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Tildrakizumab: Drug information

Tildrakizumab: Drug information
(For additional information see "Tildrakizumab: Patient drug information")

For abbreviations, symbols, and age group definitions used in Lexicomp (show table)
Brand Names: US
  • Ilumya
Brand Names: Canada
  • Ilumya
Pharmacologic Category
  • Antipsoriatic Agent;
  • Interleukin-23 Inhibitor;
  • Monoclonal Antibody
Dosing: Adult

Dosage guidance:

Safety: Prior to initiation, certain assessments (clinical and laboratory) are required with documentation and ensure age-appropriate vaccinations are up to date. In general, live vaccines should not be administered within 4 weeks prior to starting therapy (Ref). Refer to institutional protocols for vaccination and monitoring requirements prior to initiating therapy.

Plaque psoriasis

Plaque psoriasis: SUBQ: 100 mg at weeks 0, 4, and then every 12 weeks thereafter.

Dosing: Kidney Impairment: Adult

There are no dosage adjustments provided in the manufacturer's labeling (has not been studied).

Dosing: Hepatic Impairment: Adult

There are no dosage adjustments provided in the manufacturer's labeling (has not been studied).

Dosing: Older Adult

Refer to adult dosing.

Adverse Reactions

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

Contraindications

Serious hypersensitivity to tildrakizumab or any component of the formulation

Warnings/Precautions

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 (latent TB) prior to initiating therapy. Do not administer to patients with TB disease (active TB). Treatment for TB infection should be administered prior to administering tildrakizumab. Consider anti-TB therapy prior to treatment initiation in patients with a history of TB infection or disease in whom an adequate course of TB treatment cannot be confirmed. Monitor closely for signs/symptoms of TB disease 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.

Dosage Forms: US

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]

Generic Equivalent Available: US

No

Pricing: US

Solution Prefilled Syringe (Ilumya Subcutaneous)

100 mg/mL (per mL): $19,699.97

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Dosage Forms: Canada

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Solution Prefilled Syringe, Subcutaneous:

Ilumya: Tildrakizumab-asmn 100 mg/mL (1 mL) [contains polysorbate 80]

Administration: Adult

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.

Medication Guide and/or Vaccine Information Statement (VIS)

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

Use: Labeled Indications

Plaque psoriasis: Treatment of adults with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy.

Medication Safety Issues
Sound-alike/look-alike issues:

Ilumya may be confused with Ilaris

Metabolism/Transport Effects

None known.

Drug Interactions

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. Management: Consider alternatives to the use of belimumab with other biologic therapies. Monitor closely for increased toxicities related to additive immunosuppression (ie, infection, malignancy) if combined. Risk D: Consider therapy modification

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

Rozanolixizumab: May diminish the therapeutic effect of Fc Receptor-Binding Agents. Risk C: Monitor therapy

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

Reproductive Considerations

During the initial studies of tildrakizumab, contraception was required for patients who could become pregnant and patients with partners who could become pregnant (Haycraft 2020).

In general, patients who may become pregnant should use effective contraception while using biologic therapy for the treatment of psoriasis (Smith 2020; Yeung 2020).

Pregnancy Considerations

Tildrakizumab is a humanized monoclonal antibody (IgG1). Human IgG crosses the placenta. Fetal exposure is dependent upon the IgG subclass, maternal serum concentrations, placental integrity, newborn birth weight, and GA, generally increasing as pregnancy progresses. The lowest exposure would be expected during the period of organogenesis and the highest during the third trimester (Clements 2020; Palmeira 2012; Pentsuk 2009).

Outcome data following inadvertent exposure to tildrakizumab during pregnancy are limited. During the initial studies, tildrakizumab was discontinued in all cases (n = 14) once pregnancy was confirmed (Haycraft 2020). Agents other than tildrakizumab are currently recommended for the treatment of psoriasis during pregnancy (AAD/NPF [Menter 2019]; Smith 2020; Yeung 2020).

Data collection to monitor pregnancy and infant outcomes following exposure to tildrakizumab is ongoing. Health care providers are encouraged to enroll exposed pregnant patients in the MotherToBaby Pregnancy Studies conducted by the Organization of Teratology Information Specialists (OTIS) (877-311-8972 or http://mothertobaby.org). Patients may also enroll themselves.

Breastfeeding Considerations

It is not known if tildrakizumab is present in breast milk.

Tildrakizumab is a humanized monoclonal antibody (IgG1). Human IgG is present in breast milk; concentrations are dependent upon IgG subclass and postpartum age (Anderson 2021).

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 the benefits of treatment to the mother.

Monitoring Parameters

Prior to therapy start:

• Evaluate for malignancy (especially skin cancer), current or latent infection, lymphadenopathy, ensure age-appropriate vaccinations are up to date, and, in general, no live vaccines are administered within 4 weeks of starting therapy (AAD [Menter 2019]; EuroGuiDerm [Nast 2020]). Refer to institutional protocols for vaccination and monitoring requirements prior to initiating therapy.

