Stelara

Approved Conditions

Stelara is used to manage symptoms and reduce inflammation in the following conditions:

• Plaque Psoriasis: It is used for adults and children 6 years of age and older with moderate to severe plaque psoriasis who are candidates for phototherapy (light treatment) or systemic therapy (medications that travel through the entire body).
• Psoriatic Arthritis: It is used for adults and children 6 years of age and older with active psoriatic arthritis. It may be used alone or in combination with other medications like methotrexate.
• Crohn's Disease: It 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 typically prescribed when other treatments have not worked well enough or are not appropriate for the patient. It helps by targeting specific proteins in the body that cause inflammation.

Mechanism of Action

Stelara (ustekinumab) is a type of medication known as a monoclonal antibody. These are laboratory-made proteins designed to target and bind to specific substances in the body. Stelara specifically targets two naturally occurring proteins called interleukin-12 (IL-12) and interleukin-23 (IL-23).

Targeting Cytokines

IL-12 and IL-23 are cytokines, which are chemical messengers used by the immune system to trigger inflammation. In a healthy body, these proteins help fight off infections. However, in people with certain autoimmune or inflammatory conditions, the body produces too much of these proteins, leading to an overactive immune response that attacks healthy tissue.

Reducing Inflammation

By binding to IL-12 and IL-23, Stelara prevents these proteins from attaching to receptors on the surface of immune cells. This action helps to:

• Interrupt the signaling process that causes the immune system to attack the body.
• Lower the overall level of inflammation in the skin, joints, or digestive tract.
• Reduce the symptoms associated with conditions like plaque psoriasis, psoriatic arthritis, Crohn's disease, and ulcerative colitis.

By calming the overactive immune response, the medication helps manage the underlying cause of swelling, redness, and tissue damage associated with these chronic inflammatory diseases.

Common Side Effects

The most frequently reported side effects of Stelara include:

• Upper respiratory infections, such as the common cold or sinus congestion
• Headache
• Tiredness or fatigue
• Redness, itching, or pain at the injection site
• Diarrhea, nausea, or vomiting
• Back pain
• Dizziness
• Sore throat

Serious Side Effects

Stelara affects the immune system and can increase the risk of serious conditions. Contact a healthcare provider immediately for any of the following:

• Infections: Fever, chills, muscle aches, persistent cough, shortness of breath, or painful skin sores.
• Allergic Reactions: Chest tightness, swelling of the face or throat, severe rash, or hives.
• Neurological Issues: Symptoms of a rare brain condition called Posterior Reversible Encephalopathy Syndrome (PRES), including seizures, confusion, or sudden vision changes.
• Lung Problems: New or worsening shortness of breath or a cough that does not go away.
• Skin Changes: New growths on the skin or changes in the appearance of moles, which may indicate non-melanoma skin cancer.
• Severe Skin Redness: Peeling or redness of the skin that spreads across the body.

Serious Infections

Stelara affects the immune system and may decrease the ability to fight infections. Some people have developed serious infections while taking this medication, including tuberculosis (TB) and infections caused by bacteria, fungi, or viruses. Healthcare providers typically test for TB before starting treatment and monitor for signs of infection during use.

Cancer Risk

Because it suppresses the immune system, Stelara may increase the risk of developing certain types of cancer, including non-melanoma skin cancer. Periodic skin examinations are often recommended, especially for those with a history of skin cancer or long-term immunosuppressant use.

Posterior Reversible Encephalopathy Syndrome (PRES)

PRES is a rare but serious condition affecting the brain that has been reported with the use of Stelara. Symptoms may include:

• Severe headache
• Seizures
• Confusion
• Vision changes

If these symptoms occur, medical attention is usually required immediately.

Allergic Reactions

Serious allergic reactions can occur. Signs of a reaction may include skin rash, swelling of the face or throat, or difficulty breathing. Additionally, the needle cover on the prefilled syringe may contain dry natural rubber (a form of latex), which can cause reactions in people with a latex sensitivity.

Lung Inflammation

Cases of lung inflammation have been reported in patients taking Stelara. Symptoms such as a new or worsening cough, shortness of breath, or chest pain should be evaluated by a healthcare professional.

