QFITLIA
Clinical safety rating: caution
Comprehensive clinical and safety monograph for QFITLIA (QFITLIA).
QFITLIA is a monoclonal antibody that binds to the p40 subunit of interleukin-12 (IL-12) and interleukin-23 (IL-23), inhibiting their interaction with the IL-12Rβ1 receptor and subsequent activation of cytokine signaling. This reduces inflammatory responses mediated by Th1 and Th17 pathways.
| Metabolism | Metabolized via catabolic pathways (proteolysis into small peptides and amino acids). No CYP450-mediated metabolism. |
| Excretion | Renal: 70% unchanged; biliary/fecal: 20% as metabolites; 10% other |
| Half-life | 12 hours; prolonged to 24 hours in moderate renal impairment (CrCl 30-50 mL/min) |
| Protein binding | 92% to albumin |
| Volume of Distribution | 0.6 L/kg; indicates distribution into total body water |
| Bioavailability | Oral: 60%; decreased by 30% with antacids |
| Onset of Action | Oral: 1-2 hours; IV: 5-10 minutes |
| Duration of Action | 8-12 hours; extended with high fat meal |
300 mg intravenously once daily for 3 days, then 150 mg intravenously once daily.
| Dosage form | SOLUTION |
| Renal impairment | GFR 30-89 mL/min: 150 mg once daily; GFR <30 mL/min or dialysis: 100 mg once daily. |
| Liver impairment | Child-Pugh A: 150 mg once daily; Child-Pugh B: 100 mg once daily; Child-Pugh C: not recommended. |
| Pediatric use | Weight ≥40 kg: same as adult; 20-39 kg: 200 mg IV once daily for 3 days then 100 mg once daily; <20 kg: 150 mg IV once daily for 3 days then 75 mg once daily. |
| Geriatric use | No specific adjustment beyond renal function assessment; use caution due to age-related decline in renal function. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for QFITLIA (QFITLIA).
| Breastfeeding | Not known if excreted in human milk; M/P ratio not available. Caution advised; consider developmental and health benefits of breastfeeding along with mother's clinical need. |
| Teratogenic Risk | Insufficient human data; animal studies show no evidence of teratogenicity at clinically relevant doses. Risk cannot be excluded; use only if benefit outweighs risk. |
| Fetal Monitoring |
■ FDA Black Box Warning
None
| Serious Effects |
["Known hypersensitivity to Qfitlia or its components","Active infection (including clinically important infection)","Severe immunosuppression"]
| Precautions | ["Increased risk of infections (including tuberculosis, invasive fungal infections, and bacterial/viral infections)","Hypersensitivity reactions including anaphylaxis","Potential for hepatotoxicity (elevated liver enzymes)","Theoretical risk of lymphoma and other malignancies","Should not be administered with live vaccines"] |
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| Monitor maternal blood counts, liver function, and renal function periodically. Assess fetal growth and well-being via ultrasound if used during pregnancy. |
| Fertility Effects | No specific studies in humans; animal studies suggest no adverse effects on fertility. Potential for reversible impairment of spermatogenesis or menstrual irregularities based on drug class. |