Tildrakizumab-asmn
Tildrakizumab-asmn Uses, Dosage, Side Effects, Food Interaction and all others data.
Tildrakizumab-asmn is a high-affinity, humanized, IgG1 κ antibody targeting interleukin 23 p19 that shows promise in the evolution of treatment strategy in chronic plaque psoriasis .
The Food and Drug Administration (FDA) approved ILUMYA (tildrakizumab-asmn) for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy in March 2018. The approved recommended dosage of ILUMYA is a subcutaneous injection of 100 mg at Weeks 0, 4, and every 12 weeks thereafter .
A study was performed on the pharmacokinetics of this drug on various ethnicities. The pharmacokinetics of tildrakizumab were similar in Japanese, Caucasian, and Chinese subjects .
| Trade Name | Tildrakizumab-asmn |
| Availability | Prescription only |
| Generic | Tildrakizumab |
| Tildrakizumab Other Names | Tildrakizumab, tildrakizumab-asmn |
| Related Drugs | Humira, Otezla, Cosentyx, methotrexate, Enbrel, Remicade, Stelara, cyclosporine, infliximab |
| Type | Subcutaneous |
| Formula | C6426H9918N1698O2000S46 |
| Weight | 144400.0 Da |
| Groups | Approved, Investigational |
| Therapeutic Class | |
| Manufacturer | |
| Available Country | United States |
| Last Updated: | September 19, 2023 at 7:00 am |
Uses
Tildrakizumab-asmn is an interleukin-23 antagonist used to treat moderate to severe plaque psoriasis.
Moderate-severe plaque psoriasis , .
Tildrakizumab-asmn is also used to associated treatment for these conditions: Moderate-to-severe Plaque Psoriasis
How Tildrakizumab-asmn works
This drug selectively binds interleukin (IL)-23 p19 subunit of cytokine IL-23 and neutralizes its function IL-23 regulates Th17 cells and is a powerful activator of keratinocyte proliferation . Targeting IL-23p19 alone has been found to be a promising treatment approach in patients with moderate-to-severe chronic plaque psoriasis. Upon administration, downregulation of Th17 and Th22 cell responses occur .
IL-23 is a naturally occurring cytokine that is involved in inflammatory and immune responses. Tildrakizumab-asmn inhibits the release of proinflammatory cytokines and chemokines .
Toxicity
It is advised to evaluate patients for tuberculosis infection prior to initiating treatment with ILUMYA. This drug may increase the risk of infection . It is advisable to perform tests for current tuberculosis status, as this drug may lead to reactivation of latent infection .
A common issue for monoclonal antibody drugs is the development of antibodies to the drugs, thus rendering them less effective or completely ineffective . A clinical trial was done to assess antibody development to this drug , . Up until week 64, approximately 6.5% of subjects treated with ILUMYA 100 mg developed antibodies to tildrakizumab. Of the subjects who developed antibodies to tildrakizumab, approximately 40% (2.5% of all patients receiving ILUMYA) had antibodies that were considered neutralizing. The development of neutralizing antibodies to tildrakizumab was associated with lower serum tildrakizumab concentrations and decreased efficacy .
Most common (≥ 1% and at a higher rate than placebo) adverse reactions associated with ILUMYA treatment are upper respiratory infections, injection site reactions, and diarrhea .
Cases of angioedema and urticaria occurred in ILUMYA treated subjects in various clinical trials. If a hypersensitivity reaction occurs, the drug should be discontinued immediately and appropriate therapy should be initiated .
In an embryo-fetal study, subcutaneous doses up to 300 mg/kg tildrakizumab were given to pregnant cynomolgus monkeys once every two weeks during organogenesis to 118 days gestation (22 days from parturition). No maternal or embryo-fetal toxicities were seen at doses up to 300 mg/kg (159 times the MRHD of 100 mg, based on AUC comparison). Tildrakizumab-asmn crossed the placenta in monkeys .
Food Interaction
No interactions found.Tildrakizumab-asmn Disease Interaction
Volume of Distribution
The geometric mean (CV%) volume of distribution is 10.8 L (24%) .
Elimination Route
The mean (± SD) steady-state trough concentrations at 16 weeks post initiation of treatment ranged from 1.22 ± 0.94 mcg/mL to 1.47 ± 1.12 mcg/mL. The geometric mean (CV%) steady-state Cmax was 8.1 mcg/mL (34%) .
The absolute bioavailability of tildrakizumab is estimated to be about 73-80% after subcutaneous administration. The peak concentration (Cmax) is reached by approximately 6 days .
Half Life
The half-life is approximately 23 days (23%) .
Clearance
The mean (CV%) systemic clearance is 0.32 L/day (38%) .
Innovators Monograph
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