Drug Safety-related Labeling Changes (SrLC)

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Drug Safety-related Labeling Changes (SrLC) Database

ANDA	Abbreviated New Drug Application
BLA	Biologics License Application
CDER	Center for Drug Evaluation and Research
MG	Medication Guide
NDA	New Drug Application
PCI	Patient Counseling Information
PI	Patient Information
PLR	Physician Labeling Rule
PLLR	Pregnancy and Lactation Labeling Rule
Italics	For the most part, italics indicate an FDA comment such as: Additions and/or revisions underlined These italics usually appear at the beginning of the section. In some cases, italics may be an inherent part of the label, and will most often appear in the body of the section.
Underlines	Any text that is underlined indicates text that has been added or revised. There are exceptions where underlining occurs in a section subtitle or heading. This is the case when there is just one word underlined in the body of the text.

Sections

BW	Box Warning
WP	Warnings and Precautions all in one section (PLR-format) Warnings as one section (pre-PLR format) Precautions as one section (pre-PLR format)
AR	Adverse Reactions (in pre-PLR format, this may be a subheading under precautions).
DI	Drug Interactions (in pre-PLR format, this may be a subheading under precautions).
USP	Use in Specific Populations (Inclusive on one or more of the following: Pregnancy; Lactation (PLLR- format); Nursing Mothers (pre-PLLR format); Females and Males of Reproductive Potential (PLLR format only); Pediatric Use, Geriatric Use, Renal Impairment, Hepatic Impairment, Sex, Race (these last six may be a subheading of precautions if label in pre-PLLR format.
PCI/PI/MG	Patient Counseling Information (PLR format only) - summarizes the information that a health care provider should convey to a patient (or caregiver when applicable) when a counseling discussion is taking place (e.g., a physician prescribing a drug during an office visit, a nurse providing discharge instructions at a hospital, or a pharmacist conveying information at a pharmacy). Patient Information - FDA approved patient labeling. Medication Guide - paper handouts that come with many prescription medicines. The guides address issues that are specific to particular drugs and drug classes, and they contain FDA-approved information that can help patients avoid serious adverse events.

Only NDAs and CDER regulated BLAs are included in this database. ANDAs are not included.

Applications that remain active, even if the product has been discontinued, undergo safety-related labeling changes.

COSENTYX (BLA-761349)

(SECUKINUMAB)

Safety-related Labeling Changes Approved by FDA Center for Drug Evaluation and Research (CDER)

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04/17/2026 (SUPPL-11)

Approved Drug Label (PDF)

5 Warnings and Precautions

5.6 Risk of Hypersensitivity in Latex-Sensitive Individuals

Additions and/or revisions underlined:

The removable cap of the COSENTYX Sensoready pen and prefilled syringes (150 mg/mL, 75 mg/0.5 mL) contains natural rubber latex, which may cause a hypersensitivity reaction in latex-sensitive individuals. The safe use of the COSENTYX Sensoready pen or prefilled syringes (150 mg/mL, 75 mg/0.5 mL) in latex-sensitive individuals has not been studied.

8 Use in Specific Populations

8.4 Pediatric Use

Additions and/or revisions underlined:

. . .

Juvenile Psoriatic Arthritis

The safety and effectiveness of COSENTYX have been established for the treatment of active JPsA in pediatric patients aged 2 years and older who weigh 15 kg or more [see Adverse Reactions (6.1) and Clinical Studies (14.6)].

The safety and effectiveness of COSENTYX in pediatric patients with JPsA below the age of 2 years old or with a body weight less than 15 kg have not been established.

Juvenile Ankylosing Spondylitis

The safety and effectiveness of COSENTYX have been established for treatment of JAS in pediatric patients 12 years of age and older. Use of COSENTYX for this indication is supported by safety and efficacy data from adequate and well-controlled trials in adult subjects with AS. Additional evidence includes pharmacokinetic data from adult subjects with PsO, PsA, and AS and pediatric subjects with PsO, JPsA, and ERA, as well as safety data from clinical trials in pediatric subjects with PsO, JPsA, and ERA. The pharmacokinetics are predicted to be comparable between adult AS and pediatric subjects with JAS [see Adverse Reactions (6.1), Clinical Pharmacology (12.3), and Clinical Studies (14.4)].

