Wezlana

Conditions Treated

Wezlana is an injectable medicine used to manage symptoms and reduce inflammation in specific autoimmune disorders. It is primarily prescribed for the following conditions:

Skin and Joint Conditions

• Plaque Psoriasis: Wezlana is used for adults and children 6 years of age and older with moderate to severe plaque psoriasis. It is typically prescribed for patients who are candidates for phototherapy (light treatment) or systemic therapy (medications that travel through the bloodstream).
• Psoriatic Arthritis: It is used to treat active psoriatic arthritis in adults and children 6 years of age and older.

Inflammatory Bowel Diseases

• Crohn's Disease: Wezlana is used for adults with moderately to severely active Crohn's disease.
• Ulcerative Colitis: It is used for adults with moderately to severely active ulcerative colitis.

This medication is a biosimilar to ustekinumab. It works by targeting specific proteins in the body that cause inflammation, helping to control the symptoms of these chronic conditions.

Targeting Inflammation

Wezlana 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 naturally occurring proteins called interleukin-12 (IL-12) and interleukin-23 (IL-23).

Interrupting the Immune Response

In people with certain autoimmune conditions, the body produces too much IL-12 and IL-23. These proteins act as messengers that tell the immune system to trigger inflammation. This process can lead to various symptoms, such as:

• The rapid overgrowth of skin cells in plaque psoriasis.
• Joint swelling and pain in psoriatic arthritis.
• Inflammation and damage in the digestive tract in Crohn’s disease and ulcerative colitis.

Wezlana works by binding to these proteins before they can attach to immune cells. When the proteins are blocked, they cannot deliver the signals that cause inflammation. By interrupting this pathway, Wezlana helps to calm the overactive immune response and reduce the symptoms associated with these chronic inflammatory conditions.

Common Side Effects

The most common side effects reported with Wezlana include:

• Upper respiratory infections, such as the common cold or sore throat
• Headache
• Fatigue or feeling tired
• Injection site reactions, including pain, swelling, or redness
• Diarrhea, nausea, or vomiting
• Itching
• Back pain or joint pain

Serious Side Effects

While less common, Wezlana can cause serious side effects that require immediate medical attention. These include:

• Serious Infections: Because Wezlana affects the immune system, it may increase the risk of serious bacterial, fungal, or viral infections, including tuberculosis (TB).
• Allergic Reactions: Severe allergic reactions can occur. Seek emergency help if you experience hives, swelling of the face or throat, or difficulty breathing.
• Posterior Reversible Encephalopathy Syndrome (PRES): This is a rare brain condition. Symptoms include headache, seizures, confusion, or vision changes.
• Skin Cancer: Some patients may have an increased risk of certain types of non-melanoma skin cancer.
• Lung Problems: In rare cases, lung inflammation can occur. Contact your doctor if you develop a new or worsening cough or shortness of breath.

Serious Infections

Wezlana may decrease the body's ability to fight infections, potentially increasing the risk of serious bacterial, fungal, or viral infections. Some infections may require hospitalization. Individuals are typically screened for tuberculosis (TB) before starting treatment and monitored for active infection symptoms during therapy.

Malignancies

Because this medication affects the immune system, there is a potential increased risk of developing certain cancers, including non-melanoma skin cancers. Regular skin examinations are recommended for those receiving treatment.

Hypersensitivity Reactions

Serious allergic reactions, including anaphylaxis and angioedema, have been reported. If a severe reaction occurs, the medication is typically discontinued and appropriate medical treatment is started.

Posterior Reversible Encephalopathy Syndrome (PRES)

PRES is a rare condition affecting the brain that has been observed in patients taking ustekinumab products. Symptoms may include headache, seizures, confusion, or vision loss. If PRES is suspected, the medication is usually stopped immediately.

Non-infectious Pneumonia

Inflammation of the lungs (pneumonitis) that is not caused by an infection has occurred in some patients. Symptoms can include a new or worsening cough, shortness of breath, or fever.

Immunizations

Live vaccines should be avoided during treatment with Wezlana. It is recommended that all age-appropriate vaccinations be completed before beginning therapy. Specific caution is advised regarding the BCG vaccine.

Latex Sensitivity

The needle cover on the prefilled syringe contains dry natural rubber (a derivative of latex), which may cause allergic reactions in individuals with latex sensitivities.

Contraindications

Wezlana should not be used by individuals with a known history of serious hypersensitivity to ustekinumab or any of the ingredients in the formulation.

Pregnancy

Limited data are available regarding the use of Wezlana in pregnant women. Because Wezlana is a monoclonal antibody, it can cross the placenta and reach the developing fetus, especially during the second and third trimesters. Research has not established a clear link between the medication and an increased risk of major birth defects or pregnancy loss, but the evidence is not yet conclusive.

Individuals who are pregnant or planning to become pregnant should discuss their treatment plan with a healthcare provider. A clinician can help weigh the benefits of managing the underlying condition against any potential risks to the pregnancy.

Breastfeeding

Small amounts of ustekinumab, the active ingredient in Wezlana, have been found in human breast milk. It is currently unknown if the medication is absorbed by the nursing infant or if it has any impact on milk production.

The decision to breastfeed while using Wezlana involves considering the following factors:

• The health and developmental benefits of breastfeeding for the baby.
• The mother's clinical need for the medication to treat her condition.
• Any potential adverse effects on the breastfed child from the medication or the mother's condition.

Consult a healthcare professional to determine the most appropriate approach for your specific situation.

Available Forms

Wezlana is supplied in the following forms for administration:

• Subcutaneous Injection: This form is available in single-dose prefilled syringes and single-dose vials for injection under the skin.
• Intravenous Infusion: This form is available as a solution in a single-dose vial. It is intended for dilution and administration through a vein by a healthcare professional.

FDA Approval and Interchangeability

The U.S. Food and Drug Administration (FDA) approved Wezlana (ustekinumab-auub) in October 2023. It is designated as an interchangeable biosimilar to its reference product, Stelara. This status means that, depending on state pharmacy laws, Wezlana may be substituted for the reference product by a pharmacist without requiring a new prescription from the healthcare provider who wrote the original order.

Approved Indications

Wezlana is approved for use in the following patient populations and conditions:

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

Regulatory Safety Information

The FDA approval was based on a comprehensive review of evidence showing that Wezlana is highly similar to its reference product, with no clinically meaningful differences in safety, purity, or potency. While the medication does not have a Boxed Warning, the FDA-approved labeling includes warnings regarding the potential for serious infections and malignancies. There is currently no Risk Evaluation and Mitigation Strategy (REMS) required for this medication.

Discontinuation of Wezlana

Wezlana is a biologic medication and is not considered to be habit-forming or addictive. There are no documented reports of physical withdrawal syndromes occurring when the medication is stopped. Unlike some other classes of drugs, it does not typically require a tapering schedule where the dose is slowly reduced over time.

Return of Symptoms

The main risk of stopping Wezlana is the return of the underlying chronic condition. Because the medication works by suppressing specific parts of the immune system to control inflammation, stopping treatment allows that inflammation to return. This may lead to a relapse of symptoms, such as:

• New or worsening skin plaques and redness in patients with psoriasis.
• Increased joint pain, stiffness, and swelling in patients with psoriatic arthritis.
• A return of abdominal pain, diarrhea, or rectal bleeding in patients with Crohn's disease or ulcerative colitis.

It is important to continue using the medication exactly as prescribed by your healthcare provider. Do not stop treatment or change your dosing schedule without medical consultation, as your doctor will need to monitor your condition and discuss alternative management options.