tildrakizumab (Rx)

Brand and Other Names:Ilumya, tildrakizumab-asmn
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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

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Interactions

Interaction Checker

and tildrakizumab

No Results

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    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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            Adverse Effects

            >10%

            Upper respiratory infections (14%)

            1-10%

            Injection site reactions (3%)

            Diarrhea (2%)

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            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
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            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.

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            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

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            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)
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            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.

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