The safety and effectiveness of COSENTYX in pediatric patients with JAS below the age of 12 years old have not been established.

Axial Juvenile Spondyloarthritis

Six pediatric patients with axial symptoms were participants in a study for JPsA and ERA (NCT03031782). Due to the limited number of patients and uncertainty fulfilling Axial Juvenile Spondyloarthritis (AxJSpA) classification criteria, the effectiveness and safety of COSENTYX in AxJSpA has not been established. Safety was comparable to pediatric patients treated with COSENTYX for JPsA and ERA [see Adverse Reactions (6.1)].

Enthesitis-Related Arthritis

The safety and effectiveness of COSENTYX have been established for the treatment of active ERA in pediatric patients aged 4 years and older who weigh 15 kg or more [see Adverse Reactions (6.1) and Clinical Studies (14.6)].

The safety and effectiveness of COSENTYX in pediatric patients with ERA below the age of 4 years old or with body weight less than 15 kg have not been established.

Hidradenitis Suppurativa

The safety and effectiveness of COSENTYX have been established for the treatment of moderate to severe HS in pediatric patients 12 years of age and older who weigh 30 kg or more. Use of COSENTYX for this indication is supported by safety and efficacy data from adequate and well-controlled trials in adult subjects with moderate to severe HS. Additional evidence includes population pharmacokinetic modeling and simulation based on data from adult subjects with PsO and HS and pediatric subjects with PsO, as well as safety data from clinical trials in pediatric subjects with PsO and JIA (JPsA and ERA) [see Adverse Reactions (6.1), Clinical Pharmacology (12.3), and Clinical Studies (14.7)].

The safety and effectiveness of COSENTYX in pediatric patients with HS below the age of 12 years old or with a body weight less than 30 kg have not been established.

. . .

17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)

PATIENT COUNSELING INFORMATION

Additions and/or revisions underlined:

. . .

Risk of Hypersensitivity in Latex-Sensitive Individuals

Advise latex-sensitive patients that the removal cap of the COSENTYX Sensoready pen and prefilled syringes (150 mg/mL, 75 mg/0.5 mL) contains natural rubber latex, which may cause an allergic reaction in latex-sensitive individuals [see Warnings and Precautions (5.6)].

. . .

04/17/2026 (SUPPL-12)

5 Warnings and Precautions

5.6 Risk of Hypersensitivity in Latex-Sensitive Individuals

Additions and/or revisions underlined:

8 Use in Specific Populations

8.4 Pediatric Use

Additions and/or revisions underlined:

. . .

The safety and effectiveness of COSENTYX in pediatric patients with JPsA below the age of 2 years old or with a body weight less than 15 kg have not been established.

Juvenile Ankylosing Spondylitis

The safety and effectiveness of COSENTYX in pediatric patients with JAS below the age of 12 years old have not been established.

Axial Juvenile Spondyloarthritis

Enthesitis-Related Arthritis

The safety and effectiveness of COSENTYX in pediatric patients with ERA below the age of 4 years old or with body weight less than 15 kg have not been established.

Hidradenitis Suppurativa

The safety and effectiveness of COSENTYX in pediatric patients with HS below the age of 12 years old or with a body weight less than 30 kg have not been established.

. . .

17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)

PATIENT COUNSELING INFORMATION

Additions and/or revisions underlined:

. . .

Risk of Hypersensitivity in Latex-Sensitive Individuals

. . .

08/06/2025 (SUPPL-8)

Approved Drug Label (PDF)

4 Contraindications

Additions and/or revisions underlined:

COSENTYX is contraindicated in patients with a previous serious hypersensitivity reaction to secukinumab or to any of the excipients in COSENTYX. Cases of anaphylaxis and angioedema have been reported during treatment with COSENTYX [see Warnings and Precautions (5.2)].

