Question 1

What is Stelara?

Accepted Answer

Stelara is a biologic medication classified as a human monoclonal antibody. It works by binding to and interfering with two specific proteins in the body, interleukin-12 and interleukin-23, which play a key role in the inflammatory process.

By inhibiting these proteins, the medication helps to regulate an overactive immune response. This action reduces the inflammation that contributes to various long-term health conditions.

Question 2

What is Stelara used for?

Accepted Answer

Stelara is used to treat Crohn disease , plaque psoriasis , psoriatic arthritis , and others.

Question 3

How does Stelara work?

Accepted Answer

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.

Question 4

What are the active ingredients in Stelara?

Accepted Answer

The active ingredient in Stelara is ustekinumab .

Question 5

What are the side effects of Stelara?

Accepted Answer

Common side effects of Stelara may include:

Upper respiratory infection

Fatigue

Headache

Always consult with a healthcare professional about potential side effects.

Question 6

What drug class is Stelara?

Accepted Answer

Stelara belongs to the interleukin-12 and interleukin-23 antagonist drug class.

Question 7

What is the dosage of Stelara and how do I take it?

Accepted Answer

Administration Methods

Stelara is administered either as an injection under the skin (subcutaneous) or as an infusion into a vein (intravenous). The method used depends on the condition being treated and the stage of the treatment plan.

Intravenous Infusion: For certain inflammatory bowel conditions, the initial dose is typically given as an infusion into a vein by a healthcare professional in a clinical setting.

Subcutaneous Injection: Maintenance doses for bowel conditions, and all doses for skin or joint conditions, are usually given as injections under the skin. These are typically administered at regular intervals, such as every few weeks or months.

Self-Administration

A healthcare provider may train you or a caregiver to give the subcutaneous injections at home. It is important to use the medication exactly as directed and to follow the specific instructions provided by your medical team.

Do not shake the syringe or vial, as this can damage the medication.

Before use, check the liquid. It should be clear to slightly yellow and may contain tiny white particles. Do not use the medication if it is cloudy, discolored, or contains large particles.

Injection sites should be rotated. Common areas for injection include the upper arms, thighs, buttocks, or the abdomen. Avoid injecting into skin that is tender, bruised, red, or hard.

Missed Dose

If you miss a scheduled dose or an appointment for an injection, contact your healthcare provider as soon as possible to receive instructions on when to take the next dose. Do not use extra medication to make up for a missed dose.

Question 8

Is Stelara safe during pregnancy and breastfeeding?

Accepted Answer

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.

Question 9

What forms and strengths does Stelara come in?

Accepted Answer

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.

Question 10

What is the FDA approval status of Stelara?

Accepted Answer

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.

Question 11

What should I know about Stelara and cost?

Accepted Answer

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.

Stelara

Medication Quick Facts

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What It's Used For

How It Works

Side Effects

Warnings & Precautions

Dosage & How to Take

Pregnancy & Breastfeeding

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FDA / Regulatory Status

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