Cosentyx

Approved Uses

Cosentyx is primarily used to manage symptoms of autoimmune and inflammatory disorders. It is approved for the following conditions:

Plaque Psoriasis

It is used to treat moderate to severe plaque psoriasis in adults and children 6 years of age and older. It is typically prescribed for patients who may benefit from systemic therapy or phototherapy.

Psoriatic Arthritis

Cosentyx is used to treat active psoriatic arthritis in adults and children 2 years of age and older. This condition involves both skin psoriasis and joint inflammation.

Axial Spondyloarthritis

This medication is used to treat two types of inflammatory spine disease in adults:

• Ankylosing Spondylitis: A type of arthritis that primarily affects the spine.
• Non-radiographic Axial Spondyloarthritis: A condition that causes spine inflammation and pain but does not show up on X-rays.

Enthesitis-Related Arthritis

It is used for children 4 years of age and older with active enthesitis-related arthritis, a type of juvenile arthritis that involves inflammation where tendons and ligaments attach to bone.

Hidradenitis Suppurativa

Cosentyx is used to treat moderate to severe hidradenitis suppurativa in adults. This is a chronic skin condition characterized by painful lumps, sores, and scarring, often in areas where skin rubs together.

Mechanism of Action

Cosentyx contains the active ingredient secukinumab, which is a human monoclonal antibody. It is designed to target a specific protein in the immune system called interleukin-17A (IL-17A).

IL-17A is a cytokine, a type of messenger protein that plays a key role in the body's natural immune response. In people with certain inflammatory conditions, the body produces too much IL-17A. This excess protein triggers an overactive immune response, leading to:

• Inflammation and redness of the skin.
• The rapid overproduction of skin cells, which causes the thick, scaly patches seen in plaque psoriasis.
• Swelling, pain, and potential damage in the joints and spine.

By binding directly to IL-17A, Cosentyx prevents the protein from attaching to its receptors on the surface of cells. This action helps block the inflammatory signals that cause skin lesions and joint pain.

Common Side Effects

Many people using Cosentyx experience mild side effects. These may include:

• Cold symptoms such as a runny nose, sneezing, or sore throat
• Diarrhea
• Upper respiratory tract infections
• Nausea
• Redness, itching, or swelling at the injection site

Serious Side Effects

While less common, some side effects can be serious and require immediate medical attention. These include:

• Signs of a serious infection, such as fever, chills, cough, shortness of breath, or painful urination
• New or worsening symptoms of inflammatory bowel disease, including stomach pain, cramping, or bloody diarrhea
• Severe allergic reactions, which may cause hives, difficulty breathing, or swelling of the face, lips, or tongue
• Fungal infections, such as oral thrush or athlete's foot
• Skin sores or blisters that do not heal

Infection Risk

Cosentyx affects the immune system, which can increase the risk of developing infections or worsening existing ones. These may include upper respiratory tract infections and fungal infections such as oral thrush. Treatment is generally not started if a person has a clinically important active infection.

Tuberculosis Screening

Before beginning treatment, healthcare providers usually test for tuberculosis (TB). If a person has latent TB, it must be treated before starting Cosentyx to prevent the infection from becoming active during therapy.

Inflammatory Bowel Disease

This medication may cause new cases of inflammatory bowel disease (IBD) or worsen existing conditions like Crohn's disease or ulcerative colitis. Monitoring for symptoms such as persistent abdominal pain, fever, or bloody diarrhea is necessary during treatment.

Allergic Reactions

Serious allergic reactions, including anaphylaxis, can occur. Immediate medical attention is needed if symptoms such as hives, difficulty breathing, or swelling of the face, lips, or tongue develop.

Latex Sensitivity

The removable needle cap on the Cosentyx Sensoready pen and prefilled syringes contains dry natural rubber, which is a derivative of latex. This may cause allergic reactions in individuals with a known latex sensitivity.

Vaccinations

Live vaccines should be avoided while taking Cosentyx. It is generally recommended that all age-appropriate immunizations be completed according to current guidelines before starting therapy.

Pregnancy

There are no well-controlled studies on the use of secukinumab in pregnant women. While animal studies have not shown evidence of harm to the fetus, animal research does not always predict human response. Because secukinumab is a monoclonal antibody, it is expected to cross the placenta during the third trimester.

If you are pregnant or planning to become pregnant, discuss the potential risks and benefits with your healthcare provider. This medication should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Breastfeeding

It is currently unknown whether secukinumab passes into human breast milk or if it could affect a nursing infant. Because many drugs are excreted in breast milk, caution is advised. You should talk with your doctor about the risks and benefits of breastfeeding while using this medication.

Available Forms

Cosentyx is provided in several delivery formats depending on the specific condition being treated and whether the medication is administered at home or in a clinical setting:

• Sensoready Pen: A single-dose, prefilled auto-injector used for subcutaneous injection.
• UnoReady Pen: A single-dose, prefilled auto-injector for subcutaneous use.
• Prefilled Syringe: A single-dose syringe containing a liquid solution for subcutaneous injection.
• Intravenous Infusion: A solution administered directly into a vein by a healthcare provider.
• Lyophilized Powder: A powder in a single-use vial that must be reconstituted into a liquid by a healthcare professional before administration.

The subcutaneous forms are typically used for self-administration or administration by a caregiver after receiving proper training from a healthcare provider. The intravenous and vial-based forms are generally reserved for use in a medical facility.

FDA Approval and Indications

Cosentyx was first approved by the U.S. Food and Drug Administration (FDA) in 2015. It is indicated for the treatment of several autoimmune and inflammatory conditions in adults and certain pediatric populations:

• Moderate to severe plaque psoriasis in patients who are candidates for systemic therapy or phototherapy.
• Active psoriatic arthritis.
• Active ankylosing spondylitis.
• Active non-radiographic axial spondyloarthritis with objective signs of inflammation.
• Active enthesitis-related arthritis.
• Moderate to severe hidradenitis suppurativa.

Regulatory Requirements and Safety

The FDA requires that patients be evaluated for tuberculosis infection prior to starting treatment with Cosentyx. Because the medication affects the immune system, it may increase the risk of serious infections. Regulatory labeling also includes warnings regarding the potential for new or worsening inflammatory bowel disease during treatment.

There are no current boxed warnings or Risk Evaluation and Mitigation Strategies (REMS) programs associated with Cosentyx. However, the medication must be provided with an FDA-approved Medication Guide to inform patients of potential side effects and safety concerns.

Factors Influencing Cost

The cost of Cosentyx is influenced by several variables, including your insurance plan, the specific condition being treated, and the required dosage. Because it is a biologic medication, it is generally more expensive than traditional systemic drugs.

Insurance Coverage

Most private insurance plans and Medicare Part D provide coverage for Cosentyx, though it often requires prior authorization. This process involves your healthcare provider submitting documentation to your insurer to justify the medical necessity of the drug. Your out-of-pocket costs will depend on your plan's deductible, co-pay, or co-insurance requirements.

Financial Assistance

The manufacturer offers programs to help manage the cost of treatment:

• Co-pay Savings: Eligible patients with commercial insurance may use a co-pay card to reduce their monthly out-of-pocket expenses.
• Patient Assistance: For those without insurance or with limited coverage, programs may provide the medication at no cost or a significantly reduced rate based on financial need.

Generic and Biosimilar Status

There is currently no generic version of Cosentyx available. While biosimilars may be developed in the future, none are currently available as interchangeable alternatives at the pharmacy.