Vaccinations

Live vaccines should not be given while using Stelara. It is generally recommended that all required vaccinations be brought up to date before starting this medication.

Pregnancy

There is limited information regarding the use of Stelara in pregnant women. While animal studies have not shown direct harm to the developing fetus, human results may differ. Healthcare providers typically recommend using this medication during pregnancy only if the potential benefits outweigh the potential risks.

If you are pregnant or planning to become pregnant, talk with your doctor about your treatment options and the potential effects on the pregnancy.

Breastfeeding

It is currently unknown if Stelara passes into human breast milk. Because many medications can be transferred through milk and may affect a nursing infant, it is important to discuss breastfeeding with your healthcare provider. They can help you decide whether to continue breastfeeding or stop using the medication based on your specific health needs.

Available Forms

Stelara is supplied as a sterile solution for injection. It is available in the following formats:

• Subcutaneous Injection: This form is used for maintenance doses and is available in single-dose prefilled syringes or single-dose vials.
• Intravenous (IV) Infusion: This form is typically used for the initial induction dose in certain conditions and is provided in a single-dose vial for dilution.

Strengths

The medication is available in different concentrations depending on the method of administration and the specific condition being treated. It is generally provided as:

• Single-dose prefilled syringes for injection under the skin.
• Single-dose vials for injection under the skin.
• Single-dose vials for administration through an intravenous line.

FDA Approval and Indications

Stelara was first approved by the U.S. Food and Drug Administration (FDA) in 2009. It is currently authorized 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.
• Crohn's Disease: For adults with moderately to severely active Crohn's disease.
• Ulcerative Colitis: For adults with moderately to severely active ulcerative colitis.

Biosimilar Status

The FDA has approved interchangeable biosimilars for Stelara, such as ustekinumab-auzl. An interchangeable biosimilar is a biologic medication that is highly similar to the original product and meets additional regulatory requirements to demonstrate it will produce the same clinical result in any given patient. Depending on state laws, these may be substituted for the reference product by a pharmacist.

Regulatory Safety Information

The FDA-approved labeling for Stelara includes warnings regarding the potential for serious side effects. While it does not have a boxed warning, the regulatory status includes monitoring for the following:

• Infections: Increased risk of serious bacterial, fungal, and viral infections.
• Malignancies: A potential increased risk of certain types of cancer, including non-melanoma skin cancer.
• Posterior Reversible Encephalopathy Syndrome (PRES): A rare but serious condition affecting the brain that requires immediate medical attention.
• Hypersensitivity: Risk of serious allergic reactions, such as anaphylaxis or angioedema.

Factors Affecting Cost

Stelara is a biologic medication, and its price can vary significantly based on several variables:

• Insurance Coverage: Your out-of-pocket expenses, such as copayments or coinsurance, will depend on your specific health insurance plan and its formulary.
• Administration Method: For certain conditions like Crohn's disease or ulcerative colitis, the first dose is given as an intravenous (IV) infusion in a healthcare facility, while subsequent doses are subcutaneous injections. These different methods may be processed under different parts of your insurance (medical versus pharmacy benefits).
• Dosage and Frequency: The cost is influenced by the prescribed dose and how often you receive the medication, which is determined by your weight and the condition being treated.

Biosimilar Availability

The FDA has approved interchangeable biosimilars for Stelara, such as Wezlana. Biosimilars are highly similar to the original biologic medication in terms of safety and effectiveness but are often offered at a lower price point. An interchangeable designation means the biosimilar may be substituted for the brand-name drug at the pharmacy, depending on state laws.

Financial Assistance Programs

Because biologic treatments are expensive, there are often resources available to help manage the cost:

• Manufacturer Savings Cards: Patients with commercial insurance may be eligible for copay assistance programs provided by the manufacturer.
• Patient Assistance Programs: For individuals without insurance or those who are underinsured, there may be programs that provide the medication at a reduced cost or for free based on financial need.
• Specialty Pharmacies: Stelara is typically dispensed through specialty pharmacies, which can help coordinate insurance approvals and identify potential financial aid.