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Generic Name: guselkumab
Dosage Form: Injection
Date of Approval: July 13, 2017
Company: Janssen Biotech, Inc.

Treatment for: Plaque Psoriasis

FDA Approves Tremfya

The U.S. Food and Drug Administration (FDA) has approved Tremfya (guselkumab), an interleukin-23 blocker for the treatment of adult patients with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy.

Medication Guide

Read this Medication Guide before you start treatment and each time you get a refill. There may be new information. This information does not take the place of talking with your healthcare provider about your medical condition or treatment.

Important information

Tremfya may cause serious side effects, including:
Infections. Tremfya 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 Tremfya and may treat you for TB before you begin treatment 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.

  • 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 Tremfya side effects for more information about side effects.

What is Tremfya?

Tremfya is a prescription medicine used to treat adults with moderate to severe plaque psoriasis who may benefit from taking injections or pills (systemic therapy) or phototherapy (treatment using ultraviolet or UV light).

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

Before using Tremfya

Before you start treatment, tell your healthcare provider about all of your medical conditions, including if you:

  • have any of the conditions or symptoms listed in the section Important information.
  • have an infection that does not go away or that keeps coming back.
  • have TB or have been in close contact with someone with TB.
  • have recently received or are scheduled to receive an immunization (vaccine). You should avoid receiving live vaccines during treatment with Tremfya.
  • are pregnant or plan to become pregnant. It is not known if Tremfya can harm your unborn baby.
  • are breastfeeding or plan to breastfeed. It is not known if Tremfya passes into your breast milk.

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

How should I use Tremfya?

See the detailed Instructions for Use that comes with your prescription for information on how to prepare and inject a dose, and how to properly throw away (dispose of) the used prefilled syringes.

  • Use Tremfya exactly as your healthcare provider tells you to use it.
  • If you miss your 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.

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

Tremfya side effects

Tremfya may cause serious side effects. See Important information.

The most common side effects include:

  • upper respiratory infections
  • joint pain (arthralgia)
  • fungal skin infections
  • headache
  • diarrhea
  • herpes simplex infections
  • injection site reactions
  • stomach flu (gastroenteritis)

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

General information about the safe and effective use of Tremfya

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use this medicine for a condition for which it was not prescribed. Do not give it to other people, even if they have the same symptoms that you have. It may harm them. You can ask your healthcare provider or pharmacist for information that is written for health professionals.

More about Tremfya (guselkumab)

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