Tremfya (Guselkumab) – Subcutaneous

What Is Tremfya?

Tremfya (guselkumab) is an injectable prescription medicine used to treat plaque psoriasis and psoriatic arthritis in adults. Tremfya belongs to a group of drugs called monoclonal antibodies. It works by decreasing naturally-occurring substances in your body that can lead to inflammation and worsen your symptoms.

Tremfya is available as a subcutaneous (under the skin) injection and is administered using a needle.

What Is Tremfya Used For?

Tremfya is used to treat adults with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy. Plaque psoriasis is the most common form of psoriasis and causes red, scaly patches (plaques) to form on your skin. People with plaque psoriasis often experience significant itching that can interfere with their quality of life.

Your healthcare provider may consider Tremfya if your plaque psoriasis symptoms are too severe to be controlled by topical (on the skin) treatments alone.

Tremfya is also approved by the Food and Drug Administration (FDA) to treat adults with psoriatic arthritis. Psoriatic arthritis is an inflammatory form of arthritis that most commonly affects people with a history of psoriasis. People with psoriatic arthritis often experience joint pain, stiffness, and swelling of their fingers or toes. Other symptoms, such as skin plaques or nail problems, can also occur.

How to Take Tremfya

Tremfya is an injectable medicine that you or your healthcare provider will administer subcutaneously (under your skin) using a needle. An initial dose is given, and then second dose of Tremfya is given four weeks after the first. After that, you'll only need to receive Tremfya every eight weeks.

Tremfya is available as a prefilled syringe or One-Press injector pen. Each syringe or pen contains one dose and should only be used once. You may receive your Tremfya dose at your healthcare provider's office, or they may train you to administer your dose.

If you inject Tremfya at home, follow these steps to ensure that you receive your dose safely:

• Remove the Tremfya carton from the refrigerator. Let the carton sit at room temperature for 30 minutes. This will help decrease injection discomfort. Do not remove the syringe or One-Press injector from the carton.
• After 30 minutes, remove Tremfya from the carton and inspect the liquid. The Tremfya liquid should be clear and colorless, or slightly yellow. There may be tiny white or clear particles floating in the liquid. Do not use if the liquid appears cloudy or discolored or contains large particles.
• Inject your dose of Tremfya following your healthcare provider's instructions. You may inject Tremfya into the front part of your thighs or your lower stomach area, but not within 2 inches of your belly button. If someone else is injecting your dose, you may also use the back of your upper arms.
• Do not inject Tremfya into skin that's tender, bruised, red, hard, thick, or scaly. Avoid any areas that are affected by psoriasis.
• Do not rub the injection site after administering your dose.
• Throw away the Tremfya syringe or One-Press injector into an FDA-approved sharps disposal container. Talk with your healthcare provider or pharmacist about the proper way to dispose of Tremfya.

Storage

Store your Tremfya prescription in the refrigerator (36 degrees to 46 degrees Fahrenheit) in its original carton packaging until it's time for your dose. Never freeze or shake Tremfya.

What Are the Side Effects of Tremfya?

This is not a complete list of side effects and others may occur. A healthcare provider can advise you on side effects. If you experience other effects, contact your pharmacist or a healthcare provider. You may report side effects to the FDA at fda.gov/medwatch or 800-FDA-1088.

Common Side Effects

You may experience side effects from Tremfya that may go away within a few days or a couple of weeks. Let your healthcare provider know about any side effects that bother you or don't go away.

Common side effects include:

• Upper respiratory infections, with symptoms including runny or stuffy nose, coughing, sneezing, excess mucus production
• Headache
• Injection site reactions, including redness, bruising, swelling, itching, pain, discoloration, and hardening of the skin
• Joint pain
• Fungal skin or nail infections
• Diarrhea
• Herpes simplex infection
• Stomach flu
• Bronchitis

Severe Side Effects

Though rare, Tremfya may cause serious side effects. Contact your healthcare provider right away if you develop any signs of a severe reaction. Call 911 if your symptoms feel life-threatening.

