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:
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. Pre-existing low lymphocyte counts: not studied. Serious infection; consider withholding until resolved. Monitor for signs/symptoms of herpes zoster and other opportunistic infections; evaluate and treat if develop. 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 325mg or food may reduce incidence of flushing. Pregnancy. Nursing mothers.
Adverse Reactions:
Flushing, abdominal pain, diarrhea, nausea; anaphylaxis, PML, opportunistic infections (eg, herpes zoster), lymphopenia, liver injury.
Note:
Enroll pregnant patients exposed to Tecfidera by calling (866) 810-1462.
Generic Availability:
NO
How Supplied:
Starter Pack (30-day)—1 (120mg × 14 + 240mg × 46); Del-rel caps 120mg—14; 240mg—60
