Tecfidera

Multiple Sclerosis Treatment

Tecfidera is used to manage relapsing forms of multiple sclerosis (MS) in adults. MS is a chronic condition where the immune system attacks the protective covering of nerves, leading to communication problems between the brain and the rest of the body.

Approved Indications

This medication is specifically indicated for several types of relapsing MS, including:

• Clinically isolated syndrome (CIS): This refers to a single, first episode of neurologic symptoms that lasts at least 24 hours.
• Relapsing-remitting MS (RRMS): This is the most common form of MS, characterized by clearly defined attacks of new or increasing neurologic symptoms followed by periods of partial or complete recovery.
• Active secondary progressive MS (SPMS): This occurs when the disease begins to progress more steadily, but the patient still experiences occasional relapses or new activity on imaging tests.

Goals of Therapy

The primary purpose of Tecfidera is to decrease the number of relapses (flare-ups) a person experiences. By reducing these episodes, the medication also aims to slow down the accumulation of physical disability over time. It is important to note that while Tecfidera helps manage the disease, it is not a cure for multiple sclerosis.

Mechanism of Action

The exact way Tecfidera (dimethyl fumarate) works to treat multiple sclerosis (MS) is not fully understood. However, researchers believe it helps manage the condition through two primary methods:

• Reducing Inflammation: It is thought to change how the immune system responds, leading to a decrease in the inflammation that attacks the protective covering of nerves.
• Protecting Cells: The medication may activate a specific pathway in the body called the Nrf2 pathway. This pathway helps cells defend themselves against oxidative stress, which can cause damage to the brain and spinal cord.

By lowering inflammation and protecting nerve cells, the drug helps reduce the frequency of MS relapses and may slow the progression of physical disability associated with the disease.

Common Side Effects

Many people experience mild to moderate side effects when starting Tecfidera. These symptoms often occur early in treatment and may improve over time. Common side effects include:

• Flushing: This may include redness, itching, or a warm sensation on the skin.
• Digestive issues: Stomach pain, diarrhea, nausea, vomiting, and indigestion.

Taking Tecfidera with food may help reduce the severity of flushing and stomach-related side effects.

Serious Side Effects

While less common, some side effects require immediate medical attention. Contact a healthcare provider right away if you experience any of the following:

• Liver problems: Signs include yellowing of the skin or eyes (jaundice), dark urine, and pain on the upper right side of the stomach.
• Low white blood cell counts: This medication can decrease the number of lymphocytes in your blood, which may increase the risk of infections.
• Progressive Multifocal Leukoencephalopathy (PML): This is a rare but serious brain infection. Symptoms include new or worsening weakness on one side of the body, vision changes, confusion, or loss of coordination.
• Severe allergic reactions: Symptoms include hives, swelling of the face or throat, and difficulty breathing.
• Herpes zoster (shingles): Serious opportunistic infections, including shingles and other viral or fungal infections, have been reported.

Progressive Multifocal Leukoencephalopathy (PML)

PML is a rare and serious opportunistic viral infection of the brain that can lead to death or severe disability. Cases of PML have been reported in patients taking Tecfidera, typically in those who have experienced prolonged low white blood cell counts (lymphopenia). Healthcare providers monitor for new or worsening neurological signs or symptoms that may indicate this infection.

Low White Blood Cell Counts (Lymphopenia)

Tecfidera may cause a decrease in lymphocyte counts. A complete blood count (CBC) is typically performed before starting treatment and every 6 to 12 months during therapy. If white blood cell counts become severely low, treatment may be interrupted to reduce the risk of infection.

Liver Injury

Clinically significant liver injury has been reported in patients using this medication. Signs of liver problems may include yellowing of the skin or eyes (jaundice), dark urine, or pain on the right side of the stomach area. Liver function tests are usually conducted before starting the drug and as needed during treatment.

