Ustekinumab

Plaque Psoriasis

Ustekinumab is used to treat moderate to severe plaque psoriasis in adults and children 6 years of age and older. It is generally prescribed for patients who are candidates for systemic therapy (medications that work throughout the body) or phototherapy (light treatment).

Psoriatic Arthritis

This medicine is used to treat active psoriatic arthritis in adults and children 6 years of age and older. It may be used alone or with other medications, such as methotrexate, to help manage joint symptoms and improve physical function.

Crohn's Disease and Ulcerative Colitis

Ustekinumab is approved for use in adults with moderately to severely active Crohn's disease or ulcerative colitis. It works by targeting specific proteins in the body that cause inflammation in the lining of the digestive tract, helping to reduce symptoms and maintain remission.

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.

Common Side Effects

• Nasal congestion, sore throat, or runny nose
• Upper respiratory infections
• Headache
• Feeling tired
• Itching
• Nausea, vomiting, or diarrhea
• Stomach pain
• Joint pain
• Redness, swelling, or pain at the injection site

Serious Side Effects

Seek medical attention immediately if you experience any of the following serious symptoms:

• Signs of infection, such as fever, chills, muscle aches, cough, shortness of breath, or painful skin sores
• Signs of a severe allergic reaction, including hives, skin rash, or swelling of the face, lips, or throat
• Symptoms of a rare brain condition called Posterior Reversible Encephalopathy Syndrome (PRES), such as severe headache, confusion, seizures, or vision changes
• New or changing skin growths
• Chest pain or a persistent cough

Serious Infections

Ustekinumab affects the immune system and may decrease the ability to fight infections. Serious bacterial, fungal, and viral infections requiring hospitalization have been reported. Treatment should not be started during an active infection. Healthcare providers typically screen for tuberculosis (TB) before starting this medication, as latent TB can become active during treatment.

Malignancies

Because this medication suppresses the immune system, there is a potential risk for developing certain types of cancer. Some patients have developed non-melanoma skin cancers. Periodic skin examinations are often recommended, especially for those with risk factors.

Allergic Reactions

Serious allergic reactions, including anaphylaxis and angioedema, can occur. Symptoms may include chest tightness, swelling of the face or throat, or difficulty breathing. Some delivery devices may contain natural rubber latex, which can cause reactions in sensitive individuals.

Neurological and Lung Conditions

• Posterior Reversible Encephalopathy Syndrome (PRES): This is a rare condition affecting the brain. Symptoms include headache, seizures, confusion, or vision changes.
• Lung Inflammation: Non-infectious pneumonia or lung inflammation has been reported. Patients should report new or worsening cough or shortness of breath.

Vaccinations

Live vaccines should be avoided while using ustekinumab. It is generally recommended that all age-appropriate vaccinations be completed before starting therapy.

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.

Available Forms

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.

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.

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.