Guselkumab

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

Usage of 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.

Guselkumab side effects

Guselkumab may cause serious side effects including:

See "Important information" above.

The most common side effects of guselkumab include:

upper respiratory infections

joint pain (arthralgia)

fungal skin infections

headache

diarrhea

herpes simplex infections

injection site reactions

stomach flu (gastroenteritis)

bronchitis

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.

Before taking Guselkumab

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.

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How to use Guselkumab

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.

Warnings

Guselkumab may cause serious side effects, including:

Serious allergic reactions. Stop using guselkumab and get emergency medical help right away if you develop any of the following symptoms of a serious allergic reaction:

fainting, dizziness, feeling lightheaded (low blood pressure)

swelling of your face, eyelids, lips, mouth, tongue or throat

trouble breathing or throat tightness

chest tightness

skin rash, hives

itching

Infections. Guselkumab is a medicine that may lower the ability of your immune system to fight infections and may increase your risk of infections. Your healthcare provider should check you for infections and tuberculosis (TB) before starting treatment with guselkumab and may treat you for TB before you begin treatment with guselkumab if you have a history of TB or have active TB. Your healthcare provider should watch you closely for signs and symptoms of TB during and after treatment with guselkumab. Tell your healthcare provider right away if you have an infection or have symptoms of an infection, including:

fever, sweats, or chills

cough

shortness of breath

blood in your phlegm (mucus)

muscle aches

warm, red, or painful skin or sores on your body different from your psoriasis

weight loss

diarrhea or stomach pain

burning when you urinate or urinating more often than normal

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

What other drugs will affect Guselkumab

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

Disclaimer

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