Cosentyx
Generic Name: secukinumab
(SEK ue KIN ue mab)
Brand Names: Cosentyx
INDICATIONS AND USAGE Plaque
Psoriasis
Cosentyx® is indicated for the
treatment of moderate to severe plaque psoriasis in adult patients who are
candidates for systemic therapy or phototherapy.
Psoriatic
Arthritis
Cosentyx is indicated for the
treatment of adult patients with active psoriatic arthritis.
Ankylosing
Spondylitis
Cosentyx is indicated for the
treatment of adult patients with active ankylosing spondylitis.
DOSAGE AND ADMINISTRATION Plaque
Psoriasis
The recommended dosage is 300
mg by subcutaneous injection at Weeks 0, 1, 2, 3, and 4 followed by 300 mg
every 4 weeks. Each 300 mg dosage is given as 2 subcutaneous injections of 150
mg.
For some patients, a dosage of
150 mg may be acceptable.
Psoriatic
Arthritis
For psoriatic arthritis
patients with coexistent moderate to severe plaque psoriasis, use the dosing
and administration recommendations for plaque psoriasis [see Dosage and Administration (2.1)].
For other psoriatic arthritis
patients, administer Cosentyx with or without a loading dosage by subcutaneous
injection. The recommended dosage:
With a loading dosage is 150 mg at weeks 0, 1, 2,
3, and 4 and every 4 weeks thereafterWithout a loading dosage is 150 mg every 4 weeksIf a patient continues to have active psoriatic
arthritis, consider a dosage of 300 mg.
Cosentyx may be administered
with or without methotrexate.
2.3 Ankylosing Spondylitis
Administer Cosentyx with or
without a loading dosage by subcutaneous injection. The recommended dosage:
With a loading dosage is 150 mg at weeks 0, 1, 2,
3, and 4 and every 4 weeks thereafterWithout a loading dosage is 150 mg every 4 weeks Assessment
Prior to Initiation of Cosentyx
Evaluate patients for
tuberculosis (TB) infection prior to initiating treatment with Cosentyx [see Warnings and Precautions (5.2)].
Important
Administration Instructions
There are three presentations
for Cosentyx (i.e., Sensoready pen, prefilled syringe, and lyophilized powder
in vial for reconstitution). The Cosentyx “Instructions for Use” for each
presentation contains more detailed instructions on the preparation and
administration of Cosentyx [see Instructions for
Use].
Cosentyx is intended for use
under the guidance and supervision of a physician. Patients may self-inject
after proper training in subcutaneous injection technique using the Sensoready
pen or prefilled syringe and when deemed appropriate. The lyophilized powder
for reconstitution is for healthcare provider use only. Administer each
injection at a different anatomic location (such as upper arms, thighs, or any
quadrant of abdomen) than the previous injection, and not into areas where the
skin is tender, bruised, erythematous, indurated, or affected by psoriasis.
Administration of Cosentyx in the upper, outer arm may be performed by a
caregiver or healthcare provider.
Preparation
for Use of Cosentyx Sensoready® Pen and Prefilled Syringe
Before injection, remove
Cosentyx Sensoready pen or Cosentyx prefilled syringe from the refrigerator and
allow Cosentyx to reach room temperature (15 to 30 minutes) without removing
the needle cap.
The removable cap of the
Cosentyx Sensoready pen and the Cosentyx prefilled syringe contains natural
rubber latex and should not be handled by latex-sensitive individuals [see Warnings and Precautions (5.5)].
Inspect Cosentyx visually for
particulate matter and discoloration prior to administration. Cosentyx
injection is a clear to slightly opalescent, colorless to slightly yellow
solution. Do not use if the liquid contains visible particles, is discolored or
cloudy. Cosentyx does not contain preservatives; therefore, administer the Sensoready
pen or prefilled syringe within 1 hour after removal from the refrigerator.
Discard any unused product remaining in the Sensoready pen or prefilled
syringe.
Reconstitution
and Preparation of Cosentyx Lyophilized Powder
Cosentyx lyophilized powder
should be prepared and reconstituted with Sterile Water for Injection by a
trained healthcare provider using aseptic technique and without interruption.
The preparation time from piercing the stopper until end of reconstitution on
average takes 20 minutes and should not exceed 90 minutes.
a) Remove the vial of Cosentyx
lyophilized powder from the refrigerator and allow to stand for 15 to 30
minutes to reach room temperature. Ensure the Sterile Water for Injection is at
room temperature.
b) Slowly inject 1 mL of
Sterile Water for Injection into the vial containing Cosentyx lyophilized
powder and direct the stream of Sterile Water for Injection onto the
lyophilized powder.
c) Tilt the vial at an angle
of approximately 45 degrees and gently rotate between the fingertips for
approximately 1 minute. Do not shake or invert the vial.
d) Allow the vial to stand for
about 10 minutes at room temperature to allow for dissolution. Note that
foaming may occur.
e) Tilt the vial at an angle
of approximately 45 degrees and gently rotate between the fingertips for
approximately 1 minute. Do not shake or invert the vial.
f) Allow the vial to stand
undisturbed at room temperature for approximately 5 minutes. The reconstituted
Cosentyx solution should be essentially free of visible particles, clear to
opalescent, and colorless to slightly yellow. Do not use if the lyophilized
powder has not fully dissolved or if the liquid contains visible particles, is
cloudy or discolored.
g) Prepare the required number
of vials (1 vial for the 150 mg dose or 2 vials for the 300 mg dose).
h) The Cosentyx reconstituted
solution contains 150 mg of secukinumab in 1 mL of solution. After
reconstitution, use the solution immediately or store in the refrigerator at
2ºC to 8ºC (36ºF to 46ºF) for up to 24 hours. Do not freeze.
i) If stored at 2ºC to 8ºC
(36ºF to 46ºF), allow the reconstituted Cosentyx solution to reach room
temperature (15 to 30 minutes) before administration. Cosentyx does not contain
preservatives; therefore, administer within 1 hour after removal from 2ºC to
8ºC (36ºF to 46ºF) storage.
DOSAGE FORMS AND STRENGTHSInjection: 150 mg/mL solution in a single-use
Sensoready penInjection: 150 mg/mL solution in a single-use
prefilled syringeFor Injection: 150 mg, lyophilized powder in a
single-use vial for reconstitution (for healthcare professional use only) CONTRAINDICATIONS
Cosentyx is contraindicated in
patients with a previous serious hypersensitivity reaction to secukinumab or to
any of the excipients [see Warnings and Precautions
(5.4)].
WARNINGS AND PRECAUTIONS Infections
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 patients 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 infections with 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 patients with psoriatic arthritis and ankylosing
spondylitis [see Adverse Reactions (6.1)].
The incidence of some types of infections appeared to be dose-dependent in
clinical studies [see Adverse Reactions (6.1)].
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, the patient should be closely monitored
and Cosentyx should be discontinued until the infection resolves.
Pre-treatment
Evaluation for Tuberculosis
Evaluate patients for
tuberculosis (TB) infection prior to initiating treatment with Cosentyx. Do not
administer Cosentyx to patients with active TB infection. Initiate treatment of
latent TB prior to administering Cosentyx. Consider anti-TB 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 confirmed. Patients receiving
Cosentyx should be monitored closely for signs and symptoms of active TB during
and after treatment.
Inflammatory
Bowel Disease
Caution should be used when
prescribing Cosentyx to patients with inflammatory bowel disease.
Exacerbations, in some cases serious, occurred in Cosentyx treated patients
during clinical trials in plaque psoriasis, psoriatic arthritis and ankylosing
spondylitis. In addition, new onset inflammatory bowel disease cases occurred
in clinical trials with Cosentyx. In an exploratory study in 59 patients 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 [see Adverse
Reactions (6.1)].
Hypersensitivity
Reactions
Anaphylaxis and cases of
urticaria occurred in Cosentyx treated patients in clinical trials. If an
anaphylactic or other serious allergic reaction occurs, administration of
Cosentyx should be discontinued immediately and appropriate therapy
initiated [see Adverse Reactions (6.1)].
Risk
of Hypersensitivity in Latex-sensitive Individuals
The removable cap of the
Cosentyx Sensoready pen and the Cosentyx prefilled syringe contains natural
rubber latex which may cause an allergic reaction in latex-sensitive
individuals. The safe use of Cosentyx Sensoready pen or prefilled syringe in
latex-sensitive individuals has not been studied.
Vaccinations
Prior to initiating therapy
with Cosentyx, consider completion of all age appropriate immunizations
according to current immunization guidelines. Patients treated with Cosentyx
should not receive live vaccines.
Non-live vaccinations received
during a course of Cosentyx may not elicit an immune response sufficient to
prevent disease.
ADVERSE REACTIONS
The following adverse
reactions are discussed in greater detail elsewhere in the labeling:
Infections [see
Warnings and Precautions (5.1)]Inflammatory Bowel Disease [see Warnings and Precautions (5.3)]Hypersensitivity Reactions [see Warnings and Precautions (5.4)] Clinical
Trials Experience
Because clinical trials are
conducted under widely varying conditions, adverse reaction rates observed in
the clinical trials of a drug cannot be directly compared to rates in the
clinical trials of another drug and may not reflect the rates observed in
practice.
Plaque
Psoriasis
A total of 3430 plaque
psoriasis subjects were treated with Cosentyx in controlled and uncontrolled
clinical trials. Of these, 1641 subjects were exposed for at least 1 year.
Four placebo-controlled phase
3 trials in plaque psoriasis subjects were pooled to evaluate the safety of
Cosentyx in comparison to placebo up to 12 weeks after treatment initiation, in
Trials 1, 2, 3, and 4. In total, 2077 subjects were evaluated (691 to Cosentyx
300 mg group, 692 to Cosentyx 150 mg group, and 694 to placebo group) [see Clinical Studies (14)].
Table 1 summarizes the adverse
reactions that occurred at a rate of at least 1% and at a higher rate in the
Cosentyx groups than the placebo group during the 12-week placebo-controlled
period of the placebo-controlled trials.
