Tildrakizumab

What is Tildrakizumab?

Tildrakizumab (ILUMYA) is an interleukin-23 antagonist used to treat adults with moderate to severe plaque psoriasis.

What are the uses of this medicine?

This medicine is used to treat adults with moderate to severe plaque psoriasis who may benefit from taking injections, pills (systemic therapy) or treatment using ultraviolet or UV light (phototherapy).

How does this medicine work?

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.

Who Should Not Use this medicine ?

This medicine cannot be used in patients with:

• previous serious hypersensitivity reaction to tildrakizumab or to any of the excipients.

What drug interactions can this medicine cause?

• Avoid use of live vaccines in patients treated with ILUMYA.

Is this medicine FDA approved?

• It was approved for use in the United States in 2018.

How should this medicine be used?

Evaluate patients for tuberculosis (TB) infection prior to initiating treatment with ILUMYA.

Recommended Dosage

• The recommended dose is 100 mg at Weeks 0, 4, and every twelve weeks thereafter. Each syringe contains 1 mL of 100 mg/mL tildrakizumab-asmn.

Administration

• ILUMYA should only be given to you by a healthcare provider.
• ILUMYA 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.
• If you miss a follow-up appointment and do not receive your dose of ILUMYA, schedule another appointment as soon as possible.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Injection: 100 mg/mL solution in a single-dose prefilled syringe

This medicine is available in fallowing brand namesː

• ILUMYA

What side effects can this medication cause?

The most common side effects of this medicine include:

• upper respiratory infections
• injection site reactions
• diarrhea

ILUMYA may cause serious side effects, including:

• Serious allergic reactions
• Infections

What special precautions should I follow?

• If a serious allergic reaction occurs, discontinue ILUMYA immediately and initiate appropriate therapy.
• ILUMYA may increase the risk of infection. Instruct patients to seek medical advice if signs or symptoms of clinically important chronic or acute infection occur. If a serious infection develops, consider discontinuing ILUMYA until the infection resolves.
• Evaluate for TB prior to initiating treatment.

What to do in case of emergency/overdose?

• In the event of overdosage, monitor the patient for any signs or symptoms of adverse reactions and administer appropriate symptomatic treatment immediately.

Can this medicine be used in pregnancy?

• Limited available data with ILUMYA use in pregnant women are insufficient to inform a drug associated risk of adverse developmental outcomes.

Can this medicine be used in children?

• Safety and effectiveness of ILUMYA in pediatric patients (<18 years of age) have not been established.

What are the active and inactive ingredients in this medicine?

• Active ingredient: tildrakizumab-asmn
• Inactive ingredients: L-histidine, L-histidine hydrochloride monohydrate, polysorbate 80, sucrose, and Water for Injection, USP.

Who manufactures and distributes this medicine?

• Manufactured in Germany for: Sun Pharma Global FZE

Sharjah, U.A.E.

• Distributed by: Sun Pharmaceutical Industries, Inc.

Cranbury, NJ 08512

What should I know about storage and disposal of this medication?

• 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.
• Do not freeze.
• Do not shake.
• ILUMYA 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).

• Dailymed label info on Tildrakizumab
• FDA Tildrakizumab