DimethylFumarate mainly exerts immune regulation and cell protection effects by activating the Nrf2 pathway.

1、 Drug name

Common name (trade name): DimethylFumarate, trade name: TECFIDERA ®)

2、 Indications

Used to treat adult recurrent multiple sclerosis (MS), including clinically isolated syndrome, relapsing remitting disease, and active secondary progressive disease.

3、 Specifications and characteristics

1. This product is a hard gelatin enteric coated capsule.

2. Specifications: 120mg (green cap/white bottle body) and 240mg (green cap/green bottle body).

3. Appearance: The capsule shell is printed with black words "BG12120mg" or "BG-12240mg". The content is white to off white powder.

4、 Main components

Active ingredient: Dimethyl fumarate.

5、 Usage and dosage

1. Standard treatment course:

Initial dose: Take 120mg orally twice a day for 7 consecutive days.

Maintenance dose: After 7 days, the dose is increased to 240 milligrams twice daily, orally.

2. Usage:

The capsule should be swallowed whole and should not be crushed, chewed, or spilled on food.

Can be taken with food or on an empty stomach.

3. Dose adjustment:

For patients who cannot tolerate the maintenance dose, temporary reduction to 120 milligrams twice a day can be considered, but the recommended maintenance dose of 240 milligrams should be restored within 4 weeks.

If the patient still cannot tolerate the recovered dose, discontinuation of the medication should be considered.

If there is still a flushing reaction when taken with food, non enteric coated aspirin (up to 325 milligrams) can be taken 30 minutes before medication, which may help reduce the incidence or severity of flushing.

6、 Medication precautions

1. Taken with meals: To reduce the occurrence of flushing reactions, it is recommended to take it with food.

2. Handling of missed doses: The drug instructions do not provide specific recommendations for handling. In case of missed doses, the general principle is to skip the missed dose if it is close to the next dose, and take the next dose according to the original plan. Do not take double the dose at once. Please follow the doctor's advice or consult a pharmacist for specific instructions.

3. Vomiting treatment: No special dietary guidelines for post vomiting were mentioned. If vomiting occurs shortly after taking it, it may affect drug absorption. It is recommended to consult a doctor.

4. Red tide management: Red tide is a common reaction that usually appears in the early stages of treatment and improves over time. Taking food together or taking non enteric coated aspirin in advance (as mentioned above) can help alleviate symptoms.

7、 Medication for special populations

1. Pregnant women: Existing data does not indicate an increased risk of major birth defects, miscarriage, or other adverse pregnancy outcomes, but animal experiments have shown developmental toxicity. Medication requires weighing the pros and cons.

2. Breastfeeding women: It is unclear whether the medication will be secreted with breast milk. The benefits of breastfeeding and the clinical needs of mothers for treatment, as well as the potential impact of medication on infants, should be considered.

3. Children: Safety and efficacy have not yet been established in pediatric patients.

4. Elderly patients: Clinical studies did not include a sufficient number of patients aged 65 and above to determine whether their reactions were different from those of younger patients.

8、 Adverse reactions

1. Common adverse reactions (incidence ≥ 10%, and incidence ≥ 2% higher than placebo group): flushing, abdominal pain, diarrhea, nausea.

2. Other common adverse reactions include vomiting, itching, rash, indigestion, and elevation of aspartate aminotransferase.

3. Serious adverse reactions (to be cautious):

Allergic reactions and vascular edema: can occur at any time during the first dose or treatment period.

Progressive multifocal leukoencephalopathy: a rare but potentially fatal viral infection of the brain.

Herpes zoster and other severe opportunistic infections.

Lymphocytopenia: Complete blood cell count and lymphocyte count should be monitored before treatment, 6 months after the start of treatment, and every 6 to 12 months thereafter.

Liver injury: Liver function (serum transaminase, alkaline phosphatase, total bilirubin) should be monitored before and during treatment.

Severe gastrointestinal reactions: including perforation, ulceration, bleeding, and obstruction, some of which can be fatal.

Redness: may cause treatment interruption.

9、 Contraindications

Patients with known hypersensitivity reactions to dimethyl fumarate or any excipients of TECFIDERA are contraindicated.

10、 Drug interactions

1. Research has shown that the likelihood of significant interactions between dimethyl fumarate or its active metabolites and other drugs is low.

2. Specific studies did not find any pharmacokinetic interactions related to interferon beta-1a, glatirade acetate, or aspirin (taken 30 minutes in advance).

3. No significant effects were observed when combined with oral contraceptives such as norgestrel and ethinylestradiol.

4. Simultaneous use with non live vaccines (tetanus toxoid vaccine, pneumococcal polysaccharide vaccine, meningococcal vaccine) did not weaken antibody response. The safety and efficacy of simultaneous use with live or attenuated vaccines have not been evaluated yet.

11、 Storage method

1. Storage temperature: 15 ° C to 30 ° C (59 ° F to 86 ° F).

2. Store in a dark place and place in the original container.

12、 Manufacturer

Produced by Biogen Inc., located in Cambridge, Massachusetts, USA.

Dimethyl Fumarateinformation