Table 1: Adverse Reactions Reported by
Greater Than 1% of Subjects with Plaque Psoriasis Through Week 12 in Trials
1, 2, 3, and 4
|
|
|
Cosentyx
|
|
|
Adverse Reactions
|
300 mg
(N=691)
n (%)
|
150 mg
(N=692)
n (%)
|
Placebo
(N=694)
n (%)
|
|
Nasopharyngitis
|
79 (11.4)
|
85 (12.3)
|
60 (8.6)
|
|
Diarrhea
|
28 (4.1)
|
18 (2.6)
|
10 (1.4)
|
|
Upper
respiratory tract infection
|
17 (2.5)
|
22 (3.2)
|
5 (0.7)
|
|
Rhinitis
|
10 (1.4)
|
10 (1.4)
|
5 (0.7)
|
|
Oral herpes
|
9 (1.3)
|
1 (0.1)
|
2 (0.3)
|
|
Pharyngitis
|
8 (1.2)
|
7 (1.0)
|
0 (0)
|
|
Urticaria
|
4 (0.6)
|
8 (1.2)
|
1 (0.1)
|
|
Rhinorrhea
|
8 (1.2)
|
2 (0.3)
|
1 (0.1)
|
Adverse reactions that
occurred at rates less than 1% in the placebo-controlled period of Trials 1, 2,
3, and 4 through Week 12 included: sinusitis, tinea pedis, conjunctivitis,
tonsillitis, oral candidiasis, impetigo, otitis media, otitis externa, inflammatory
bowel disease, increased liver transaminases, and neutropenia.
Infections
In the placebo-controlled
period of the clinical trials in plaque psoriasis (a total of 1382 subjects
treated with Cosentyx and 694 subjects treated with placebo up to 12 weeks),
infections were reported in 28.7% of subjects treated with Cosentyx compared
with 18.9% of subjects treated with placebo. Serious infections occurred in
0.14% of patients treated with Cosentyx and in 0.3% of patients treated with
placebo [see Warnings and Precautions (5.1)].
Over the entire treatment
period (a total of 3430 plaque psoriasis subjects treated with Cosentyx for up
to 52 weeks for the majority of subjects), infections were reported in 47.5% of
subjects treated with Cosentyx (0.9 per patient-year of follow-up). Serious
infections were reported in 1.2% of subjects treated with Cosentyx (0.015 per
patient-year of follow-up).
Phase 3 data showed an
increasing trend for some types of infection with increasing serum
concentration of secukinumab. Candida infections, herpes viral infections,
staphylococcal skin infections, and infections requiring treatment increased as
serum concentration of secukinumab increased.
Neutropenia was observed in
clinical trials. Most cases of secukinumab-associated neutropenia were
transient and reversible. No serious infections were associated with cases of
neutropenia.
Inflammatory
Bowel Disease
Cases of inflammatory bowel
disease, in some cases serious, were observed in clinical trials with Cosentyx.
In the plaque psoriasis program, with 3430 patients exposed to Cosentyx over
the entire treatment period for up to 52 weeks (2,725 patient-years), there
were 3 cases (0.11 per 100 patient-years) of exacerbation of Crohn’s disease, 2
cases (0.08 per 100 patient-years) of exacerbation of ulcerative colitis, and 2
cases (0.08 per 100 patient-years) of new onset ulcerative colitis. There were
no cases in placebo patients (N=793; 176 patient-years) during the 12 week
placebo-controlled period.
One case of exacerbation of
Crohn’s disease was reported from long-term non-controlled portions of ongoing
clinical trials in plaque psoriasis [see Warnings
and Precautions (5.3)].
Hypersensitivity
Reactions
Anaphylaxis and cases of
urticaria occurred in Cosentyx treated patients in clinical trials [see Warnings and Precautions (5.4)].
Psoriatic
Arthritis
Cosentyx was studied in two
placebo controlled psoriatic arthritis trials with 1003 patients (703 patients
on Cosentyx and 300 patients on placebo). Of the 703 patients who received Cosentyx,
299 patients received a subcutaneous loading dose of Cosentyx (PsA1) and 404
patients received an intravenous loading dose of secukinumab (PsA2) followed by
Cosentyx administered by subcutaneous injection every four weeks. During the
16-week placebo-controlled period of the trials in patients with psoriatic
arthritis, the overall proportion of patients with adverse events was similar
in the secukinumab and placebo-treatment groups (59% and 58%, respectively).
The adverse events that occurred at a proportion of at least 2% and at a higher
proportion in the Cosentyx groups than the placebo groups during the 16-week
placebo-controlled period were nasopharyngitis, upper respiratory tract
infection, headache, nausea, and hypercholesterolemia. The safety profile
observed in patients with psoriatic arthritis treated with Cosentyx is
consistent with the safety profile in psoriasis.
Similar to the clinical trials
in patients with psoriasis, there was an increased proportion of patients with
infections in the Cosentyx groups (29%) compared to placebo group (26%) [see Warnings and Precautions (5.1)].
There were cases of Crohn’s
disease and ulcerative colitis that include patients who experienced either
exacerbations or the development of new disease. There were three cases of
inflammatory bowel disease, of which two patients received secukinumab and one
received placebo [see Warnings and Precautions
(5.3)].
Ankylosing
Spondylitis
Cosentyx was studied in two
placebo controlled ankylosing spondylitis trials with 590 patients (394
patients on Cosentyx and 196 patients on placebo). Of the 394 patients who
received Cosentyx, 145 patients received a subcutaneous load of Cosentyx (study
AS1) and 249 received an intravenous loading dose of secukinumab (study AS2)
followed by Cosentyx administered by subcutaneous injection every four weeks.
During the 16-week placebo-controlled period of the trials in patients with
ankylosing spondylitis, the overall proportion of patients with adverse events
was higher in the secukinumab groups than the placebo-treatment groups (66% and
59%, respectively). The adverse events that occurred at a proportion of at
least 2% and at a higher proportion in the Cosentyx groups than the placebo
groups during the 16-week placebo-controlled period were nasopharyngitis,
nausea, and upper respiratory tract infection. The safety profile observed in
patients with ankylosing spondylitis treated with Cosentyx is consistent with
the safety profile in psoriasis.
Similar to clinical trials in
patients with psoriasis, there was an increased proportion of patients with
infections in the Cosentyx groups (31%) compared to the placebo group
(18%) [see Warnings and Precautions (5.1)].
In the ankylosing spondylitis
program, with 571 patients exposed to Cosentyx there were 8 cases of
inflammatory bowel disease during the entire treatment period (5 Crohn’s (0.7
per 100 patient-years) and 3 ulcerative colitis (0.4 per 100 patient-years).
During the placebo-controlled 16-week period, there were 2 Crohn’s disease
exacerbations and 1 new onset ulcerative colitis case that was a serious
adverse event in patients treated with Cosentyx compared to none of the
patients treated with placebo. During the remainder of the study when all
patients received Cosentyx, 1 patient developed Crohn’s disease, 2 patients had
Crohn’s exacerbations, 1 patient developed ulcerative colitis, and 1 patient
had an ulcerative colitis exacerbation [see
Warnings and Precautions (5.3)].
Immunogenicity
As with all therapeutic
proteins, there is the potential for immunogenicity. The immunogenicity of
Cosentyx was evaluated using an electrochemiluminescence-based bridging
immunoassay. Less than 1% of subjects treated with Cosentyx developed
antibodies to secukinumab in up to 52 weeks of treatment. However, this assay
has limitations in detecting anti-secukinumab antibodies in the presence of
secukinumab; therefore the incidence of antibody development might not have
been reliably determined. Of the subjects who developed antidrug antibodies,
approximately one-half had antibodies that were classified as neutralizing.
Neutralizing antibodies were not associated with loss of efficacy.
The detection of antibody
formation is highly dependent on the sensitivity and specificity of the assay.
Additionally, the observed incidence of antibody (including neutralizing
antibody) positivity in an assay may be influenced by several factors including
assay methodology, sample handling, timing of sample collection, concomitant
medications, and underlying disease. For these reasons, comparison of incidence
of antibodies to Cosentyx with the incidences of antibodies to other products
may be misleading.
DRUG INTERACTIONS Live
Vaccines
Patients treated with Cosentyx
may not receive live vaccinations [see Warnings and
Precautions (5.6)].
Non-Live
Vaccines
Patients treated with Cosentyx
may receive non-live vaccinations. Healthy individuals who received a single
150 mg dose of Cosentyx 2 weeks prior to vaccination with a non-U.S. approved
group C meningococcal polysaccharide conjugate vaccine and a non-U.S. approved
inactivated seasonal influenza vaccine had similar antibody responses compared
to individuals who did not receive Cosentyx prior to vaccination. The clinical
effectiveness of meningococcal and influenza vaccines has not been assessed in
patients undergoing treatment with Cosentyx [see
Warnings and Precautions (5.6)].
CYP450
Substrates
The formation of CYP450
enzymes can be altered by increased levels of certain cytokines (e.g., IL-1,
IL-6, IL-10, TNFα, IFN) during chronic inflammation.
Results from a drug-drug
interaction study in subjects with moderate to severe psoriasis showed no
clinically relevant interaction for drugs metabolized by CYP3A4.
Upon initiation or
discontinuation of Cosentyx in patients who are receiving concomitant CYP450
substrates, particularly those with a narrow therapeutic index, consider
monitoring for therapeutic effect or drug concentration and consider dosage
adjustment as needed [see Clinical Pharmacology
(12.3)].
USE IN SPECIFIC POPULATIONS Pregnancy
Pregnancy
Category B
There are no adequate and well
controlled trials of Cosentyx in pregnant women. Developmental toxicity studies
conducted with monkeys found no evidence of harm to the fetus due to
secukinumab. Cosentyx should be used during pregnancy only if the potential
benefit justifies the potential risk to the fetus.
