A message from Novartis on COVID-19

A message from Novartis on COVID-19

Thank you for your expertise in treating autoimmune/autoinflammatory diseases. The arrival of COVID-19 has increased the complexity of your calling, and we want to acknowledge you for the deep commitment you have to your patients.

What does the availability of COVID-19 vaccines mean for patients taking COSENTYX® (secukinumab)?

  • According to the COSENTYX Prescribing Information, 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.
  • As of June 24, 2021, all COVID-19 vaccines with emergency use authorization are non-live vaccines, and at this time, there are no live COVID-19 vaccines in phase 3 clinical development.2
Please click here for the COSENTYX Medical team letter to help you make informed clinical decisions regarding COVID-19 vaccines in patients taking COSENTYX.

What does COVID-19 mean for patients taking COSENTYX?

  • At this time, Novartis does not have data on patients with COVID-19 who start or continue on COSENTYX.
  • COSENTYX may increase the risk of infections. Exercise caution when considering the use of COSENTYX in patients with a chronic infection or a history of recurring infection.1
  • Instruct patients to seek medical advice if signs and symptoms suggestive of an infection occur. If a patient develops a serious infection, monitor the patient closely and discontinue COSENTYX until the infection resolves.1
Please click here for the COSENTYX Medical team letter to help you make informed clinical decisions regarding COVID-19 in patients taking COSENTYX.

Availability & Manufacturing

  • Secukinumab is manufactured in France and Switzerland in sterile, state-of-the-art manufacturing facilities.3
  • At this time, Novartis Pharmaceuticals Corporation does not anticipate supply chain disruption due to the COVID-19 outbreak. We are confident that our existing stock is sufficient to cover production/distribution needs for the time being.
  • Where required, we have enacted mitigation plans to ensure ongoing drug supply.4
  • The quality, safety, and efficacy of our products are of fundamental importance to Novartis, and we are committed to ensuring that all our marketed products meet the highest quality standards.

Additional Information

Please refer to the following:

Novartis COVID-19 Information Center American Academy of Dermatology American College of Rheumatology US Centers for Disease Control and Prevention World Health Organization

For additional questions regarding this information, please contact Novartis Medical Information @ 1-888-NOW-NOVA 1-888-NOW-NOVA (1-888-669-6682) (1-888-669-6682)
from Monday - Friday, 8:30 AM - 5:00 PM ET.

References: 1. Cosentyx [prescribing information].East Hanover, NJ: Novartis Pharmaceuticals Corp; May 2021. 2. American College of Rheumatology. December 2020 update: Information from the American College of Rheumatology regarding vaccination against SARS-CoV-2. https://www.rheumatology.org/Portals/0/Files/ACR-Information-Vaccination-Against-SARS-CoV-2.pdf. Accessed January 12, 2021. 3. Data on File. Novartis Pharmaceuticals Corporation; East Hanover, NJ. 4. Novartis Global Website. Coronavirus disease (COVID-19) update. Accessed: March 13, 2020. https://www.novartis.com/news/coronavirus-disease-covid-19-update.

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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.

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.

INDICATIONS

COSENTYX® (secukinumab) is indicated for the treatment of moderate to severe plaque psoriasis
in patients 6 years and older who are candidates for systemic therapy or phototherapy.

COSENTYX is indicated for the treatment of active psoriatic arthritis (PsA) in patients 2 years of age and older.

COSENTYX is indicated for the treatment of adult patients with active ankylosing spondylitis (AS).

COSENTYX is indicated for the treatment of adult patients with active non-radiographic axial spondyloarthritis (nr-axSpA) with objective signs of inflammation.

COSENTYX is indicated for the treatment of active enthesitis-related arthritis (ERA) in patients 4 years of age and older.

INDICATIONS

COSENTYX® (secukinumab) is indicated for the treatment of moderate to severe plaque psoriasis in patients 6 years and older who are candidates for systemic therapy or phototherapy.

COSENTYX is indicated for the treatment of active psoriatic arthritis (PsA) in patients 2 years of age and older.

COSENTYX is indicated for the treatment of adult patients with active ankylosing spondylitis (AS).

COSENTYX is indicated for the treatment of adult patients with active non-radiographic axial spondyloarthritis (nr-axSpA) with objective signs of inflammation.

COSENTYX is indicated for the treatment of active enthesitis-related arthritis (ERA) in patients 4 years of age and older.

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.

COSENTYX is indicated for the treatment of active enthesitis-related arthritis (ERA) in patients 4 years of age and older.

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 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 subjects with psoriatic arthritis, ankylosing spondylitis and non-radiographic axial spondyloarthritis. The incidence of some types of infections appeared to be dose-dependent in clinical studies. In the postmarketing setting, serious and some fatal infections have been reported in patients receiving COSENTYX.

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

Caution should be used when prescribing COSENTYX to patients with inflammatory bowel disease. Exacerbations, in some cases serious, occurred in COSENTYX treated subjects during clinical trials in plaque psoriasis, psoriatic arthritis, ankylosing spondylitis and non-radiographic axial spondyloarthritis. In addition, new onset inflammatory bowel disease cases occurred in clinical trials with COSENTYX. In an exploratory trial in 59 subjects with active Crohn's disease, there were trends toward greater disease activity and increased adverse events in the secukinumab group as compared to the placebo group. Patients who are treated with COSENTYX should be monitored for signs and symptoms of inflammatory bowel disease.

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.