Cosentyx (Secukinumab): Uses, Dosage & Side Effects

What Is Cosentyx and What Is It Used For?

Cosentyx contains the active substance secukinumab, a fully human immunoglobulin G1 kappa (IgG1κ) monoclonal antibody produced in Chinese hamster ovary (CHO) cells using recombinant DNA technology. It belongs to a class of medications known as interleukin (IL) inhibitors, specifically targeting and neutralizing the pro-inflammatory cytokine interleukin-17A (IL-17A). By binding to IL-17A with high affinity and specificity, secukinumab prevents it from interacting with its receptor on cell surfaces, thereby inhibiting the downstream release of pro-inflammatory cytokines, chemokines, and tissue-damaging mediators that drive the inflammatory processes underlying several autoimmune conditions.

IL-17A is a naturally occurring cytokine that plays an important role in normal immune defense, particularly against extracellular bacteria and fungi. However, in autoimmune and inflammatory conditions such as psoriasis, psoriatic arthritis, and axial spondyloarthritis, IL-17A is produced in abnormally high quantities, contributing to chronic tissue inflammation, joint destruction, and skin pathology. Cosentyx was first approved by the European Medicines Agency (EMA) in 2015 and by the U.S. Food and Drug Administration (FDA) in the same year, marking a significant advance in targeted biologic therapy for these conditions.

Plaque Psoriasis

Cosentyx is approved for the treatment of moderate to severe plaque psoriasis in adults, adolescents, and children aged 6 years and older who are candidates for systemic therapy or phototherapy. Plaque psoriasis is a chronic autoimmune skin condition characterized by red, raised, scaly patches (plaques) that can appear anywhere on the body but most commonly affect the elbows, knees, scalp, and lower back. In clinical trials (ERASURE and FIXTURE), Cosentyx demonstrated superior efficacy compared to both placebo and etanercept, with approximately 77–82% of patients achieving PASI 75 (at least 75% improvement in the Psoriasis Area and Severity Index) at week 12, and 59–65% achieving PASI 90 (near-complete skin clearance). Many patients report significant improvement in skin scaling, itching, and pain, as well as improvements in quality of life.

Hidradenitis Suppurativa

Cosentyx is approved for the treatment of moderate to severe hidradenitis suppurativa (HS), also known as acne inversa or Verneuil’s disease, in adults who have had an inadequate response to conventional systemic therapy. HS is a chronic, painful inflammatory skin condition characterized by recurrent painful nodules and abscesses, typically in areas where skin rubs together such as the armpits, groin, under the breasts, and buttocks. These lesions can rupture and drain pus, leading to sinus tract formation and significant scarring. Clinical trials (SUNSHINE and SUNRISE) demonstrated that Cosentyx significantly reduced the number of inflammatory nodules and abscesses, decreased pain, and improved quality of life compared to placebo. Cosentyx may be used alone or in combination with antibiotics for HS.

Psoriatic Arthritis

Cosentyx is approved for the treatment of active psoriatic arthritis (PsA) in adults, either alone or in combination with methotrexate, when the response to prior disease-modifying antirheumatic drug (DMARD) therapy has been inadequate. PsA is a chronic inflammatory joint disease that occurs in association with psoriasis, affecting up to 30% of people with psoriasis. It can cause joint pain, stiffness, swelling, and progressive joint damage. In the FUTURE 1 and FUTURE 2 clinical trials, Cosentyx demonstrated significant improvements in joint signs and symptoms (ACR20/50/70 responses), physical function, radiographic progression, and skin manifestations. For patients who have not responded adequately to tumor necrosis factor alpha (TNFα) inhibitors, the recommended dose is 300 mg; for other patients, 150 mg is the standard starting dose, with dose escalation to 300 mg if needed.

Axial Spondyloarthritis

Cosentyx is approved for the treatment of active ankylosing spondylitis (AS, also called radiographic axial spondyloarthritis) and active non-radiographic axial spondyloarthritis (nr-axSpA) with objective signs of inflammation (elevated C-reactive protein or MRI evidence) in adults who have responded inadequately to conventional therapy. These are chronic inflammatory conditions primarily affecting the spine and sacroiliac joints, causing back pain, stiffness, and reduced mobility. In the MEASURE 1 and MEASURE 2 trials for AS, and the PREVENT trial for nr-axSpA, Cosentyx demonstrated significant improvements in disease activity (ASAS20/40 responses), spinal mobility, and patient-reported outcomes. The recommended starting dose is 150 mg, with the option to increase to 300 mg based on clinical response.

Juvenile Idiopathic Arthritis

Cosentyx is also approved for the treatment of active enthesitis-related arthritis (ERA) and juvenile psoriatic arthritis (JPsA) in patients aged 6 years and older. These are subtypes of juvenile idiopathic arthritis (JIA), a group of chronic inflammatory conditions affecting the joints and the sites where tendons attach to bone (entheses) in children and adolescents. Clinical studies demonstrated that Cosentyx effectively reduced joint inflammation, enthesitis, and improved physical function in this younger patient population. Dosing is weight-based: 75 mg for patients weighing less than 50 kg and 150 mg for those weighing 50 kg or more.