An embryofetal development
study was performed in cynomolgus monkeys with secukinumab. No malformations or
embryofetal toxicity were observed in fetuses from pregnant monkeys that were
administered secukinumab weekly by the subcutaneous route during the period of
organogenesis at doses up to 30 times the maximum recommended human dose (MRHD;
on a mg/kg basis at a maternal dose of 150 mg/kg).
A pre- and post-natal
development toxicity study was performed in mice with a murine analog of
secukinumab. No treatment related effects on functional, morphological or
immunological development were observed in fetuses from pregnant mice that were
administered the murine analog of secukinumab on gestation days 6, 11, and 17
and on postpartum days 4, 10, and 16 at doses up to 150 mg/kg/dose.
Nursing
Mothers
It is not known whether
secukinumab is excreted in human milk or absorbed systemically after ingestion.
Because many drugs are excreted in human milk, caution should be exercised when
Cosentyx is administered to a nursing woman.
Pediatric
Use
Safety and effectiveness of
Cosentyx in pediatric patients have not been evaluated.
Geriatric
Use
Of the 3430 plaque psoriasis
subjects exposed to Cosentyx in clinical trials, a total of 230 were 65 years
or older, and 32 subjects were 75 years or older. Although no differences in
safety or efficacy were observed between older and younger subjects, the number
of subjects aged 65 years and older was not sufficient to determine whether
they responded differently from younger subjects.
OVERDOSAGE
Doses up to 30 mg/kg
intravenously have been administered in clinical trials without dose-limiting
toxicity. In the event of overdosage, it is recommended that the patient be
monitored for any signs or symptoms of adverse reactions and appropriate
symptomatic treatment be instituted immediately.
DESCRIPTION
Secukinumab is a recombinant
human monoclonal IgG1/κ antibody that binds specifically to IL-17A. It is
expressed in a recombinant Chinese Hamster Ovary (CHO) cell line. Secukinumab
has a molecular mass of approximately 151 kDa; both heavy chains of secukinumab
contain oligosaccharide chains.
Cosentyx
Injection
Cosentyx injection is a
sterile, preservative-free, clear to slightly opalescent, colorless to slightly
yellow solution. Cosentyx is supplied in a single-use Sensoready pen with a
27-gauge fixed ½-inch needle, or a single-use prefilled syringe with a 27-gauge
fixed ½-inch needle. The removable cap of the Cosentyx Sensoready pen or
prefilled syringe contains natural rubber latex.
Each Cosentyx Sensoready pen
or prefilled syringe contains 150 mg of secukinumab formulated in:
L-histidine/histidine hydrochloride monohydrate (3.103 mg), L-methionine (0.746
mg), polysorbate 80 (0.2 mg), trehalose dihydrate (75.67 mg), and Sterile Water
for Injection, USP, at pH of 5.8.
Cosentyx
for Injection
Cosentyx for injection is
supplied as a sterile, preservative free, white to slightly yellow, lyophilized
powder in single-use vials. Each Cosentyx vial contains 150 mg of secukinumab
formulated in L-histidine/histidine hydrochloride monohydrate (4.656 mg), polysorbate
80 (0.6 mg), and sucrose (92.43 mg). Following reconstitution with 1 mL Sterile
Water for Injection, USP, the resulting pH is approximately 5.8.
CLINICAL PHARMACOLOGY Mechanism
of Action
Secukinumab is a human IgG1
monoclonal antibody that selectively binds to the interleukin-17A (IL-17A)
cytokine and inhibits its interaction with the IL-17 receptor. IL-17A is a
naturally occurring cytokine that is involved in normal inflammatory and immune
responses. Secukinumab inhibits the release of proinflammatory cytokines and
chemokines.
Pharmacodynamics
Elevated levels of IL-17A are
found in psoriatic plaques. Treatment with Cosentyx may reduce epidermal
neutrophils and IL-17A levels in psoriatic plaques. Serum levels of total
IL-17A (free and secukinumab-bound IL-17A) measured at Week 4 and Week 12 were
increased following secukinumab treatment. These pharmacodynamic activities are
based on small exploratory studies. The relationship between these
pharmacodynamic activities and the mechanism(s) by which secukinumab exerts its
clinical effects is unknown.
Increased numbers of IL-17A
producing lymphocytes and innate immune cells and increased levels of IL-17A
have been found in the blood of patients with psoriatic arthritis and
ankylosing spondylitis.
Pharmacokinetics
The PK properties of
secukinumab observed in psoriatic arthritis and ankylosing spondylitis patients
were similar to the PK properties displayed in plaque psoriasis patients.
Absorption
Following a single
subcutaneous dose of either 150 mg (one-half the recommended dose) or 300 mg in
plaque psoriasis patients, secukinumab reached peak mean (± SD) serum
concentrations (Cmax) of 13.7 ± 4.8 mcg/mL and 27.3 ± 9.5 mcg/mL, respectively, by
approximately 6 days post dose.
Following multiple
subcutaneous doses of secukinumab, the mean (± SD) serum trough concentrations
of secukinumab ranged from 22.8 ± 10.2 mcg/mL (150 mg) to 45.4 ± 21.2 mcg/mL
(300 mg) at Week 12. At the 300 mg dose at Week 4 and Week 12, the mean trough
concentrations resulted from the Sensoready pen were 23% to 30% higher than
those from the lyophilized powder and 23% to 26% higher than those from the
prefilled syringe based on cross-study comparisons.
Steady-state concentrations of
secukinumab were achieved by Week 24 following the every 4 week dosing
regimens. The mean (± SD) steady-state trough concentrations ranged from 16.7 ±
8.2 mcg/mL (150 mg) to 34.4 ± 16.6 mcg/mL (300 mg).
In healthy subjects and
subjects with plaque psoriasis, secukinumab bioavailability ranged from 55% to
77% following subcutaneous dose of 150 mg (one-half the recommended dose) or
300 mg.
Distribution
The mean volume of
distribution during the terminal phase (Vz) following a single intravenous
administration ranged from 7.10 to 8.60 L in plaque psoriasis patients.
Intravenous use is not recommended [see Dosage and
Administration (2)].
Secukinumab concentrations in
interstitial fluid in lesional and non-lesional skin of plaque psoriasis
patients ranged from 27% to 40% of those in serum at 1 and 2 weeks after a
single subcutaneous dose of secukinumab 300 mg.
Elimination
The metabolic pathway of
secukinumab has not been characterized. As a human IgG1κ monoclonal antibody
secukinumab is expected to be degraded into small peptides and amino acids via
catabolic pathways in the same manner as endogenous IgG.
The mean systemic clearance
(CL) ranged from 0.14 L/day to 0.22 L/day and the mean half-life ranged from 22
to 31 days in plaque psoriasis subjects following intravenous and subcutaneous
administration across all psoriasis trials. Intravenous use is not
recommended [see Dosage and Administration (2)].
Dose
Linearity
Secukinumab exhibited
dose-proportional pharmacokinetics in subjects with psoriasis over a dose range
from 25 mg (approximately 0.083 times the recommended dose) to 300 mg following
subcutaneous administrations.
Weight
Secukinumab clearance and
volume of distribution increase as body weight increases.
Specific
Populations
Hepatic
or Renal Impairment:
No formal trial of the effect
of hepatic or renal impairment on the pharmacokinetics of secukinumab was
conducted.
Age:
Geriatric Population:
Population pharmacokinetic
analysis indicated that the clearance of secukinumab was not significantly
influenced by age in adult subjects with plaque psoriasis, psoriatic arthritis
and ankylosing spondylitis. Subjects who are 65 years or older had apparent
clearance of secukinumab similar to subjects less than 65 years old.
Drug
Interactions
Cytochrome
P450 Substrates
In subjects with plaque
psoriasis, midazolam (CYP3A4 substrate) pharmacokinetics was similar when
administered alone, or when administered following either a single or five
weekly subcutaneous administrations of 300 mg secukinumab [see Drug interactions (7.3)].
NONCLINICAL TOXICOLOGY Carcinogenesis,
Mutagenesis, Impairment of Fertility
Animal studies have not been
conducted to evaluate the carcinogenic or mutagenic potential of Cosentyx. Some
published literature suggests that IL-17A directly promotes cancer cell
invasion in vitro, whereas other reports indicate IL-17A promotes T-cell
mediated tumor rejection. Depletion of IL-17A with a neutralizing antibody
inhibited tumor development in mice. The relevance of experimental findings in
mouse models for malignancy risk in humans is unknown.
No effects on fertility were
observed in male and female mice that were administered a murine analog of
secukinumab at subcutaneous doses up to 150 mg/kg once weekly prior to and
during the mating period.
CLINICAL STUDIES Plaque
Psoriasis
Four multicenter, randomized,
double-blind, placebo-controlled trials (Trials 1, 2, 3, and 4) enrolled 2403
subjects (691 randomized to Cosentyx 300 mg, 692 to Cosentyx 150 mg, 694 to
placebo, and 323 to a biologic active control) 18 years of age and older with
plaque psoriasis who had a minimum body surface area involvement of 10%, and
Psoriasis Area and Severity Index (PASI) score greater than or equal to 12, and
who were candidates for phototherapy or systemic therapy.
Trial 1 enrolled 738 subjects (245 randomized to
Cosentyx 300 mg, 245 to Cosentyx 150 mg, and 248 to placebo). Subjects
received subcutaneous treatment at Weeks 0, 1, 2, 3, and 4 followed by
dosing every 4 weeks. Subjects randomized to Cosentyx received 300 mg or
150 mg doses at Weeks 0, 1, 2, 3, and 4 followed by the same dose every 4
weeks. Subjects randomized to receive placebo that were non-responders at
Week 12 were then crossed over to receive Cosentyx (either 300 mg or 150
mg) at Weeks 12, 13, 14, 15, and 16 followed by the same dose every 4
weeks. All subjects were followed for up to 52 weeks following first
administration of study treatment.Trial 2 enrolled 1306 subjects (327 randomized to
Cosentyx 300 mg, 327 to Cosentyx 150 mg, 326 to placebo, and 323 to a
biologic active control). Cosentyx and placebo data are described.
