Tremfya

Plaque Psoriasis

Tremfya is used to treat adults with moderate-to-severe plaque psoriasis. It is specifically intended for patients who are candidates for systemic therapy (medications that work throughout the body) or phototherapy (treatment using ultraviolet light).

Psoriatic Arthritis

This medication is approved for the treatment of adults with active psoriatic arthritis. It helps reduce the joint pain, stiffness, and swelling associated with this chronic inflammatory condition.

Ulcerative Colitis

Tremfya is used to treat adults with moderately to severely active ulcerative colitis. This condition involves inflammation and sores in the lining of the colon and rectum.

Tremfya belongs to a class of drugs known as interleukin-23 (IL-23) blockers. It is typically prescribed when other treatments have not provided adequate relief or are not appropriate for the patient.

Mechanism of Action

Tremfya belongs to a class of medications known as interleukin-23 (IL-23) blockers. It is a human monoclonal antibody designed to target and bind to a specific protein called IL-23.

In people with conditions like plaque psoriasis or psoriatic arthritis, the immune system produces too much IL-23. This excess protein triggers an inflammatory response that leads to:

• Rapid overgrowth of skin cells, resulting in thick, scaly plaques.
• Inflammation in the joints, causing pain and swelling.

By binding to the p19 subunit of the IL-23 protein, Tremfya prevents it from interacting with its receptors on the surface of immune cells. This action helps to normalize the immune response and reduce the inflammation that causes symptoms.

Common Side Effects

Many people using Tremfya experience mild side effects. These often improve as the body adjusts to the medication. Common side effects include:

• Upper respiratory tract infections, such as the common cold or sinus infections
• Headache
• Injection site reactions, including redness, itching, pain, or swelling where the shot was given
• Joint pain
• Diarrhea
• Stomach flu (gastroenteritis)
• Fungal skin infections
• Herpes simplex infections, such as cold sores

Serious Side Effects

While less common, Tremfya can cause serious side effects. Because this medication affects the immune system, it may increase the risk of developing severe infections.

Contact a healthcare provider immediately if you experience symptoms of a serious infection, such as fever, sweats, chills, muscle aches, cough, shortness of breath, or warm, red, or painful skin sores.

Serious allergic reactions are also possible. Seek emergency medical help if you notice signs of an allergic reaction, including:

• Hives or skin rash
• Swelling of the face, lips, tongue, or throat
• Difficulty breathing or chest tightness
• Feeling faint or dizzy

Infections

Tremfya affects the immune system and may lower the ability to fight infections. This can increase the risk of developing infections or make existing infections worse. Treatment is generally not started if there is an active, clinically important infection.

Healthcare providers typically monitor for signs and symptoms of infection during and after treatment. If a serious infection develops or if an infection does not respond to standard treatment, the medication may need to be stopped until the infection is resolved.

Tuberculosis Screening

Before starting Tremfya, patients are evaluated for tuberculosis (TB). If a latent TB infection is found, treatment for TB is usually completed before starting this medication. Monitoring for signs and symptoms of active TB continues throughout the course of treatment.

Allergic Reactions

Serious hypersensitivity reactions, including anaphylaxis and hives, have occurred with the use of this medication. If a serious allergic reaction happens, the medication must be discontinued immediately, and medical help should be sought.

Vaccinations

It is recommended that all age-appropriate immunizations be completed before starting treatment. While using Tremfya, live vaccines should be avoided.

Pregnancy

There is limited research on the use of Tremfya in pregnant women. While animal studies did not show direct harm to the fetus at high doses, monoclonal antibodies like Tremfya are known to cross the placenta, especially during the third trimester. This could potentially affect the immune system of the newborn.

If you are pregnant or planning to become pregnant, discuss the potential risks and benefits with your healthcare provider. They can help determine if the treatment is appropriate for your situation.

Breastfeeding

It is not known if Tremfya passes into human breast milk or if it could affect a nursing infant. Because many drugs can be present in breast milk, you should consult with your doctor to determine if you should continue breastfeeding while using this medication. Decisions should consider the health benefits of breastfeeding alongside the mother's clinical need for the drug.

Available Forms

Tremfya is supplied in the following delivery formats:

• Subcutaneous Injection: This form is available as a prefilled syringe or a patient-controlled injector for administration under the skin.
• Intravenous Infusion: This form is administered by a healthcare professional directly into a vein.

FDA Approval History

Tremfya (guselkumab) was first approved by the U.S. Food and Drug Administration (FDA) in July 2017. It was the first approved treatment that selectively blocks interleukin-23 (IL-23), a protein that plays a role in inflammatory and immune responses.

Approved Indications

The FDA has approved Tremfya for the treatment of the following conditions in adult patients:

• Plaque Psoriasis: For those with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy.
• Psoriatic Arthritis: For the treatment of active psoriatic arthritis.
• Ulcerative Colitis: For the treatment of moderately to severely active ulcerative colitis.

Regulatory Status and Safety

There are currently no Boxed Warnings or Risk Evaluation and Mitigation Strategy (REMS) programs required by the FDA for Tremfya. However, regulatory guidelines require that patients be evaluated for tuberculosis infection prior to starting treatment, as the medication can affect the immune system's ability to fight infections.

Factors Affecting Price

Tremfya is a biologic medication, and these types of drugs generally have a higher cost than standard medications. The amount you pay out of pocket will depend on several factors, including:

• Your specific health insurance plan and its list of covered drugs (formulary).
• Your remaining annual deductible and your required copayment or coinsurance.
• Whether the medication is administered by a healthcare professional in a clinic or self-injected at home.

Financial Assistance and Savings

Many patients do not pay the full list price for Tremfya due to various assistance options. These may include:

• Manufacturer Savings Cards: Patients with commercial or private insurance may qualify for a savings card that significantly reduces the cost of each dose.
• Patient Assistance Programs: For individuals who are uninsured or underinsured, the manufacturer or independent non-profit organizations may offer programs to provide the medication at a reduced cost or for free, depending on financial need.

Insurance and Medicare Coverage

Most private insurance plans provide coverage for Tremfya, though they often require prior authorization. This means your doctor must provide documentation to the insurance company explaining why the medication is medically necessary before they will agree to pay for it. Medicare and Medicaid coverage varies depending on the specific plan and state regulations. In some instances, Tremfya may be covered under your medical benefit rather than your pharmacy benefit if it is administered in a doctor's office.