What Should You Know Before Taking Cosentyx?

Contraindications

There are specific situations in which Cosentyx must not be used. You should not use Cosentyx if you have a known allergy (hypersensitivity) to secukinumab or any of the other ingredients in the formulation (trehalose dihydrate, histidine, histidine hydrochloride monohydrate, methionine, polysorbate 80, and water for injections). You should also not start Cosentyx if you have a clinically important active infection, such as active tuberculosis. Your prescribing physician will evaluate your infection status before initiating treatment.

Warnings and Precautions

Before starting treatment with Cosentyx, you should inform your doctor if any of the following apply to you, as they may affect whether Cosentyx is appropriate for your situation:

• Current infection: If you currently have an infection, even a minor one, your doctor may decide to delay starting Cosentyx until the infection has resolved.
• Chronic or recurrent infections: If you have a history of recurring infections or conditions that make you more susceptible to infections, discuss this with your doctor before starting treatment.
• Tuberculosis (TB): Your doctor will screen you for TB before starting Cosentyx. If you have latent TB, you may need to start TB treatment before initiating Cosentyx. Tell your doctor immediately if you develop symptoms of TB during treatment, including persistent cough, unexplained weight loss, fatigue, or fever.
• Hepatitis B: Inform your doctor if you have or have previously had hepatitis B virus (HBV) infection. Cosentyx may cause reactivation of HBV. Your doctor may monitor you for signs of HBV reactivation during treatment, including worsening fatigue, jaundice (yellowing of the skin or eyes), dark urine, loss of appetite, nausea, or pain in the upper right abdomen.
• Inflammatory bowel disease (IBD): If you have Crohn’s disease or ulcerative colitis, tell your doctor. Cases of new-onset or exacerbation of IBD have been reported with Cosentyx. Stop using Cosentyx and seek immediate medical attention if you develop abdominal cramps, pain, diarrhea, weight loss, or blood in your stool.
• Latex allergy: The needle cap of the pre-filled pen may contain a derivative of natural rubber latex, which may cause allergic reactions in individuals with latex sensitivity.
• Vaccinations: Tell your doctor if you have recently been vaccinated or plan to be vaccinated. You should not receive live vaccines while using Cosentyx. Ideally, all recommended vaccinations should be completed before starting treatment.
• Other immunosuppressive treatments: If you are receiving other treatments for psoriasis such as other biologics, immunosuppressants, or phototherapy, inform your doctor, as combining these treatments with Cosentyx has not been studied and may increase infection risk.

Pregnancy and Breastfeeding

Cosentyx should preferably be avoided during pregnancy. The effects of this medication on pregnant women are not sufficiently known, and as an IgG1 monoclonal antibody, secukinumab is expected to cross the placental barrier, particularly during the second and third trimesters. Animal studies have not revealed direct harmful effects on pregnancy, embryonic or fetal development, parturition, or postnatal development, but these findings do not guarantee safety in humans.

If you are a woman of childbearing potential, you should use effective contraception during treatment with Cosentyx and for at least 20 weeks after the last dose. This 20-week washout period is based on the drug’s elimination half-life. Talk to your doctor if you are pregnant, think you may be pregnant, or are planning to become pregnant, so that you can discuss the potential risks and benefits together.

It is not known whether secukinumab is excreted in human breast milk, although human IgG antibodies are known to be present in breast milk. You and your doctor should decide together whether to breastfeed or to use Cosentyx; you should not do both simultaneously. If you choose to breastfeed, you should not use Cosentyx for at least 20 weeks after the last dose.

Children and Adolescents

Cosentyx is not recommended for children under 6 years of age with plaque psoriasis or juvenile idiopathic arthritis, as it has not been studied in this age group. Cosentyx is not recommended for children and adolescents under 18 years of age for the treatment of hidradenitis suppurativa, psoriatic arthritis, ankylosing spondylitis, or non-radiographic axial spondyloarthritis, as it has not been studied in these age groups for those specific indications.

Driving and Operating Machinery

Cosentyx is unlikely to influence your ability to drive or use machines. No studies have been conducted on the effects of secukinumab on driving ability, but based on its mechanism of action and safety profile, no impairment is expected.

How Does Cosentyx Interact with Other Drugs?

As a monoclonal antibody, secukinumab is not metabolized by cytochrome P450 (CYP450) enzymes and is not expected to directly interact with most conventional medications through pharmacokinetic mechanisms. However, there are several clinically important considerations regarding drug interactions that patients and healthcare providers should be aware of.

Major Interactions

Minor Interactions

What Is the Correct Dosage of Cosentyx?

Cosentyx is administered as a subcutaneous injection (under the skin) using the SensoReady pre-filled pen. Your doctor will determine the appropriate dose and duration of treatment based on your specific condition, body weight, and treatment response. Always use Cosentyx exactly as prescribed. If you are unsure, consult your doctor, nurse, or pharmacist. It is important not to attempt self-injection unless you have received training from a healthcare professional. A caregiver may also administer the injection after appropriate training.