Subjects received subcutaneous treatment at Weeks 0, 1, 2, 3, and 4
followed by dosing every 4 weeks. Subjects randomized to Cosentyx received
300 mg or 150 mg doses at Weeks 0, 1, 2, 3, and 4 followed by the same
dose every 4 weeks. Subjects randomized to receive placebo that were
non-responders at Week 12 then crossed over to receive Cosentyx (either
300 mg or 150 mg) at Weeks 12, 13, 14, 15, and 16 followed by the same
dose every 4 weeks. All subjects were followed for up to 52 weeks
following first administration of study treatment.Trial 3 enrolled 177 subjects (59 randomized to
Cosentyx 300 mg, 59 to Cosentyx 150 mg, and 59 to placebo) and assessed
safety, tolerability, and usability of Cosentyx self-administration via
prefilled syringe for 12 weeks. Subjects received subcutaneous treatment
at Weeks 0, 1, 2, 3, and 4, followed by the same dose every 4 weeks for up
to 12 weeks total.Trial 4 enrolled 182 subjects (60 randomized to
Cosentyx 300 mg, 61 to Cosentyx 150 mg, and 61 to placebo) and assessed
safety, tolerability, and usability of Cosentyx self-administration via
Sensoready pen for 12 weeks. Subjects received subcutaneous treatment at
Weeks 0, 1, 2, 3, and 4, followed by the same dose every 4 weeks for up to
12 weeks total.
Endpoints
In all trials, the endpoints
were the proportion of subjects who achieved a reduction in PASI score of at
least 75% (PASI 75) from baseline to Week 12 and treatment success (clear or
almost clear) on the Investigator’s Global Assessment modified 2011 (IGA).
Other evaluated outcomes included the proportion of subjects who achieved a
reduction in PASI score of at least 90% (PASI 90) from baseline at Week 12, maintenance
of efficacy to Week 52, and improvements in itching, pain, and scaling at Week
12 based on the Psoriasis Symptom Diary©.
The PASI is a composite score
that takes into consideration both the percentage of body surface area affected
and the nature and severity of psoriatic changes within the affected regions
(induration, erythema and scaling). The IGA is a 5-category scale including “0
= clear”, “1 = almost clear”, “2 = mild”, “3 = moderate” or “4 = severe”
indicating the physician’s overall assessment of the psoriasis severity
focusing on induration, erythema and scaling. Treatment success of “clear” or
“almost clear” consisted of no signs of psoriasis or normal to pink coloration
of lesions, no thickening of the plaque, and none to minimal focal scaling.
Baseline Characteristics
Across all treatment groups
the baseline PASI score ranged from 11 to 72 with a median of 20 and the
baseline IGA score ranged from “moderate” (62%) to “severe” (38%). Of the 2077
plaque psoriasis subjects who were included in the placebo-controlled trials,
79% were biologic-naïve (have never received a prior treatment with biologics)
and 45% were non-biologic failures (failed to respond to a prior treatment with
non-biologics therapies). Of the patients who received a prior treatment with
biologics, over one-third were biologic failures. Approximately 15% to 25% of
trial subjects had a history of psoriatic arthritis.
Clinical
Response
The results of Trials 1 and 2
are presented in Table 2.
Table 2: Clinical Outcomes at Week 12 in
Adults with Plaque Psoriasis in Trials 1 and 2
|
|
|
Trial 1
|
Trial 2
|
|
|
Cosentyx
300 mg
(N=245)
n (%)
|
Cosentyx
150 mg
(N=245)
n (%)
|
Placebo
(N=248)
n (%)
|
Cosentyx
300 mg
(N=327)
n (%)
|
Cosentyx
150 mg
(N=327)
n (%)
|
Placebo
(N=326)
n (%)
|
|
PASI 75 response
|
200 (82)
|
174 (71)
|
11 (4)
|
249 (76)
|
219 (67)
|
16 (5)
|
|
IGA of clear or almost clear
|
160 (65)
|
125 (51)
|
6 (2)
|
202 (62)
|
167 (51)
|
9 (3)
|
The results of Trials 3 and 4
are presented in Table 3.
Table 3: Clinical Outcomes at Week 12 in
Adults with Plaque Psoriasis in Trials 3 and 4
|
|
|
Trial 3
|
Trial 4
|
|
|
Cosentyx
300 mg
(N=59)
n (%)
|
Cosentyx
150 mg
(N=59)
n (%)
|
Placebo
(N=59)
n (%)
|
Cosentyx
300 mg
(N=60)
n (%)
|
Cosentyx
150 mg
(N=61)
n (%)
|
Placebo
(N=61)
n (%)
|
|
PASI 75 response
|
44 (75)
|
41 (69)
|
0 (0)
|
52 (87)
|
43 (70)
|
2 (3)
|
|
IGA of clear or almost clear
|
40 (68)
|
31 (53)
|
0 (0)
|
44 (73)
|
32 (52)
|
0 (0)
|
Examination of age, gender,
and race subgroups did not identify differences in response to Cosentyx among
these subgroups. Based on post-hoc sub-group analyses in patients with moderate
to severe psoriasis, patients with lower body weight and lower disease severity
may achieve an acceptable response with Cosentyx 150 mg.
PASI 90 response at Week 12
was achieved with Cosentyx 300 mg and 150 mg compared to placebo in 59%
(145/245) and 39% (95/245) versus 1% (3/248) of subjects, respectively (Trial
1) and 54% (175/327) and 42% (137/327) versus 2% (5/326) of subjects,
respectively (Trial 2). Similar results were seen in Trials 3 and 4.
With continued treatment over
52 weeks, subjects in Trial 1 who were PASI 75 responders at Week 12 maintained
their responses in 81% (161/200) of the subjects treated with Cosentyx 300 mg
and in 72% (126/174) of subjects treated with Cosentyx 150 mg. Trial 1 subjects
who were clear or almost clear on the IGA at Week 12 also maintained their
responses in 74% (119/160) of subjects treated with Cosentyx 300 mg and in 59%
(74/125) of subjects treated with Cosentyx 150 mg. Similarly in Trial 2, PASI
75 responders maintained their responses in 84% (210/249) of subjects treated
with Cosentyx 300 mg and in 82% (180/219) of subjects treated with Cosentyx 150
mg. Trial 2 subjects who were clear or almost clear on the IGA also maintained their
responses in 80% (161/202) of subjects treated with Cosentyx 300 mg and in 68%
(113/167) of subjects treated with Cosentyx 150 mg.
Among the subjects who chose
to participate (39%) in assessments of patient reported outcomes, improvements
in signs and symptoms related to itching, pain, and scaling, at Week 12
compared to placebo (Trials 1 and 2) were observed using the Psoriasis Symptom
Diary©.
Psoriatic
Arthritis
The safety and efficacy of
Cosentyx were assessed in 1003 patients, in 2 randomized, double-blind,
placebo-controlled studies (PsA1 and PsA2) in adult patients, age 18 years and
older with active psoriatic arthritis (greater than 3 swollen and greater than
3 tender joints) despite non-steroidal anti-inflammatory drug (NSAID),
corticosteroid or disease modifying anti-rheumatic drug (DMARD) therapy.
Patients in these studies had a diagnosis of PsA of at least 5 years across
both studies. At baseline, over 62% and 47% of the patients had enthesitis and
dactylitis, respectively. Overall, 32% of patients discontinued previous
treatment with anti-TNFα agents due to either lack of efficacy or intolerance.
In addition, approximately 55% of patients from both studies had concomitant
methotrexate (MTX) use. Patients with different subtypes of PsA were enrolled
including polyarticular arthritis with no evidence of rheumatoid nodules (80%),
asymmetric peripheral arthritis (62%), distal interphalangeal involvement
(59%), spondylitis with peripheral arthritis (20%) and arthritis mutilans (7%).
PsA1 Study evaluated 397
patients, who were treated with Cosentyx 75 mg, 150 mg or 300 mg subcutaneous
treatment at Weeks 0, 1, 2, 3 and 4, followed by the same dose every 4 weeks.
Patients receiving placebo were re-randomized to receive Cosentyx (either 150
mg or 300 mg every 4 weeks) at Week 16 or Week 24 based on responder status.
The primary endpoint was the percentage of patients achieving an ACR20 response
at Week 24.
PsA2 Study evaluated 606
patients, who were treated with secukinumab 10 mg/kg, intravenous treatment (or
placebo) at Weeks 0, 2, and 4, followed by either 75 mg or 150 mg subcutaneous
Cosentyx treatment (or placebo) every 4 weeks. Patients receiving placebo were
re-randomized to receive Cosentyx (either 75 mg or 150 mg every 4 weeks) at
Week 16 or Week 24 based on responder status.
Clinical
Response
In PsA1, patients treated with
150 mg or 300 mg Cosentyx demonstrated a greater clinical response including
ACR20, ACR50, and ACR70 compared to placebo at Week 24 (Table 4). Responses
were similar in patients regardless of concomitant methotrexate treatment.
Responses were seen regardless of prior anti-TNFα exposure.
In patients with coexistent
plaque psoriasis receiving Cosentyx (n=99), the skin lesions of psoriasis
improved with treatment, relative to placebo, as measured by the Psoriasis Area
Severity Index (PASI).
