Cosentyx

Medical Author: John P. Cunha, DO, FACOEP Last updated on RxList: 1/6/2022
Cosentyx Side Effects Center

What Is Cosentyx?

Cosentyx (secukinumab) for Injection is a human interleukin-17A antagonist used to treat moderate to severe plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy.

What Are Side Effects for Cosentyx?

Common side effects of Cosentyx include:

Dosage for Cosentyx

The recommended dose of Cosentyx 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.

What Drugs, Substances, or Supplements Interact with Cosentyx?

Cosentyx may interact with:

  • warfarin,
  • cyclosporine, or
  • "live" vaccines.

Tell your doctor all medications and supplements you use and all vaccines you recently received.

Cosentyx During Pregnancy and Breastfeeding

Tell your doctor if you are pregnant or plan to become pregnant before using Cosentyx. It is unknown if this drug passes into breast milk. Consult your doctor before breastfeeding.

Additional Information

Our Cosentyx (secukinumab) for Injection Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

SLIDESHOW

Types of Psoriasis: Medical Pictures and Treatments See Slideshow
Cosentyx Consumer Information

Get emergency medical help if you have signs of an allergic reaction: hives; chest tightness, difficult breathing; feeling like you might pass out; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

  • redness, warmth, or painful sores on your skin;
  • cough, shortness of breath, cough with red or pink mucus;
  • increased urination, burning when you urinate;
  • sores or white patches in your mouth or throat (yeast infection or "thrush");
  • diarrhea, stomach pain; or
  • fever, chills, sweating, muscle pain, weight loss.

Common side effects may include:

  • diarrhea; or
  • cold symptoms such as stuffy nose, sneezing, sore throat.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Cosentyx (Secukinumab Injection)

QUESTION

Psoriasis causes the top layer of skin cells to become inflamed and grow too quickly and flake off. See Answer
Cosentyx Professional Information

SIDE EFFECTS

The following adverse reactions are discussed in greater detail elsewhere in the labeling:

  • Infections [see WARNINGS AND PRECAUTIONS]
  • Inflammatory Bowel Disease [see WARNINGS AND PRECAUTIONS]
  • Hypersensitivity Reactions [see WARNINGS AND PRECAUTIONS]

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.

Adult 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 PsO1, PsO2, PsO3, and PsO4. In total, 2077 subjects were evaluated (691 to COSENTYX 300 mg group, 692 to COSENTYX 150 mg group, and 694 to placebo group). Subjects randomized to COSENTYX received 300 mg or 150 mg doses subcutaneously at Weeks 0, 1, 2, 3, and 4 followed by the same dose every 4 weeks [see Clinical Studies].

Table 2 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 2: Adverse Reactions Reported by Greater Than 1% of Subjects with Plaque Psoriasis Through Week 12 in Trials PsO1, PsO2, PsO3, and PsO4

Adverse Reactions COSENTYX Placebo
(N = 694) n (%)
300 mg
(N = 691) n (%)
150 mg
(N = 692) 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 PsO1, PsO2, PsO3, and PsO4 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 subjects treated with COSENTYX and in 0.3% of subjects treated with placebo.

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.

In the psoriasis open-label extension of Trials PsO1 and PsO2 (median follow-up of 3.9 years), representing 3582 subject-years of exposure, 74% of COSENTYX treated subjects reported infections (55 per 100 patient-years). Serious infections were reported in 4.5% of subjects (1.4 per 100 patient-years). Sepsis was reported in 5 subjects (0.2 per 100 patient-years).

Neutropenia was observed in controlled portion of clinical trials. Most cases of secukinumab-associated neutropenia were transient and reversible. No serious infections were associated with cases of neutropenia.

In the open-label extension of Trials PsO1 and PsO2, neutropenia (ANC < 1 x109/L) was reported in 1% of COSENTYX treated subjects (0.3 per 100 patient-years). Some cases of serious infections were associated with neutropenia; however the causal relationship was not established.

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 subjects exposed to COSENTYX over the entire treatment period for up to 52 weeks (2725 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 subjects (N = 793; 176 patient-years) during the 12-week placebo-controlled period.

