ATZUMI
Clinical safety rating: caution
Comprehensive clinical and safety monograph for ATZUMI (ATZUMI).
Atzumi is a monoclonal antibody that binds to the programmed death-ligand 1 (PD-L1) receptor, blocking its interaction with PD-1 and CD80, thereby restoring anti-tumor T-cell activity.
| Metabolism | Metabolized via catabolic pathways into small peptides and amino acids; not metabolized by cytochrome P450 enzymes. |
| Excretion | Approximately 70% of the dose is excreted renally as unchanged drug; 20% is eliminated via biliary/fecal routes as metabolites, with <5% as unchanged drug in feces. |
| Half-life | Terminal elimination half-life is 12-15 hours in patients with normal renal function (CrCl >90 mL/min), allowing once-daily dosing. Renal impairment prolongs half-life (up to 30 hours in CrCl 30-50 mL/min). |
| Protein binding | 95% bound to albumin and alpha-1-acid glycoprotein; binding is saturable at high concentrations. |
| Volume of Distribution | 2.5-3.5 L/kg, indicating extensive extravascular distribution (e.g., tissues, erythrocytes). |
| Bioavailability | Oral: 70-80% (first-pass metabolism reduces bioavailability; food increases absorption by 15%). |
| Onset of Action | Oral: 1-2 hours; Intravenous: 5-10 minutes (peak effect at 30 minutes). |
| Duration of Action | Oral: 24 hours (supports once-daily dosing); Intravenous: 6-8 hours for acute effects, with sustained action up to 24 hours due to active metabolite. |
1.2 g intravenously every 12 hours over 10-12 hours.
| Dosage form | POWDER |
| Renal impairment | CrCl 30-60 mL/min: 1.2 g every 18 hours; CrCl 10-29 mL/min: 1.2 g every 24 hours; CrCl <10 mL/min: 1.2 g loading dose then 0.6 g every 24 hours. |
| Liver impairment | Child-Pugh A: no adjustment; Child-Pugh B: reduce dose by 25%; Child-Pugh C: reduce dose by 50%. |
| Pediatric use | Not approved for pediatric patients under 18 years. |
| Geriatric use | No specific dose adjustment required; monitor renal function. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for ATZUMI (ATZUMI).
| Breastfeeding | No data on excretion in human milk; M/P ratio unknown. Caution advised; use only if clearly needed. |
| Teratogenic Risk | Insufficient human data; animal studies show embryotoxicity at maternal toxic doses. First trimester: potential risk based on animal data. Second/third trimester: limited data; avoid unless benefit outweighs risk. |
| Fetal Monitoring | Monitor maternal vital signs, liver and renal function, complete blood count. Fetal monitoring: ultrasound for growth and amniotic fluid volume. |
■ FDA Black Box Warning
None.
| Serious Effects |
["Severe hypersensitivity to atzumi or any excipients","Active severe autoimmune disease requiring systemic immunosuppression (relative)","Pregnancy (embryofetal toxicity)"]
| Precautions | ["Immune-mediated adverse reactions including pneumonitis, colitis, hepatitis, endocrinopathies, nephritis, and skin adverse reactions","Infusion-related reactions","Embryofetal toxicity","Increased risk of severe or fatal infection","Use caution in patients with autoimmune disease or organ transplant"] |
| Food/Dietary | Avoid alcohol consumption during therapy and for 48 hours after last dose due to risk of disulfiram-like reaction (nausea, vomiting, flushing, headache). No other significant food interactions known. |
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| Fertility Effects | Animal studies show impaired fertility at high doses. Human data insufficient; potential reversible effects on spermatogenesis and ovulation. |
| Clinical Pearls | ATZUMI (aztreonam) is a monobactam antibiotic with activity against aerobic gram-negative bacteria, including Pseudomonas aeruginosa. It is often used in patients with severe beta-lactam allergies (e.g., anaphylaxis to penicillins) due to minimal cross-reactivity. Monitor renal function (creatinine clearance) as dose adjustment is required in renal impairment. For cystic fibrosis patients, higher doses or continuous infusion may be considered. Administer over 20-60 minutes to reduce infusion-related phlebitis. Note: Inhaled aztreonam lysine (not ATZUMI) is used for chronic pulmonary infections in cystic fibrosis. |
| Patient Advice | Take this medication exactly as prescribed; do not skip doses or stop early unless instructed. · Report any signs of allergic reaction (rash, hives, itching, difficulty breathing, swelling of face/tongue) immediately. · Infusion site reactions (redness, swelling, pain) are common; notify healthcare provider if severe. · This drug may cause diarrhea, especially if prolonged; contact your doctor if watery or bloody stools occur. · Avoid alcohol while on this medication to reduce risk of disulfiram-like reaction (nausea, vomiting, headache). · Inform your doctor if you are pregnant, planning to become pregnant, or breastfeeding. · Complete full course even if you feel better to prevent antibiotic resistance. |