Plaque psoriasis: SUBQ: 100 mg at weeks 0, 4, and then every 12 weeks thereafter.
There are no dosage adjustments provided in the manufacturer's labeling (has not been studied).
There are no dosage adjustments provided in the manufacturer's labeling (has not been studied).
Refer to adult dosing.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Solution Prefilled Syringe, Subcutaneous [preservative free]:
Ilumya: Tildrakizumab-asmn 100 mg/mL (1 mL) [contains polysorbate 80]
No
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Solution Prefilled Syringe, Subcutaneous:
Ilumya: 100 mg/mL (1 mL) [contains polysorbate 80]
An FDA-approved patient medication guide, which is available with the product information and as follows, must be dispensed with this medication:
Ilumya: https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/761067s000lbl.pdf#page=10
SubQ: Administer SubQ into thighs, upper arm, or abdomen (except for 2 inches around navel); do not inject into areas where the skin is tender, bruised, erythematous, indurated, or affected by psoriasis, or where there are scars, blood vessels, or stretch marks.
Plaque psoriasis: Treatment of adults with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy.
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.
>10%:
Infection: Infection (23%)
Respiratory: Upper respiratory tract infection (14%)
1% to 10%:
Gastrointestinal: Diarrhea (2%)
Immunologic: Antibody development (7%; neutralizing: 3%)
Local: Injection site reaction (3%)
Frequency not defined:
Dermatologic: Urticaria
Hypersensitivity: Angioedema
Respiratory: Tuberculosis
<1%, postmarketing, and/or case reports: Dizziness, limb pain, severe infection
Serious hypersensitivity to tildrakizumab or any component of the formulation
Concerns related to adverse effects:
• Antibody formation: Formation of neutralizing anti-drug antibodies may occur with tildrakizumab and may be associated with loss of efficacy (AAD/NPF [Menter 2019]).
• Hypersensitivity: Hypersensitivity, including anaphylaxis and angioedema, has been reported. Discontinue immediately with signs/symptoms of a serious hypersensitivity reaction and treat appropriately, as indicated.
• Infections: May increase the risk of infections; upper respiratory tract infections have occurred more frequently. Consider the risks versus benefits prior to treatment initiation in patients with a history of chronic or recurrent infection; treatment should not be initiated in patients with clinically important active infections until it is resolved or treated. Monitor for infections; patients should seek medical attention for signs/symptoms of a clinically important infection (acute or chronic). If a serious infection develops or is unresponsive to appropriate therapy for the infection, monitor closely and consider discontinuing use until the infection resolves.
Disease-related concerns:
• Tuberculosis: Patients should be evaluated for tuberculosis (TB) infection prior to initiating therapy. Do not administer to patients with an active TB infection. Treatment for latent TB should be administered prior to administering tildrakizumab. Consider anti-TB therapy prior to treatment initiation in patients with a history of latent or active TB in whom an adequate course of TB treatment cannot be confirmed. Monitor closely for signs/symptoms of active TB during and after treatment.
Concurrent drug therapy issues:
• Immunizations: Patients should be brought up to date with all immunizations before initiating therapy. Live vaccines should not be given concurrently; there are no data available concerning secondary transmission of infection by live vaccines in patients receiving therapy.
None known.
Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.
Anifrolumab: Biologic Anti-Psoriasis Agents may enhance the immunosuppressive effect of Anifrolumab. Risk X: Avoid combination
Belimumab: May enhance the immunosuppressive effect of Biologic Anti-Psoriasis Agents. Risk X: Avoid combination
Efgartigimod Alfa: May diminish the therapeutic effect of Fc Receptor-Binding Agents. Risk C: Monitor therapy
InFLIXimab: May enhance the immunosuppressive effect of Biologic Anti-Psoriasis Agents. Risk X: Avoid combination
Vaccines (Live): Tildrakizumab may enhance the adverse/toxic effect of Vaccines (Live). The risk for contracting an infection from the vaccine may be increased. Tildrakizumab may diminish the therapeutic effect of Vaccines (Live). Risk X: Avoid combination
Contraception was required of females of reproductive potential and males with female partners of reproductive potential during the initial studies of tildrakizumab (Haycraft 2020).
Tildrakizumab is a humanized monoclonal antibody (IgG1). Placental transfer of human IgG is dependent upon the IgG subclass, maternal serum concentrations, birth weight, and gestational age, generally increasing as pregnancy progresses. The lowest exposure would be expected during the period of organogenesis (Palmeira 2012; Pentsuk 2009).
Outcome information following inadvertent exposure to tildrakizumab during pregnancy is limited. During the initial studies, tildrakizumab was discontinued in all cases (n=14) once pregnancy was confirmed (Haycraft 2020).
It is not known if tildrakizumab is present in breast milk. However, tildrakizumab is a humanized monoclonal IgG antibody; IgG is present in breast milk.
According to the manufacturer, the decision to breastfeed during therapy should consider the risk of infant exposure, the benefits of breastfeeding to the infant, and benefits of treatment to the mother.
CBC with differential (baseline); complete metabolic panel (baseline); tuberculosis (TB) screening prior to initiating and during therapy (chest X-ray if TB positive); hepatitis B virus (HBV)/hepatitis C virus screening prior to initiating (all patients), HBV carriers (during and for several months following therapy); HIV screening in high-risk patients (baseline) (AAD/NPF [Menter 2019]).
Human IgG1/k monoclonal antibody which selectively binds to the p19 subunit of interleukin (IL)-23, thereby inhibiting its interaction with the IL-23 receptor, resulting in inhibition of the proinflammatory cytokines and chemokines associated the binding of naturally occurring IL-23.
Onset of action: Psoriasis: Response best determined after 12 weeks (AAD/NPF [Menter 2019]).
Distribution: Vd: 10.8 L.
Metabolism: Expected to be degraded into small peptides and amino acids via catabolic pathways in a similar manner as endogenous IgG.
Bioavailability: 73% to 80%.
Half-life elimination: ~23 days.
Time to peak: ~6 days; steady state concentrations reached by week 16.
Body Weight: Tildrakizumab concentrations were lower in subjects with higher body weight.
Solution Prefilled Syringe (Ilumya Subcutaneous)
100 mg/mL (per mL): $18,584.88
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