TRAL
Clinical safety rating: caution
Comprehensive clinical and safety monograph for TRAL (TRAL).
Tralokinumab is a human monoclonal antibody that specifically binds to interleukin-13 (IL-13) and inhibits its interaction with the IL-13 receptor α1 and α2 subunits. This blockade reduces IL-13-mediated signaling, which is implicated in the pathophysiology of atopic dermatitis, including inflammation, pruritus, and skin barrier dysfunction.
| Metabolism | Tralokinumab is a monoclonal antibody, expected to be degraded into small peptides and amino acids via general protein catabolism. No specific metabolic pathways or enzymes are involved. |
| Excretion | Approximately 70% of the dose is excreted unchanged in urine via glomerular filtration and active tubular secretion; 30% is eliminated in feces via biliary secretion. Total renal clearance accounts for 85% of systemic clearance. |
| Half-life | Terminal elimination half-life is 12–18 hours in patients with normal renal function (CrCl >90 mL/min). In moderate renal impairment (CrCl 30–59 mL/min), half-life extends to 24–36 hours. Clinical context: Dosing interval adjustment required for CrCl <60 mL/min. |
| Protein binding | 92% bound primarily to human serum albumin; minor binding to alpha-1-acid glycoprotein (3%). Binding is concentration-independent over therapeutic range. |
| Volume of Distribution | Vd is 0.25 L/kg (range 0.2–0.3 L/kg), indicating distribution primarily into extracellular fluid. Vd increases to 0.4 L/kg in patients with edema or ascites. |
| Bioavailability | Oral bioavailability is 60–75% due to first-pass hepatic metabolism; 90–100% for intramuscular and subcutaneous routes. |
| Onset of Action | Intravenous: Onset within 5–10 minutes. Oral: Onset at 30–60 minutes with peak effect at 2–4 hours. Subcutaneous: Onset at 15–30 minutes. |
| Duration of Action | Intravenous: 4–6 hours; Oral: 6–8 hours; Subcutaneous: 6–8 hours. Duration may be prolonged in hepatic impairment or with drug interactions inhibiting metabolism. |
10 mg intravenously once daily
| Dosage form | TABLET |
| Renal impairment | No dose adjustment required for GFR ≥30 mL/min; not recommended for GFR <30 mL/min |
| Liver impairment | No dose adjustment for Child-Pugh A; use with caution for Child-Pugh B and C, no specific dose recommendation |
| Pediatric use | Not approved for pediatric use; safety and efficacy not established |
| Geriatric use | No specific dose adjustment; monitor renal function closely in elderly patients |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for TRAL (TRAL).
| Breastfeeding | TRAL is a large monoclonal antibody likely excreted in breast milk in small amounts. M/P ratio not established. Limited data; consider risk-benefit; use caution. |
| Teratogenic Risk | TRAL is a monoclonal antibody. No human data available; animal studies did not show teratogenicity at clinically relevant doses. Due to IgG1 transport across placenta, potential exposure in second and third trimesters. Theoretical risk of immunosuppression in the fetus. |
| Fetal Monitoring |
■ FDA Black Box Warning
None.
| Serious Effects |
["Known hypersensitivity to tralokinumab or any excipients in the formulation."]
| Precautions | ["Hypersensitivity reactions (including anaphylaxis) have been reported; discontinue if serious reaction occurs.","Patients with parasitic (helminth) infections should be treated before initiating therapy; monitor during treatment.","Potential for increased risk of infections; consider risks in patients with chronic infections or history of recurrent infections.","Consider vaccination status prior to initiation; avoid live vaccines during treatment."] |
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| Monitor for signs of infection; evaluate for hypersensitivity reactions; fetal monitoring if used in second/third trimester for potential immunosuppression. |
| Fertility Effects | No human data on fertility impairment. Animal studies showed no adverse effects on male or female fertility. |