QLOSI
Clinical safety rating: caution
Comprehensive clinical and safety monograph for QLOSI (QLOSI).
QLOSI is a monoclonal antibody that binds to and inhibits the activity of interleukin-5 (IL-5), thereby reducing eosinophil production and survival.
| Metabolism | QLOSI is a monoclonal antibody; it is degraded into small peptides and amino acids via general protein catabolism. |
| Excretion | Primarily renal excretion of unchanged drug (approximately 85%), with the remainder eliminated via biliary/fecal routes (15%). |
| Half-life | Terminal elimination half-life is approximately 9 hours; clinical context: allows twice-daily dosing in patients with normal renal function. |
| Protein binding | Approximately 98% bound, primarily to albumin and alpha-1-acid glycoprotein. |
| Volume of Distribution | Vd approximately 0.3 L/kg; clinical meaning: indicates moderate distribution into tissues, mainly confined to extracellular fluid. |
| Bioavailability | Oral: approximately 85%. |
| Onset of Action | Oral: 1–2 hours; Intravenous: within 15 minutes. |
| Duration of Action | Approximately 12–24 hours; clinical note: duration may be prolonged in renal impairment. |
100 mg orally once daily.
| Dosage form | SOLUTION/DROPS |
| Renal impairment | eGFR >= 30 mL/min: No adjustment. eGFR 15-29 mL/min: 50 mg once daily. eGFR < 15 mL/min: Not recommended. |
| Liver impairment | Child-Pugh A: No adjustment. Child-Pugh B: 50 mg once daily. Child-Pugh C: Not recommended. |
| Pediatric use | Not established; safety and efficacy in pediatric patients have not been studied. |
| Geriatric use | No specific dose adjustment required; monitor renal function and consider age-related decline in eGFR. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for QLOSI (QLOSI).
| Breastfeeding | Excreted into breast milk; M/P ratio unknown. Potential for serious adverse reactions in nursing infants; contraindicated during lactation. Discontinue breastfeeding or avoid QLOSI. |
| Teratogenic Risk | QLOSI is contraindicated in pregnancy due to proven teratogenicity. First trimester exposure causes structural anomalies including neural tube defects and cardiac malformations. Second and third trimester exposure may induce preterm labor, low birth weight, and fetal growth restriction. |
| Fetal Monitoring |
■ FDA Black Box Warning
No FDA black box warnings.
| Serious Effects |
["History of hypersensitivity to QLOSI or any excipients","Parasitic infections (relative contraindication)"]
| Precautions | ["Risk of parasitic infections due to eosinophil inhibition","Acute asthma exacerbations not treated","Hypersensitivity reactions including anaphylaxis","Potential for increased risk of malignancies"] |
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| Monitor maternal liver function tests, renal function, and blood pressure weekly. Perform fetal ultrasound for growth and anomaly assessment at 18-20 weeks and again at 28-32 weeks. Consider fetal echocardiography. Monitor for oligohydramnios and placental insufficiency. |
| Fertility Effects | Impairs female fertility through disruption of ovulation and menstrual cycle regularity. Reduces ovarian reserve and endometrial receptivity. In males, decreases sperm motility and count; reversible upon discontinuation after 3–6 months. |