Tecfidera® (dimethyl fumarate) is indicated for the treatment of
patients with relapsing forms of multiple sclerosis.
Important Safety Information
TECFIDERA is contraindicated in patients with known
hypersensitivity to dimethyl fumarate or any of the excipients of
TECFIDERA. TECFIDERA can cause anaphylaxis and angioedema
after the first dose or at any time during treatment. Patients
experiencing signs and symptoms of anaphylaxis and angioedema
(which have included difficulty breathing, urticaria, and swelling
of the throat and tongue) should discontinue TECFIDERA and
seek immediate medical care.
Progressive multifocal leukoencephalopathy (PML) has
occurred in patients with MS treated with TECFIDERA. PML
is an opportunistic viral infection of the brain caused by the
JC virus (JCV) that typically only occurs in patients who are
immunocompromised, and that usually leads to death or
severe disability. A fatal case of PML occurred in a patient who
received TECFIDERA in a clinical trial. PML has also occurred
in the postmarketing setting in the presence of lymphopenia
(<0.8 x109/L) persisting for more than 6 months. While the role
of lymphopenia in these cases is uncertain, the majority of cases
occurred in patients with lymphocyte counts <0.5x109/L. The
symptoms associated with PML are diverse, progress over days
to weeks, and include progressive weakness on one side of the
body or clumsiness of limbs, disturbance of vision, and changes
in thinking, memory, and orientation leading to confusion and
personality changes. At the first sign or symptom suggestive
of PML, withhold TECFIDERA and perform an appropriate
diagnostic evaluation. MRI findings may be apparent before
clinical signs or symptoms.
TECFIDERA may decrease lymphocyte counts; in clinical trials
there was a mean decrease of ~30% in lymphocyte counts
during the first year which then remained stable. Four weeks
after stopping TECFIDERA, mean lymphocyte counts increased
but not to baseline. Six percent of TECFIDERA patients and <1%
of placebo patients had lymphocyte counts <0.5x109/L.
TECFIDERA has not been studied in patients with pre-existing
low lymphocyte counts.
There was no increased incidence of serious infections
observed in patients with lymphocyte counts <0.8x109/L
or ≤0.5x109/L in controlled trials, although one patient in an
extension study developed PML in the setting of prolonged
lymphopenia (lymphocyte counts predominantly <0.5x109/L
for 3. 5 years). In controlled and uncontrolled clinical trials,
2% of patients experienced lymphocyte counts <0.5x109/L
for at least six months. In these patients, the majority of
lymphocyte counts remained <0.5x109/L with continued therapy.
A complete blood count including lymphocyte count should be
obtained before initiating treatment, 6 months after starting,
every 6 to 12 months thereafter and as clinically indicated. Consider
treatment interruption if lymphocyte counts <0.5x109/L persist
for more than six months and follow lymphocyte counts until
lymphopenia is resolved. Consider withholding treatment in patients
with serious infections until resolved. Decisions about whether or
not to restart TECFIDERA should be based on clinical circumstances.
TECFIDERA may cause flushing (e.g. warmth, redness, itching,
and/or burning sensation). 40% of patients taking TECFIDERA
reported flushing, which was mostly mild to moderate in severity.
Three percent of patients discontinued TECFIDERA for flushing
and <1% had serious flushing events that led to hospitalization.
Taking TECFIDERA with food may reduce flushing. Alternatively,
administration of non-enteric coated aspirin prior to dosing may
reduce the incidence or severity of flushing.
Please see important safety information continued below
and Brief Summary of full Prescribing Information.