Taltz

Approved Uses

Taltz is used to manage symptoms and reduce inflammation in patients with the following conditions:

• Plaque Psoriasis: It is prescribed for adults and children 6 years of age and older with moderate-to-severe plaque psoriasis. It is typically used for those who are candidates for systemic therapy (medication that travels through the entire body) or phototherapy (light treatment).
• Psoriatic Arthritis: It is used to treat adults with active psoriatic arthritis, a condition that causes both joint inflammation and skin lesions.
• Ankylosing Spondylitis: It is used for adults with active ankylosing spondylitis, also known as radiographic axial spondyloarthritis, which primarily affects the spine and large joints.
• Non-radiographic Axial Spondyloarthritis: It is used for adults with active non-radiographic axial spondyloarthritis who show objective signs of inflammation but do not have visible damage on X-rays.

In many cases, Taltz is prescribed when other treatments have not worked well enough. For conditions like psoriatic arthritis, it may be used alone or in combination with other medications such as conventional disease-modifying antirheumatic drugs (DMARDs).

How Taltz Functions

Taltz is a biologic medication known as an interleukin-17A (IL-17A) antagonist. It is a monoclonal antibody, which is a type of protein designed to recognize and bind to a specific target in the body.

In certain autoimmune conditions, the immune system becomes overactive and produces high levels of a protein called IL-17A. This protein acts as a messenger that signals the body to create inflammation. In the skin, this leads to the rapid buildup of cells that form plaques. In the joints, it causes swelling, pain, and potential damage.

Taltz works by identifying and attaching itself to the IL-17A protein. Once bound, the protein can no longer interact with its receptors on the surface of cells. By blocking this interaction, Taltz interrupts the inflammatory cycle. This helps to:

• Reduce the redness, thickening, and scaling of the skin.
• Decrease joint pain and swelling.
• Lower the overall level of inflammation in the body.

Because this medication specifically targets one part of the immune system rather than suppressing the entire system, it is considered a targeted therapy. However, because it affects immune activity, it may impact the body's ability to respond to some infections.

Common Side Effects

Many people using Taltz experience mild side effects. These most frequently include:

• Injection site reactions: Redness, pain, or swelling where the medicine was injected.
• Upper respiratory infections: Symptoms like a sore throat, runny nose, or sinus congestion.
• Nausea: Feeling sick to the stomach.
• Fungal infections: Minor skin infections such as athlete's foot.

Serious Side Effects

While less common, Taltz can cause serious health problems. Seek medical attention immediately if you experience:

• Serious allergic reactions: Symptoms may include skin rash, hives, swelling of the face, eyelids, or lips, and difficulty breathing.
• Inflammatory bowel disease: New or worsening symptoms of Crohn's disease or ulcerative colitis, such as abdominal pain, cramping, or frequent diarrhea.
• Serious infections: Because Taltz affects the immune system, it may increase the risk of developing severe bacterial, fungal, or viral infections.

Infection Risk

Taltz affects the immune system, which can increase the risk of infections. These infections may be serious and include fungal, bacterial, or viral types. Healthcare providers typically screen for tuberculosis (TB) before treatment begins. If a TB infection is found, it is usually treated before Taltz is started.

Allergic Reactions

Serious allergic reactions, including anaphylaxis and hives, have occurred. Symptoms of a severe reaction can include swelling of the face or throat, difficulty breathing, and feeling faint.

Inflammatory Bowel Disease

This medication may cause new cases of inflammatory bowel disease or worsen existing conditions like Crohn’s disease or ulcerative colitis. Monitoring for symptoms such as chronic diarrhea or abdominal pain is common during therapy.

Vaccinations

Live vaccines should not be administered while using Taltz. It is generally advised to complete all necessary vaccinations before starting this medication.

Pregnancy

There are no adequate and well-controlled studies of Taltz in pregnant women. While animal reproduction studies did not show evidence of harm to the fetus, the results of animal studies do not always predict human response. Because of this, Taltz should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

If you are pregnant or plan to become pregnant, inform your healthcare provider. They can help you weigh the risks of the medication against the risks of leaving your condition untreated. There may also be pregnancy registries available to monitor the health of mothers and babies exposed to the medication.

Breastfeeding

It is not known whether ixekizumab, the active ingredient in Taltz, is excreted in human milk or if it has any effect on the breastfed infant or milk production. Because many drugs are present in human milk and the potential for adverse effects is unknown, caution is advised.

The decision to continue or discontinue breastfeeding while using Taltz should be made in consultation with a medical professional, considering the developmental and health benefits of breastfeeding alongside the mother's clinical need for the drug.

Available Forms

Taltz is supplied as a clear and colorless to slightly yellow solution for injection under the skin. It is available in two types of single-dose delivery systems:

• Autoinjector: A pre-filled, single-use device designed for easy administration.
• Prefilled Syringe: A single-use syringe containing a pre-measured dose of the medication.

Both delivery methods are designed for subcutaneous use and are intended to be disposed of after a single use.

FDA Approval History

The U.S. Food and Drug Administration (FDA) first approved Taltz in March 2016. It was initially indicated for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy.

Approved Indications

Since its initial release, the FDA has expanded the approved uses for Taltz to include:

• Plaque Psoriasis: Treatment of moderate-to-severe plaque psoriasis in adults and pediatric patients aged 6 years and older.
• Psoriatic Arthritis: Treatment of adults with active psoriatic arthritis.
• Ankylosing Spondylitis: Treatment of adults with active ankylosing spondylitis.
• Non-radiographic Axial Spondyloarthritis: Treatment of adults with active non-radiographic axial spondyloarthritis with objective signs of inflammation.

Regulatory Status and Safety

Taltz is classified as an interleukin-17A (IL-17A) antagonist. It is available only by prescription and is administered via subcutaneous injection. There are currently no FDA Boxed Warnings associated with this medication. However, regulatory labeling requires healthcare providers to screen patients for tuberculosis (TB) before starting treatment, as the drug may increase the risk of infections.

Factors Influencing Cost

The out-of-pocket cost for Taltz can vary based on several factors, including your specific health insurance plan, your pharmacy, and your prescribed dosage schedule. Because it is a biologic medication, it is often classified as a specialty drug, which may affect how it is covered under your plan's formulary.

Insurance and Prior Authorization

Most insurance providers require prior authorization for Taltz. This process involves your healthcare provider submitting documentation to your insurance company to prove the medical necessity of the drug before coverage is approved. Patients may be responsible for a co-payment or co-insurance amount once the drug is approved.

Financial Assistance Options

There are several programs designed to help reduce the cost of Taltz for eligible patients:

• Manufacturer Savings Cards: Patients with commercial insurance may qualify for a savings card that reduces monthly co-pays to a lower fixed amount.
• Patient Assistance Programs: For individuals who are uninsured or underinsured, there are programs that may provide the medication at no cost or a significantly reduced rate based on financial need.
• Specialty Pharmacies: Taltz is typically dispensed through specialty pharmacies rather than standard retail pharmacies. These pharmacies often have staff dedicated to helping patients navigate insurance claims and find financial assistance.