Cosentyx

Injection for subcutaneous use:

• 300 mg/2 mL as a clear to opalescent, colorless to slightly yellowish solution in a single-dose UnoReady pen
• 300 mg/2 mL as a clear to opalescent, colorless to slightly yellowish solution in a single-dose prefilled syringe
• 150 mg/mL as a clear to opalescent, colorless to slightly yellowish solution in a single-dose Sensoready pen
• 150 mg/mL as a clear to opalescent, colorless to slightly yellowish solution in a single-dose prefilled syringe
• 75 mg/0.5 mL as a clear to opalescent, colorless to slightly yellowish solution in a single-dose prefilled syringe (for pediatric patients less than 50 kg)

Injection for intravenous use:

• 125 mg/5 mL as a clear to opalescent, colorless to slightly yellowish solution in a single-dose vial for dilution prior to intravenous infusion (for healthcare professional use only).

Limited available human data with COSENTYX use in pregnant women are insufficient to inform a drug-associated risk of adverse developmental outcomes. In an embryo-fetal development study, no adverse developmental effects were observed in infants born to pregnant monkeys after subcutaneous administration of secukinumab during organogenesis at doses up to 30 times the maximum recommended human dose (MRHD)

The background risk of major birth defects and miscarriage for the indicated population is unknown; however, the background risk in the U.S. general population of major birth defects is 2% to 4% and of miscarriage is 15% to 20% of clinically recognized pregnancies.

An embryo-fetal development study was performed in cynomolgus monkeys with secukinumab. No malformations or embryo-fetal toxicity were observed in fetuses from pregnant monkeys that were administered secukinumab weekly by the subcutaneous route during the period of organogenesis at doses up to 30 times the MRHD (on a mg/kg basis at a maternal dose of 150 mg/kg).

A pre- and post-natal development toxicity study was performed in mice with a murine analog of secukinumab. No treatment-related effects on functional, morphological, or immunological development were observed in fetuses from pregnant mice that were administered the murine analog of secukinumab on gestation days 6, 11, and 17 and on postpartum days 4, 10, and 16 at doses up to 150 mg/kg/dose.

• Infections
  : Serious infections have occurred. Exercise caution when considering the use of COSENTYX in patients with a chronic infection or a history of recurrent infection. If a serious infection develops, discontinue COSENTYX until the infection resolves. (
  5.1     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

  [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.
  )
• Hypersensitivity Reactions
  : If an anaphylactic reaction or other serious allergic reaction occurs, discontinue COSENTYX immediately and initiate appropriate therapy. (
  5.2     Hypersensitivity Reactions

  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)]

  .
  )
• Tuberculosis (TB)
  : Prior to initiating treatment with COSENTYX, evaluate for TB. (
  5.3     Pre-Treatment Evaluation for Tuberculosis

  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.
  )
• Inflammatory Bowel Disease (IBD)
  : Cases of IBD were observed in clinical trials. Exercise caution when prescribing COSENTYX to patients with IBD. (
  5.4     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

  [see Adverse Reactions (6.1)]

  .
  )
• Eczematous Eruptions
  : Cases of severe eczematous eruptions have occurred in patients receiving COSENTYX. (
  5.5     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.
  )
• Immunizations
  : Avoid use of live vaccines in patients treated with COSENTYX. (
  5.7     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

  [see Clinical Pharmacology (12.2)]

  .
  )

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

• Infections
  [see Warnings and Precautions (5.1)]
• Hypersensitivity Reactions
  [see Warnings and Precautions (5.2)]
• Inflammatory Bowel Disease
  [see Warnings and Precautions (5.4)]
• Eczematous Eruptions
  [see Warnings and Precautions (5.5)]