Tildrakizumab

Pronunciation: TIL-dra-KIZ-ue-mab
Generic name: tildrakizumab
Brand name: Ilumya
Dosage form: subcutaneous injection (100 mg/mL)
Drug class: Interleukin inhibitors

Medically reviewed by Melisa Puckey, BPharm. Last updated on Dec 12, 2024.

What is tildrakizumab? 

Tildrakizumab injection is used for moderate-to-severe plaque psoriasis to help reduce plaques, scales, and redness, making the skin clearer and less itchy. Ilumya works to balance the overactive immune system by blocking the IL-23 protein involved in inflammatory and immune responses. Tildrakizumab brand name is Ilumya

Tildrakizumab mechanism of action (MOA) is it selectively binds to the p19 subunit of interleukin-23  (IL-23) and blocks its interaction with the IL-23 receptor. This decreases the release of proteins  (cytokines and chemokine) that cause inflammation, which improves plaque psoriasis symptoms. Ilumya injection is a humanized IgG1/k monoclonal antibody.

Tildrakizumab asmn is given as an injection under the skin (subcutaneous) monthly and then every 12 weeks as a maintenance dose.

Who can use tildrakizumab?

Tildrakizumab FDA approval is for adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy. Tildrakizumab asmn FDA approval was granted on March 21, 2018, after positive results from clinical trials reSURFACE 1 study.  In the study, 74 percent (229 patients) using tildrakizumab-asmn achieved 75 percent skin clearance at week 28 after three doses, and 84 percent of patients who continued receiving Ilumya 100 mg maintained PASI 75 at week 64 compared to 22 percent of patients who were re-randomized to placebo. 

Tildrakizumab side effects

Common tildrakizumab side effects

Common tildrakizumab side effects may include:

• including pain, itching, rash, redness, swelling, bruising, or bleeding where the medicine was injected injections site reactions)
• diarrhea; or
• cold symptoms including stuffy nose, sneezing, sore throat (upper respiratory infections).

 Serious tildrakizumab side effects

You may get infections more easily, even serious or fatal infections. Call your doctor right away if you have signs of infection, such as:

• fever, chills, sweating;
• skin sores;
• muscle pain;
• increased urination, pain or burning when you urinate;
• stomach pain, diarrhea, weight loss; or
• cough, shortness of breath, coughing up pink or red mucus.

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

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

Warnings

Infections. tildrakizumab affects your immune system, and you may get infections more easily. Call your doctor if you have signs or symptoms of clinically important chronic or acute infection, including fever, chills, aches, cough, shortness of breath, skin sores, diarrhea, weight loss, or burning when you urinate. If a serious infection develops, your doctor may consider discontinuing Ilumya until the infection has cleared.

Tuberculosis (TB). Before starting Ilumya treatment, your healthcare provider will test you for tuberculosis (TB). If you have active TB or a history of it, you will receive treatment for TB first. You will also be monitored for any signs and symptoms of TB. 

Serious allergic reactions: Get emergency medical help right away if you get any symptoms of serious allergic reactions, including feeling faint, skin rash, swelling of your face, eyelids, lips, trouble breathing or throat tightness, mouth, tongue or throat, chest tightness.

 Immunizations: Avoid the use of live vaccines.

Before receiving this medicine

You should not be treated with Ilumya if you are allergic to the active ingredient tildrakizumab or any inactive ingredients. There is a full list of ingredients at the bottom of this page.

Tell your doctor if you have a chronic infection or are scheduled to receive any vaccine.

Tell your doctor if you have ever had tuberculosis, or if anyone in your household has tuberculosis.

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

It may not be safe to breastfeed while using this medicine. Ask your doctor about any risks.

How is tildrakizumab given?

Tildrakizumab is given as an injection under your skin (subcutaneous injection) in areas of your body such as your thighs, stomach area (abdomen), or upper arm.

A healthcare provider will administer your tildrakizumab injection.

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

Tildrakizumab Dosing information

Usual Adult tildrakizumab Dose for Plaque Psoriasis:

• 100 mg subcutaneously at Weeks 0 and 4 and every 12 weeks after that.

General dosing information

Evaluate patients for tuberculosis (TB) infection before initiating therapy.