5 Warnings and Precautions

5.2 Hypersensitivity Reactions

Additions and/or revisions underlined:

ASerious hypersensitivity reactions including anaphylaxis, angioedema, and urticaria have been reported in COSENTYX treated subjects in clinical trials and in the post-marketing setting [see Adverse Reactions (6.1, 6.2)]. If an anaphylactic or other serious allergic reaction occurs, immediately discontinue administration of COSENTYX and initiate appropriate therapy [see Contraindications (4)].

6 Adverse Reactions

6.2 Postmarketing Experience

Additions and/or revisions underlined:

The following adverse reactions have been reported during post-approval use of COSENTYX. Because they are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Immune system disorders: anaphylaxis, angioedema, systemic vasculitis

Skin and subcutaneous tissue disorders: eczematous eruptions (atopic dermatitis-like eruptions, dyshidrotic eczema, and

erythroderma), cutaneous vasculitis, pyoderma gangrenosum

. . .

10/04/2024 (SUPPL-5)

Approved Drug Label (PDF)

5 Warnings and Precautions

5.2 Hypersensitivity Reactions

Additions and revisions underlined:

Serious hypersensitivity reactions including anaphylaxis, angioedema, and urticaria have been reported in COSENTYX treated subjects in clinical trials and in the post-marketing setting [see Adverse Reactions (6.1, 6.2)]. If an anaphylactic or other serious allergic reaction occurs, immediately discontinue administration of COSENTYX and initiate appropriate therapy [see Contraindications (4)].

6 Adverse Reactions

6.2 Postmarketing Experience

Additions and revisions underlined:

Immune system disorders: anaphylaxis, angioedema

08/16/2024 (SUPPL-6)

Approved Drug Label (PDF)

5 Warnings and Precautions

5.1 Infections

Additions and/or revisions underlined:

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 [see Adverse Reactions (6.1)].

In the postmarketing setting, serious bacterial, viral, and fungal opportunistic infections, and some fatal infections have been reported in patients receiving IL-17 inhibitors including COSENTYX. Cases of Hepatitis B virus reactivation have been reported [see Adverse Reactions (6.2)].

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.

If signs of Hepatitis B virus reactivation occur, consult a hepatitis specialist. COSENTYX is not recommended for use in patients with active viral hepatitis.

5.3 Pre-Treatment Evaluation for Tuberculosis

Additions and/or revisions underlined:

Evaluate patients for active or latent 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.

In the postmarketing setting, cases were reported where patients with a history of latent tuberculosis (TB) who were treated with COSENTYX developed active TB.

6 Adverse Reactions

6.2 Postmarketing Experience

Additions and/or revisions underlined:

The following adverse reactions have been reported during post-approval use of COSENTYX. Because they are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Skin and Subcutaneous Tissue Disorders: Eczematous eruptions (atopic dermatitis-like eruptions, dyshidrotic eczema, and erythroderma) [see Warnings and Precautions (5.5)], and pyoderma gangrenosum.

Infections: bacterial, viral, and fungal opportunistic infections, including esophageal candidiasis, tracheobronchial candidiasis, cutaneous aspergillosis, cytomegalovirus gastroenteritis/colitis, herpes simplex encephalitis, herpes simplex keratitis, Pneumocystis jiroveci pneumonia, Hepatitis B virus reactivation, histoplasmosis, toxoplasmosis [see Warnings and Precautions (5.1)]

17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)

PATIENT COUNSELING INFORMATION

Additions and/or revisions underlined:

Advise the patient to read the FDA-approved patient labeling (Medication Guide and Instructions for Use). Infections

Inform patients that COSENTYX may lower the ability of their immune system to fight infections and that serious infections, including opportunistic infections, may occur with the use of COSENTYX. 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)].

…

11/21/2023 (SUPPL-4)

Approved Drug Label (PDF)

6 Adverse Reactions

6.2 Postmarketing Experience

Additions and revisions underlined:

The following adverse reactions have been reported during postapproval use of COSENTYX. Because they are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.