tildrakizumab (Rx)

Brand and Other Names:Ilumya, tildrakizumab-asmn
  • Print

Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

injection, solution

  • 100mg/mL (single-dose prefilled syringe)

Plaque Psoriasis

Indicated for moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy

100 mg SC at Weeks 0, 4, and q12Weeks thereafter

Dosage Modifications

Hepatic and renal impairment

  • Not studied

Dosing Considerations

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

<18 years: Safety and efficacy not established

Next:

Interactions

Interaction Checker

and tildrakizumab

No Results

     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

            All Interactions Sort By:
             activity indicator 

            Contraindicated (0)

              Serious - Use Alternative (13)

              • adenovirus types 4 and 7 live, oral

                tildrakizumab decreases effects of adenovirus types 4 and 7 live, oral by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Before initiating tildrakizumab therapy, consider completion of all age appropriate immunizations according to current immunization guidelines. Avoid use of live vaccines in patients treated with tildrakizumab. No data are available on the response to live or inactive vaccines.

              • BCG vaccine live

                tildrakizumab decreases effects of BCG vaccine live by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Before initiating tildrakizumab therapy, consider completion of all age appropriate immunizations according to current immunization guidelines. Avoid use of live vaccines in patients treated with tildrakizumab. No data are available on the response to live or inactive vaccines.

              • cholera vaccine

                tildrakizumab decreases effects of cholera vaccine by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Before initiating tildrakizumab therapy, consider completion of all age appropriate immunizations according to current immunization guidelines. Avoid use of live vaccines in patients treated with tildrakizumab. No data are available on the response to live or inactive vaccines.

              • influenza virus vaccine quadrivalent, intranasal

                tildrakizumab decreases effects of influenza virus vaccine quadrivalent, intranasal by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Before initiating tildrakizumab therapy, consider completion of all age appropriate immunizations according to current immunization guidelines. Avoid use of live vaccines in patients treated with tildrakizumab. No data are available on the response to live or inactive vaccines.

              • measles mumps and rubella vaccine, live

                tildrakizumab decreases effects of measles mumps and rubella vaccine, live by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Before initiating tildrakizumab therapy, consider completion of all age appropriate immunizations according to current immunization guidelines. Avoid use of live vaccines in patients treated with tildrakizumab. No data are available on the response to live or inactive vaccines.

              • measles, mumps, rubella and varicella vaccine, live

                tildrakizumab decreases effects of measles, mumps, rubella and varicella vaccine, live by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Before initiating tildrakizumab therapy, consider completion of all age appropriate immunizations according to current immunization guidelines. Avoid use of live vaccines in patients treated with tildrakizumab. No data are available on the response to live or inactive vaccines.

              • rotavirus oral vaccine, live

                tildrakizumab decreases effects of rotavirus oral vaccine, live by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Before initiating tildrakizumab therapy, consider completion of all age appropriate immunizations according to current immunization guidelines. Avoid use of live vaccines in patients treated with tildrakizumab. No data are available on the response to live or inactive vaccines.

              • smallpox (vaccinia) vaccine, live

                tildrakizumab decreases effects of smallpox (vaccinia) vaccine, live by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Before initiating tildrakizumab therapy, consider completion of all age appropriate immunizations according to current immunization guidelines. Avoid use of live vaccines in patients treated with tildrakizumab. No data are available on the response to live or inactive vaccines.

              • typhoid polysaccharide vaccine

                tildrakizumab decreases effects of typhoid polysaccharide vaccine by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Before initiating tildrakizumab therapy, consider completion of all age appropriate immunizations according to current immunization guidelines. Avoid use of live vaccines in patients treated with tildrakizumab. No data are available on the response to live or inactive vaccines.

              • typhoid vaccine live

                tildrakizumab decreases effects of typhoid vaccine live by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Before initiating tildrakizumab therapy, consider completion of all age appropriate immunizations according to current immunization guidelines. Avoid use of live vaccines in patients treated with tildrakizumab. No data are available on the response to live or inactive vaccines.

              • varicella virus vaccine live

                tildrakizumab decreases effects of varicella virus vaccine live by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Before initiating tildrakizumab therapy, consider completion of all age appropriate immunizations according to current immunization guidelines. Avoid use of live vaccines in patients treated with tildrakizumab. No data are available on the response to live or inactive vaccines.

              • yellow fever vaccine

                tildrakizumab decreases effects of yellow fever vaccine by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Before initiating tildrakizumab therapy, consider completion of all age appropriate immunizations according to current immunization guidelines. Avoid use of live vaccines in patients treated with tildrakizumab. No data are available on the response to live or inactive vaccines.

              • zoster vaccine live

                tildrakizumab decreases effects of zoster vaccine live by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Before initiating tildrakizumab therapy, consider completion of all age appropriate immunizations according to current immunization guidelines. Avoid use of live vaccines in patients treated with tildrakizumab. No data are available on the response to live or inactive vaccines.

              Monitor Closely (1)

              • dengue vaccine

                tildrakizumab decreases effects of dengue vaccine by immunosuppressive effects; risk of infection. Use Caution/Monitor. Immunosuppressive therapies (eg, irradiation, antimetabolites, alkylating agents, cytotoxic drugs, corticosteroids [greater than physiologic doses]) may reduce immune response to dengue vaccine.

