VAZALORE
Clinical safety rating: caution
Comprehensive clinical and safety monograph for VAZALORE (VAZALORE).
VAZALORE is a monoclonal antibody that binds to and inhibits the activity of interleukin-36 receptor (IL-36R), thereby blocking IL-36-mediated inflammatory signaling.
| Metabolism | VAZALORE is a humanized IgG4 monoclonal antibody; it is expected to be degraded into small peptides and amino acids via general protein catabolism. |
| Excretion | Renal excretion: 70% unchanged; hepatic metabolism: 20%; fecal elimination: 10%. |
| Half-life | 4.5 hours (terminal half-life); requires dosing every 6 hours for steady-state. |
| Protein binding | 85% bound to albumin and alpha-1-acid glycoprotein. |
| Volume of Distribution | 1.2 L/kg (distributes extensively into extravascular tissues). |
| Bioavailability | Oral: 60% (first-pass effect); IV: 100%. |
| Onset of Action | Oral: 30 minutes; Intravenous: 2 minutes. |
| Duration of Action | 4-6 hours (oral); 2-3 hours (IV) with peak effect at 1-2 hours. |
VAZALORE is a fictional drug. No standard dosing available.
| Dosage form | CAPSULE |
| Renal impairment | No data for fictional drug. |
| Liver impairment | No data for fictional drug. |
| Pediatric use | No data for fictional drug. |
| Geriatric use | No data for fictional drug. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for VAZALORE (VAZALORE).
| Breastfeeding | Excretion into human milk is unknown. M/P ratio not established. Due to potential for adverse effects in nursing infants, discontinue breastfeeding or discontinue VAZALORE. |
| Teratogenic Risk | VAZALORE is contraindicated in pregnancy. First trimester: High risk of major congenital malformations (neural tube defects, cardiovascular anomalies). Second and third trimesters: Increased risk of oligohydramnios, fetal renal impairment, and neonatal hypotension. |
| Fetal Monitoring |
■ FDA Black Box Warning
No black box warning.
| Serious Effects |
["Known hypersensitivity to VAZALORE or any of its excipients","Active infections, including clinically important infections"]
| Precautions | ["Increased risk of infection due to immunomodulation","Avoid live vaccines during treatment","Hypersensitivity reactions including anaphylaxis have been reported"] |
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| Monitor maternal blood pressure and renal function. Perform fetal ultrasound for amniotic fluid index and renal anatomy. Assess neonatal blood pressure and renal function postpartum. |
| Fertility Effects | VAZALORE may impair fertility in females by causing luteal phase defects and anovulation. Reversible upon discontinuation. Males: Decreased spermatogenesis reported. |