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Overview
Secukinumab is a human interleukin-17A antagonist that is FDA approved for the treatment of moderate to severe plaque psoriasis in adult patients. Common adverse reactions include nasopharyngitis, diarrhea, and upper respiratory tract infection.
Adult Indications and Dosage
FDA-Labeled Indications and Dosage (Adult)
Indications
COSENTYXTM is indicated for the treatment of moderate to severe plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy.
Recommended Dosage
The recommended dose is 300 mg by subcutaneous injection at Weeks 0, 1, 2, 3, and 4 followed by 300 mg every 4 weeks. Each 300 mg dose is given as 2 subcutaneous injections of 150 mg.
For some patients, a dose of 150 mg may be acceptable.
Off-Label Use and Dosage (Adult)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Secukinumab in adult patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Secukinumab in adult patients.
Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
There is limited information regarding FDA-Labeled Use of Secukinumab in pediatric patients.
Off-Label Use and Dosage (Pediatric)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Secukinumab in pediatric patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Secukinumab in pediatric patients.
Contraindications
COSENTYX is contraindicated in patients with a previous serious hypersensitivity reaction to secukinumab or to any of the excipients
Warnings
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, 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. 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.
5.2 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.
5.3 Exacerbations of Crohn’s Disease
Exercise caution when prescribing COSENTYX to patients with active Crohn’s disease, as exacerbations of Crohn’s disease, in some cases serious, were observed in COSENTYX-treated patients during clinical trials. Patients who are treated with COSENTYX and have active Crohn’s disease should be monitored closely [see Adverse Reactions (6.1)].
5.4 Hypersensitivity Reactions
Anaphylaxis and cases of urticaria occurred in COSENTYX-treated patients in the 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)].
5.5 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.
5.6 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
Clinical Trials Experience
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.
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.
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.
Exacerbation of Crohn’s Disease
Exacerbations of Crohn’s disease, in some cases serious, were observed in clinical trials in both COSENTYX and placebo treated patients. In the psoriasis program, with 3430 patients exposed to COSENTYX there were 3 cases of exacerbation of Crohn’s disease [see Warnings and Precautions (5.3)].
Hypersensitivity Reactions
Anaphylaxis and cases of urticaria occurred in COSENTYX-treated patients in clinical trials.
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.
Postmarketing Experience
There is limited information regarding Postmarketing Experience of Secukinumab in the drug label.
Australian Drug Evaluation Committee (ADEC) Pregnancy Category
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Secukinumab in women who are pregnant.
Labor and Delivery
There is no FDA guidance on use of Secukinumab during labor and delivery.
Nursing Mothers
There is no FDA guidance on the use of Secukinumab with respect to nursing mothers.
Pediatric Use
There is no FDA guidance on the use of Secukinumab with respect to pediatric patients.
Geriatic Use
There is no FDA guidance on the use of Secukinumab with respect to geriatric patients.
Gender
There is no FDA guidance on the use of Secukinumab with respect to specific gender populations.
Race
There is no FDA guidance on the use of Secukinumab with respect to specific racial populations.
Renal Impairment
There is no FDA guidance on the use of Secukinumab in patients with renal impairment.
Hepatic Impairment
There is no FDA guidance on the use of Secukinumab in patients with hepatic impairment.
Females of Reproductive Potential and Males
There is no FDA guidance on the use of Secukinumab in women of reproductive potentials and males.
Immunocompromised Patients
There is no FDA guidance one the use of Secukinumab in patients who are immunocompromised.
Administration and Monitoring
Administration
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.
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.
2.3 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.
2.4 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.
Monitoring
There is limited information regarding Monitoring of Secukinumab in the drug label.
Description
IV Compatibility
There is limited information regarding IV Compatibility of Secukinumab in the drug label.
Overdosage
Acute Overdose
Signs and Symptoms
Description
Management
Description
Chronic Overdose
There is limited information regarding Chronic Overdose of Secukinumab in the drug label.
Pharmacology
There is limited information regarding Secukinumab Pharmacology in the drug label.
