of Tecfidera in children have not been established.

In older adults: Clinical studies of Tecfidera did not include a sufficient number of people 65 and over to determine whether they responded any differently versus Tecfidera efficacy/safety in younger people. Be sure to discuss with your healthcare provider how your age or physical fitness may impact your ability to tolerate Tecfidera.

Missed Dose

If you forget to take a dose of Tecfidera, you can take it as soon as you remember. However, if you are closer to your next dose than the dose you missed, go ahead and skip the missed dose and wait for your next scheduled one.

For example, if you usually take it at 8 am and 8 pm, and you remember at 5 pm that you forgot your morning dose, wait and take your next dose that night at 8 pm. Do not double up doses to make up for missed ones.

Overdose: What Happens If I Take Too Much Tecfidera?

Cases of overdose have been reported with Tecfidera, and symptoms were mostly consistent with the known side effects of the drug. There aren’t any known interventions to remove Tecfidera from your body quickly, and there is no antidote. Therefore, any treatment for overdosage would most likely be in response to symptoms you are experiencing and keeping you generally well.

In the event of taking too much Tecfidera and experiencing side effects, contact your healthcare provider as soon as possible or go to the nearest emergency department.

Precautions

What Are Reasons I Shouldn't Take Tecfidera?

Tecfidera is not or may not be the best choice for you if you:

• Have a known hypersensitivity or allergy to Tecfidera.
• Have an active infection. If you have an active, chronic, or recurrent infection of any organ or if you have sepsis, you should wait until the infection has cleared to start taking Abrilada. Make sure to let your healthcare provider know if you’re experiencing symptoms of infection such as chills, fever, sweats, muscle aches, or cough.
  

What Other Medications May Interact With Tecfidera?

There are some drugs that can interact with Tecfidera and should be monitored by your healthcare provider.

Examples include:

• Live vaccines. Live vaccines include chickenpox (varicella), FluMist (flu vaccine nasal spray), measles-mumps-rubella (MMR), Yellow fever vaccine, and others. Let anyone who may be giving you a vaccine know that you take Tecfidera. However, know that non-live or inactivated vaccinations are fine.
• Biologic or biosimilar drugs that suppress your immune system may increase your risk for serious infections more than taking Tecfidera alone. Examples include Ocrevus (ocrelizumab), Kesimpta (ofatumumab), and Rituxan (rituximab).
  

What Medications Are Similar to Tecfidera?

Other medications used to treat MS, similarly to Tecfidera, are called disease-modifying therapies, or DMTs. Some work similarly to Tecfidera; others have different mechanisms.

Examples include:

• Gilenya (fingolimod), Mayzent (siponimod), Zeposia (ozanimod), and Ponvory (ponesimod) are oral medications like Tecfidera. They are called sphingosine 1-phosphate receptor (S1PR) modulators and work by preventing your immune cells from attacking the nerves in your brain and spinal cord.
• Lemtrada (alemtuzumab) is an intravenous (IV) drug that reduces the number of MS relapses. Infusions are received one year apart.
• Ocrevus (ocrelizumab), Kesimpta (ofatumumab), and Rituxan (rituximab) are monoclonal antibodies, or biologic drugs, that target CD20 cells which can damage your brain and spinal cord and lead to MS symptoms.

This is a list of drugs also prescribed to treat MS. It is not a list of drugs recommended to take with Tecfidera; however, sometimes treatments may overlap or be combined when treatment with one is insufficient to relieve symptoms.

Ask your pharmacist or a healthcare provider if you have questions.

How Can I Stay Healthy While Taking Tecfidera?

No one can deny that living with MS comes with plenty of challenges. It can be very hard to accept that your body is damaging its cells in a way that leads to such difficult symptoms.

Apart from the obvious physical difficulties like pain and poor muscle control, emotional and mental struggles like accepting the diagnosis and adjusting your work and social life can be just as challenging.

One bright spot is that a variety of disease-modifying therapies are available, such as Tecfidera and many other oral and injectable MS medications. These can lower the number of relapses you experience each year by anywhere from 30% to about 70%.

Working with your healthcare provider to come up with a treatment plan and sticking to it while prioritizing your mental, emotional and physical self-care can help you live as normal a life as possible.