One case of exacerbation of Crohn's disease was reported in open-labeled portions of clinical trials in plaque psoriasis.

Hypersensitivity Reactions

Anaphylaxis and cases of urticaria occurred in COSENTYX treated subjects in clinical trials [see WARNINGS AND PRECAUTIONS].

Pediatric Plaque Psoriasis

The safety of COSENTYX was assessed in two Phase 3 trials in pediatric subjects with plaque psoriasis.

The first was a randomized, double-blind, placebo and active-controlled, 236-week trial (Trial PsO6) that enrolled 162 pediatric subjects 6 years of age and older, with severe plaque psoriasis (defined by PASI score ≥ 20, an IGA modified 2011 score of 4, and involving ≥ 10% of the body surface area) who were candidates for systemic therapy. The 162 subjects were randomized to receive placebo, a biologic active control, or COSENTYX. In the COSENTYX groups, subjects with body weight < 25 kg received 75 mg, subjects with body weight 25 to < 50 kg received either 75 mg or 150 mg (2 times the recommended dose), and subjects with body weight ≥ 50 kg received either 150 mg or 300 mg (2 times the recommended dose).

The second trial was a randomized, open-label, 208-week trial (Trial PsO7; NCT03668613) of 84 subjects 6 years of age and older with moderate to severe plaque psoriasis (defined by a PASI score ≥ 12, IGA mod 2011 score of ≥ 3, and BSA involvement of ≥ 10% at randomization) who were randomized into two COSENTYX arms [Arm 1: 75 mg for body weight (BW) < 50 kg or 150 mg for ≥ 50 kg and Arm 2: 75 mg forBW < 25 kg, 150 mg for BW ≥ 25 kg and < 50 kg, or 300 mg for BW ≥ 50 kg].

The safety profile reported in these trials was consistent with the safety profile reported in adult plaque psoriasis trials.

Infections

One case of methicillin-resistant Staphylococcus aureus (MRSA) toxic shock syndrome (TSS) was reported in a COSENTYX treated subject during the placebo-controlled period.

In the pediatric safety pool, which includes all subjects who took at least one dose of COSENTYX during the treatment periods [198 subjects (287 patient years)], 22 (11%) subjects reported ≥ CTCAE Grade 2 neutropenia (≥1,000 to < 1,500 cells/mm³) with 57% of subjects followed for one year or more and 30% of subjects followed for two years or more. During the placebo-controlled period which included a total of 80 subjects treated with secukinumab and 41 subjects treated with placebo up to 12 weeks, ≥ CTCAE Grade 2 neutropenia was reported in 3 (4%) of the subjects treated with secukinumab compared with no subjects treated with placebo. No serious infections were associated with cases of neutropenia.

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 16week 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%).

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.

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. In a third controlled study of AS (study AS3), the safety profile of the 300 mg dose of COSENTYX was consistent with the safety profile of the 150 mg dose of COSENTYX.

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%).

In the original 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.

Non-Radiographic Axial Spondyloarthritis

COSENTYX was studied in one randomized, double-blind, placebo-controlled non-radiographic axial spondyloarthritis trial with 555 patients (185 patients on with load COSENTYX, 184 patients on without load COSENTYX and 186 patients on placebo). The safety profile for patients with nr-axSpA treated with COSENTYX was overall similar to the safety profile seen in patients with AS and other previous experience with COSENTYX. Patients in nr-axSpA1 study who received the loading dosing regimen compared to those without the loading regimen, had higher incidence of infections and infestations (92 per 100 patient-years vs 72 per 100 patient years), including nasopharyngitis, upper respiratory tract infection and urinary tract infection, and gastrointestinal disorders (27 per 100 patient-years vs 22 per 100 patient-years), including gastritis, lower abdominal pain, colitis, diarrhea, and hematochezia.

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

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.

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 of the CYP450 substrate as needed [see CLINICAL PHARMACOLOGY].

Read the entire FDA prescribing information for Cosentyx (Secukinumab Injection)

© Cosentyx Patient Information is supplied by Cerner Multum, Inc. and Cosentyx Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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