Pronunciation: trem fye´ ah
Generic name: guselkumab [ GUE-sel-KOO-mab ]
Dosage forms: injection (Tremfya Pen, Prefilled syringe, One-Press Injector), infusion (single dose vial)
Drug class: Interleukin inhibitors

Medically reviewed by Melisa Puckey, BPharm. Last updated on March 26, 2025.

What is Tremfya?

Tremfya (guselkumab) is a prescription medication used to treat plaque psoriasis, psoriatic arthritis, Crohn’s disease, and ulcerative colitis, in certain patients. Tremfya injection works by blocking a protein in your body called IL-23 (interleukin-23), which is involved in the immune response and inflammation, in these autoimmune conditions. By blocking IL-23, Tremyfa helps reduce inflammation, pain, swelling, and skin, joint and gastric symptoms. 

Tremfya belongs to the class of medicines known as interleukin inhibitors and may also be called a human monoclonal antibody.

Tremfya can be self-administered as an injection under the skin (subcutaneous injection) using pre-filled syringes or pens or may be given as an infusion by a healthcare professional, depending on your condition and stage of treatment. Tremfya is given every 4 to 8 weeks as maintenance treatment, after initial doses.

Subcutaneous injection is used for: 

• Induction and maintenance doses for plaque psoriasis, psoriatic arthritis, and ulcerative colitis.
• Maintenance doses for Crohn’s disease.

Intravenous infusion is used for:

• Induction doses for ulcerative colitis and Crohn’s disease.

Crohn’s disease induction dose can be given as a subcutaneous injection or intravenous infusion.

What is Tremfya used for?

Tremfya FDA-approved indications are to treat:

• Plaque Psoriasis in adult patients with moderate-to-severe plaque psoriasis who may benefit from taking injections or pills (systemic therapy) or phototherapy (treatment using ultraviolet or UV light)
• Psoriatic Arthritis in adult patients with active psoriatic arthritis.
• Ulcerative Colitis in adult patients with moderately to severely active ulcerative colitis
• Crohn’s Disease in adult patients with moderately to severely active Crohn’s disease.

How does Tremfya work?

Tremfya mechanism of action (MOA) is by binding selectively to the p19 subunit of interleukin-23 (IL-23) which is a naturally occurring cytokine (protein). Cytokines are substances released by cells of the immune system that influence other cells and play a key role in promoting inflammation and immune response, in chronic immune-mediated diseases.

By blocking the effects of IL-23, Tremfya helps to regulate the immune system and control inflammation so that symptoms of these conditions improve.

Tremfya is an interleukin-23 antagonist.

Tremfya side effects

Common Tremfya side effects

The most common side effects of Tremfya include:

• Infections (23%)
• Upper respiratory tract infection (14.3%)
• Headache (4.6%)
• Injection site reaction including pain, itching, swelling, redness, or bruising where the medicine was injected (4.5%)
• Joint pain (2.7%)
• Elevated liver enzymes (2.6%)
• Diarrhea (1.6%)
• Gastroenteritis, inflammation of your stomach into your intestines, causing pain, vomiting, and diarrhea (1.3%)
• Fungal skin infections (1.1%)
• Herpes simplex infections (1.1%)

These common side effects occurred in 1% or more of plaque psoriasis patients being treated with Tremfya for 16 weeks in clinical trials Ps01 and Ps02.

Serious side effects and warnings

Hypersensitivity reactions

Get emergency medical help if you have signs of an allergic reaction to Tremfya: hives, rash, itching; chest tightness, difficulty breathing; feeling light-headed; swelling of your face, lips, tongue, or throat.

Infections

This medicine 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, tingling, blisters, oozing, or sores that look different from psoriasis.

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 the FDA at 1-800-FDA-1088.

Related/similar drugs

Before taking this medicine

Allergies

You should not use Tremfya if you are allergic to the active ingredient guselkumab, polysorbate 80, or any other of the inactive ingredients in this medication

Tuberculosis

Tell your doctor if you have ever had tuberculosis, or if anyone in your household has tuberculosis. Also, tell your doctor if you have recently traveled. Tuberculosis and some fungal infections are more common in certain parts of the world, and you may have been exposed during travel.

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

To make sure Tremfya 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.

Vaccines

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

Avoid use of live vaccines while being treated with this medicine.

Hepatotoxicity

Medicine-induced liver injury has been reported with this medicine. When being treated for Crohn’s disease or ulcerative colitis your liver enzymes and bilirubin levels will be monitored at baseline, and for at least 16 weeks of treatment, and periodically thereafter according to routine patient management. If drug-induced liver injury is suspected your treatment will be paused until this diagnosis is excluded.

Pregnancy

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

If you are pregnant, your name may be listed on a pregnancy registry called MotherTOBaby to track the effects of Tremfya on the baby. You can enroll in this registry by visiting www.mothertobaby.org/ongoing-study/tremfya-guselkumab, by calling 1-877-311-8972, or emailing MotherToBaby@health.ucsd.edu. Breastfeeding

Breastfeeding

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

How should I use Tremfya?

Patients with plaque psoriasis or psoriatic arthritis will receive Tremfya as an injection under the skin (subcutaneous injection). 

Patients with ulcerative colitis will receive their initial (induction) doses through a vein in the arm (intravenous infusion) in a healthcare facility by a healthcare provider. After completing the induction doses, patients will receive maintenance treatments as a subcutaneous injection which may be self-administered.

