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Proportion relapsing 29% 41% 0.0020
Relative risk reduction 34%
Proportion with disability progression 13% 17% 0.25
Relative risk reduction 21%
MRI Endpoint N=147 N=144
Mean number of new or newly enlarging T2 lesions over 2 years 5.1 17.4 <0.0001
Percentage of subjects with no new or newly enlarging lesions 27% 12%
Number of Gd+ lesions at 2 years Mean (median) 0.5 (0.0) 2.0 (0.0)
Percentage of subjects with
0 lesions 80% 61%
1 lesion 11% 17%
2 lesions 3% 6%
3 to 4 lesions 3% 2%
5 or more lesions 3% 14%
Relative odds reduction (percentage) 74% <0.0001
Mean number of new T1 hypointense lesions over 2 years 3.0 7.0 <0.0001
How Supplied/Storage and Handling
Tecfidera is available as hard gelatin delayed-release capsules in two strengths containing either 120 mg or 240 mg of dimethyl fumarate. The green and white 120 mg capsules are printed with “BG-12 120 mg” in black ink. The green 240 mg capsules are printed with “BG-12 240 mg” in black ink. Tecfidera is available as follows:
30-day Starter Pack, (NDC 64406-007-03):
7-day bottle 120 mg capsules, quantity 14
23-day bottle 240 mg capsules, quantity 46
120 mg capsules:
7-day bottle of 14 capsules (NDC 64406-005-01)
240 mg capsules:
30-day bottle of 60 capsules (NDC 64406-006-02)
Store at 15°C – 30°C (59-86°F). Protect the capsules from light. Store in original container. Once opened, discard bottles of Tecfidera after 90 days.
Patient Counseling Information
See FDA-approved patient labeling (Patient Information)
Dosage
Inform patients that they will be provided two strengths of Tecfidera when starting treatment: 120 mg capsules for the 7 day starter dose and 240 mg capsules for the maintenance dose, both to be taken twice daily. Inform patients to swallow Tecfidera capsules whole and intact. Inform patients to not crush, chew, or sprinkle capsule contents on food. Inform patients that Tecfidera can be taken with or without food [see Dosage and Administration()2.1].
Flushing and Gastrointestinal (GI) Reactions
Flushing and GI reactions (abdominal pain, diarrhea, and nausea) are the most common reactions, especially at the initiation of therapy, and may decrease over time. Advise patients to contact their healthcare provider if they experience persistent and/or severe flushing or GI reactions, as taking Tecfidera with food may help [See Adverse Reactions()6.1].
Pregnancy and Pregnancy Registry
Instruct patients that if they are pregnant or plan to become pregnant while taking Tecfidera they should inform thei