• Tildrakizumab should only be administered by a healthcare provider.
• Before injection, remove the carton from the refrigerator and let the prefilled syringe (in the carton with the lid closed) sit at room temperature for 30 minutes.
• Follow the instructions on the carton to remove the prefilled syringe correctly, and remove only when ready to inject. Do not pull off the needle cover until you are ready to inject.
• Inspect the syringe visually for particulate matter and discoloration before administration. The product is a clear to slightly opalescent, colorless to slightly yellow solution. Do not use if the liquid contains visible particles or the syringe is damaged. Air bubbles may be present; there is no need to remove them.
• Choose an injection site with clear skin and easy access (such as abdomen, thighs, or upper arm). Do not administer 2 inches around the navel or where the skin is tender, bruised, erythematous, indurated, or affected by psoriasis. Do not inject into scars, stretch marks, or blood vessels.
• While holding the body of the syringe, pull the needle cover straight off (do not twist) and discard.
  Inject the full amount (1 mL), which provides 100 mg of drug per syringe.
• Press down the blue plunger until it can go no further. This activates the safety mechanism that will ensure full retraction of the needle after the injection is given.
• Remove the needle from the skin entirely before letting go of the blue plunger. After the blue plunger is released, the safely lock will draw the needle inside the needle guard.
• If a dose is missed, administer the dose as soon as possible; thereafter, resume dosing at the regularly scheduled interval.

Tildrakizumab J code

Tildrakizumab J code is J3245 (Ilumya 1 mg, injection)
J codes are used for medicines that are not taken orally and include injections, inhalations chemotherapies. J codes are important, accurate, and consistent coding for billing and reimbursement purposes.

Your physician will need an Ilumya J-code when filling out forms for your treatment.

Tildrakizumab cost and savings

You may pay as little as $0 for Tildrakizumab (Brand Ilumya) using the Ilumya copay card available for Ilumya Support. Ilumya Support is a program to help with financial support if you are eligible, and helps patients with personalized email and text message support when being treated with Ilumya for moderate-to-severe plaque psoriasis.

Ilumya Enrolment form and Ilumya copay card

To access the support program, you will need to fill out the Ilumya enrolment form which is available on the Ilumya prices and coupon page.

With the Ilumya Copay card, you may pay as little as $0 for Ilumya if you have commercial insurance that provides coverage for this medicine and are a resident of the United States, Puerto Rico, Guam, or the Virgin Islands. This coverage is for out-of-pocket costs, which may include Copay, co-insurance, or deductible. 

You are not eligible for the copay program is you are enrolled in any state or federally-funded insurance program, including, but not limited to, Medicare, Medicaid, TRICARE, Veterans Affairs Health Care, CHAMPUS, the Puerto Rico Government Health Insurance Plan, or any other state or federal assistance program. Check the terms and conditions for the copay program at Ilumya Support.

What happens if I miss a dose?

If you miss a follow-up appointment and do not receive your dose, schedule another appointment as soon as possible.

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 receiving tildrakizumab?

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

What other drugs will affect tildrakizumab?

Other drugs may interact with tildrakizumab, 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.

Tildrakizumab FDA label

Review the tildrakizumab FDA label (Ilumya FDA label) for more detailed information about this medicine. The FDA label contains more comprehensive information on Indications and Usage, Dosage and Administration, Clinical Pharmacology, Clinical Studies, Drug Interaction, and more. Discuss any medical questions with your doctor or other health care provider. This is not all the information you need about this medicine for safe and effective use, and it does not take the place of talking to your doctor about your treatment.

The FDA label is sometimes called Tildrakizumab Label or Tildrakizumab Package Insert.

Storage 

• Store refrigerated at 2°C to 8°C (36°F to 46°F) in the original carton to protect from light until the time of use. 
• It can be kept at room temperature at 25°C (77°F) for up to 30 days in the original carton to protect from light. Once stored at room temperature, do not place back in the refrigerator. If not used within 30 days, discard ILUMYA. Do not store ILUMYA above 25°C (77°F).
• Do not freeze. 
• Do not shake.

Ingredients

Active ingredient: tildrakizumab-asmn

Inactive ingredients: L-histidine, L-histidine hydrochloride monohydrate, polysorbate 80, sucrose, and Water for Injection, USP.

Company

Sun Pharma tildrakizumab 

Tildrakizumab (Ilumya brand) Manufactured by Sun Pharmaceutical Industries Limited Mumbai, Maharashtra India 400 063

Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512

Tildrakizumab-asmn (active ingredient) is a Product of South Korea.

Tildrakizumab 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 tildrakizumab.

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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