Moderate-to-severe plaque psoriasis in patients who are candidates for phototherapy or systemic therapy.
Binds to the p19 protein subunit of the interleukin (IL)-23 cytokine to prevent its interaction with the IL-23 receptor. This cytokine is normally involved in inflammatory and immune responses. Binding to interleukins antagonizes their effects, inhibiting the release of proinflammatory cytokines and chemokines.
Decrease in area and severity of psoriatic lesions.
Absorption: 73–80% absorbed following subcutaneous administration.
Distribution: Well distributed to tissues.
Metabolism and Excretion: Broken down by catabolic processes into peptides and amino acids.
Half-life: 23 days.
TIME/ACTION PROFILE (plasma concentrations)
|Subcut||unknown||6 days||12 wk|
- Active, untreated infection.
Use Cautiously in:
- History of tuberculosis (possibility of reactivation);
- OB: Use only if potential maternal benefit justifies potential risk to fetus;
- Lactation: Use only if potential maternal benefit justifies potential risk to fetus;
- Pedi: Safety and effectiveness not established.
Exercise Extreme Caution in:
Chronic infection or history of recurrent infection.
Adverse Reactions/Side Effects
Local: injection site reactions
Misc: HYPERSENSITIVITY REACTIONS (ANGIOEDEMA, URTICARIA), infection
* CAPITALS indicate life-threatening.
Underline indicate most frequent.
May ↓ antibody response to and ↑ risk of adverse reactions from live vaccines ; avoid use during therapy.
SC (Adults): 100 mg initially and 4 wk later, then 100 mg every 12 wk.
Solution for subcutaneous injection: 100 mg/mL in prefilled syringes
- Assess affected area(s) prior to and periodically during therapy.
- Assess patient for latent tuberculosis with a tuberculin skin test prior to initiation of therapy. Treatment of latent tuberculosis should be started before therapy with tildrakizumab. Monitor patients for signs and symptoms of active TB during and after therapy.
- Assess for signs of infection (fever, dyspnea, flu-like symptoms, frequent or painful urination, redness or swelling at the site of a wound), including tuberculosis, prior to injection. Monitor new infections closely; most common are upper respiratory tract infections, bronchitis, and urinary tract infections.
- Injection should be administered by a health care professional.
- Update immunizations to current prior to initiating therapy.
- SC Allow prefilled syringe to sit in carton at room temperature for 30 min prior to injection. Solution is clear to slightly opalescent, colorless to slightly yellow solution; do not administer solutions that are cloudy, discolored or contain particulate matter. Air bubbles in solution do not need removal; do not shake. Inject into abdomen, thigh, or upper arm. Do not inject within 2 inches of umbilicus, or into skin that is tender, bruised, erythematous, indurated, affected by psoriasis or into scars, stretch marks, or blood vessels. Follow manufacturer's directions for retractable needle syringe. Store in refrigerator in original carton until time of use; do not freeze. May be stored at room temperature in original carton for up to 30 days.
- Explain purpose of tildrakizumab to patient. If a dose is missed, administer as soon as possible. Resume dosing at regularly scheduled interval. Advise patient and caregiver to read the Medication Guide before starting therapy and with each Rx refill in case of changes.
- Advise patient to notify health care professional if signs and symptoms of hypersensitivity reaction (feel faint, swelling of face, eyelids, lips, mouth, tongue or throat, skin rash, trouble breathing or throat tightness, chest tightness and infection (fever; sweats; chills; sore throat; cough; shortness of breath); blood in phlegm (mucus); muscle aches; warm, red, or painful skin or sores different from psoriasis; weight loss; diarrhea or stomach pain; burning during urination or urinating more often than normal) occur.
- Instruct patient to avoid receiving live vaccines during therapy.
- Instruct patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and consult health care professional before taking any new medications.
- Advise female patient to notify health care professional if pregnancy is planned or suspected or if breast feeding.
Decrease in extent and severity of psoriatic lesions.
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