Tecfidera (Dimethyl fumarate)

Do’s

• Read the Patient Information Leaflet if available from your pharmacist before starting Tecfidera and each time you get a refill. If you have any questions, ask your healthcare provider.
• Your healthcare provider will usually direct you to start Tecfidera at a low dose for the first 7 days of treatment and then increase your dose after 7 days. Follow their instructions carefully.
• Take Tecfidera by mouth, with or without food, as directed by your healthcare provider, usually twice daily. Swallow the capsules whole. 
• If flushing occurs, taking Tecfidera with food may reduce this side effect. Additionally, taking a plain (non-enteric coated) aspirin 30 minutes before taking Tecfidera may also help prevent flushing. Consult your healthcare provider to determine if this treatment is suitable for you.
• Take Tecfidera regularly at the same times each day to get the most benefit from it.
• Inform your healthcare provider if your condition worsens.

Don’ts

• Do not open, crush, or chew the capsules, as doing so can release all of the drug at once, increasing the risk of side effects.

• Infection
• Abdominal pain
• Flushing
• Increased serum aspartate aminotransferase
• Pruritus
• Skin rash
• Vomiting
• Lymphocytopenia
• Erythema of skin

Tecfidera may cause a serious viral infection of the brain that can lead to disability or death. If you experience any change in your mental state, decreased vision, weakness on one side of your body, or problems with speech or walking, call your healthcare provider right away.

These are not all the possible side effects of Tecfidera. If you notice any other effects not listed above or if you develop serious side effects while taking Tecfidera, contact your healthcare provider. 

At the first sign or symptom suggestive of Progressive Multifocal Leukoencephalopathy (PML), Tecfidera should be withheld and undergo an appropriate diagnostic evaluation.

Serious cases of herpes zoster have occurred with Tecfidera, including disseminated herpes zoster, herpes zoster ophthalmicus, herpes zoster meningoencephalitis, and herpes zoster meningomyelitis. Patients should be advised to contact their healthcare provider if they experience persistent and/or severe flushing.

Tecfidera may decrease lymphocyte counts. A blood test should be obtained before starting therapy, after 6 months of treatment, every 6 to 12 months thereafter, and as clinically indicated.

Patients should be instructed to report promptly any symptoms that may indicate liver injury, including fatigue, anorexia, right upper abdominal discomfort, dark urine, or jaundice. A blood test should be obtained before starting therapy and during treatment, as clinically indicated.

Tecfidera is contraindicated in patients with known hypersensitivity to dimethyl fumarate or to any of the excipients of Tecfidera. Reactions have included anaphylaxis and angioedema

These warnings and precautions are important to consider when using Tecfidera. Consult with a healthcare provider for a comprehensive understanding of the risks and benefits associated with this medication.