COSENTYX® (secukinumab) is contraindicated in patients
with a previous serious
hypersensitivity reaction to secukinumab or to any of the
excipients in COSENTYX.
Cases of anaphylaxis have been reported during treatment with
WARNINGS AND PRECAUTIONS
COSENTYX may increase the risk of infections. In clinical trials,
a higher rate of infections
was observed in COSENTYX treated subjects compared to
placebo-treated subjects. In
placebo-controlled clinical trials in subjects with moderate to
severe plaque psoriasis,
higher rates of common infections, such as nasopharyngitis
(11.4% versus 8.6%), upper
respiratory tract infection (2.5% versus 0.7%) and mucocutaneous
candida (1.2% versus 0.3%) were observed with COSENTYX compared
with placebo. A similar
increase in risk of infection was seen in placebo-controlled
trials in subjects with
psoriatic arthritis, ankylosing spondylitis and non-radiographic
The incidence of some types of infections appeared to be
dose-dependent in clinical
studies. In the postmarketing setting, serious and some fatal
infections have been
reported in patients receiving COSENTYX.
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Important Safety Information
Exercise caution when considering the use of COSENTYX in patients
with a chronic infection
or a history of recurrent infection.
Instruct patients to seek medical advice if signs or symptoms
suggestive of an infection
occur. If a patient develops a serious infection, monitor the
patient closely and
discontinue COSENTYX until the infection resolves.
Pre-treatment Evaluation for Tuberculosis
Evaluate patients for tuberculosis (TB) infection prior to
initiating treatment with
COSENTYX. Avoid administration of COSENTYX to patients with
active TB infection.
Initiate treatment of latent TB prior to administering COSENTYX.
therapy prior to initiation of COSENTYX in patients with a past
history of latent
or active TB in whom an adequate course of treatment cannot be
patients closely for signs and symptoms of active TB during and
Inflammatory Bowel Disease
Caution should be used when prescribing COSENTYX to patients with
disease. Exacerbations, in some cases serious, occurred in
COSENTYX treated subjects
during clinical trials in plaque psoriasis, psoriatic arthritis,
and non-radiographic axial spondyloarthritis. In addition, new
bowel disease cases occurred in clinical trials with COSENTYX.
In an exploratory
trial in 59 subjects with active Crohn’s disease, there were
trends toward greater
disease activity and increased adverse events in the secukinumab
group as compared
to the placebo group. Patients who are treated with COSENTYX
should be monitored
for signs and symptoms of inflammatory bowel disease.
Anaphylaxis and cases of urticaria occurred in COSENTYX treated
subjects in clinical
trials. If an anaphylactic or other serious allergic reaction
of COSENTYX should be discontinued immediately and appropriate
The removable caps of the COSENTYX Sensoready® pen and the COSENTYX 1 mL
and 0.5 mL prefilled syringes contain natural rubber latex,
which may cause an allergic
reaction in latex-sensitive individuals. The safe use of the
COSENTYX Sensoready pen or prefilled syringe in latex-sensitive
individuals has not been studied.
Prior to initiating therapy with COSENTYX, consider completion of
all age appropriate immunizations according to current
immunization guidelines. COSENTYX may alter a patient’s immune
response to live vaccines. Avoid use of live vaccines
in patients treated with COSENTYX.
MOST COMMON ADVERSE
Most common adverse reactions (>1%) are nasopharyngitis,
diarrhea, and upper respiratory tract infection.
Please see full Prescribing Information,
including Medication Guide.