• Labs: CBC with differential; complete metabolic panel; testing for tuberculosis (TB) infection (latent TB) (eg, Quantiferon Gold) or interferon gamma release assay for TB in patients who have had Bacillus Calmette-Guérin (BCG) vaccine; chest radiograph if testing for TB infection is positive; serologic testing for hepatitis B virus (hepatitis B surface antigen, hepatitis B surface antibody, hepatitis B core antibody), hepatitis C virus antibody, HIV; pregnancy test, C-reactive protein (AAD [Menter 2019]; EuroGuiDerm [Nast 2020]).

During therapy:

• Evaluate for infection, malignancy (specifically skin cancer screening, especially for patients who have a history of skin cancer or UV phototherapy), and infusion/injection-site reactions (AAD [Menter 2019]; EuroGuiDerm [Nast 2020]).

• Labs: CBC and LFTs every 3 to 6 months or as clinically indicated, pregnancy test as needed; annual testing/chest radiograph for TB in high-risk patients (eg, contact with individuals with TB disease [active TB]) (AAD [Menter 2019]; EuroGuiDerm [Nast 2020]); hepatitis B carriers should be periodically evaluated for signs/symptoms of active hepatitis B infection (ADD [Menter 2019]).

After therapy:

Hepatitis B carriers should be periodically evaluated for signs/symptoms of active hepatitis B infection (AAD [Menter 2019]).

Mechanism of Action

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.

Pharmacokinetics (Adult Data Unless Noted)

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.

Pharmacokinetics: Additional Considerations (Adult Data Unless Noted)

Body Weight: Tildrakizumab concentrations were lower in subjects with higher body weight.

Brand Names: International
International Brand Names by Country
For country code abbreviations (show table)

  • (AT) Austria: Ilumetri;
  • (AU) Australia: Ilumya;
  • (BE) Belgium: Ilumetri;
  • (CH) Switzerland: Ilumetri;
  • (CZ) Czech Republic: Ilumetri;
  • (DE) Germany: Ilumetri;
  • (ES) Spain: Ilumetri;
  • (FR) France: Ilumetri;
  • (GB) United Kingdom: Ilumetri;
  • (IE) Ireland: Ilumetri;
  • (IT) Italy: Ilumetri;
  • (JO) Jordan: Ilumya;
  • (JP) Japan: Ilumya;
  • (LU) Luxembourg: Ilumetri;
  • (NL) Netherlands: Ilumetri;
  • (NO) Norway: Ilumetri;
  • (PL) Poland: Ilumetri;
  • (PR) Puerto Rico: Ilumya;
  • (PT) Portugal: Ilumetri;
  • (RO) Romania: Ilumetri;
  • (SA) Saudi Arabia: Ilumya;
  • (SE) Sweden: Ilumetri;
  • (SK) Slovakia: Ilumetri
  1. Anderson PO. Monoclonal antibodies during breastfeeding. Breastfeed Med. 2021;16(8):591-593. doi:10.1089/bfm.2021.0110 [PubMed 33956488]
  2. Clements T, Rice TF, Vamvakas G, et al. Update on transplacental transfer of IgG subclasses: impact of maternal and fetal factors. Front Immunol. 2020;11:1920. doi:10.3389/fimmu.2020.01920 [PubMed 33013843]
  3. Haycraft K, DiRuggiero D, Rozzo SJ, Mendelsohn AM, Bhutani T. Outcomes of pregnancies from the tildrakizumab phase I-III clinical development program. Br J Dermatol. 2020;183(1):184-186. doi:10.1111/bjd.18897 [PubMed 31995637]
  4. Ilumya (tildrakizumab-asmn) [prescribing information]. Cranbury, NJ: Sun Pharmaceutical Industries Inc; December 2022.
  5. Menter A, Strober BE, Kaplan DH, et al. Joint AAD-NPF guidelines of care for the management and treatment of psoriasis with biologics. J Am Acad Dermatol. 2019;80(4):1029-1072. [PubMed 30772098]
  6. Nast A, Smith C, Spuls PI, et al. EuroGuiDerm guideline on the systemic treatment of Psoriasis vulgaris - part 1: treatment and monitoring recommendations. J Eur Acad Dermatol Venereol. 2020;34(11):2461-2498. doi:10.1111/jdv.16915 [PubMed 33349983]
  7. Palmeira P, Quinello C, Silveira-Lessa AL, Zago CA, Carneiro-Sampaio M. IgG placental transfer in healthy and pathological pregnancies. Clin Dev Immunol. 2012;2012:985646. [PubMed 22235228]
  8. Pentsuk N, van der Laan JW. An interspecies comparison of placental antibody transfer: new insights into developmental toxicity testing of monoclonal antibodies. Birth Defects Res B Dev Reprod Toxicol. 2009;86(4):328-344. [PubMed 19626656]
  9. Smith CH, Yiu ZZN, Bale T, et al; British Association of Dermatologists’ Clinical Standards Unit. British Association of Dermatologists guidelines for biologic therapy for psoriasis 2020: a rapid update. Br J Dermatol. 2020;183(4):628-637. doi:10.1111/bjd.19039 [PubMed 32189327]
  10. Yeung J, Gooderham MJ, Grewal P, et al. Management of plaque psoriasis with biologic therapies in women of child-bearing potential consensus paper. J Cutan Med Surg. 2020;24(1 suppl):S3-S14. doi:10.1177/1203475420928376 [PubMed 32500730]
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