Adults – Plaque Psoriasis

Children (6 Years and Older) – Plaque Psoriasis

Adults – Hidradenitis Suppurativa

Adults – Psoriatic Arthritis

Adults – Ankylosing Spondylitis (Radiographic Axial Spondyloarthritis)

Adults – Non-Radiographic Axial Spondyloarthritis

Children (6 Years and Older) – Juvenile Idiopathic Arthritis (ERA and JPsA)

Cosentyx is intended for long-term treatment. Your doctor will regularly monitor your condition to ensure the treatment is having the desired effect. Do not stop treatment without consulting your doctor, as your symptoms may return.

Missed Dose

If you have forgotten to inject a dose of Cosentyx, inject the next dose as soon as you remember. Then contact your doctor to discuss when to inject the following dose. Do not inject a double dose to make up for a missed one.

Overdose

If you have received more Cosentyx than prescribed, or if the dose was given earlier than directed by your doctor, inform your doctor. In clinical studies, doses up to 30 mg/kg intravenously (approximately 2,000–3,000 mg) have been administered without dose-limiting toxicity. If overdose occurs, it is recommended that the patient be monitored for any signs or symptoms of adverse reactions and that appropriate symptomatic treatment be instituted immediately.

What Are the Side Effects of Cosentyx?

Like all medicines, Cosentyx can cause side effects, although not everyone experiences them. The side effects listed below are based on data from controlled clinical trials and post-marketing surveillance involving tens of thousands of patients treated with secukinumab across multiple indications. Most side effects are mild to moderate in severity and do not require discontinuation of treatment. However, some side effects can be serious and require prompt medical attention.

If you experience any side effects, including any not listed here, talk to your doctor, pharmacist, or nurse. You can also report suspected side effects directly to your national pharmacovigilance authority (for example, the MHRA Yellow Card scheme in the UK, the FDA MedWatch program in the US, or the EMA EudraVigilance system in Europe). Reporting side effects helps to continuously monitor the benefit-risk balance of medicines.

How Should You Store Cosentyx?

Proper storage of Cosentyx is essential to ensure the medication remains effective and safe to use. As a biologic protein-based medication, secukinumab is sensitive to temperature extremes and light exposure. Follow these storage guidelines carefully:

• Refrigeration: Store the sealed pre-filled pen in its original carton in a refrigerator at 2°C–8°C (36°F–46°F). The carton protects the medication from light.
• Do not freeze: Never freeze Cosentyx. If the medication has been accidentally frozen, do not use it.
• Do not shake: Shaking may damage the protein structure of the antibody and affect its efficacy.
• Room temperature storage: If necessary, Cosentyx may be stored at room temperature (up to 30°C / 86°F) for a single period of up to 4 days. Once removed from the refrigerator for room temperature storage, use within 4 days or discard.
• Before injection: Remove the pen from the refrigerator 15–30 minutes before injection to allow it to reach room temperature for a more comfortable injection.
• Expiry date: Do not use Cosentyx after the expiry date stated on the carton or pen after “EXP.” The expiry date refers to the last day of that month.
• Visual inspection: Do not use if the liquid contains clearly visible particles, is cloudy, or is distinctly brown in color. The solution should be clear. Its color may range from colorless to slightly yellow. A small air bubble may be visible, which is normal.
• Child safety: Keep this medicine out of the sight and reach of children.
• Single use only: Each pre-filled pen is for single use only. Never attempt to reuse a pen.
• Disposal: Dispose of used pens in a puncture-resistant sharps disposal container. Do not throw away medicines via household waste or wastewater. Ask your pharmacist about proper disposal methods to help protect the environment.

What Does Cosentyx Contain?

Each Cosentyx 150 mg SensoReady pre-filled pen contains 150 mg of secukinumab, a fully human IgG1 kappa monoclonal antibody produced by recombinant DNA technology in Chinese hamster ovary (CHO) cells. The inactive ingredients serve important functions in maintaining the stability, solubility, and shelf life of the biologic protein:

• Trehalose dihydrate: A sugar that acts as a stabilizer to protect the antibody protein from degradation during storage and handling.
• Histidine and histidine hydrochloride monohydrate: Amino acid buffer system that maintains the solution at the optimal pH for protein stability.
• Methionine: An amino acid antioxidant that protects the antibody from oxidative damage.
• Polysorbate 80: A surfactant that prevents protein aggregation and adsorption to container surfaces.
• Water for injections: The solvent base for the solution.

Cosentyx is available as a solution for injection in a pre-filled pen (SensoReady pen). The solution is clear and may range from colorless to slightly yellow. The pens are available in pack sizes containing 1 or 2 pre-filled pens, and in multipacks containing 6 pens (3 packs of 2). Not all pack sizes may be marketed in all countries.

The marketing authorization holder is Novartis Europharm Limited, Dublin, Ireland. Cosentyx is manufactured by Sandoz GmbH and Novartis Pharmaceutical Manufacturing GmbH in Langkampfen, Austria, and by Novartis Pharma GmbH in Nuremberg, Germany.