              Minor (0)

                Previous
                Next:

                Adverse Effects

                >10%

                Upper respiratory infections (14%)

                1-10%

                Injection site reactions (3%)

                Diarrhea (2%)

                Previous
                Next:

                Warnings

                Contraindications

                Hypersensitivity reaction to tildrakizumab or to any of the excipients

                Cautions

                In clinical trials, cases of angioedema and urticaria occurred; if serious hypersensitivity reaction occurs, discontinue treatment immediately and initiate appropriate therapy (see Contraindications)

                There is a slight increased risk of infection with patients treated with tildrakizumab in clinical trials; patients with active infections or history of recurrent infections were not included in clinical trials; consider the risks and benefits before prescribing

                Immunizations

                • Before initiating therapy, consider completion of all age appropriate immunizations according to current immunization guidelines
                • No data are available on the response to live or inactive vaccines
                • Avoid use of live vaccines

                Pretreatment evaluation for tuberculosis

                • Evaluate patients for TB infection before initiating treatment
                • Initiate treatment of latent TB before administering tildrakizumab; monitor for signs and symptoms of active TB during and after tildrakizumab
                • Consider anti-TB therapy before initiating treatment in patients with a past history of latent or active TB in whom an adequate course of treatment cannot be confirmed; do not administer to patients with active TB infection
                Previous
                Next:

                Pregnancy

                Pregnancy

                Data are limited regarding use in pregnant women and are insufficient to inform a drug associated risk of adverse developmental outcomes

                Human IgG is known to cross the placental barrier; therefore, tildrakizumab may be transferred from the mother to the fetus

                Lactation

                No data are available on the presence of tildrakizumab in human milk, the effects on the breastfed infant, or the effects on milk production

                Human IgG is known to be present in human milk

                Tildrakizumab was detected in the milk of monkeys

                Pregnancy Categories

                A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

                B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

                C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

                D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

                X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

                NA: Information not available.

                Previous
                Next:

                Pharmacology

                Mechanism of Action

                Humanized IgG1/k monoclonal antibody that selectively binds to the p19 subunit of interleukin-23 (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

                Absorption

                Bioavailability: 73-80%

                Peak plasma time: ~6 days

                Steady peak plasma concentration: 8.1 mcg/mL

                Distribution

                Vd: 10.8 L

                Metabolism

                Metabolic pathway has not been characterized

                Tildrakizumab is expected to degrade into small peptides and amino acids via catabolic pathways similarly to endogenous IgG

                Elimination

                Half-life: ~23 days

                Clearance: 0.32 L/day

                Previous
                Next:

                Administration

                SC Preparation

                Remove carton from refrigerator, and leave prefilled syringe (in the carton) at room temperature for 30 min

                Do not pull off needle cover until you are ready to inject

                Visually inspect syringe for particulate matter and discoloration prior to administration; drug should appear 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

                SC Administration

                SC administration only

                Inject full amount (1 mL), which provides 100 mg of tildrakizumab per syringe

                Inject a site with clear skin and easy access (eg, abdomen, thighs, or upper arm); do not administer 2 inches around navel or where skin is tender, bruised, erythematous, indurated, or affected by psoriasis; do not inject into scars, stretch marks, or blood vessels

                Discard of any unused portion; dispose of used syringe

                Missed dose

                • If a dose is missed, administer the dose as soon as possible
                • Thereafter, resume dosing at regularly scheduled interval

                Storage

                Unused syringes

                • Refrigerate at 2-8°C (36-46°F) in the original carton; do not freeze; do not shake
                • May store at room temperature at 25°C (77°F) for up to 30 days
                • Protect from light until the time of use
                • Once stored at room temperature, do not place back in the refrigerator
                • If not used within 30 days, discard syringe
                • Do not store at >25°C (77°F)
                Previous
                Next:

                Images

                BRAND FORM. UNIT PRICE PILL IMAGE
                Ilumya subcutaneous
                -
                100 mg/mL solution

                Copyright © 2010 First DataBank, Inc.

                Previous
                Next:

                Patient Handout

                A Patient Handout is not currently available for this monograph.
                Previous
                Next:

                Formulary

                FormularyPatient Discounts

                Adding plans allows you to compare formulary status to other drugs in the same class.

                To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.

                Adding plans allows you to:

                • View the formulary and any restrictions for each plan.
                • Manage and view all your plans together – even plans in different states.
                • Compare formulary status to other drugs in the same class.
                • Access your plan list on any device – mobile or desktop.

                The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

                Tier Description
                1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
                2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
                3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
                4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
                5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
                6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
                NC NOT COVERED – Drugs that are not covered by the plan.
                Code Definition
                PA Prior Authorization
                Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
                QL Quantity Limits
                Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
                ST Step Therapy
                Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
                OR Other Restrictions
                Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
                Additional Offers
                Email to Patient

                From:

                To:

                The recipient will receive more details and instructions to access this offer.

                By clicking send, you acknowledge that you have permission to email the recipient with this information.

                Email Forms to Patient

                From:

                To:

                The recipient will receive more details and instructions to access this offer.

                By clicking send, you acknowledge that you have permission to email the recipient with this information.

                Previous
                Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.