Ustekinumab-aekn

Plaque Psoriasis

Ustekinumab-aekn is used to treat 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 work throughout the entire body).

Psoriatic Arthritis

This medication is also approved for the treatment of active psoriatic arthritis in adults and children 6 years of age and older. It may be used alone or in combination with other medications, such as methotrexate, to help manage joint pain, swelling, and stiffness associated with the condition.

Mechanism of Action

Ustekinumab-aekn belongs to a class of medications known as monoclonal antibodies. It works by targeting the body's immune system to reduce inflammation. Specifically, it binds to two proteins called interleukin-12 (IL-12) and interleukin-23 (IL-23).

These proteins are cytokines, which are messengers used by the immune system to trigger inflammation. In people with certain conditions, the body produces too much of these proteins, leading to an overactive immune response. This overactivity can cause skin cells to grow too quickly or lead to joint pain and swelling.

By attaching to these proteins, ustekinumab-aekn prevents them from binding to their receptors on the surface of immune cells. This action helps to:

• Interrupt the inflammatory signaling pathway.
• Decrease the production of other inflammatory chemicals.
• Slow down the rapid growth of skin cells in plaque psoriasis.
• Reduce swelling and damage in the joints for those with psoriatic arthritis.

Common Side Effects

Many people using ustekinumab-aekn experience mild side effects. These may include:

• Upper respiratory infections, such as the common cold, sore throat, or runny nose
• Headache
• Feeling tired or fatigued
• Injection site reactions, including pain, redness, or swelling
• Diarrhea
• Back pain
• Dizziness
• Itching

Serious Side Effects

Ustekinumab-aekn can lower the ability of your immune system to fight infections. Contact a healthcare provider immediately if you notice signs of a serious condition, such as:

• Infections: Fever, sweats, chills, muscle aches, cough, shortness of breath, weight loss, or warm, red, or painful skin sores. This medication may increase the risk of tuberculosis (TB) or other bacterial, fungal, and viral infections.
• Severe Allergic Reactions: Swelling of the face, eyelids, tongue, or throat; chest tightness; or a skin rash.
• Brain Conditions: Posterior Reversible Encephalopathy Syndrome (PRES) is a rare but serious condition. Symptoms include a sudden, severe headache, confusion, seizures, or vision changes.
• Lung Inflammation: Shortness of breath or a cough that does not go away, which may indicate non-infectious pneumonia.
• Skin Cancer: Certain types of non-melanoma skin cancers have been reported. Check your skin for any new growths or changes to moles.

Serious Infections

Ustekinumab-aekn affects the immune system and may decrease the body's ability to fight infections. Serious bacterial, fungal, and viral infections have occurred in people taking this medication, sometimes requiring hospitalization. Treatment is typically not started during an active, clinically important infection.

Tuberculosis Screening

Individuals are usually screened for tuberculosis (TB) before beginning treatment. If active TB is present, it must be treated before starting the medication. For those with latent TB, preventive therapy is often initiated before or during treatment.

Malignancies

Because the medication suppresses the immune system, there is a potential risk for developing certain types of cancer. Non-melanoma skin cancers have been reported. Periodic skin examinations are often recommended, particularly for older patients or those with a history of prolonged immunosuppressant therapy.

Posterior Reversible Encephalopathy Syndrome (PRES)

PRES is a rare condition affecting the brain that has been reported with this medication. Symptoms may include:

• Severe headache
• Seizures
• Confusion
• Vision changes or vision loss

Hypersensitivity Reactions

Serious allergic reactions, including anaphylaxis and angioedema, can occur. Symptoms may include chest tightness, swelling of the face or throat, and low blood pressure. Some prefilled syringes may contain natural rubber latex, which can cause reactions in individuals with a latex sensitivity.

Immunizations

Live vaccines should not be given while using this medication. It is recommended that patients receive all necessary immunizations according to current guidelines before starting therapy. Additionally, infants exposed to the medication in the womb should wait at least six months after birth before receiving live vaccines.

Non-infectious Pneumonia

Cases of lung inflammation, such as interstitial pneumonia and eosinophilic pneumonia, have been reported. Symptoms like shortness of breath, cough, or fever that do not improve should be monitored closely.

Pregnancy

There is limited data on the use of ustekinumab-aekn in pregnant women. While animal studies did not show evidence of harm to the fetus, there is not enough information from human studies to determine if the drug causes birth defects or pregnancy loss.

This medication is known to cross the placenta, especially during the later stages of pregnancy. If you are pregnant or planning to become pregnant, talk to your healthcare provider about the potential risks and benefits of treatment.

Breastfeeding

Ustekinumab-aekn passes into breast milk in small amounts. It is currently unknown how this affects a nursing infant or if it impacts milk production. Because the risks are not fully understood, it is important to discuss with your doctor whether to continue breastfeeding or to stop using the medication while nursing.

Available Forms

Ustekinumab-aekn is supplied as a sterile, preservative-free solution for injection. It is available in the following format:

• Single-dose prefilled syringe: Designed for subcutaneous injection (under the skin).

The solution is typically clear to slightly opalescent and colorless to light yellow. It is intended for use under the guidance of a healthcare professional, though patients or caregivers may be trained to perform injections at home.

FDA Approval and Biosimilar Status

The U.S. Food and Drug Administration (FDA) approved ustekinumab-aekn in April 2024. It is approved as a biosimilar to Stelara (ustekinumab). A biosimilar is a biological product that is highly similar to an already approved biological medicine, with no clinically meaningful differences in safety, purity, or potency.

Approved Indications

Ustekinumab-aekn is FDA-approved for the treatment of the following 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.

Safety and Regulatory Oversight

The FDA does not currently require a Boxed Warning or a Risk Evaluation and Mitigation Strategy (REMS) for ustekinumab-aekn. However, regulatory approval includes requirements for monitoring serious safety concerns, such as the risk of serious infections and certain types of malignancies. Healthcare providers are instructed to evaluate patients for tuberculosis infection prior to initiating treatment.

Factors Affecting Price

The actual price a patient pays for ustekinumab-aekn depends on several variables:

• Insurance Coverage: Most insurance plans, including Medicare and Medicaid, have different levels of coverage for specialty medications. Out-of-pocket costs like copays or coinsurance will depend on the specific plan's formulary.
• Biosimilar Status: Ustekinumab-aekn is a biosimilar medication. Biosimilars are typically introduced at a lower price point than the original reference product to provide more affordable treatment options.
• Dosage and Administration: The cost is influenced by the dose prescribed, which is often based on the patient's weight and the condition being treated. Additionally, costs may differ if the medication is administered in a clinical setting versus self-administered at home.

Financial Assistance Programs

There are options available to help manage the cost of this medication:

• Copay Cards: The manufacturer may offer savings cards for patients with commercial insurance to help lower out-of-pocket expenses.
• Patient Assistance Programs: For individuals who are uninsured or have limited income, programs may be available to provide the medication at a reduced cost or free of charge.

Patients are encouraged to speak with their healthcare provider, pharmacist, or insurance company to get an accurate estimate of their specific costs.