Cosentyx SensoReady® Pen | COSENTYX® (secukinumab)

The UnoReady^® and Sensoready^® pens are designed to help patients inject comfortably and confidently^1,2

Trust the COSENTYX^® you know

The UnoReady^®pen delivers 300 mg COSENTYX in a single injection^3*

Adult patients prescribed a COSENTYX dosage of 300 mg can get started with the UnoReady^® pen^3‡

Remove the UnoReady^® pen from the refrigerator 30 to 45 minutes before injection to allow it to reach room temperature³

*After loading doses; 1 injection every 4 weeks. The maintenance dose may be increased to 300 mg every 2 weeks based on clinical response.³
^†Please note that the UnoReady^® pen's cap is not made with natural rubber latex.³
^‡The 150-mg Sensoready^® pen is still available, so patients can continue therapy without disruption.

In a study of patients with moderate to severe PsO

Watch a step-by-step guide on how to use the UnoReady^® pen

Please note that if existing patients want to use the UnoReady^® pen, they may need a prior authorization (PA).

Positive injection experience with the Sensoready^® pen^§

Each pen contains 150 mg of COSENTYX

Each 300 mg dose is supplied in a carton containing two 150 mg Sensoready^®pens
Each 150 mg dose is supplied in a carton containing one 150 mg Sensoready^® pen

Prefilled syringes are also available—each contains 150 mg or 75 mg³

^§Coprimary end points of the JUNCTURE study were efficacy of COSENTYX vs placebo at Week 12 based on PASI 75 responses and scores of 0 or 1 and a ≥2-grade improvement from baseline on the IGA mod 2011 scale. Secondary end points included usability of the autoinjector, determined by observer rating of successful, hazard-free self-injection, and subject rating of autoinjector acceptability.⁴

In a study of adult patients with moderate to severe PsO,
>99% reported no injection site reactions at Week 12 (n=1382)^5||¶

^||Based on safety analysis of 4 pivotal randomized, placebo-controlled trials in patients with moderate to severe plaque psoriasis (N=2399, with n=1382 exposed to any dose of COSENTYX).⁵
^¶Individual results may vary.

The Sensoready^® pen can be operated without assistance^4#**

See the prefilled syringe injection video

UnoReady^® and Sensoready^® at a glance

^#Usability of the autoinjector in the JUNCTURE study was determined by observer rating of successful, hazard-free self-injection and subject rating of autoinjector acceptability. Successful self-administration was defined as subject successfully performing critical steps as per the Instructions for Use. All evaluable subjects (N=178) successfully self-administered treatment at Week 1. Ease of use was also evaluated using the SIAQ at Week 12. Scores for the entire cohort ranged from 8.95 to 9.28, indicating excellent subject-reported autoinjector ease of use.⁴
**Adults only.

Routine maintenance dosing for PsO

PsO Dosing

Routine maintenance dosing for HS

HS Dosing

Get your patients started on COSENTYX

Access and Support

Tap to see IMPORTANT SAFETY INFORMATION and INDICATIONS

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS
COSENTYX is contraindicated in patients with a previous serious hypersensitivity reaction to secukinumab or to any of the excipients in COSENTYX. Cases of anaphylaxis have been reported during treatment with COSENTYX...

CONTRAINDICATIONS

COSENTYX is contraindicated in patients with a previous serious hypersensitivity reaction to secukinumab or to any of the excipients in COSENTYX. Cases of anaphylaxis have been reported during treatment with COSENTYX.

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 subjects with moderate to severe PsO, 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 in subjects treated with COSENTYX compared to placebo-treated subjects. A similar increase in risk of infection in subjects treated with COSENTYX was seen in placebo-controlled trials in subjects with PsA, AS and nr-axSpA. The incidence of some types of infections, including fungal infections, appeared to be dose-dependent in clinical trials.

In the postmarketing setting, serious and some fatal infections have been reported in patients treated with COSENTYX.

Exercise caution when considering the use of COSENTYX in patients with a chronic infection or a history of recurrent infection. Instruct patients to seek medical advice if signs or symptoms suggestive of an infection occur. If a patient develops a serious infection, monitor the patient closely and discontinue COSENTYX until the infection resolves.

Pre-treatment Evaluation for Tuberculosis

Evaluate patients for tuberculosis (TB) infection prior to initiating treatment with COSENTYX. Avoid administration of COSENTYX to patients with active TB infection. Initiate treatment of latent TB prior to administering COSENTYX. 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. Monitor patients closely for signs and symptoms of active TB during and after treatment.

