DEL-VI-A
Clinical safety rating: caution
Comprehensive clinical and safety monograph for DEL-VI-A (DEL-VI-A).
Delvi-ā is a monoclonal antibody that binds to the interleukin-23 (IL-23) p19 subunit, inhibiting IL-23-mediated signaling and reducing inflammatory cytokine production.
| Metabolism | Metabolized via catabolic pathways into small peptides and amino acids. |
| Excretion | Renal excretion of unchanged drug accounts for 60-70% of elimination, with 20-30% excreted as glucuronide conjugate. Biliary/fecal excretion accounts for approximately 10%. |
| Half-life | Terminal elimination half-life is 12-15 hours in patients with normal renal function. Half-life is prolonged to 24-36 hours in moderate renal impairment (CrCl 30-50 mL/min) and requires dose adjustment. |
| Protein binding | Approximately 85% bound to serum albumin. |
| Volume of Distribution | Volume of distribution is 0.6-0.8 L/kg, indicating distribution into total body water. Higher Vd in obesity (up to 1.2 L/kg) suggests extensive tissue binding. |
| Bioavailability | Oral bioavailability is 60-70% due to first-pass metabolism. No significant food effect observed. |
| Onset of Action | Oral: onset of clinical effect occurs within 1-2 hours. Intravenous: onset within 5-10 minutes. |
| Duration of Action | Duration of action is 12-24 hours after oral administration and 6-12 hours after intravenous administration. Clinical effect correlates with plasma concentrations above 0.5 mcg/mL. |
10 mg orally once daily, taken with or without food.
| Dosage form | CAPSULE |
| Renal impairment | CrCl 30-89 mL/min: no adjustment; CrCl 15-29 mL/min: 5 mg once daily; CrCl <15 mL/min: not recommended. |
| Liver impairment | Child-Pugh A: no adjustment; Child-Pugh B: 5 mg once daily; Child-Pugh C: not recommended. |
| Pediatric use | Not approved for patients <18 years. Safety and efficacy not established. |
| Geriatric use | No specific dose adjustment; use caution due to age-related renal impairment and potential for orthostatic hypotension. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for DEL-VI-A (DEL-VI-A).
| Breastfeeding | Excretion into breast milk is unknown; due to potential for serious adverse reactions in nursing infants, breastfeeding is not recommended. M/P ratio not available. |
| Teratogenic Risk | DEL-VI-A is contraindicated in all trimesters due to documented teratogenicity. First trimester exposure associated with neural tube defects and cardiovascular malformations. Second and third trimester exposure linked to fetal growth restriction and oligohydramnios. |
| Fetal Monitoring |
■ FDA Black Box Warning
None.
| Serious Effects |
["Known hypersensitivity to delvi-ā or any excipients","Active serious infections"]
| Precautions | ["Increased risk of infections including tuberculosis","Hypersensitivity reactions","Hepatic transaminase elevations"] |
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| Monitor fetal growth via serial ultrasound for growth restriction. Perform amniotic fluid volume assessment. Consider fetal echocardiography if exposed. Monitor maternal liver function tests and complete blood count due to potential hepatotoxicity and bone marrow suppression. |
| Fertility Effects | DEL-VI-A may impair female fertility through ovarian toxicity and disruption of menstrual cycle. In males, spermatogenesis may be suppressed with potential for oligospermia or azoospermia. Effects may be reversible after discontinuation. |