Serious side effects and their symptoms include:

Allergic reactions: This includes a serious and sometimes life-threatening form called anaphylaxis. Stop using Tremfya and seek medical care if you develop any of the following:

• Dizziness, light-headedness, or fainting
• Swelling of your face, eyelids, lips, mouth, tongue, or throat
• Trouble breathing
• Chest tightness
• Itching, a rash, or hives

Serious infections: Tremfya may weaken your immune system and make it harder for your body to fight off infections. Your healthcare provider will check you for infections, including tuberculosis, before starting Tremfya. Let your healthcare provider know if you notice any signs of an infection, including:

• Fevers, sweats, chills
• Cough
• Shortness of breath
• Blood in mucus you cough up (phlegm)
• Muscle aches
• Warm, red, or painful skin or sores that are not from psoriasis
• Weight loss
• Diarrhea or stomach pain
• Frequent urination or pain when you urinate
  

Dosage: How Much Tremfya Should I Take?

Modifications

The following modifications (changes) should be kept in mind when using Tremfya:

Adults over the age of 65 years: During clinical trials, Tremfya was just as safe and effective in older adults as in younger adults. However, because only a small number of clinical trial participants were adults over the age of 65, it's possible that differences may exist. Let your healthcare provider know about any side effects or concerns you have.

Children: Tremfya has not been studied in children and is only approved to treat adults.

Lactation: It is not known if Tremfya passes into breast milk or what effect it would have on a breastfed baby. Talk with your healthcare provider and your child's pediatrician about ways to feed your baby.

Pregnancy: Tremfya has not been studied in pregnant people, and the effect of Tremfya on a fetus is unknown. Let your healthcare provider know if you're pregnant or plan to become pregnant before starting Tremfya.

Missed Dose

If you forget to inject your dose of Tremfya, administer it as soon as you remember. Inject your next dose at the regularly scheduled time. Call your healthcare provider if you are unsure when to take your dose.

Overdose: What Happens If I Take Too Much Tremfya?

If you inject more than one dose of Tremfya or inject your dose too soon, call your healthcare provider. They may recommend monitoring you for side effects.

Precautions

What Are Reasons I Shouldn’t Take Tremfya?

You should not take Tremfya if you are allergic to guselkumab or any other ingredient in Tremfya. Ask your pharmacist or healthcare provider for a full list of the ingredients if you're unsure.

What Other Medications Interact With Tremfya?

Before starting Tremfya, let your healthcare provider know about all the medicines you take or plan to take, including prescription medications, over-the-counter (nonprescription) products, vitamins, herbs, and plant-based medicines.

Certain vaccines (live vaccines) may not be safe to take with Tremfya. Talk with your healthcare provider about getting any necessary vaccines before starting Tremfya.

What Medications Are Similar?

Tremfya is a monoclonal antibody (a lab-made protein that binds to special cells in your body). It works by blocking substances in your body that contribute to inflammation. Another monoclonal antibody that works similarly to Tremfya and treats plaque psoriasis and psoriatic arthritis is Stelara (ustekinumab).

Like Tremfya, Stelara is a subcutaneous injection (given under the skin), but it's given every 12 weeks instead of every eight weeks. Unlike Tremfya, Stelara is approved to treat children 6 years and older with moderate or severe plaque psoriasis.

How Can I Stay Healthy While Taking Tremfya?

If you're struggling to get your plaque psoriasis under control, topical medicines (medicines on the skin) may not be enough. Your healthcare provider may discuss starting a biologic treatment such as Tremfya.

Tremfya is highly effective and can help you achieve clearer skin and improve symptoms such as itching, burning, and pain. But because Tremfya targets your immune system, you may be at an increased risk of developing infections, which can sometimes be serious. Talk with your healthcare provider about warning signs. And contact your healthcare provider at the first sign of any problem.

It's worth noting that vitamin D deficiency has also been noted in people with psoriasis, especially during the winter. Be sure to talk with your healthcare provider if you have questions about your vitamin D status, or if you want to know more about using vitamin D with Tremfya.