Skip to main content

Guselkumab

Generic name: guselkumab
Brand name: Tremfya
Dosage form: subcutaneous injection
Drug class: Interleukin inhibitors

Medically reviewed by Philip Thornton, DipPharm. Last updated on Apr 4, 2023.

What is guselkumab?

Guselkumab is an injectable medication used to treat two inflammatory, autoimmune conditions called plaque psoriasis and psoriatic arthritis.

Guselkumab is a type of biological drug called a human immunoglobulin G1 lambda (IgG1λ) monoclonal antibody. It works by blocking the action of interleukin-23 (IL-23) at its receptor. IL-23 is a naturally occurring small protein called a cytokine, which plays a role in your normal inflammatory and immune responses. By blocking the action of IL-23, guselkumab inhibits the release of small proteins called chemokines and cytokines that cause inflammation.

Guselkumab was first approved by the US Food and Drug Administration (FDA) in 2017. It comes in the form of a prefilled syringe and a One-Press injector.

No biosimilars of guselkumab have been approved. Biosimilars are highly similar versions of a biological drug that are designed to work in the same was as the original version of the drug, but they are not identical.

What is guselkumab used for?

Guselkumab is a prescription medicine used to treat adults:

It is not known if guselkumab is safe and effective in children under 18 years of age.

Important information

Guselkumab may cause serious side effects, including:

See "What are the side effects of guselkumab?" below for more information about side effects.

Who should not use guselkumab?

Do not use guselkumab if you have had a serious allergic reaction to guselkumab or any of the other ingredients in guselkumab. See below for a complete list of ingredients in guselkumab.

What should I tell my doctor before using guselkumab?

Before using guselkumab, tell your healthcare provider about all of your medical conditions, including if you:

How should I use guselkumab?

What happens if I miss a dose?

If you miss your guselkumab dose, inject a dose as soon as you remember. Then, take your next dose at your regular scheduled time. Call your healthcare provider if you are not sure what to do.

What happens if I overdose?

If you inject more guselkumab than prescribed, call your healthcare provider right away.

Dosing information

In patients with plaque psoriasis and psoriatic arthritis the recommended dose of guselkumab is 100 mg administered by subcutaneous injection at Week 0, Week 4 and every 8 weeks thereafter. In patients with psoriatic arthritis, guselkumab can be used alone or in combination with a conventional disease-modifying antirheumatic drugs (DMARDs) such as methotrexate.

See full prescribing information for further information about guselkumab dosing.

What are the side effects of guselkumab?

Guselkumab may cause serious side effects including:

The most common side effects of guselkumab include:

These are not all the possible side effects of guselkumab. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Interactions

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Pregnancy and breastfeeding

Tell your doctor if you are pregnant or plan to become pregnant. It is not known if guselkumab can harm your unborn baby.

Tell your doctor if you are breastfeeding or plan to breastfeed. It is not known if guselkumab passes into your breast milk.

Storage

Keep guselkumab prefilled syringe or One-Press injector and all medicines out of reach of children.

How should I dispose of the used prefilled syringe or One-Press injector?

If you do not have an FDA-cleared sharps disposal container, you may use a household container that is:

When your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container. There may be state or local laws about how you should throw away used needles and syringes.

For more information about safe sharps disposal, and for specific information about sharps disposal in the state that you live in, go to the FDA's website at: www.fda.gov/safesharpsdisposal

What are the ingredients in guselkumab?

Active ingredient: guselkumab

Inactive ingredients: L-histidine, L-histidine monohydrochloride monohydrate, polysorbate 80, sucrose and water for injection

Not made with natural rubber latex.

Guselkumab is manufactured under the brand name Tremfya by Janssen Biotech, Inc., Horsham, PA 19044, U.S.

Popular FAQ

Yes, Tremfya is a biological medicine approved to treat adults with moderate-to-severe plaque psoriasis and psoriatic arthritis. A biological medicine is a large complex molecule made from living organisms using specialized technology. Tremfya works by blocking interleukin 23 (IL-23). Continue reading

More FAQ

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.