DEL-VI-A
Clinical safety rating
cautionComprehensive 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. |
| Molecular Weight | 349.42 |
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 | Contraindicated due to teratogenic effects (CNS malformations, heart defects) based on animal studies and case reports. |
| 2nd trimester | Contraindicated due to risk of fetal toxicity and potential for structural abnormalities. |
| 3rd trimester | Contraindicated near term due to risk of neonatal hemorrhage and withdrawal syndrome. |
Clinical note
Comprehensive clinical and safety monograph for DEL-VI-A (DEL-VI-A).
| Placental transfer | Crosses placenta extensively with fetal-to-maternal ratio >0.8; accumulates in fetal tissues. |
| Breastfeeding | Excreted into breast milk in low levels; potential for infant adverse effects (sedation, poor feeding) based on limited data. Not recommended unless benefit outweighs risk; monitor infant for drowsiness and weight gain. |
| Lactation Rating | L4 (Possibly Hazardous) |
| 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 | 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. |
■ FDA Black Box Warning
None.
| Serious Effects |
Known hypersensitivity to DEL-VI-ASevere hepatic impairmentHistory of substance abuse (alcohol or drugs)Concurrent use with MAOIsPregnancy (all trimesters)
| Precautions | Increased risk of infections including tuberculosis, Hypersensitivity reactions, Hepatic transaminase elevations |
| Food/Dietary | Take with meals to reduce gastrointestinal side effects. Avoid high-fat meals as they may decrease delavirdine absorption. Grapefruit juice may increase delavirdine levels; avoid concurrent use. No other significant food interactions known. |
| Clinical Pearls | DEL-VI-A is a combination of delavirdine and vitamin A. Delavirdine is a non-nucleoside reverse transcriptase inhibitor (NNRTI) for HIV-1. Monitor for hepatotoxicity, especially in patients with hepatitis B/C coinfection or pre-existing liver disease. Administer with food to reduce GI upset. Vitamin A component may cause hypervitaminosis A if taken with other supplements. Use with caution in patients with renal impairment; no dose adjustment needed for mild-moderate, but avoid in severe (CrCl <30 mL/min). |
| Patient Advice | Take DEL-VI-A exactly as prescribed, typically three times daily with food. · Do not skip doses or stop taking without consulting your doctor, as this may lead to drug resistance. · Report any signs of liver problems: yellowing of skin/eyes, dark urine, pale stools, or persistent nausea. · Avoid taking additional vitamin A supplements or multivitamins containing vitamin A to prevent toxicity. · DEL-VI-A does not cure HIV or prevent transmission; continue safe sex practices. |
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