Tecfidera

The usual starting dose of dimethyl fumarate is 120 mg taken twice a day. This is taken for the first 7 days and then the dose is increased to 240 mg taken twice a day.

Many things can affect the dose of medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are taking the medication without consulting your doctor.

Dimethyl fumarate may be taken with or without food. If you experience flushing, or stomach problems, take the medication with food to reduce these effects.

Swallow the capsules whole with water or another fluid. Do not divide, crush, dissolve, suck, or chew on the capsule.

It is important to take Tecfidera (Dimethyl-fumarate) exactly as prescribed by your doctor. If you miss a dose, take it as soon as possible and continue with your regular schedule. If it is less than 4 hours before your next dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.

Store Tecfidera (Dimethyl-fumarate) at room temperature, protect it from light and moisture, and keep it out of the reach of children.

Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.

In addition to its desired action, this medication may cause some adverse effects, notably: it may cause diarrhea; it may cause stomach ache; it may cause spots or redness of the skin; it may cause redness of the face; it may cause nausea and vomiting. Each person may react differently to a treatment. If you think this medication may be causing adverse effects (including those described here, or others), talk to your health care professional. He or she can help you to determine whether or not the medication is the source of the problem.

120 mg
Each delayed-release capsule with a green cap and white body, printed with "BG-12 120 mg" in black ink, is filled with enteric-coated microtablets containing 120 mg of dimethyl fumarate. Nonmedicinal ingredients: colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, methacrylic acid copolymer (type A), methacrylic acid copolymer dispersion, microcrystalline cellulose, polysorbate 80, simethicone, sodium lauryl sulfate, talc, and triethyl citrate. The capsule shell contains black iron oxide, FD&C Blue 1, gelatin, titanium dioxide, and yellow iron oxide.

240 mg
Each delayed-release capsule with a green cap and white body, printed with "BG-12 240 mg" in black ink, is filled with enteric-coated microtablets containing 240 mg of dimethyl fumarate. Nonmedicinal ingredients: colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, methacrylic acid copolymer (type A), methacrylic acid copolymer dispersion, polysorbate 80, silicified microcrystalline cellulose, simethicone, sodium lauryl sulfate, talc, and triethyl citrate. The capsule shell contains black iron oxide, FD&C Blue 1, gelatin, titanium dioxide, and yellow iron oxide.

Do not take Tecfidera (Dimethyl-fumarate) if you are allergic to dimethyl fumarate or any ingredients of the medication.

There may be an interaction between dimethyl fumarate and any of the following:

• aminoglycoside antibiotics (e.g., gentamicin, tobramycin)
• anti-cancer medications (e.g., Mitoxantrone)
• Cyclosporine
• diuretics (water pills; e.g., Furosemide, Hydrochlorothiazide)
• fumaric acid
• lithium
• live vaccines (e.g., yellow fever vaccine, Chickenpox vaccine)
• mitoxantrone
• Mycophenolate Mofetil
• non-steroidal anti-inflammatory medications (NSAIDs; e.g., Ibuprofen, Ketorolac, Naproxen)
• other medications for MS (e.g., Fingolimod, Natalizumab)

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

• stop taking one of the medications,
• change one of the medications to another,
• change how you are taking one or both of the medications, or
• leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with Tecfidera (Dimethyl-fumarate). Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the Nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

Before you begin using a medication, be sure to inform your doctor of any medical conditions or Allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use Tecfidera (Dimethyl-fumarate).

Infection: Dimethyl fumarate can reduce the number of cells that fight infection in the body (white blood cells). If you are taking medications or have an illness that reduces your body's ability to fight infection, discuss with your doctor how Tecfidera (Dimethyl-fumarate) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Tecfidera (Dimethyl-fumarate), and whether any special monitoring is needed.

Tell your doctor immediately if you notice signs of an infection, such as fever or chills, severe diarrhea, shortness of breath, prolonged dizziness, headache, stiff neck, or unexplained weight loss. Your doctor will do blood tests regularly to monitor your white blood cell count.

Kidney function: Treatment with dimethyl fumarate may cause an increase in the amount of protein removed from the body by the kidneys. In some cases, this may indicate a decrease in kidney function. If you have reduced kidney function or Kidney Disease, discuss with your doctor how Tecfidera (Dimethyl-fumarate) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Tecfidera (Dimethyl-fumarate), and whether any special monitoring is needed.

Your doctor may want to test your kidney function regularly while you are taking Tecfidera (Dimethyl-fumarate).

Tell your doctor immediately if you experience symptoms of protein in the urine, such as swelling of the face or legs.

Liver function: Treatment with dimethyl fumarate may cause an increase in liver enzymes, which are chemicals produced by the liver. In some cases, increased liver enzymes can indicate a decrease in liver function. If you have liver problems, discuss with your doctor how Tecfidera (Dimethyl-fumarate) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Tecfidera (Dimethyl-fumarate), and whether any special monitoring is needed. Your doctor may want to test your liver function regularly with blood tests while you are taking Tecfidera (Dimethyl-fumarate).

Tell your doctor immediately if you experience symptoms of liver problems such as fatigue, feeling unwell, loss of appetite, nausea, yellowing of the skin or whites of the eyes, dark urine, pale stools, abdominal pain or swelling, and itchy skin.

Progressive multifocal leukoencephalopathy (PML): There have been reports of PML after using dimethyl fumarate. PML is a rare disorder that causes nerve damage in the brain and is more likely to occur in people who have a weakened immune system. If you experience memory loss, vision loss, trouble thinking, or difficulty walking, contact your doctor immediately.

Vaccines: Live attenuated vaccines such as yellow fever, BCG, Cholera, typhoid, varicella, meningococcal, and diphtheria should not be given while you are taking dimethyl fumarate.

Pregnancy: Tecfidera (Dimethyl-fumarate) should not be used during pregnancy unless the benefits outweigh the risks. If you become pregnant while taking Tecfidera (Dimethyl-fumarate), tell your doctor immediately.

Breast-feeding: It is not known if dimethyl fumarate passes into breast milk. If you are a breast-feeding mother and are taking Tecfidera (Dimethyl-fumarate), it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

Children: The safety and effectiveness of using Tecfidera (Dimethyl-fumarate) have not been established for children below the age of 18.

Seniors: Seniors are more likely to have medical conditions that may be affected by dimethyl fumarate. If you are a senior and taking Tecfidera (Dimethyl-fumarate), your doctor should closely monitor your medical conditions while you are taking Tecfidera (Dimethyl-fumarate).

This medication is typically used twice a day. However, your pharmacist may have suggested a different schedule that is more appropriate for you. Important: Follow the instructions on the label. Do not use more of this product, or more often, than prescribed. It must be used regularly and continuously to maintain its beneficial effects. Be sure to keep an adequate supply on hand. The capsule of this medication should not be opened, crushed or chewed. If you forget a dose and there is more than 4 hours left before the next dose, take immediately the missed dose. Do not double the next dose to catch up. This medication may be taken with or without food. If it were, however, to cause stomach problems (nausea or irritation), taking the product with food could provide relief.