Generic name: tildrakizumab
Brand name: Ilumya
Dosage form: subcutaneous solution (100 mg/mL)
Drug class: Interleukin inhibitors
What is tildrakizumab?
Tildrakizumab is a prescription medicine that is used to treat plaque psoriasis.
Tildrakizumab-asmn is a humanized IgG1/k antibody that specifically binds to the p19 subunit of interleukin-23 (IL-23).
Tildrakizumab-asmn is produced in a recombinant Chinese hamster ovary (CHO) cell line and has an approximate molecular mass of 147 kilodaltons.
ILUMYA (tildrakizumab-asmn) injection, for subcutaneous use, is a sterile, clear to slightly opalescent, colorless to slightly yellow solution. ILUMYA is supplied in a single-dose prefilled syringe with a glass barrel and 29-gauge fixed, 1/2-inch needle.
The syringe is fitted with a passive needle guard and a needle cover.
Each 1 mL single-dose prefilled syringe contains 100 mg of tildrakizumab-asmn formulated in: L-histidine (0.495 mg), L-histidine hydrochloride monohydrate (1.42 mg), polysorbate 80 (0.5 mg), sucrose (70.0 mg), and Water for Injection, USP with a pH of 5.7-6.3.
Mechanism of Action
Tildrakizumab is a humanized IgG1/k monoclonal antibody that selectively binds to the p19 subunit of IL-23 and inhibits its interaction with the IL-23 receptor. IL-23 is a naturally occurring cytokine that is involved in inflammatory and immune responses. Tildrakizumab inhibits the release of proinflammatory cytokines and chemokines.
Before taking tildrakizumab, tell your doctor:
- If you are allergic to tildrakizumab; any part of this medicine; or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.
- If you have an infection.
- If you have active TB (tuberculosis).
This is not a list of all drugs or health problems that interact with tildrakizumab.
Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take tildrakizumab with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.
What are some things I need to know or do while I take tildrakizumab?
- Tell all of your health care providers that you take tildrakizumab. This includes your doctors, nurses, pharmacists, and dentists.
- Make sure you are up to date with all your vaccines before treatment with tildrakizumab.
- Talk with your doctor before getting any vaccines. Use of some vaccines with tildrakizumab may either raise the chance of an infection or make the vaccine not work as well.
- You may have more chance of getting an infection. Wash hands often. Stay away from people with infections, colds, or flu.
- TB (tuberculosis) has been seen in patients started on tildrakizumab. These patients were exposed to TB in the past, but never got the infection. You will be tested to see if you have been exposed to TB before starting tildrakizumab.
- Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using tildrakizumab while you are pregnant.
- Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.
How to use Tildrakizumab
Before injection, remove ILUMYA carton from the refrigerator, and let the prefilled syringe (in the ILUMYA carton with the lid closed) sit at room temperature for 30 minutes.
Follow the instructions on the ILUMYA 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 ILUMYA visually for particulate matter and discoloration prior to administration. ILUMYA 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. Also 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 ILUMYA subcutaneously as recommended
- 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.
- Discard of any unused portion. Dispose of used syringe.
Use tildrakizumab as ordered by your doctor. Read all information given to you. Follow all instructions closely.
- It is given as a shot into the fatty part of the skin.
What do I do if I miss a dose?
- Call your doctor to find out what to do.
What are the side effects of tildrakizumab that I need to call my doctor about immediately?
WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:
- Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
- Signs of infection like fever, chills, very bad sore throat, ear or sinus pain, cough, more sputum or change in color of sputum, pain with passing urine, mouth sores, or wound that will not heal.
- Coughing up blood.
- Warm, red, or painful skin or sores on the body.
- Sweating a lot.
- Muscle pain or weakness.
- Shortness of breath.
- Passing urine more often.
- Belly pain.
- Weight loss.
- Very bad dizziness or passing out.
What are some other side effects of tildrakizumab?
All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:
- Signs of a common cold.
- Irritation where the shot is given.
These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.
You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.
If overdose is suspected:
If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.
How do I store and/or throw out tildrakizumab?
- If you need to store tildrakizumab at home, talk with your doctor, nurse, or pharmacist about how to store it.
PACKAGE/LABEL DISPLAY PANEL
- NDC 47335-177-95
- 100 mg/mL
- For Subcutaneous Use Only
Dispense the enclosed Medication Guide to each patient.
Single-dose prefilled syringe.
Discard unused portion.
- Sterile Solution – Contains No Preservative
- Sun Pharmaceutical Industries, Inc.
SRC: NLM .