Multiple sclerosis:

Indications for: TECFIDERA

Relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease.

Adult Dosage:

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 Dosage:

Not established.

TECFIDERA Warnings/Precautions:

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

Adverse Reactions:

Flushing, abdominal pain, diarrhea, nausea; anaphylaxis, lymphopenia, liver injury.


Enroll pregnant patients exposed to Tecfidera by calling (866) 810-1462.

Generic Drug Availability:

Del-rel caps (YES); Starter Pack (NO)

How Supplied:

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