NOTE: Depending on the supplier/strength selected, the products shipped may have different packaging.

Why is Tecfidera prescribed?

Tecfidera (Dimethyl Fumarate) is a disease-modifying therapy approved for adults with relapsing forms of multiple sclerosis (MS). It is indicated for the treatment of:

• Clinically isolated syndrome (CIS), an initial episode suggestive of MS.
• Relapsing-remitting MS (RRMS), the most common type of MS.
• Active secondary-progressive MS (SPMS), a more advanced stage of RRMS.

What does it do?

Tecfidera (Dimethyl Fumarate) may help shield cells from stress-related damage while enhancing the body’s natural repair and maintenance processes. The body quickly converts Tecfidera (Dimethyl Fumarate) to its active form, monomethyl fumarate (MMF), despite not fully understanding its exact mechanism. MMF activates the Nrf2 (nuclear factor (erythroid-derived 2) antioxidant pathway, which helps reduce oxidative stress on nerve cells, suppress inflammatory immune responses, and support neuroprotection in the central nervous system.

How should I take it?

Always follow your doctor’s instructions or the directions on the product label when taking this medication. Tecfidera is available in delayed-release oral capsules of 120 mg and 240 mg. The recommended dosing begins with 120 mg twice daily for the first 7 days, followed by a maintenance dose of 240 mg twice daily starting on day 8.

Capsules should be swallowed whole without crushing, chewing, or sprinkling it on food. It may be taken with or without food, although taking it with a meal may help reduce flushing. For patients who cannot tolerate resuming the maintenance dose, a temporary dose reduction or discontinuation of Tecfidera may be necessary.

What if I missed a dose?

If you miss a dose of Tecfidera, take it as soon as you remember. However, if your next scheduled dose is approaching, skip the missed dose and proceed with your usual dosing routine. Do not take extra or double doses to make up for the missed dose.

What are the special precautions before taking Tecfidera?

Inform your doctor about all the medications you are taking, your current and previous medical history. Before taking Tecfidera, here are several important precautions to keep in mind:

Do not take Tecfidera if you're allergic to Dimethyl Fumarate, Diroximel Fumarate, or any of the ingredients in the medication. Note that Anaphylaxis and Angioedema can occur at the onset of treatment immediately discontinue or restart treatment.

Disclose all your current or past medical conditions to your doctor, particularly if you have:

• Liver problems
• Low white blood cell counts
• Serious or severe infections (Herpes Zoster)
• Other medical conditions

The safety and effectiveness of this medication in people younger than 18 years have not yet been determined.

Does it have any side effects?

It is important to note that all drugs have corresponding side effects and adverse reactions. Additional information may be obtained when you ask your doctor or pharmacist.

Common side effects may include:
• Flushing
• Abdominal pain
• Nausea
• Headache

Serious side effects may include:
• Progressive multifocal leukoencephalopathy (PML)
• Low white blood cell counts (lymphopenia)
• Herpes zoster (shingles)
• Yellowing of the skin or eyes (jaundice)
• Swelling of the face, lips, mouth, tongue, or throat

This is not a complete list of potential side effects, and other unexpected reactions may occur. Always consult your healthcare provider for comprehensive information and personalized medical advice.

Is it safe to take it with another drug?

Tecfidera (Dimethyl Fumarate) can interact with various medications, so it's important to check for potential interactions before taking it with another drug. Some interactions may increase side effects or reduce effectiveness.

Before taking Tecfidera, consult your doctor if you are using any of the following medications:

• Prednisone
• Ibuprofen
• Fexinidazole
• Immunosuppressant
• Live vaccines

This is not a complete list of all the possible drug interactions. To ensure your safety, always consult your doctor or pharmacist before taking Tecfidera with any other medications.

How should I store it?

Store Tecfidera in its original container at room temperature, ideally between 15°C and 30°C (59°F to 86°F). Keep the medication in a cool, dry place, away from direct sunlight, and ensure it is kept out of reach of children and pets.

What action should I take in case of overdose?

If you suspect an overdose of Tecfidera (Dimethyl Fumarate), it's important to act quickly and seek immediate medical attention. Contact emergency services or go to the nearest hospital. While there’s limited data on overdose cases, the prescribing information emphasizes supportive care and monitoring as the primary response.

Is it safe for pregnant or breastfeeding women?

Tecfidera (Dimethyl Fumarate) may not be fully safe during pregnancy or breastfeeding, and decisions should be made with a healthcare provider. Animal studies suggest potential fetal harm, but human data is limited and inconclusive.

While for breastfeeding, small amounts of the active metabolite may pass into breast milk. Although levels are low and unlikely to harm the infant, especially after the first month, monitoring for side effects like flushing or GI upset is recommended.

If you are pregnant, planning to become pregnant, or breastfeeding, consult your healthcare provider for guidance on its use to ensure safety for both you and your baby.

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