Tremfya
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
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.
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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.
Tremfya (guselkumab) - Janssen Biotech, Inc.
Formulation type | Strength |
---|---|
Autoinjector | 100 mg/mL |
Autoinjector | 200 mg/2 mL (100 mg/mL) |
Pre-Filled Syringe | 100 mg/mL |
Pre-Filled Syringe | 200 mg/2 mL (100 mg/mL) |
Single-Dose Vial | 200 mg/20 mL (10 mg/mL) |
Popular FAQ
What are monoclonal antibodies?
Monoclonal antibodies (mAbs) are man-made proteins that mimic the natural antibodies produced by our immune systems. Monoclonal antibodies can be formulated into medicines to treat various types of illnesses, such as cancer, rheumatoid arthritis or psoriasis. Continue reading
How long does it take for Tremfya to work?
It takes about 12 to 16 weeks for Tremfya to start working in most people, depending on the condition being treated. Continue reading
How and where do you inject Tremfya?
The best place to inject Tremfya is into the front of your thighs or the lower part of your abdomen, avoiding the area around your belly button (stay an inch away from your belly button). If somebody else is giving you your injection they can also administer it into the outer area of your upper arm. If you have been shown how to self-inject Tremfya, twist and pull off the bottom cap, keeping your hands away from the needle guard. Position the One-Press injector straight up and down on the skin (at a 90-degree angle). Push the handle straight down, the medication will inject as you push. The injection is complete when the handle is pushed all the way down and you hear a click, and the teal body is no longer visible. Continue reading
How long can Tremfya be out of the fridge?
Tremfya can be left out of the refrigerator for NOT more than 4 hours, ONE-TIME ONLY, before being used. If it has been left out of the refrigerator for more than a few minutes, then it should not be put back into the refrigerator. If it cannot be used within four hours, then it should be thrown away. Continue reading
Can Tremfya cause cancer?
There is a slightly higher risk of non-melanoma skin cancers (NMSC) in people taking Tremfya compared with those taking adalimumab but combined data from clinical trials indicate that in general, the risk of cancer is not increased in people taking Tremfya compared to the general US population. Continue reading
Is Tremfya a biological?
Yes, Tremfya is a biological medicine approved to treat adults with moderate-to-severe plaque psoriasis, psoriatic arthritis, ulcerative colitis. and Crohn's disease. 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
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