Table 4: Responsesa in PsA1 Study at Week 16 and Week 24
|
|
a Patients who met escape criteria
(less than 20% improvement in tender or swollen joint counts) at Week 16 were
considered non-responders
|
|
|
Cosentyx
|
Cosentyx
|
Placebo
|
Difference from placebo (95% CI)
|
|
|
150 mg
(N=100)
|
300 mg
(N=100)
|
(N=98)
|
Cosentyx
150 mg
|
Cosentyx
300 mg
|
|
ACR20 response
|
|
|
|
Week 16 (%)
|
60
|
57
|
18
|
42
(30, 54)
|
38
(26, 51)
|
|
Week 24 (%)
|
51
|
54
|
15
|
36
(24, 48)
|
39
(27, 51)
|
|
ACR50 response
|
|
|
|
Week 16 (%)
|
37
|
35
|
6
|
31
(21, 42)
|
28
(18, 39)
|
|
Week 24 (%)
|
35
|
35
|
7
|
28
(18, 38)
|
28
(17, 38)
|
|
ACR70 response
|
|
|
|
Week 16 (%)
|
17
|
15
|
2
|
15
(7, 23)
|
13
(5, 20)
|
|
Week 24 (%)
|
21
|
20
|
1
|
20
(12, 28)
|
19
(11, 27)
|
The percentage of patients
achieving ACR20 response by visit is shown in Figure 1. Patients on placebo who
received Cosentyx without a loading regimen achieved similar ACR20 responses
over time (data not shown).
Figure
1: Percent of Patients Achieving ACR 20 Responsea in
PsA1 Study Through Week 24
a Patients who met escape criteria (less than 20%
improvement in tender or swollen joint counts) at Week 16 were considered
non-responders
The improvements in the components
of the ACR response criteria are shown in Table 5.
Table 5: Mean Change from Baseline in ACR
Components at Week 16a (PsA1 Study)
|
|
a Week 16 rather than Week 24 data
are displayed to provide comparison between arms prior to placebo escape to Cosentyx.
b Mean Change based upon observed
data
|
|
|
Cosentyx
150 mg
(N=100)
|
Cosentyx
300 mg
(N=100)
|
Placebo
(N=98)
|
|
No. of Swollen Joints
|
|
Baseline
|
12.0
|
11.2
|
12.1
|
|
Mean change at
Week 16
|
-4.86
|
-5.83
|
-3.22
|
|
Number of Tender Joints
|
|
Baseline
|
24.1
|
20.2
|
23.5
|
|
Mean change at
Week 16
|
-10.70
|
-10.01
|
-1.77
|
|
Patient’s assessment of Pain
|
|
Baseline
|
58.9
|
57.7
|
55.4
|
|
Mean change at
Week 16
|
-22.91
|
-23.97
|
-7.98
|
|
Patient Global Assessment
|
|
Baseline
|
62.0
|
60.7
|
57.6
|
|
Mean change at
Week 16
|
-25.47
|
-25.40
|
-8.25
|
|
Physician Global Assessment
|
|
Baseline
|
56.7
|
55.0
|
55.0
|
|
Mean change at
Week 16
|
-29.24
|
-34.71
|
-14.95
|
|
Disability Index (HAQ)
|
|
Baseline
|
1.2200
|
1.2828
|
1.1684
|
|
Mean change at
Week 16
|
-0.45
|
-0.55
|
-0.23
|
|
CRP (mg/L)
|
|
Baseline
|
14.15
|
10.88
|
7.87
|
|
Mean Change at
Week 16b
|
-8.41
|
-7.21
|
0.79
|
Improvements in enthesitis and
dactylitis scores were observed in each Cosentyx group compared to placebo at
Week 24.
Physical
Function and Health Related Quality of Life
Improvement in physical
function as assessed by Health Assessment Questionnaire-Disability Index
(HAQ-DI) demonstrated that the proportion of patients who achieved at least
-0.3 improvement in HAQ-DI score from baseline was greater in the Cosentyx 150
mg and 300 mg groups compared to placebo at Week 16 and 24. At Week 16 in PsA1
study, estimated mean change from baseline was -0.23 in the placebo group
compared with -0.45 in the Cosentyx 150 mg group and -0.55 in the Cosentyx 300
mg group.
Ankylosing
Spondylitis
The safety and efficacy of
Cosentyx were assessed in 590 patients in two randomized, double-blind,
placebo-controlled studies (AS1 and AS2) in adult patients 18 years of age and
older with active ankylosing spondylitis. Patients had active disease as
defined by the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)
greater or equal to 4 despite non-steroidal anti-inflammatory drug (NSAID),
corticosteroid or disease modifying anti-rheumatic drug (DMARD) therapy. At
baseline, approximately 14% and 26% used concomitant methotrexate or sulfasalazine,
respectively. Overall, 33% of patients discontinued previous treatment with
anti-TNFα agents due to either lack of efficacy or intolerance.
AS1 Study evaluated 219
patients, who were treated with Cosentyx 75 mg or 150 mg subcutaneous treatment
at Weeks 0, 1, 2, 3 and 4, followed by the same dose every 4 weeks. At Week 16,
patients receiving placebo were re-randomized to either Cosentyx 75 mg or 150
mg every 4 weeks. The primary endpoint was the percentage of patients achieving
an ASAS20 response at Week 16.
AS2 Study evaluated 371
patients, who were treated with secukinumab 10 mg/kg intravenous treatment at
Weeks 0, 2, and 4 (for both treatment arms) or placebo, followed by either 75
mg or 150 mg subcutaneous Cosentyx treatment every 4 weeks or placebo. Patients
receiving placebo were re-randomized to receive Cosentyx (either 75 mg or 150
mg every 4 weeks) at Week 16 or Week 24 based on responder status.
Clinical
Response
In AS1, patients treated with
150 mg Cosentyx demonstrated greater improvements in ASAS20 and ASAS40
responses compared to placebo at Week 16 (Table 6). Responses were similar in
patients regardless of concomitant therapies.
Table 6: ASAS20 and ASAS40 Responses in
All AS Patients at Week 16 in Study AS1
|
|
|
Cosentyx
150 mg
(n = 72)
|
Placebo
(n = 74)
|
Difference from placebo
(95% CI)
|
|
ASAS20 response, %
|
61
|
28
|
33
(18, 48)
|
|
ASAS40 response, %
|
36
|
11
|
25
(12, 38)
|
The improvements in the main
components of the ASAS20 response criteria and other measures of disease
activity are shown in Table 7.
Table 7: ASAS20 Components and Other
Measures of Disease Activity at Week 16 (AS1 Study)
|
|
1. Percent
of subjects with at least a 20% and 10 unit improvement measured on a Visual
Analog Scale (VAS) with 0= none, 100= severe
2. Bath
Ankylosing Spondylitis Functional Index
3. Inflammation
is the mean of two patient-reported stiffness self-assessment in BASDAI
4. Bath
Ankylosing Spondylitis Disease Activity Index
5. Bath
Ankylosing Spondylitis Metrology Index
6. High
sensitivity C-reactive protein / mean change based upon observed data
|
|
|
Cosentyx
150 mg
(N = 72)
|
Placebo
(N = 74)
|
|
|
Baseline
|
Week 16
change from baseline
|
Baseline
|
Week 16
change from baseline
|
|
ASAS20 Response criteria
|
|
|
|
|
|
-Patient Global Assessment of Disease Activity (0-100 mm)1
|
67.5
|
-27.7
|
70.5
|
-12.9
|
|
-Total spinal pain (0-100 mm)
|
66.2
|
-28.5
|
69.2
|
-10.9
|
|
-BASFI (0-10)2
|
6.2
|
-2.2
|
6.1
|
-0.7
|
|
-Inflammation (0-10)3
|
6.5
|
-2.5
|
6.5
|
-0.8
|
|
BASDAI Score4
|
6.6
|
-2.2
|
6.8
|
-0.9
|
|
BASMI5
|
3.6
|
-0.51
|
3.9
|
-0.22
|
|
hsCRP6 (mg/L) Mean Change at Week 16
|
27.0
|
-17.2
|
15.9
|
0.8
|
The percent of patients
achieving ASAS20 responses by visit is shown in Figure 2. Patients on placebo
who received Cosentyx without a loading regimen achieved similar ASAS20
responses over time (data not shown).
Figure
2: ASAS20 Responses in all AS1 Study Patients Over Time Up to Week 16
Cosentyx treated patients
showed improvement compared to placebo-treated patients in health-related
quality of life as assessed by ASQoL at Week 16.
HOW SUPPLIED/STORAGE AND HANDLING
How
Supplied
Cosentyx Sensoready pen:
NDC 0078-0639-41: Carton of two 150 mg/mL (300 mg
dose) Sensoready pens (injection)
NDC 0078-0639-68: Carton of one 150 mg/mL
single-use Sensoready pen (injection)
Cosentyx prefilled syringe:
NDC 0078-0639-98: Carton of two 150 mg/mL (300 mg
dose) single-use prefilled syringes (injection)
NDC 0078-0639-97: Carton of one 150 mg/mL
single-use prefilled syringe (injection)
The removable cap of the
Cosentyx Sensoready pen and prefilled syringe contains natural rubber latex.
Each Sensoready pen and prefilled syringe is equipped with a needle safety
guard.
Cosentyx vial (for healthcare
professional use only):
NDC 0078-0657-61: Carton of one 150 mg lyophilized
powder in a single-use vial (for injection) Storage
and Handling
Cosentyx Sensoready pens,
prefilled syringes and vials must be refrigerated at 2ºC to 8ºC (36ºF to 46ºF).
Keep the product in the original carton to protect from light until the time of
use. Do not freeze. To avoid foaming do not shake. Cosentyx does not contain a
preservative; discard any unused portion.
PATIENT COUNSELING INFORMATION
Advise the patient to read
FDA-approved patient labeling [Medication Guide and
Instructions for Use].
Patient
Counseling
Instruct patients to read the
Medication Guide before starting Cosentyx therapy and to reread the Medication
Guide each time the prescription is renewed.
Advise patients of the
potential benefits and risks of Cosentyx.
Infections
Inform patients that Cosentyx
may lower the ability of their immune system to fight infections. Instruct
patients of the importance of communicating any history of infections to the
doctor and contacting their doctor if they develop any symptoms of
infection [see Warnings and Precautions (5.1)].
Hypersensitivity
Advise patients to seek
immediate medical attention if they experience any symptoms of serious
hypersensitivity reactions [see Warnings and
Precautions (5.4)].
