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. |
| Molecular Weight | 147000 |
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 | Avoid due to potential teratogenicity; insufficient human data. |
| 2nd trimester | Avoid unless benefit outweighs risk; animal studies show fetal harm. |
| 3rd trimester | Avoid in third trimester due to risk of neonatal infection or immunological effects. |
Clinical note
Comprehensive clinical and safety monograph for YESINTEK (YESINTEK).
| Placental transfer | Yes, crosses placenta; IgG monoclonal antibodies are actively transported, especially in third trimester. |
| Breastfeeding | Excreted in human milk in low concentrations; risk of infant exposure unknown. Use caution, especially in neonates or premature infants. |
| Lactation Rating |
■ FDA Black Box Warning
None.
| Serious Effects |
Known hypersensitivity to YESINTEK or any excipientsActive severe infection requiring antimicrobial treatment
| 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. |
| Food/Dietary | No known food interactions. Take with or without food. Maintain a balanced diet as tolerated. |
| Clinical Pearls |
Loading safety data…
| L3 (Moderately Safe) |
| 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. |
| 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. |
| YESINTEK (efgartigimod alfa) is a neonatal Fc receptor antagonist approved for generalized myasthenia gravis (gMG) in anti-AChR antibody-positive adults. Monitor for infusion reactions, including hypotension, fever, and chills. Administer as an IV infusion over 1 hour weekly for 4 weeks; consider repeat cycles based on clinical response. May reduce IgG levels; monitor for infections. Not studied in patients with severe renal impairment (eGFR <30 mL/min/1.73m²). |
| Patient Advice | Report any signs of infection such as fever, chills, or persistent sore throat during treatment. · Infusion reactions can occur; tell your healthcare provider immediately if you experience dizziness, shortness of breath, or rash during the infusion. · You may need to receive a cycle of 4 weekly infusions; treatment may be repeated based on your doctor's assessment. · Avoid live vaccines during treatment; discuss vaccination history with your doctor. · This drug can lower antibody levels; wash hands frequently and avoid sick contacts. |