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guselkumab

Generic Name: guselkumab (GUE sel KOO mab)
Brand Name: Tremfya

What is guselkumab?

Guselkumab is a monoclonal antibody that blocks a certain protein in the body that can cause inflammation and other immune responses.

Guselkumab is used to treat moderate to severe plaque psoriasis in adults.

Guselkumab may also be used for purposes not listed in this medication guide.

What is the most important information I should know about guselkumab?

Guselkumab can weaken (suppress) your immune system, and you may get an infection more easily.

Call your doctor if you have signs of infection such as fever, chills, body aches, weight loss, severe diarrhea, stomach cramps, pain or burning when you urinate, cough (may contain blood or mucus), shortness of breath, or skin sores that look different from psoriasis.

What should I discuss with my healthcare provider before using guselkumab?

You should not use guselkumab if you are allergic to it.

Tell your doctor if you have ever had tuberculosis, if anyone in your household has tuberculosis, or if you have recently traveled to an area where tuberculosis is common.

Before you start treatment with guselkumab, your doctor may perform tests to make sure you do not have tuberculosis or other infections.

To make sure guselkumab is safe for you, tell your doctor if you have:

  • an active or chronic infection;

  • active tuberculosis infection that is not being treated; or

  • if you have recently received or are scheduled to receive any vaccine.

Make sure you are current on all vaccines before you start treatment with guselkumab.

It is not known whether this medicine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

It is not known whether guselkumab passes into breast milk or if it could affect the nursing baby. Tell your doctor if you are breast-feeding.

Guselkumab is not approved for use by anyone younger than 18 years old.

How should I use guselkumab?

Follow all directions on your prescription label. Do not use this medicine in larger or smaller amounts or for longer than recommended.

Guselkumab is injected under the skin. You may be shown how to use injections at home. Do not give yourself this medicine if you do not understand how to use the injection and properly dispose of used needles and syringes.

The first two injections are usually given 4 weeks apart, followed by one injection every 8 weeks. Your doctor will determine how long to treat you with guselkumab.

Read all patient information, medication guides, and instruction sheets provided to you. Ask your doctor or pharmacist if you have any questions.

Store this medicine in the refrigerator. Protect from light and do not freeze.

Take the medicine out of the refrigerator and allow it to reach room temperature for 30 minutes before injecting your dose. Do not remove the needle cap until you are ready to give the injection.

Do not shake the prefilled syringe. Prepare your dose only when you are ready to give an injection.

Guselkumab should appear clear to light yellow in color. Do not use the medicine if it looks cloudy or has particles in it. Call your pharmacist for new medicine.

Do not inject guselkumab into an active psoriasis lesion. Avoid injecting into skin that is thick, scaly, bruised, red, or tender.

Each single-use prefilled syringe is for one use only. Throw it away after one use, even if there is still medicine left inside.

Use a disposable needle and syringe only once. Follow any state or local laws about throwing away used needles and syringes. Use a puncture-proof "sharps" disposal container (ask your pharmacist where to get one and how to throw it away). Keep this container out of the reach of children and pets.

What happens if I miss a dose?

Use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while using guselkumab?

Do not receive a "live" vaccine while using guselkumab. The vaccine may not work as well during this time, and may not fully protect you from disease. Live vaccines include measles, mumps, rubella (MMR), polio, rotavirus, typhoid, yellow fever, varicella (chickenpox), zoster (shingles), and nasal flu (influenza) vaccine.

Guselkumab side effects

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Guselkumab can weaken (suppress) your immune system, and you may get an infection more easily.

Call your doctor at once if you have signs of infection, such as:

  • fever, chills, body aches, night sweats;

  • weight loss, feeling very tired;

  • cough (may contain blood or mucus), shortness of breath;

  • pain or burning when you urinate;

  • severe diarrhea or stomach cramps; or

  • skin redness, blisters, oozing, or sores that look different from psoriasis.

Common side effects may include:

  • headache, joint pain;

  • diarrhea, stomach pain;

  • cold symptoms such as stuffy nose, sneezing, sore throat;

  • skin infections; or

  • pain, itching, swelling, redness, or bruising where the medicine was injected.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Side Effects (complete list)

Guselkumab dosing information

Usual Adult Dose for Plaque Psoriasis:

100 mg subcutaneously at Week 0, Week 4, and every 8 weeks thereafter

Comments:
-Evaluate patients for TB prior to initiating therapy.

Use: For the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy

What other drugs will affect guselkumab?

Other drugs may interact with guselkumab, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.

Where can I get more information?

  • Your pharmacist can provide more information about guselkumab.
  • Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
  • Disclaimer: Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2012 Cerner Multum, Inc. Version: 1.01.

Date modified: December 03, 2017
Last reviewed: August 04, 2017

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