Instruction
on Injection Technique
Perform the first
self-injection under the supervision of a qualified healthcare professional. If
a patient or caregiver is to administer Cosentyx, instruct him/her in injection
techniques and assess their ability to inject subcutaneously to ensure the
proper administration of Cosentyx [see Medication
Guide and Instructions for Use].
Instruct patients or
caregivers in the technique of proper syringe and needle disposal, and advise
them not to reuse these items. Instruct patients to inject the full amount of
Cosentyx (1 or 2 subcutaneous injections of 150 mg) according to the directions
provided in the Medication Guide and Instructions for Use. Dispose of needles,
syringes and pens in a puncture-resistant container.
Manufactured by:
Novartis Pharmaceuticals Corporation
East Hanover, New Jersey 07936
US License No. 1244
© Novartis
T2017-94
|
This Medication
Guide has been approved by the U.S. Food and Drug Administration
|
Revised: January 2016
|
|
MEDICATION GUIDE
Cosentyx® (koe-sen’-tix)
(secukinumab) Injection
|
|
What is the most important information I should know about Cosentyx?
Cosentyx is a medicine that affects your immune system. Cosentyx may increase
your risk of having serious side effects such as:
Infections. Cosentyx may lower the
ability of your immune system to fight infections and may increase your risk
of infections.
• Your healthcare provider should check you for tuberculosis (TB) before
starting treatment with Cosentyx.
• If your healthcare provider feels that you are at risk for TB, you may be
treated with medicine for TB before you begin treatment with Cosentyx and
during treatment with Cosentyx.
• Your healthcare provider should watch you closely for signs and symptoms of
TB during treatment with Cosentyx. Do not take
Cosentyx if you have an active TB infection.
|
|
Before starting Cosentyx, tell your healthcare provider if you:
• are being treated for an infection
• have an infection that does not go away or that keeps coming back
• have TB or have been in close contact with someone with TB
• think you have an infection or have symptoms of an infection such as:
|
|
o
fever, sweats, or chills
|
o warm, red, or
painful skin or sores on your body
|
|
o
muscle aches
|
o diarrhea or
stomach pain
|
|
o
cough
|
o burning when
you urinate or urinate more often than normal
|
|
o
shortness of breath
|
|
|
o
blood in your phlegm
|
|
|
o
weight loss
|
|
|
After starting Cosentyx, call your healthcare provider right
away if you have any of the signs of infection listed above. Do not use Cosentyx if you have any
signs of infection unless you are instructed to by your healthcare provider.
See “What are the possible side effects of
Cosentyx?” for more information about side effects.
|
|
What is Cosentyx?
Cosentyx is a prescription medicine used to treat adults:
with moderate to severe plaque
psoriasis that involves large areas or many areas of the body, and who
may benefit from taking injections or pills (systemic therapy) or
phototherapy (treatment using ultraviolet or UV light alone or with
systemic therapy)with active psoriatic arthritiswith active ankylosing spondylitis
Cosentyx may
improve your psoriasis, psoriatic arthritis and ankylosing spondylitis but it
may also lower the ability of your immune system to fight infections.
It is not known if Cosentyx is safe and effective in children.
|
|
Do not take Cosentyx:
Do not use Cosentyx if you have had a severe allergic reaction to secukinumab
or any of the other ingredients in Cosentyx. See the end of this Medication
Guide for a complete list of ingredients in Cosentyx.
|
|
Before taking Cosentyx, tell your healthcare provider about all of
your medical conditions, including if you: have any of the conditions or symptoms listed
in the section “What is the most important
information I should know about Cosentyx?”
• have inflammatory bowel disease (Crohn’s disease or ulcerative colitis)
• are allergic to latex. The needle cap on the Cosentyx Sensoready® pen and
prefilled syringe contains latex.
• have recently received or are scheduled to receive an immunization (vaccine).
People who take Cosentyx should not receive
live vaccines.
• have any other medical conditions
• are pregnant or plan to become pregnant. It is not known if Cosentyx can
harm your unborn baby. You and your healthcare provider should decide if you
will use Cosentyx.
• are breastfeeding or plan to breastfeed. It is not known if Cosentyx passes
into your breast milk.
Tell your healthcare provider about all the medicines you take, including
prescription and over-the-counter medicines, vitamins, and herbal
supplements.
Know the medicines you take. Keep a list of your medicines to show your
healthcare provider and pharmacist when you get a new medicine.
|
|
How should I use Cosentyx?
See the detailed “Instructions for Use” that comes with
your Cosentyx for information on how to prepare and inject a dose of
Cosentyx, and how to properly throw away (dispose of) used Cosentyx
Sensoready pens and prefilled syringes.
• Use Cosentyx exactly as prescribed by your healthcare provider.
• If your healthcare provider decides that you or a caregiver may give your
injections of Cosentyx at home, you should receive training on the right way
to prepare and inject Cosentyx. Do not try to inject Cosentyx yourself, until
you or your caregiver has been shown how to inject Cosentyx by your
healthcare provider.
• Cosentyx comes in a Sensoready pen or prefilled syringe that you or your
caregiver may use at home to give injections. Your healthcare provider will
decide which type of Cosentyx is best for you to use at home.
• Your healthcare provider will prescribe the dose of Cosentyx that is right
for you.
o If your prescribed dose of Cosentyx is 150 mg, you must give 1
injection of Cosentyx for each dose.
o If your prescribed dose of Cosentyx is 300 mg, you must give 2
injections for each dose.
• Cosentyx is given as an injection under your skin (subcutaneous injection),
in your upper legs (thighs) or stomach-area (abdomen) by you or a caregiver.
A caregiver may also give you an injection of Cosentyx in your upper outer
arm.
• Do not give an injection in an
area of the skin that is tender, bruised, red or hard, or in an area of skin
that is affected by psoriasis.
• Each injection should be given at a different site. Do
not use the 2-inch area around your navel (belly button).
• If you inject more Cosentyx than prescribed, call your healthcare provider
or go to the nearest emergency room right away.
|
|
What are the possible side effects of Cosentyx?
See “What is the most important information I should
know about Cosentyx?”
• Inflammatory bowel disease. New cases of inflammatory bowel disease or
“flare-ups” can happen with Cosentyx, and can sometimes be serious. If you
have inflammatory bowel disease (ulcerative colitis or Crohn’s disease), tell
your healthcare provider if you have worsening disease symptoms during
treatment with Cosentyx or develop new symptoms of stomach pain or diarrhea.
• Serious allergic reactions. Get emergency medical help right away if you
get any of the following symptoms of a serious allergic reaction:
o feel faint
o swelling of your face, eyelids, lips, mouth,
tongue, or throat
o trouble breathing or throat tightness
o chest tightness
o skin rash
If you have a severe allergic reaction, do not give another
injection of Cosentyx.
The most common side effects of Cosentyx include:
• cold symptoms
• diarrhea
• upper respiratory infections
These are not all of the possible side effects of Cosentyx.
Call your doctor for medical advice about side effects. You may report side
effects to FDA at 1-800-FDA-1088.
|
|
How should I store Cosentyx?
• Store Cosentyx in a refrigerator, between 36°F to 46°F (2°C to 8°C).
• Keep Cosentyx in the original carton until ready for use to protect from
light.
• Do not freeze Cosentyx.
• Do not shake Cosentyx.
Keep Cosentyx and all medicines out of the reach of
children.
|
|
General information about the safe and effective use of Cosentyx.
Medicines are sometimes prescribed for purposes other than those listed in a
Medication Guide. Do not use Cosentyx for a condition for which it was not
prescribed. Do not give Cosentyx to other people, even if they have the same
symptoms that you have. It may harm them.
You can ask your healthcare provider or pharmacist for information about Cosentyx
that is written for health professionals.
|
|
What are the ingredients in Cosentyx?
Active ingredient: secukinumab
Inactive ingredients: Sensoready pen and prefilled
syringe: L-histidine/histidine hydrochloride monohydrate,
L-methionine, polysorbate 80, trehalose dihydrate, and sterile water for
injection.
Vial: L-histidine/histidine hydrochloride
monohydrate, polysorbate 80, and sucrose.
For more information, call 1-888-669-6682 or go to www.Cosentyx.com
Manufactured by: Novartis Pharmaceuticals Corporation
East Hanover, New Jersey 07936
T2016-02
|
INSTRUCTIONS
FOR USE
CosentyxTM (koe-sen’-tix)
(secukinumab)
For
Injection
The
following information is intended for medical or healthcare professionals only.
IMPORTANT:
The single-use vial contains 150 mg of Cosentyx for
reconstitution with Sterile Water for Injection (SWFI). Do not use the
vial after the expiry date shown on the outer box or vial. If it has
expired, return the entire pack to the pharmacy.The preparation of the solution for subcutaneous
injection shall be done without interruption ensuring that aseptic
technique is used. The preparation time from piercing the stopper until
end of reconstitution on average takes 20 minutes and should not exceed 90
minutes.Throw away (dispose of) the used syringe right away
after use. Do not re-use a syringe. See “How should
I dispose of a used syringe?” at the end of this Instructions
for Use.
How
should I store Cosentyx?
Store the vial of Cosentyx in the refrigerator between
2°C to 8°C (36°F to 46°F).
To prepare Cosentyx 150 mg for
injection, please adhere to the following instructions:
Instructions
for reconstitution of Cosentyx 150 mg for injection:
|
Step 1. Remove
the vial of Cosentyx 150 mg for injection from the refrigerator and allow to
stand for 15 to 30 minutes to reach room temperature. Ensure the Sterile
Water for Injection (SWFI) is at room temperature.
Step 2. Reconstitute the lyophilized powder by slowly injecting 1 mL of
Sterile Water for Injection (SWFI) into the vial. Direct the stream of SWFI
onto the lyophilized powder (See Figure A).
|
Figure A
|
|
Step 3. Tilt the
vial to an angle of approximately 45 degrees and gently rotate between the
fingertips for approximately 1 minute. Do not shake or invert the vial (See Figure B).
Step 4. Keep the vial standing at room temperature for a minimum of 10
minutes to allow for dissolution. Note that foaming of the solution may
occur.
