Tecfidera (Dimethyl Fumerate) Side Effects, Price, Prescribing Information

Category: Multiple Sclerosis by Van Voong, PharmD - May 30, 2013 | Views: 5922 | Likes: 1 | Comment: 0

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Tecfidera | dimethyl fumerate delayed-release capsules

Medication Class: Multiple Sclerosis Treatment, Immunomodulator
Manufacturer: Biogen Idec
Approval Date: March 2013

Tecfidera (Dimethyl Fumerate delayed-release capsules) Side Effects, Price, Prescribing Information

What is Tecfidera and how does it work

Tecfidera is an oral prescription medicine with nervous system protective and anti-inflammatory properties.  Although the exact mechanism on how it works is unknown, Tecfidera has been shown to activate the body’s response to cellular damage in patients with multiple sclerosis. It prevents immune cells from attacking the central nervous system.

What does Tecfidera treat

Tecfidera is an oral medication used for treating adult patients with relapsing forms of multiple sclerosis.  Relapsing forms of multiple sclerosis are defined as having periods of worsening of function followed by periods of temporary improvement. Relapsing patients may develop new or previous symptoms such as loss of sensitivity, muscle weakness, numbness or tingling sensations.

How effective is Tecfidera

1234 patients with relapsing forms of multiple sclerosis were studied for 2 years. 27% of patients in the Tecfidera 240 mg twice daily group had a relapse after 2 years of treatment compared to 46% of patients in the placebo (dummy pill) group, a risk reduction of 49%. Fewer patients in the Tecfidera group developed new or newly enlarging lesions. Tecfidera 240 mg 3 times daily did not offer additional benefit over the 240 mg twice daily dose. 

In another study 722 patients with relapsing forms of multiple sclerosis were studied. In the Tecfidera group, 80 patients compared to 145 patients in the placebo group experienced a relapse during the first year of treatment.  Patients who were given Tecfidera had a 44% less chance of experiencing a relapse compared to patients who were given a placebo.

In both studies Tecfidera was more effective than taking a placebo in treating relapsing forms of multiple sclerosis.

The safety and effectiveness of Tecfidera in pregnancy and children under 18 years of age is not known. 

What are interesting facts about Tecfidera

Tecfidera is a capsule. Many multipole sclerosis drugs are given by injection.

Tecfidera is converted to its active form, monomethyl fumerate (MMF) by enzymes in the stomach, intestines, blood and tissues

Elimination of about 60% Tecfidera dose is primarily through exhalation of carbon dioxide (CO2).

Tecfidera may cause an increase in eosinophil count during the first 2 months of treatment.

Protect Tecfidera from light.  Keep the capsules in the original container.

What are the side effects of Tecfidera

Common: flushing, abdominal pain, diarrhea, nausea, vomiting, itching, and rash. More gastrointestinal (GI) events such as abdominal pain, diarrhea and vomiting occurred in the first month of therapy and decreased over time.

Serious: Low white blood cell count, possible increasing the risk of infections.  A recent complete blood cell count is recommended before starting therapy. Report any symptoms of infection such as fever or fatigue to your physician or pharmacist.

What is the dosage of Tecfidera 

Tecfidera is available as 120 mg and 240 mg delayed-release capsules.

The recommended dose is to start with 120 mg by mouth twice a day for 7 days.  After 7 days, the dose should be increased to 240 mg twice a day. 

Tecfidera capsules are to be swallowed whole and intact either with or without food. Taking Tecfidera with food may reduce the incidence of flushing.

Tecfidera drug interactions

Drug interactions have not been identified. 

What is the price of Tecfidera

Tecfidera costs $5400 for a 30 day supply.

How to obtain prescription assistance for Tecfidera

Pay only $10 a month for your treatment with the Tecfidera $10 Co-pay Program

Reference: Tecfidera FDA Prescribing Information and Medication Guide

 

This medication summary is for information only and is not a substitute for medical advice, diagnosis or treatment provided by a qualified health care provider.

 

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