Serious Allergic Reactions

Anaphylaxis and angioedema have been reported with Tecfidera use. These reactions can occur after the first dose or at any time during treatment. Symptoms may include difficulty breathing, hives, or swelling of the face, lips, or tongue.

Flushing and Gastrointestinal Effects

Flushing (warmth, redness, itching, or burning sensation) and gastrointestinal issues such as nausea, vomiting, and diarrhea are common, especially when starting the medication. These effects may be reduced by taking the medication with food.

Contraindications

Tecfidera is contraindicated in patients with a known hypersensitivity to dimethyl fumarate or any of the inactive ingredients in the formulation.

Pregnancy

There are no adequate and well-controlled studies of Tecfidera in pregnant women. Research in animals has shown that the medication may cause adverse effects on fetal development when administered at doses that also cause toxicity in the mother. Because human data is limited, this medication is generally used during pregnancy only if the potential benefit to the patient justifies the potential risk to the fetus.

If you are pregnant or planning to become pregnant, you should inform your healthcare provider to discuss the best way to manage your condition during this time.

Breastfeeding

It is currently unknown whether Tecfidera passes into human breast milk or how it might affect a nursing infant. Because many medications can be excreted in human milk, caution is advised. You should talk with your doctor about the potential risks and benefits of breastfeeding while taking this medication to determine the safest course of action for you and your baby.

Dosage Forms

Tecfidera is supplied as delayed-release capsules for oral administration. These capsules are designed to release the medication after they pass through the stomach to help with absorption and manage how the drug enters the system.

• Delayed-release capsules

The capsules must be swallowed whole and intact. They should not be crushed, chewed, or broken, and the contents should not be sprinkled on food, as this can interfere with the delayed-release properties of the medication.

FDA Approval and Indications

The U.S. Food and Drug Administration (FDA) approved Tecfidera in March 2013. It is indicated for the treatment of relapsing forms of multiple sclerosis (MS) in adults, including:

• Clinically isolated syndrome
• Relapsing-remitting disease
• Active secondary progressive disease

Safety Communications and Warnings

The FDA has issued safety communications regarding the risk of progressive multifocal leukoencephalopathy (PML), a rare and serious brain infection, in patients taking Tecfidera. This risk was identified through postmarketing reports, leading to updates in the drug's labeling. The FDA recommends that healthcare providers monitor patients for signs of PML and perform regular blood tests to check white blood cell counts, as low lymphocyte counts may increase the risk of infection.

Additionally, the FDA has monitored potential signals of serious risks through the FDA Adverse Event Reporting System (FAERS), including reports of liver injury and severe hypersensitivity reactions such as angioedema.

Regulatory Status

Tecfidera is a prescription-only medication and is not classified as a controlled substance. While it does not require a Risk Evaluation and Mitigation Strategy (REMS) program, the FDA-approved labeling includes specific instructions for clinical monitoring, including liver function tests and complete blood counts, to ensure patient safety during therapy.

Brand vs. Generic

Tecfidera is the brand name for the drug dimethyl fumarate. Generic versions of this medication are available and are generally more affordable than the brand-name product. Your healthcare provider or pharmacist can help determine if the generic version is appropriate for your treatment plan.

Insurance and Pharmacy Factors

Most insurance plans, including Medicare and private health insurance, cover dimethyl fumarate. However, the amount you pay out-of-pocket will depend on your specific plan's formulary, deductible, and copay requirements. Because Tecfidera is used to treat a chronic condition like multiple sclerosis, it is often classified as a specialty drug and may need to be filled through a specialty pharmacy rather than a standard retail pharmacy.

Financial Assistance Programs

There are several ways to potentially lower the cost of this medication:

• Copay Cards: The manufacturer may offer copay savings cards for patients with commercial insurance to help lower monthly out-of-pocket costs.
• Patient Assistance: Programs may be available for individuals who are uninsured or underinsured to help them access their medication at a lower cost or for free.
• Support Services: Many manufacturers provide dedicated support services to help patients navigate insurance approvals and find financial resources to cover their treatment.