Step 5. Tilt the vial to an angle of approximately 45 degrees and gently
rotate between the fingertips for approximately 1 minute. Do not shake or
invert the vial (See Figure B).
Step 6. Allow the vial to stand undisturbed at room temperature for
approximately 5 minutes. The resulting solution should be clear. Its color
may vary from colorless to slightly yellow. Do not use if the lyophilized
powder has not fully dissolved or if the liquid contains visible particles,
is cloudy or is discolored.
Step 7. Prepare the required number of vials (1 vial for the 150 mg dose or 2
vials for the 300 mg dose).
|
Figure B
|
|
After preparation, use the solution for subcutaneous injection immediately or
store at 2°C to 8 °C (36°F to 46°F) for up to 24 hours. Do not freeze. After
storage at 2°C to 8 °C (36°F to 46°F), allow the reconstituted solution to
come to room temperature (15 to 30 minutes) before administration. Administer
the solution within 1 hour after removal from the 2°C to 8°C (36°F to 46°F)
storage.
|
|
Instructions for administration of Cosentyx solution:
|
|
Step 1. Tilt the
vial to an angle of approximately 45 degrees and position the needle tip at
the very bottom of the solution in the vial when drawing the solution into
the syringe. DO NOT invert the vial.
Step 2. Carefully withdraw slightly more than 1 mL of the solution for
subcutaneous injection from the vial into a 1 mL graduated disposable syringe
using a suitable needle (e.g., 21G x 2”) (See Figure
C). This needle will only be used for withdrawing Cosentyx
into the disposable syringe. Prepare the required number of syringes (1
syringe for the 150 mg dose or 2 syringes for the 300 mg dose).
|
Figure C
|
|
Step 3. With the
needle pointing upward, gently tap the syringe to move any air bubbles to the
top (See Figure D).
|
Figure D
|
|
Step 4. Replace
the attached needle with a 27G x ½” needle (See
Figure E).
Step 5. Expel the air bubbles and advance the plunger to the 1 mL mark.
Step 6. Clean the injection site with an alcohol wipe.
|
Figure E
|
|
Step 7. Inject
the Cosentyx solution subcutaneously into the front of thighs, lower abdomen
[but not the area 2 inches around the navel (belly button)] or outer upper
arms (See Figure F). Choose a different
site each time an injection is administered. Do not inject into areas where
the skin is tender, bruised, red, scaly or hard, or in an area of skin that is
affected by psoriasis. Avoid areas with scars or stretch marks.
|
Figure F
|
|
How should I dispose of a used syringe?
|
|
Any remaining solution in the vial must not be used and must be discarded in
accordance with local requirements. Vials are for single use only.
|
|
Put the used syringes and needles in a FDA-cleared sharps disposal container
right away after use. Do not throw away (dispose of) the
syringes and needles in your household trash.
|
|
If you do not have an FDA-cleared sharps disposal container, you may use a
household container that is:
|
|
1. made
of a heavy-duty plastic,
2. can
be closed with a tight-fitting, puncture-resistant lid, without sharps being
able to come out,
3. upright
and stable during use,
4. leak-resistant,
and
5. properly
labeled to warn of hazardous waste inside the container.
|
|
When your sharps
disposal container is almost full, you will need to follow your community
guidelines for the right way to dispose of your sharps disposal container.
There may be state or local laws about how you should throw away used needles
and syringes. For more information about safe sharps disposal, and for
specific information about sharps disposal in the state that you live in, go
to the FDA’s website at: http://www.fda.gov/safesharpsdisposal.
|
|
This Instructions for Use has been approved by the U.S. Food and Drug
Administration.
|
|
Manufactured by:
Novartis Pharmaceuticals Corporation
East Hanover, New Jersey 07936
US License Number 1244
|
|
Issued: January 2015
|
|
© Novartis
|
|
T2015-09
|
INSTRUCTIONS
FOR USE
CosentyxTM (koe-sen’-tix)
(secukinumab)
Injection
Prefilled
Syringe
Be sure that you read,
understand, and follow this Instructions for Use before injecting Cosentyx.
Your healthcare provider should show you how to prepare and inject Cosentyx
properly using the prefilled syringe before you use it for the first time. Talk
to your healthcare provider if you have any questions.
Important:
Do not use the
Cosentyx prefilled syringe if either the seal on the outside carton or the
seal of the blister are broken. Keep the Cosentyx prefilled syringe in the
sealed carton until you are ready to use it.Inject Cosentyx within 1 hour after
taking it out of the refrigerator.Do not shake the
Cosentyx prefilled syringe.The needle caps of the prefilled
syringes contain latex. Do not handle the prefilled syringes if you are
sensitive to latex.The prefilled syringe has a needle guard that will
be activated to cover the needle after the injection is finished. The
needle guard will help to prevent needle stick injuries to anyone who
handles the prefilled syringe.Do not remove the needle cap until just before you
give the injection.Avoid touching the syringe guard wings before use.
Touching them may cause the syringe guard to be activated too early.Throw away (dispose of) the used Cosentyx prefilled
syringe right away after use. Do not re-use a
Cosentyx prefilled syringe. See “How
should I dispose of used Cosentyx prefilled syringes?” at the
end of this Instructions for Use.
How
should I store Cosentyx?
Store your carton of Cosentyx prefilled syringes in
a refrigerator, between 36°F to 46°F (2°C to 8°C).Keep Cosentyx prefilled syringes in the original
carton until ready to use to protect from light.Do not freeze Cosentyx prefilled syringes.
Keep
Cosentyx and all medicines out of the reach of children.
|
Cosentyx prefilled syringe parts (see
Figure A):
|
|
Figure A
|
|
|
|
What you need for your injection:
|
|
Included in the
carton:
|
|
A new Cosentyx
prefilled syringe.
|
|
Each Cosentyx
prefilled syringe contains 150 mg of
Cosentyx.
If your prescribed
dose of Cosentyx is 150 mg, you
must give 1 injection.If your prescribed dose of
Cosentyx is 300 mg, you must give 2 injections.
|
|
Not included in the carton (see
Figure B):
• 1 Alcohol wipe
• 1 Cotton ball or gauze
• Sharps disposal container
See “How should I dispose of used Cosentyx prefilled
syringes?” at the end of this Instructions for Use.
|
Figure B
|
|
Prepare the Cosentyx prefilled syringe
|
|
Step 1. Find a
clean, well-lit, flat work surface.
|
|
Step 2. Take the
carton containing the Cosentyx prefilled syringe out of the refrigerator and
leave it unopened on your work
surface for about 15 to 30 minutes so that it reaches room temperature.
|
|
Step 3. Wash
your hands well with soap and water.
|
|
Step 4. Remove
the Cosentyx prefilled syringe from the outer carton and take it out of the
blister.
|
|
Step 5. Look
through the viewing window on the Cosentyx prefilled syringe. The liquid
inside should be clear. The color may be colorless to slightly yellow. You
may see a small air bubble in the liquid. This is normal. Do not use the prefilled syringe if the liquid
contains visible particles, or if the liquid is cloudy or discolored.
|
|
Step 6. Do not use the Cosentyx prefilled syringe if it
is broken. Return the prefilled syringe and the package it came in to the
pharmacy.
|
|
Step 7. Do not use the Cosentyx prefilled syringe if
the expiration date has passed.
|
|
Choose and clean the injection site
|
|
· Areas
of your body that you may use as injection sites include:
o the
front of your thighs (see Figure C)
o the
lower stomach-area (abdomen), but not the
area 2 inches around your navel (belly button) (see
Figure C)
o your
upper outer arms, if a caregiver is giving you the injection (see Figure D)
· Choose
a different site for each injection of Cosentyx.
· Do not inject into areas where the skin is tender,
bruised, red, scaly, or hard, or in an area of skin that is affected by
psoriasis. Avoid areas with scars or stretch marks.
|
Figure C
|
|
Step 8. Using a
circular motion, clean the injection site with the alcohol wipe. Leave it to
dry before injecting. Do not touch the cleaned area again before injecting.
|
Figure D
|
|
Giving your injection
|
|
Step 9.
Carefully remove the needle cap from the Cosentyx prefilled syringe (see Figure E). Throw away the needle cap. You may
see a drop of liquid at the end of the needle. This is normal.
|
Figure E
|
|
Step 10. With
one hand gently pinch the skin at the injection site. With your other hand
insert the needle into your skin as shown (see
Figure F). Push the needle all the way in to make sure that you
inject your full dose.
|
Figure F
|
|
Step 11. Hold
the Cosentyx prefilled syringe finger grips as shown (see
Figure G). Slowly press down on the plunger as far as it will go,
so that the plunger head is completely between the syringe guard wings.
Step 12. Continue to press fully on the plunger for an additional 5 seconds.
Hold the syringe in place for the full 5 seconds.
|
Figure G
|
|
Step 13. Keep
the plunger fully depressed while you carefully pull the needle straight out
from the injection site (see Figure H).
|
Figure H
|
|
Step 14. Slowly
release the plunger and allow the syringe guard to automatically cover the
exposed needle (see Figure I).
Step 15. There may be a small amount of blood at the injection site. You can
press a cotton ball or gauze over the injection site and hold it for 10
seconds. Do not rub the injection site. You may cover the injection site with
a small adhesive bandage, if needed.
|
Figure I
|
|
If your prescribed dose of Cosentyx is 300 mg, repeat steps
4 through 15 with a new Cosentyx prefilled syringe.
How should I dispose of used Cosentyx prefilled syringes?
|
|
Step 16. Put your used prefilled syringes in a FDA-cleared sharps disposal
container right away after use (see Figure J). Do
not throw away (dispose of) prefilled syringes in your
household trash.
If you do not have an FDA-cleared sharps disposal container, you may use a
household container that is:
made of a heavy-duty plastic,can be closed with a tight-fitting,
puncture-resistant lid, without sharps being able to come out,upright and stable during use,leak-resistant, andproperly labeled to warn of
hazardous waste inside the container.
