Drug Information

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How does this medication work? What will it do for me?

Tildrakizumab belongs to the class of medications called immunomodulators. It is used to treat adults with moderate-to-severe plaque psoriasis for whom treatment with systemic therapy (medications that work from within the body) or phototherapy is appropriate.

For people with plaque psoriasis, the body overproduces a protein called interleukin-23 (IL-23).  Increased levels of this protein cause inflammation which can result in itching, pain, and scaling skin. Tildrakizumab recognizes this protein and blocks its action, reducing the symptoms of plaque psoriasis.

This medication may be available under multiple brand names and/or in several different forms. Any specific brand name of this medication may not be available in all the forms or approved for all of the conditions discussed here. As well, some forms of this medication may not be used for all of the conditions discussed here.

Your doctor may have suggested this medication for conditions other than those listed in these drug information articles. If you have not discussed this with your doctor or are not sure why you are taking this medication, speak to your doctor. Do not stop taking this medication without consulting your doctor.

Do not give this medication to anyone else, even if they have the same symptoms as you do. It can be harmful for people to take this medication if their doctor has not prescribed it.

How should I use this medication?

Each single-use syringe, filled with sterile, preservative-free, clear to slightly opalescent, colourless to slightly yellow solution, contains 100 mg of tildrakizumab. Nonmedicinal ingredients: L-histidine, L-histidine hydrochloride monohydrate, polysorbate 80, sucrose, and water for injection.

What form(s) does this medication come in?

The recommended dose of tildrakizumab is 100 mg injected subcutaneously (under the skin).  After the first dose of 100 mg, a second dose is given after 4 weeks. After that, tildrakizumab is given every 12 weeks.

Tildrakizumab is given by subcutaneous injection into the abdomen, thighs, or upper arm. It is important to rotate the site of injection. Avoid injecting into areas that are affected by psoriasis or those that are bruised or tender.

Do not shake this medication before using it. The solution for injection should be clear to slightly opalescent and colourless to slightly yellow. Allow the medication to warm to room temperature for 30 minutes before you inject it.

Many things can affect the dose of medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are taking the medication without consulting your doctor.

If you are using this medication at home, your doctor will ensure that you understand exactly how to use it. Make sure you ask any and all questions necessary to ensure that you use it exactly as prescribed. Please refer to the appropriate package insert for details on proper injection procedures. It is important to visit your doctor regularly during therapy to ensure that the medication is working safely and effectively.

It is important to take this medication exactly as prescribed by your doctor. If you miss a dose, take it as soon as possible and continue with your regular schedule. Do not take a double dose to make up for a missed one. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.

If you are receiving this medication at your doctor's office and miss an appointment to receive tildrakizumab, contact your doctor as soon as possible to reschedule your appointment.

Store this medication in the refrigerator. Leave it in the original carton to protect it from light and moisture, and keep it out of the reach of children. Do not allow this medication to freeze. If necessary, this medication may be left out of the refrigerator for up to 30 days, but do not return it to the refrigerator after it has warmed up to room temperature. Keep this medication out of the reach of children.

Who should NOT take this medication?

Do not take this medication if you are allergic to tildrakizumab or any ingredients of the medication.

What side effects are possible with this medication?

Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.

The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.

The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

  • changed sense of taste or smell
  • cold symptoms (e.g., sore throat, stuffy nose)
  • diarrhea
  • dizziness
  • headache
  • joint, arm, or leg pain
  • muscle aches and pains
  • redness, swelling, pain, bruising, or itching at the injection site
  • stomach pain
  • tiredness
  • upset stomach
  • vomiting

Although most of the side effects listed below don't happen very often, they could lead to serious problems if you do not seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

  • red, swollen, or bleeding gums
  • skin infection or rash
  • slowed wound healing
  • swollen tongue
  • symptoms of eye infections (e.g., redness, swelling, pain when exposed to light of one or both eyes)
  • symptoms of ear infections (e.g., fever, ear pain)
  • symptoms of infection or increased frequency of infection (e.g., fever or chills, feeling unwell, severe diarrhea, shortness of breath, prolonged dizziness, headache, stiff neck, weight loss, or listlessness)
  • symptoms of a urinary tract infection (e.g., pain when urinating, urinating more often than usual, low back or flank pain)

Stop taking the medication and seek immediate medical attention if any of the following occur:

  • signs of a serious allergic reaction (e.g., abdominal cramps, difficulty breathing, nausea and vomiting, or swelling of the face and throat)

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication.

Are there any other precautions or warnings for this medication?

Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.

Allergic reactions: As with other similar medications, it is possible to experience a severe allergic reaction with tildrakizumab. Signs of an allergic reaction include a severe rash, hives, swollen face or throat, or difficulty breathing. If these occur, contact your doctor immediately.

Infections: This medication can increase the risk of developing an infection, including serious infections such as tuberculosis. Before starting tildrakizumab treatment, your doctor may test to see if you have tuberculosis. If you notice signs of an infection such as fever, chills, pain, swelling, or coughing, contact your doctor as soon as possible. This medication should also not be started while you have an active infection.

Tell your doctor if you have a history of infections that keep coming back, or other conditions that might increase your risk of infections such as diabetes. While you are taking tildrakizumab, your doctor will monitor you for signs of infection.

Vaccines: Before starting this medication, all your immunizations should be up to date. Live vaccines (e.g., BCG, yellow fever) are not recommended for people taking this medication. Any live vaccines should be given at least 4 weeks before starting treatment with tildrakizumab. Talk to your doctor if you need any vaccinations while taking this medication.

Pregnancy: The effect of tildrakizumab on an unborn baby is not known. Effective birth control must be used while taking this medication and for 4 weeks after the last dose of tildrakizumab. This medication should not be used during pregnancy unless the benefits outweigh the risks. If you become pregnant while taking this medication, contact your doctor immediately.

Breast-feeding: It is not known whether tildrakizumab passes into breast milk. If you are breast-feeding and are taking this medication, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

Children: The safety and effectiveness of using this medication have not been established for children.

What other drugs could interact with this medication?

There may be an interaction between tildrakizumab and any of the following:

  • belimumab
  • infliximab
  • vaccines

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

  • stop taking one of the medications,
  • change one of the medications to another,
  • change how you are taking one or both of the medications, or
  • leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with this medication. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

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