Dimethyl fumarate

Yes

Tell your doctor about all prescription, non-prescription, illegal, recreational, herbal, nutritional, or dietary drugs you're taking while also using Tecfidera.

Dimethyl fumarate is a prescription medication used to treat relapsing forms of multiple sclerosis, or MS. It is not known if eimethyl fumarate is safe and effective in children under 18 years of age.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Dimethyl Fumarate is part of the drug class:

• Other immunosuppressants

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of dimethyl fumarate, there are no specific foods that you must exclude from your diet when receiving this medication.

• Store at 15°C – 30°C (59-86°F).
• Protect the capsules from light. Store in original container.
• Once opened, discard bottles of dimethyl fumarate after 90 days.
• Keep this and all medicines out of the reach of children.

Dimethyl fumarate is used to treat relapsing multiple sclerosis.

Dimethyl fumarate may also be used for purposes not listed in this medication guide.

Follow all directions on your prescription label. Your doctor may occasionally change your dose to make sure you get the best results. Do not take this medicine in larger or smaller amounts or for longer than recommended.

You may take dimethyl fumarate with or without food.

Do not crush, chew, break, or open a dimethyl fumarate capsule. Swallow it whole.

Dimethyl fumarate is usually given in two different strengths, one for a starter dose and the other for a maintenance dose. The starter dose is usually taken for only 7 days. Follow your doctor's dosing instructions very carefully.

Store at room temperature away from moisture, heat, and light. Throw away any unused capsules 90 days after you first opened the bottle.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Usual Adult Dose for Multiple Sclerosis:

Initial dose: 120 mg orally twice a day for 7 days
Maintenance dose: 240 mg orally twice a day

Approved indication: The treatment of patients with relapsing-remitting multiple sclerosis.

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For dimethyl fumarate, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to dimethyl fumarate or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of dimethyl fumarate in the pediatric population. Safety and efficacy have not been established.

Geriatric

Although appropriate studies on the relationship of age to the effects of dimethyl fumarate have not been performed in the geriatric population, geriatric-specific problems are not expected to limit the usefulness of dimethyl fumarate in the elderly.

Pregnancy

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of dimethyl fumarate. Make sure you tell your doctor if you have any other medical problems, especially:

• Infection or
• Liver problems or
• Lymphopenia (low white blood cells)—Use with caution. May make these conditions worse.

• BG-12
• Dimethylfumarate
• DMF
• FAG-201

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Capsule Delayed Release, Oral:

Tecfidera: 120 mg, 240 mg [contains brilliant blue fcf (fd&c blue #1)]

Miscellaneous, Oral:

Tecfidera: Capsule, delayed release: 120 mg (14s) and Capsule, delayed release: 240 mg (46s) (60 ea) [contains brilliant blue fcf (fd&c blue #1)]

Flushing, GI intolerance, or intolerance to maintenance dose: Consider temporary dose reduction to 120 mg twice daily (resume recommended maintenance dose of 240 mg twice daily within 4 weeks). Consider discontinuation in patients who cannot tolerate return to the maintenance dose.

Hepatic injury (suspected drug-induced), clinically significant: Discontinue treatment.

Lymphocyte count <500/mm3 persisting for >6 months: Consider treatment interruption.

Serious infection: Consider withholding treatment until infection resolves.

>10%:

Cardiovascular: Flushing (40%)

Gastrointestinal: Abdominal pain (18%), diarrhea (14%), nausea (12%)

Infection: Infection (60%; placebo: 58%)

1% to 10%:

Dermatologic: Pruritus (8%), skin rash (8%), erythema (5%)

Gastrointestinal: Vomiting (9%), dyspepsia (5%)

Genitourinary: Proteinuria (6%)

Hematologic: Lymphocytopenia (2% to 6%)

Hepatic: Increased serum AST (4%)

<1% (Limited to important or life-threatening: Anaphylaxis, angioedema, eosinophilia (transient), progressive multifocal leukoencephalopathy

CBC including lymphocyte count (obtained prior to initiation of therapy, after 6 months of treatment, then every 6 to 12 months thereafter and as clinically necessary); liver function tests (transaminases, alkaline phosphatase, total bilirubin) prior to treatment initiation and during treatment as clinically indicated; urinalysis (if proteinuria suspected and/or clinically indicated). Monitor for signs/symptoms of hypersensitivity, infections, and/or progressive multifocal leukoencephalopathy.

Animal studies have shown reproductive toxicity. There are no or limited data on the use of DMF in humans. Dimethyl fumarate is not recommended during pregnancy and in women of childbearing potential not using appropriate contraception. AU TGA pregnancy category B1: Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed. Studies in animals have not shown evidence of an increased occurrence of fetal damage. US FDA pregnancy category C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

Use DMF only if clearly needed and benefit outweighs risk. AU TGA pregnancy category: B1 US FDA pregnancy category: C