When your sharps disposal container is almost full, you will need to follow
your community guidelines for the right way to dispose of your sharps
disposal container. There may be state or local laws about how you should
throw away used needles, syringes and prefilled syringes. For more
information about safe sharps disposal, and for specific information about
sharps disposal in the state that you live in, go to the FDA’s website at:
http://www.fda.gov/safesharpsdisposal.
|
Figure J
|
|
This Instructions for Use has been approved by the U.S. Food and Drug
Administration.
|
|
Manufactured by:
Novartis Pharmaceuticals Corporation
East Hanover, New Jersey 07936
US License Number 1244
|
|
Issued: January 2015
|
|
© Novartis
|
|
T2015-10
|
INSTRUCTIONS
FOR USE
CosentyxTM (koe-sen’-tix)
(secukinumab)
Injection
Sensoready® Pen
Be sure that you read,
understand, and follow this Instructions for Use before injecting Cosentyx.
Your healthcare provider should show you how to prepare and inject Cosentyx
properly using the Sensoready Pen before you use it for the first time. Talk to
your healthcare provider if you have any questions.
Important:
Do not use the
Cosentyx Sensoready Pen if either the seal on the outer carton or the seal
on the pen is broken. Keep the Cosentyx Sensoready Pen in the sealed outer
carton until you are ready to use it.Inject Cosentyx within 1 hour after
taking it out of the refrigerator.Do not shake the
Cosentyx Sensoready Pen.The caps of the Sensoready Pens contain
latex. Do not handle the Sensoready Pens if you are
sensitive to latex.If you drop your Cosentyx Sensoready Pen, do not use it if the Sensoready Pen looks damaged,
or if you dropped it with the cap removed.Throw away (dispose of) the used Cosentyx
Sensoready Pen right away after use. Do not re-use a
Cosentyx Sensoready Pen. See “How should I dispose of used
Cosentyx Sensoready Pens?” at the end of this Instructions for Use.
How
should I store Cosentyx?
Store your carton of Cosentyx Sensoready Pen in a
refrigerator, between 36°F to 46°F (2°C to 8°C).Keep Cosentyx Sensoready Pen in the original carton
until ready to use to protect from light.Do not freeze Cosentyx Sensoready Pen.
Keep
Cosentyx and all medicines out of the reach of children.
|
Cosentyx Sensoready Pen parts (see Figure A):
|
|
Figure A
|
|
|
|
The Cosentyx
Sensoready Pen is shown above with the cap removed. Do
not remove the cap until you are ready to inject.
|
|
What you need for your injection:
|
|
Included in the
carton:
A new Cosentyx Sensoready Pen (see Figure B).
Each Cosentyx Sensoready Pen contains 150 mg of Cosentyx.
If your prescribed
dose of Cosentyx is 150 mg, you
must give 1 injection.If your prescribed dose of
Cosentyx is 300 mg, you must
give 2 injections.
|
Figure B
|
|
Not included in
the carton (see Figure C):
1 Alcohol wipe1 Cotton ball or gauzeSharps disposal container.
See “How should I dispose of used Cosentyx Sensoready Pen?” at
the end of this Instructions for Use.
|
Figure C
|
|
Before your injection:
Take the Cosentyx Sensoready Pen out of the refrigerator 15 to 30 minutes before injecting to allow it
to reach room temperature.
|
|
Step 1. Important safety checks before you inject (see Figure D):
Look through the viewing window. The
liquid should be clear. Its color may vary from colorless to slightly
yellow.
Do not use if the liquid contains visible
particles, is cloudy or is discolored. You may see a small air bubble,
which is normal.Look at the expiration
date (EXP) on your Sensoready Pen. Do
not use your Cosentyx Sensoready Pen if the expiration date
has passed.
Contact your
pharmacist if the Cosentyx Sensoready Pen fails any of these checks.
|
Figure D
|
|
Step 2. Choose your injection site:
The recommended site is the front of
the thighs. You may also use the lower abdomen, but not the area 2 inches around your navel (belly
button) (see Figure E).Choose a different site each time
you give yourself an injection.Do not inject into areas where the skin is
tender, bruised, red, scaly or hard, or in an area of skin that is
affected by psoriasis. Avoid areas with scars or stretch marks.
|
Figure E
|
|
· If
a caregiver or healthcare
provider is giving you your injection, they may also inject into
your outer upper arm (see Figure F).
|
Figure F
|
|
Step 3. Cleaning your injection site:
Wash your hands well with soap and
water.Using a circular motion, clean the
injection site with the alcohol wipe. Leave it to dry before
injecting (see Figure G).Do not touch the cleaned area again before
injecting.
|
Figure G
|
|
Your injection:
|
|
Step 4. Removing the cap:
Only remove the cap when you are
ready to use the Cosentyx Sensoready Pen.Twist off the cap in the direction
of the arrow (see Figure H).Throw away the cap. Do not try to re-attach the cap.Use the Cosentyx Sensoready Pen within 5
minutes of removing the cap.
|
Figure H
|
|
Step 5. Holding your Cosentyx Sensoready Pen:
Hold the Cosentyx Sensoready Pen at
90 degrees to the cleaned injection site (see
Figure I).
|
Figure I
|
|
Important: During the injection you will hear 2 loud
clicks:
The 1st click indicates that the injection has started.Several seconds later a 2nd click will indicate that the injection is almost finished.
You must keep
holding the Cosentyx Sensoready Pen firmly against your skin until you see
a green indicator fill the window
and stop moving.
|
|
Step 6. Starting your injection:
Press the Cosentyx Sensoready Pen
firmly against the skin to start the injection (see
Figure J).The 1st click indicates the injection has
started.Keep holding the Cosentyx Sensoready Pen
firmly against your skin.The green indicator shows
the progress of the injection.
|
Figure J
|
|
Step 7. Completing your injection:
Listen for the 2nd click. This indicates the injection
is almost complete.Check the green
indicator fills the window and has stopped moving (see Figure K).The Cosentyx Sensoready Pen can now be removed.
|
Figure K
|
|
After your injection:
|
|
Step 8. Check the green indicator fills the window (see Figure L):
This means the medicine has been
delivered. Contact your healthcare provider if the green indicator is
not visible.There may be a small amount of blood
at the injection site. You can press a cotton ball or gauze over the
injection site and hold it for 10 seconds. Do not rub the injection
site. You may cover the injection site with a small adhesive bandage, if
needed.
If your prescribed dose of Cosentyx is 300 mg, repeat steps 1 through
8 with a new Cosentyx Sensoready Pen.
|
Figure L
|
|
How should I dispose of used Cosentyx Sensoready Pens?
|
|
Step 9. Put
your used Sensoready Pens in a FDA-cleared sharps disposal container right
away after use (see Figure M). Do not throw away
(dispose of) Sensoready Pens in your household trash.
If you do not have an FDA-cleared sharps disposal container, you may use a
household container that is:
made of a heavy-duty plastic,can be closed with a tight-fitting,
puncture-resistant lid, without sharps being able to come out,upright and stable during use,leak-resistant, andproperly labeled to warn of hazardous waste
inside the container.
When your sharps
disposal container is almost full, you will need to follow your community
guidelines for the right way to dispose of your sharps disposal container.
There may be state or local laws about how you should throw away used
needles, syringes, and Sensoready Pens. For more information about safe
sharps disposal, and for specific information about sharps disposal in the
state that you live in, go to the FDA’s website at: http://www.fda.gov/safesharpsdisposal.
|
Figure M
|
|
This Instructions for Use has been approved by the U.S. Food and Drug
Administration.
Manufactured by:
Novartis Pharmaceuticals Corporation
East Hanover, New Jersey 07936
US License Number 1244
Issued: January 2015
© Novartis
T2015-11
|
PRINCIPAL
DISPLAY PANEL
CosentyxTM
(secukinumab)
Injection
150 mg/mL
1 Prefilled Syringe
NDC 0078-0639-97
Single-use Prefilled Syringe
ATTENTION: Dispense with
enclosed Medication Guide
For Subcutaneous Use Only
Sterile Solution - Contains No
Preservative
Caution: Contains Natural
Rubber Latex Which May Cause Allergic Reaction.
Rx only
|
Cosentyx secukinumab injection
|
|
Product
Information
|
|
Product Type
|
HUMAN
PRESCRIPTION DRUG LABEL
|
Item Code
(Source)
|
NDC:0078-0639
|
|
Route of Administration
|
SUBCUTANEOUS
|
DEA Schedule
|
|
|
|
Active
Ingredient/Active Moiety
|
|
Ingredient
Name
|
Basis of
Strength
|
Strength
|
|
SECUKINUMAB (SECUKINUMAB)
|
SECUKINUMAB
|
150 mg
in 1 mL
|
|
|
Inactive
Ingredients
|
|
Ingredient
Name
|
Strength
|
|
HISTIDINE
|
|
|
HISTIDINE MONOHYDROCHLORIDE MONOHYDRATE
|
|
|
METHIONINE
|
|
|
POLYSORBATE 80
|
|
|
NITROGEN
|
|
|
TREHALOSE DIHYDRATE
|
|
|
WATER
|
|
|
|
|
|
Packaging
|
|
#
|
Item Code
|
Package
Description
|
|
|
1
|
NDC:0078-0639-41
|
2 mL in 1
CARTON
|
|
|
2
|
NDC:0078-0639-68
|
1 mL in 1
CARTON
|
|
|
3
|
NDC:0078-0639-98
|
2 mL in 1
CARTON
|
|
|
4
|
NDC:0078-0639-97
|
1 mL in 1
CARTON
|
|
|
|
|
|
Marketing Information
|
|
Marketing
Category
|
Application
Number or Monograph Citation
|
Marketing
Start Date
|
Marketing
End Date
|
|
BLA
|
BLA125504
|
01/21/2015
|
|
|
|
Labeler - Novartis Pharmaceuticals Corporation (002147023)
|
|
Revised:
09/2017
Novartis
Pharmaceuticals Corporation