Inflammatory Bowel Disease

Inflammatory Bowel Disease (IBD) exacerbations, in some cases serious and/or leading to discontinuation of COSENTYX, occurred in COSENTYX treated subjects during clinical trials in PsO, PsA, AS, nr-axSpA, and HS. In adult subjects with HS, the incidence of IBD was higher in subjects who received COSENTYX 300 mg every 2 weeks (Ulcerative Colitis [UC] 1 case, EAIR 0.2/100 subject-years; Crohn’s Disease [CD] 1 case, EAIR 0.2/100 subject-years) compared to subjects who received COSENTYX 300 mg every 4 weeks (IBD 1 case, EAIR 0.2/100 subject-years). In addition, new onset IBD cases occurred in subjects treated with COSENTYX in clinical trials. In an exploratory trial in 59 subjects with active Crohn’s disease [COSENTYX is not approved for the treatment of Crohn’s disease], there were trends toward greater disease activity and increased adverse reactions in subjects treated with COSENTYX as compared to placebo-treated subjects.

Exercise caution when prescribing COSENTYX to patients with IBD. Patients treated with COSENTYX should be monitored for signs and symptoms of IBD.

Eczematous Eruptions

In postmarketing reports, cases of severe eczematous eruptions, including atopic dermatitis-like eruptions, dyshidrotic eczema, and erythroderma, were reported in patients receiving COSENTYX; some cases resulted in hospitalization. The onset of eczematous eruptions was variable, ranging from days to months after the first dose of COSENTYX.

Treatment may need to be discontinued to resolve the eczematous eruption. Some patients were successfully treated for eczematous eruptions while continuing COSENTYX.

Hypersensitivity Reactions

Anaphylaxis and cases of urticaria occurred in COSENTYX treated subjects in clinical trials. If an anaphylactic or other serious allergic reaction occurs, administration of COSENTYX should be discontinued immediately and appropriate therapy initiated.

The removable caps of the COSENTYX Sensoready^® pen and the COSENTYX 1 mL and 0.5 mL prefilled syringes contain natural rubber latex, which may cause an allergic reaction in latex-sensitive individuals. The safe use of the COSENTYX Sensoready pen or prefilled syringe in latex-sensitive individuals has not been studied.

Immunizations

Prior to initiating therapy with COSENTYX, consider completion of all age-appropriate immunizations according to current immunization guidelines. COSENTYX may alter a patient’s immune response to live vaccines. Avoid use of live vaccines in patients treated with COSENTYX.

MOST COMMON ADVERSE REACTIONS

Most common adverse reactions (>1%) are nasopharyngitis, diarrhea, and upper respiratory tract infection.

Please see Full Prescribing Information, including Medication Guide.

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The UnoReady^® and Sensoready^® pens are designed to help patients inject comfortably and confidently^1,2

Trust the COSENTYX^® you know

The UnoReady^®pen delivers 300 mg COSENTYX in a single injection^3*

In a study of patients with moderate to severe PsO

reported no pain at the injection site¹

Watch a step-by-step guide on how to use the UnoReady^® pen

Positive injection experience with the Sensoready^® pen^§

The Sensoready^® pen can be operated without assistance^4#**

See the prefilled syringe injection video

UnoReady^® and Sensoready^® at a glance

Routine maintenance dosing for PsO

Routine maintenance dosing for HS

Get your patients started on COSENTYX

Tap to see IMPORTANT SAFETY INFORMATION and INDICATIONS

IMPORTANT SAFETY INFORMATION

INDICATIONS

Definitions and references

The UnoReady® and Sensoready® pens are designed to help patients inject comfortably and confidently1,2

Trust the COSENTYX® you know

The UnoReady® pen delivers 300 mg COSENTYX in a single injection3*

In a study of patients with moderate to severe PsO

reported no pain at the injection site1

Watch a step-by-step guide on how to use the UnoReady® pen

Positive injection experience with the Sensoready® pen§

The Sensoready® pen can be operated without assistance4#**

See the prefilled syringe injection video

UnoReady® and Sensoready® at a glance

Routine maintenance dosing for PsO

Routine maintenance dosing for HS

Get your patients started on COSENTYX

Definitions and references

The UnoReady^® and Sensoready^® pens are designed to help patients inject comfortably and confidently^1,2

Trust the COSENTYX^® you know

The UnoReady^®pen delivers 300 mg COSENTYX in a single injection^3*

reported no pain at the injection site¹

Watch a step-by-step guide on how to use the UnoReady^® pen

Positive injection experience with the Sensoready^® pen^§

The Sensoready^® pen can be operated without assistance^4#**

UnoReady^® and Sensoready^® at a glance