Yesintek

Plaque Psoriasis

Yesintek is used to treat moderate to severe plaque psoriasis in adults and children 6 years of age and older. It is intended for patients who are candidates for systemic therapy (medications that work throughout the body) or phototherapy (light treatment).

Psoriatic Arthritis

This medication is used to treat active psoriatic arthritis in adults and children 6 years of age and older. It helps manage joint pain and swelling associated with the condition and can be used alone or with other medications like methotrexate.

Inflammatory Bowel Diseases

Yesintek is approved for use in adults to treat the following chronic digestive conditions:

• Crohn's Disease: For the treatment of moderately to severely active Crohn's disease.
• Ulcerative Colitis: For the treatment of moderately to severely active ulcerative colitis.

Mechanism of Action

Yesintek is a monoclonal antibody, which is a type of protein designed to recognize and bind to specific targets in the body. It specifically targets two proteins called interleukin-12 (IL-12) and interleukin-23 (IL-23).

These proteins are cytokines, which act as chemical messengers that tell the immune system to trigger inflammation. In people with certain autoimmune conditions, the body produces an excess of these proteins. This overproduction leads to the chronic inflammation, swelling, and tissue damage associated with conditions like plaque psoriasis, psoriatic arthritis, Crohn's disease, and ulcerative colitis.

By binding to these proteins, Yesintek prevents them from connecting to their receptors on the surface of immune cells. This action helps to:

• Interrupt inflammatory signaling: It stops the chemical messages that tell the immune system to attack healthy tissues.
• Reduce symptoms: By lowering inflammation, the medication helps reduce skin scaling and redness in psoriasis, as well as swelling and irritation in the digestive tract for those with inflammatory bowel diseases.
• Calm the immune system: It helps bring the overactive immune response back toward a more normal level.

Common Side Effects

Many people using Yesintek experience mild side effects. Common issues include:

• Upper respiratory infections and common cold symptoms
• Headache
• Fatigue
• Injection site reactions, such as redness, itching, or pain
• Nausea, vomiting, or diarrhea
• Joint or back pain

Serious Side Effects

Yesintek can cause serious health problems. Seek medical help immediately if you experience:

• Infections: Signs include fever, chills, muscle aches, or cough. This medication may increase the risk of serious bacterial, fungal, or viral infections, including tuberculosis.
• Allergic Reactions: Symptoms may include hives, swelling of the face or tongue, or difficulty breathing.
• Lung Problems: Shortness of breath or a cough that does not go away, which may indicate non-infectious pneumonia.
• Skin Changes: New or changing skin growths, which may indicate certain types of non-melanoma skin cancer.
• Neurological Issues: Rare cases of Posterior Reversible Encephalopathy Syndrome (PRES) have been reported, causing seizures, confusion, or vision loss.

Serious Infections

Yesintek is an immunosuppressant that may decrease the body's ability to fight infections. Serious bacterial, fungal, and viral infections have been reported in patients using this medication. Treatment is generally not initiated in individuals with an active, clinically significant infection. Before starting treatment, patients are typically evaluated for tuberculosis (TB).

Cancer Risk

Because Yesintek affects the immune system, it may increase the risk of developing certain malignancies, including non-melanoma skin cancers. Healthcare providers may perform regular skin exams, particularly for those with specific risk factors or a history of other immunosuppressive treatments.

Hypersensitivity Reactions

Serious allergic reactions, including anaphylaxis and angioedema, are possible. Signs of a reaction may include:

• Faintness or dizziness
• Swelling of the face, eyelids, or lips
• Skin rash or hives
• Chest tightness or shortness of breath

Neurological Concerns

A rare condition known as Posterior Reversible Encephalopathy Syndrome (PRES) has occurred in some patients. This condition affects the brain and requires immediate medical attention. Symptoms can include confusion, vision changes, seizures, or severe headache.

Lung Inflammation

Non-infectious lung inflammation, such as interstitial pneumonia or eosinophilic pneumonia, has been reported. Symptoms like a persistent cough, fever, or difficulty breathing should be monitored closely.

Immunizations

Live vaccines should be avoided during treatment with Yesintek. Additionally, infants who were exposed to the drug during pregnancy may need to delay receiving live vaccines for several months after birth.

Pregnancy

Data on the use of Yesintek in pregnant women are limited. While animal studies did not show evidence of harm to the fetus, it is known that this medication can cross the placenta and be found in the blood of infants born to mothers who received the drug during pregnancy.

If you are pregnant or planning to become pregnant, talk to your doctor about whether the benefits of treatment outweigh the potential risks to the baby.

Breastfeeding

Yesintek has been found in human breast milk. It is currently unknown how much of the drug is absorbed by a nursing infant or what effects it may have on the child or on milk production.

Considerations for breastfeeding while taking this medication include:

• The health benefits of breastfeeding for the infant.
• The mother's clinical need for the medication.
• Any potential adverse effects on the breastfed child from the drug or the mother's underlying condition.

Subcutaneous Injection

Yesintek is supplied as a sterile solution for subcutaneous injection. It is available in the following forms:

• Single-dose prefilled syringes

This form is typically used for maintenance dosing and is administered under the skin.

Intravenous Infusion

Yesintek is also available as a sterile solution for intravenous infusion. It is supplied in the following form:

• Single-dose vials

The infusion form is generally used for the initial loading dose in specific conditions and must be diluted by a healthcare professional before being administered through a vein.

FDA Approval and Interchangeability

The U.S. Food and Drug Administration (FDA) approved Yesintek in September 2024. It is classified as an interchangeable biosimilar to Stelara (ustekinumab). An interchangeable designation means that, depending on state pharmacy laws, Yesintek may be substituted for the reference product at the pharmacy without requiring a new prescription from the healthcare provider.

Approved Indications

Yesintek is FDA-approved for the treatment of several chronic inflammatory conditions:

• Plaque Psoriasis: For adults and pediatric patients 6 years of age and older with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy.
• Psoriatic Arthritis: For adults and pediatric patients 6 years of age and older with active psoriatic arthritis.
• Crohn's Disease: For adults with moderately to severely active Crohn's disease.
• Ulcerative Colitis: For adults with moderately to severely active ulcerative colitis.

Regulatory Safety Information

Yesintek does not currently have a Boxed Warning or a Risk Evaluation and Mitigation Strategy (REMS) program. However, the FDA requires the drug's labeling to include warnings regarding the risk of serious infections and malignancies, which are known risks associated with ustekinumab products. Regulatory status is maintained through ongoing post-marketing surveillance to monitor for long-term safety and efficacy.

Factors Affecting Cost

The actual price a patient pays for Yesintek can vary based on several variables:

• Insurance Plan: Coverage levels, deductibles, and copayments differ between insurance providers and specific plans.
• Biosimilar Pricing: Yesintek is a biosimilar to Stelara. Biosimilars are generally intended to be more cost-effective than the original reference product.
• Administration: Since Yesintek may be administered in a clinical setting or through a specialty pharmacy, the billing may fall under medical or pharmacy benefits.

Financial Assistance

Patients may have access to programs designed to reduce the financial burden of treatment:

• Manufacturer Assistance: Savings programs or copay cards may be available for patients with commercial insurance to help lower out-of-pocket expenses.
• Support Organizations: Some patients may qualify for assistance through independent foundations or manufacturer-sponsored programs if they meet certain financial and insurance criteria.

It is advisable to consult with your insurance provider and healthcare team to understand the specific costs associated with your treatment plan.