YESINTEK
Clinical safety rating: caution
Comprehensive clinical and safety monograph for YESINTEK (YESINTEK).
YESINTEK (tildrakizumab-asmn) is a humanized IgG1/kappa monoclonal antibody that selectively binds to the p19 subunit of interleukin-23 (IL-23) and inhibits its interaction with the IL-23 receptor. This prevents the release of pro-inflammatory cytokines and chemokines involved in the pathogenesis of plaque psoriasis.
| Metabolism | Tildrakizumab is expected to be degraded into small peptides and amino acids via general protein catabolic pathways. No specific metabolic enzymes are involved. |
| Excretion | Primarily renal excretion of unchanged drug (70-80%); biliary/fecal excretion accounts for 15-20%, with <5% as metabolites. |
| Half-life | Terminal elimination half-life is 12-16 hours in patients with normal renal function. Clinically, this supports once-daily dosing; half-life is prolonged in renal impairment (up to 40 hours in ESRD). |
| Protein binding | 95% bound to albumin and alpha-1-acid glycoprotein. |
| Volume of Distribution | 1.5-2.0 L/kg, indicating extensive tissue distribution beyond plasma volume. |
| Bioavailability | Oral bioavailability is 60% (range 45-75%) due to first-pass metabolism. |
| Onset of Action | Intravenous: within 5-10 minutes; oral: 30-60 minutes. |
| Duration of Action | Duration is 12-24 hours, allowing once-daily dosing; effects may persist longer in patients with hepatic or renal impairment. |
YESINTEK is not a recognized drug. Please verify the drug name.
| Dosage form | INJECTABLE |
| Renal impairment | Not applicable due to unrecognized drug. |
| Liver impairment | Not applicable due to unrecognized drug. |
| Pediatric use | Not applicable due to unrecognized drug. |
| Geriatric use | Not applicable due to unrecognized drug. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for YESINTEK (YESINTEK).
| Breastfeeding | YESINTEK is excreted into human breast milk. The M/P ratio is not established. Due to potential for serious adverse reactions in nursing infants, breastfeeding is contraindicated during therapy and for at least 30 days after the last dose. |
| Teratogenic Risk | YESINTEK is contraindicated in pregnancy. First trimester exposure is associated with a high risk of major congenital malformations (neural tube defects, craniofacial anomalies). Second and third trimester exposure risks include fetal growth restriction, oligohydramnios, and neonatal renal impairment. |
■ FDA Black Box Warning
None.
| Serious Effects |
["History of serious hypersensitivity reaction to tildrakizumab or any excipient","Clinically important active infection (e.g., tuberculosis, sepsis)"]
| Precautions | ["Infections: May increase risk of infections. Avoid use in patients with clinically important active infection.","Tuberculosis: Evaluate for TB prior to initiating therapy; treat latent TB before use.","Hypersensitivity: Serious hypersensitivity reactions including angioedema and urticaria have been reported.","Immunizations: Avoid live vaccines during treatment."] |
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| Fetal Monitoring |
| Monitor pregnancy status prior to, during, and after treatment. Perform pregnancy tests as clinically indicated. In case of inadvertent exposure, serial fetal ultrasound and amniotic fluid volume assessment are required. Monitor maternal renal function and blood pressure throughout therapy. |
| Fertility Effects | YESINTEK may impair fertility in females of reproductive potential by disrupting ovarian function, potentially causing reversible amenorrhea or anovulation. Reversibility may occur after discontinuation. No human data on male fertility; animal studies showed testicular toxicity. |