Patients with Crohn’s disease may receive their beginning (induction) doses as a subcutaneous injection or an intravenous infusion in a healthcare facility by a healthcare provider. After completing the induction doses, patients will receive maintenance treatments as a subcutaneous injection (subcutaneous injection) which may be self-administered or given by a carer.

Tremfya  injection

Use Tremfya injection exactly as prescribed by your doctor. Follow all directions on your prescription label. Do not use this medicine in larger or smaller amounts or for longer than recommended.

Tremfya is injected under the skin. You will 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 (induction treatment) then for maintenance treatment every 4 or every 8 weeks depending on the condition being treated and the dose you receive. Your doctor will determine how often to have this treatment and how long to treat you.

Read and carefully follow any Instructions for Use provided with your medicine. Ask your doctor or pharmacist if you do not understand all the instructions.

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.

Tremfya 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 Tremfya into an active psoriasis lesion. Avoid injecting into skin that is thick, scaly, bruised, red, or tender.

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

Use a needle and syringe only once and then place them in a puncture-proof "sharps" container. Follow state or local laws about how to dispose of this container. Keep it out of the reach of children and pets.

Tremfya Dosing information

Usual Adult Dose of Tremfya for Psoriatic Arthritis:

Induction dose and Maintenance dose: 100 mg subcutaneously at Week 0, Week 4, and every 8 weeks thereafter.

Comment: This drug may be administered alone or in combination with a conventional disease-modifying antirheumatic drug (cDMARD) (e.g., methotrexate)

Usual Adult Dose of Tremfya for Plaque Psoriasis:

Induction dose and Maintenance dose: 100 mg subcutaneously at Week 0, Week 4, and every 8 weeks thereafter.

Usual Adult Dose of Tremfya for Crohn’s Disease

Induction dose: 

• 200 mg administered by intravenous infusion over at least one hour at Week 0, Week 4, and Week 8, or
• 400 mg administered by subcutaneous injection at Week 0, Week 4, and Week 8

Maintenance dose:

• 100 mg administered by subcutaneous injection at Week 16, and every 8 weeks thereafter, or
• 200 mg administered by subcutaneous injection at Week 12, and every 4 weeks thereafter.

Usual Adult Dose of Tremfya for Ulcerative Colitis

Induction dose: 200 mg administered by intravenous infusion over at least one hour at Weeks 0, 4, and 8.

Maintenance dose: 

• 100 mg administered by subcutaneous injection at Week 16, and every 8 weeks thereafter, or
• 200 mg administered by subcutaneous injection at Week 12, and every 4 weeks thereafter.

Tremfya formulations

Tremfya injections are available as:

• One-Press patient-controlled injector single-dose 100 mg/mL Injection:
• Tremfya Pen single-dose prefilled pen 200 mg/2 mL
• Prefilled syringe single-dose 100 mg/mL 
• Prefilled syringe single-dose 200 mg/2 mL (100 mg/mL)

Tremfya infusion is available as:

• Single-dose vial  200 mg/20 mL (10 mg/mL) 

What happens if I miss a dose?

Use the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not use two doses at one time.

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 this medicine?

Do not receive a "live" vaccine while using Tremfya. The vaccine may not work as well and may not fully protect you from disease. 

What other drugs will affect Tremfya?

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.

CYP450 substrates. When starting Tremfya in patients who are currently on CYP450 substrates, particularly those with a narrow therapeutic index, your healthcare provider will monitor the therapeutic effect or drug concentration and consider dosage adjustment as needed.

This list is not all-inclusive and other medications may interact with Tremfya. You should refer to the prescribing information for Tremfya for a complete list of interactions or use the interactions checker below.

Tremfya Package Insert 

HCPs and patients often use the Tremfya Package Insert (PI) for more detailed information about this medicine. The Tremfya Package Insert contains more comprehensive information on Indications and Usage, Dosage and Administration, Clinical Pharmacology, Clinical Studies, Drug Interaction, and more. Discuss any medical questions you have with your HCP (health care professional). This is not all the information you need to know about this medicine for safe and effective use, and it does not take the place of talking to your doctor about your treatment.

The Package Insert is sometimes called Tremtya Prescribing Information (PI) or FDA label.

Tremfya J code

Tremfya J code is J1628.

J codes are used for medicines that are not taken orally and include injections, inhalations, and chemotherapies. J codes are important for accurate and consistent coding for billing and reimbursement purposes.

Your physician will need Tremfya J code when filling out forms for your treatment.

Storage

• Store in the refrigerator between 36 °F to 46 °F (2 °C to 8 °C). 
• Keep  in the original carton to protect it from light until time of use. 
• Do not freeze.
• Do not shake.

Ingredients 

Active ingredient: guselkumab

Inactive ingredients:

• Single-dose prefilled syringe, single-dose One-Press patient-controlled injector, single-dose prefilled pen for subcutaneous use (TREMFYA PEN): L-histidine, L-histidine monohydrochloride monohydrate, polysorbate 80, sucrose and water for injection.
• Single-dose vial for intravenous infusion: EDTA disodium dihydrate, L-histidine, L-histidine monohydrochloride monohydrate, L-methionine, polysorbate 80, sucrose and water for injection.

Tremfya is not made with natural rubber latex

Manufacturer

Tremfya manufactured Janssen Biotech, Inc., Horsham, PA 19044, USA, 

Tremfya Biosimilars

Biosimilar and interchangeable products are biological products that are highly similar to and have no clinically meaningful differences from the reference product.

Reference products

These are biological products that have already been approved by the FDA, against which biosimilar products are compared. There is 1 for Tremfya.

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Further information

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