Question 1

What is Ustekinumab?

Accepted Answer

Ustekinumab is a human monoclonal antibody that functions as an immunosuppressant. It works by blocking the activity of specific natural substances in the body that trigger inflammation and swelling.

The medication specifically targets proteins known as interleukin-12 and interleukin-23 to help regulate the immune system. This biological therapy is used to manage the underlying inflammatory processes associated with certain long-term health issues.

Question 2

What is Ustekinumab used for?

Accepted Answer

Ustekinumab is used to treat:

Plaque psoriasis

Psoriatic arthritis

Crohn's disease

and others.

Question 3

How does Ustekinumab work?

Accepted Answer

Targeting Inflammation

Ustekinumab is a type of protein called a monoclonal antibody. It works by targeting two specific substances in the body known as interleukin-12 (IL-12) and interleukin-23 (IL-23). These substances are naturally occurring proteins that help regulate the immune system and the body's inflammatory response.

Interrupting the Immune Response

In people with certain autoimmune conditions, the immune system becomes overactive and produces an excess of these interleukin proteins. This overproduction leads to the chronic inflammation and symptoms seen in conditions affecting the skin and the digestive system.

Ustekinumab works through the following process:

Binding: The medication travels through the bloodstream and binds directly to the IL-12 and IL-23 proteins.

Blocking: Once attached, it prevents these proteins from binding to their intended receptors on the surface of immune cells.

Calming: Because the proteins cannot deliver their messages to the immune cells, the cycle of inflammation is interrupted.

By blocking these specific pathways, the medication helps reduce the redness and scaling of the skin in psoriasis and decreases the swelling and irritation in the intestines for those with inflammatory bowel diseases.

Question 4

What are the brand names for Ustekinumab?

Accepted Answer

Ustekinumab is sold under the brand name Stelara .

Question 5

What are the active ingredients in Ustekinumab?

Accepted Answer

The active ingredient in Ustekinumab is ustekinumab .

Question 6

What are the side effects of Ustekinumab?

Accepted Answer

Common side effects of Ustekinumab may include:

Upper respiratory tract infection

Headache

Fatigue

Always consult with a healthcare professional about potential side effects.

Question 7

What drug class is Ustekinumab?

Accepted Answer

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

Question 8

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

Accepted Answer

Administration Methods

Ustekinumab is given by injection. For certain conditions, the first dose is typically administered by a healthcare professional through a needle placed in a vein, known as an intravenous infusion. Follow-up doses are usually given as an injection under the skin, also called a subcutaneous injection.

Self-Injection at Home

If your healthcare provider determines it is appropriate, you may be trained to perform subcutaneous injections at home. Do not attempt to self-inject until you have been shown the proper technique. When preparing the medication:

Check the liquid to ensure it is clear and colorless or slightly yellow. It may contain a few small, clear particles.

Do not use the medication if it is cloudy, significantly discolored, or contains large particles.

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

Injection Sites

Subcutaneous injections should be given in the stomach area, thighs, or buttocks. If someone else is giving the injection, the outer upper arm may also be used. It is important to rotate the injection site each time. Avoid injecting into skin that is tender, bruised, red, or hard, or areas affected by psoriasis.

Missed Doses

If you miss a scheduled dose of ustekinumab, contact your healthcare provider or pharmacist immediately to find out when to take your next dose. Do not use double doses to make up for one that was missed.

Question 9

Is Ustekinumab safe during pregnancy and breastfeeding?

Accepted Answer

Pregnancy

There is limited information regarding the use of ustekinumab in pregnant women. While animal studies have not shown a high risk of birth defects or pregnancy loss, human data are insufficient to determine if there is a drug-associated risk. Because ustekinumab can cross the placenta, it may reach the developing fetus and potentially affect its immune system.

If you are pregnant or planning to become pregnant, discuss the potential risks and benefits with your healthcare provider. They will help determine if the treatment is necessary for your condition during this time.

Breastfeeding

Ustekinumab has been found in human breast milk in small amounts. It is not yet known how the drug affects a nursing infant or if it impacts milk production. Decisions about breastfeeding while using this medication should be made in consultation with a healthcare professional, considering the importance of the drug to the mother and the potential benefits of breastfeeding for the child.

Infant Vaccinations

If you received ustekinumab during pregnancy, your baby may have a higher risk of infection. It is generally recommended to wait at least six months after birth before giving the baby any live vaccines, such as the BCG vaccine or the rotavirus vaccine. Be sure to inform your child's pediatrician if you used this medication during pregnancy.

Question 10

What forms and strengths does Ustekinumab come in?

Accepted Answer

Ustekinumab is provided as a sterile, preservative-free solution in the following forms:

Subcutaneous Injection: This form is administered by injection under the skin. It is available in single-dose prefilled syringes and single-dose vials.

Intravenous Infusion: This form is administered through a needle into a vein by a healthcare professional. It is provided as a solution in a single-dose vial that requires dilution before use.

Question 11

What is the FDA approval status of Ustekinumab?

Accepted Answer

FDA Approval Status

Ustekinumab was first approved by the U.S. Food and Drug Administration (FDA) in 2009. It is available as the reference product and as FDA-approved biosimilars, such as ustekinumab-aekn.

Approved Indications

The FDA has approved ustekinumab for the treatment of the following conditions:

Plaque Psoriasis: For adults and pediatric patients 6 years and older with moderate to severe disease who are candidates for phototherapy or systemic therapy.

Psoriatic Arthritis: For adults and pediatric patients 6 years 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.

Safety and Regulatory Monitoring

Ustekinumab does not currently have a boxed warning. However, the FDA requires specific warnings in the prescribing information regarding the risk of serious infections and malignancies. There is no Risk Evaluation and Mitigation Strategy (REMS) currently required for this medication. Regulatory authorities continue to monitor reports of rare but serious adverse events, such as Posterior Reversible Encephalopathy Syndrome (PRES) and non-infectious pneumonia.

Question 12

What should I know about Ustekinumab and cost?

Accepted Answer

Factors Affecting Cost

Ustekinumab is a biologic medication, which generally has a higher cost than traditional drugs. Several factors influence the final price paid by a patient:

Insurance Coverage: Most insurance plans require prior authorization before they will cover the cost of this medication. The out-of-pocket expense will depend on the specific plan's deductible and copayment structure.

Biosimilar Availability: Several biosimilar versions of ustekinumab, such as Wezlana, Pyzchiva, Selarsdi, and Steqeyma, have been approved. These may be available at a lower cost than the original brand-name product.

Administration Method: The initial dose for certain conditions is often given as an intravenous (IV) infusion in a healthcare setting, which may involve additional facility fees. Subsequent doses are typically given as subcutaneous injections.

Financial Assistance

Because of the high cost of biologic therapy, manufacturers often provide support programs for eligible patients. These may include:

Copay Savings Cards: These can reduce the out-of-pocket costs for patients with commercial insurance.

Patient Assistance Programs: These programs may provide the medication at no cost or a reduced cost for individuals who are uninsured or underinsured and meet specific income requirements.

Patients are encouraged to contact their insurance provider and the specialty pharmacy dispensing the medication to get an accurate estimate of their costs.

Ustekinumab

Medication Quick Facts

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Dosage & How to Take

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