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TECFIDERA
Multiple sclerosis
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Drug Name:

TECFIDERA Rx

Generic Name and Formulations:
Dimethyl fumarate 120mg, 240mg; del-rel caps.

Company:
Biogen

Therapeutic Use:

Indications for TECFIDERA:

Treatment of patients with relapsing forms of multiple sclerosis.

Adult:

Swallow whole. Initially 120mg twice daily for 7 days, then increase to maintenance dose of 240mg twice daily. If maintenance dose not tolerated, temporarily reduce back to initial dose. Within 4 weeks, resume maintenance dose; if not tolerated, consider discontinuing.

Children:

Not established.

Warnings/Precautions:

Obtain a CBC including lymphocyte count prior to initiation, after 6 months, and every 6 to 12 months thereafter; consider interruption if lymphocyte counts < 0.5 X 109/L persist for >6 months. Serious infection; consider withholding until resolved. Pre-existing low lymphocyte counts (not studied). Monitor serum aminotransferase, alkaline phosphatase, and total bilirubin prior to initiation and during treatment; discontinue if significant liver injury is suspected. Discontinue if signs/symptoms of anaphylaxis or angioedema occurs. Withhold and evaluate at first sign/symptom suggestive of PML. Administration with non-enteric coated aspirin 325mg or food may reduce incidence of flushing. Pregnancy (Cat.C). Nursing mothers.

Adverse Reactions:

Flushing, abdominal pain, diarrhea, nausea, vomiting, pruritus, rash; lymphopenia, liver injury.

Generic Availability:

NO

How Supplied:

Starter Pack (30-day)—1 (120mg × 14 + 240mg × 46); Del-rel caps 120mg—14; 240mg—60

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